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Montelukast Sodium

MONTELUKAST SODIUM

Manufacturer: RPK Pharmaceuticals, Inc.

Score: 148.0

Quick Summary

Montelukast sodium is a leukotriene receptor antagonist used for the prophylaxis and chronic treatment of asthma, prevention of exercise-induced bronchoconstriction, and relief of symptoms of allergic rhinitis. The drug works by binding to the CysLT1 receptor, inhibiting the action of cysteinyl leukotrienes, which are involved in the pathophysiology of asthma and allergic rhinitis. Montelukast sodium is administered orally, once daily, with or without food, and the recommended dose is one 10-mg tablet for adults and adolescents 15 years of age and older.

Key Clinical Findings and Indications

  • Asthma prophylaxis and chronic treatment
  • Prevention of exercise-induced bronchoconstriction
  • Relief of symptoms of allergic rhinitis

Important Safety Information

Warning

Serious neuropsychiatric events have been reported with the use of montelukast sodium, including agitation, aggression, depression, sleep disturbances, suicidal thoughts and behavior.

Contraindications

  • Hypersensitivity to any component of montelukast sodium

Adverse Reactions

  • Upper respiratory infection
  • Fever
  • Headache
  • Pharyngitis
  • Cough
  • Abdominal pain
  • Diarrhea
  • Otitis media
  • Influenza
  • Rhinorrhea
  • Sinusitis
  • Otitis

Dosing Recommendations

General Guidance

No dosage adjustment is required in patients with mild-to-moderate hepatic insufficiency or renal insufficiency.

Asthma

Adult Dose

One 10-mg tablet orally once daily in the evening

Pediatric Dose

Not established for patients under 15 years of age

Exercise-induced bronchoconstriction

Adult Dose

One 10-mg tablet orally at least 2 hours before exercise

Pediatric Dose

Not established for patients under 15 years of age

Allergic rhinitis

Adult Dose

One 10-mg tablet orally once daily

Pediatric Dose

Not established for patients under 15 years of age

Special Population Considerations

Pregnancy

  • Available data from published prospective and retrospective cohort studies have not established a drug-associated risk of major birth defects

Nursing Mothers

  • A published clinical lactation study reports the presence of montelukast in human milk, but the effects of the drug on infants are not well understood

Pediatric Use

  • The safety and effectiveness of montelukast sodium have not been established in pediatric patients under 12 months of age with asthma, under 6 months of age with perennial allergic rhinitis, and under 6 years of age with exercise-induced bronchoconstriction

Geriatric Use

  • No overall differences in safety or effectiveness were observed between geriatric patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out
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