Montelukast sodium

(Singulair®)

Singulair®

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Drug updated on 4/17/2024

Dosage FormFilm-coated tablet (oral: 10 mg); Chewable tablet (oral: 4 mg, 5 mg); Granule (oral, 4 mg)
Drug ClassLeukotriene 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.

Summary
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  • Montelukast sodium (Singulair) is indicated for prophylaxis and chronic treatment of asthma in patients 12 months of age and older, acute prevention of exercise-induced bronchoconstriction in patients 6 years old or more, as well as relief from symptoms of allergic rhinitis: seasonal allergic rhinitis in those aged 2 years or above, and perennial allergic rhinitis starting at the age of six months.
  • The information comes from a review conducted on eight systematic reviews/meta-analyses that focus on comparing Montelukast's safety and effectiveness with other treatments regarding its use for managing asthma, allergic rhinitis, cough variant asthma, and obstructive sleep apnea.
  • For adults suffering from cough variant asthma, Montelukast has been found to be superior when used alongside inhaled corticosteroids and long-acting beta2 agonists. It improves lung function tests while reducing recurrence rates. However, it does show a slight but statistically insignificant increase in adverse reactions compared to control groups using only inhaled corticosteroids and long-acting beta2 agonists.
  • In pediatric cases dealing with both asthma and allergic rhinitis, Montelukast was effective against symptoms when compared to placebo. But it did not perform as effectively as inhaled corticosteroids, especially during nighttime symptom management, suggesting that this drug might be better suited for mild instances or specific subgroups less responsive to corticosteroids.
  • When treating allergic rhinitis, combining loratadine (an antihistamine) and Montelukast significantly outperformed either drug alone or placebos by improving total nasal symptom scores along with other related outcomes, indicating potential usage within combination therapy targeting moderate-severe allergic rhinitis cases poorly responding to monotherapy.
  • Nebulized corticosteroids were found effective and well-tolerated while managing acute/chronic asthma in patients aged 5 years or younger. This suggests that while Montelukast is a viable treatment option, nebulized corticosteroids may offer direct benefits to young children suffering from asthma.

Product Monograph / Prescribing Information

Document TitleYearSource
Singulair (montelukast sodium) Prescribing Informaiton.2012Merck & Co., Inc., Whitehouse Station, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines