What is the indication and recommended dose of Montelukast (Singulair) for pediatric patients?

Montelukast Indications and Pediatric Dosing

Montelukast (Singulair) is indicated for asthma in patients 12 months and older, prevention of exercise-induced bronchoconstriction in patients 15 years and older, seasonal allergic rhinitis in patients 2 years and older, and perennial allergic rhinitis in patients 6 months and older. 1

Indications

Asthma

• Approved for chronic treatment of asthma in children as young as 12 months of age 1
• Particularly useful in children with both asthma and allergic rhinitis, as it targets both upper and lower airway symptoms 2
• Can be considered for mild persistent asthma as monotherapy when inhaled corticosteroids cannot be administered 3
• May be used as an alternative to long-acting beta agonists (LABA) as add-on therapy to inhaled corticosteroids for moderate to severe persistent asthma 3

Allergic Rhinitis

• Approved for seasonal allergic rhinitis in children 2 years and older 1
• Approved for perennial allergic rhinitis in children as young as 6 months of age 1
• Produces significant improvement in nasal symptoms and rhinoconjunctivitis quality of life scores compared to placebo 2

Exercise-Induced Bronchoconstriction (EIB)

• Approved for prevention of EIB in patients 15 years and older 1
• Should be taken at least 2 hours before exercise 1

Pediatric Dosing

Montelukast should be administered once daily, preferably in the evening for asthma. For allergic rhinitis, timing can be individualized to patient needs 1:

• Ages 15 years and older: 10 mg tablet once daily 1
• Ages 6-14 years: 5 mg chewable tablet once daily 1
• Ages 2-5 years: 4 mg chewable tablet or 4 mg oral granules once daily 1
• Ages 6-23 months: 4 mg oral granules once daily 1

Administration Guidelines

• Oral granules (for children 6-23 months) can be administered:
  • Directly in the mouth
  • Dissolved in 1 teaspoon of cold/room temperature baby formula or breast milk
  • Mixed with a spoonful of cold/room temperature applesauce, carrots, rice, or ice cream 1
• The full dose must be administered within 15 minutes of opening the packet 1
• Montelukast can be taken with or without food 4

Clinical Efficacy

• Onset of action occurs by the second day of daily treatment 2
• Response should be evaluated within 4-6 weeks; if no clear benefit is observed, alternative therapies should be considered 2
• Montelukast is less effective than inhaled corticosteroids for asthma control 2
• In children with mild persistent asthma and coexisting allergic rhinitis, montelukast has been recommended for monotherapy 2

Important Considerations

• For patients with both asthma and allergic rhinitis, only one tablet daily should be taken in the evening 1
• No dosage adjustment is required for patients with mild-to-moderate hepatic insufficiency or renal insufficiency 1
• Montelukast is generally well-tolerated with minimal side effects 5
• The medication is particularly useful for children whose parents are concerned about steroid use ("steroid-phobic") 2

Monitoring

• Monitor for symptom improvement, reduction in rescue medication use, and improved quality of life 4
• If no clear benefit is observed within 4-6 weeks, consider alternative therapies or diagnoses 2

Montelukast provides a convenient once-daily oral option for treating both upper and lower respiratory allergic conditions in children, though it is generally less effective than inhaled corticosteroids for asthma control.