Drug updated on 9/4/2024
Dosage Form | Film-coated tablet (oral: 10 mg); Chewable tablet (oral: 4 mg, 5 mg); Granule (oral, 4 mg) |
Drug Class | Leukotriene receptor antagonist |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for prophylaxis and chronic treatment of asthma in patients 12 months of age and older.
- Indicated for acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older.
- Indicated for relief of symptoms of allergic rhinitis (AR): seasonal allergic rhinitis (SAR) in patients 2 years of age and older, and perennial allergic rhinitis (PAR) in patients 6 months of age and older.
Latest News
Summary
- Singulair (montelukast sodium) is indicated for prophylaxis and chronic treatment of asthma in patients 12 months of age and older; acute prevention of exercise-induced bronchoconstriction (EIB) in patients 6 years of age and older; and relief of symptoms of allergic rhinitis (AR), including seasonal allergic rhinitis (SAR) in patients 2 years of age and older and perennial allergic rhinitis (PAR) in patients 6 months of age and older.
- This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
- In adults with cough variant asthma (CVA), montelukast combined with inhaled corticosteroids (ICS) and long-acting β2 agonists (LABAs) improved the total effective rate (RR = 1.20, 95% CI [1.13, 1.27], P < 0.01) and reduced the recurrence rate (RR = 0.28, 95% CI [0.15, 0.53], P < 0.01).
- In children with asthma or allergic rhinitis, montelukast was effective in controlling asthma symptoms (SMD = 0.90, 95% CI [0.44-1.36]), though inhaled corticosteroids were superior for controlling daytime (SMD = -0.12) and night-time symptoms (SMD = -0.23).
- The combination of loratadine and montelukast in allergic rhinitis was superior in reducing total nasal symptom scores (TNSS) compared to loratadine (SMD = -1.00), montelukast (SMD = -0.46), and placebo (SMD = -0.93).
- In adults with cough variant asthma (CVA), montelukast as an adjuvant therapy showed a higher incidence of adverse reactions compared to the control group, but this was not statistically significant (RR = 1.32, 95% CI [0.89, 1.96], P = 0.17).
- In pediatric patients with obstructive sleep apnea (OSA), reported adverse reactions to montelukast included headache, nausea, and vomiting.
- The reviewed evidence includes subgroup considerations for adults with CVA (montelukast combined with ICS and LABAs), children and adolescents with asthma/allergic rhinitis (montelukast vs. placebo and inhaled corticosteroids), children with CVA (montelukast with fluticasone), pediatric patients with mild to moderate OSA (efficacy and safety of montelukast), children aged 4 to 18 years with asthma (montelukast vs. SFC), children 5 years or younger with asthma/VIW (nebulized corticosteroids vs. montelukast), and adults and children with allergic rhinitis (montelukast vs. oral antihistamines and intranasal corticosteroids).
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Singulair (montelukast sodium) Prescribing Informaiton. | 2012 | Merck & Co., Inc., Whitehouse Station, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
2022 GINA report, global strategy for asthma management and prevention. | 2022 | GINA |
Asthma guideline updates. | 2022 | ACSAP: Pulmonary Care |