Montelukast

DRUG INFORMATION

  ADULT
    - Administration (by indications): • Asthma ( 2.1 ): Once daily in the evening for
      patients 12 months and older. • Acute prevention of EIB ( 2.2 ): One tablet at
      least 2 hours before exercise for patients 6 years of age and older. • Seasonal
      allergic rhinitis ( 2.3 ): Once daily for patients 2 years and older. • Perennial
      allergic rhinitis ( 2.3 ): Once daily for patients 6 months and older. Dosage (by
      age) ( 2 ): • 15 years and older: one 10-mg tablet.
      Source: US FDA label for montelukast (MONTELUKAST SODIUM), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Safety and efficacy of montelukast sodium have been established in adequate and
      well-controlled studies in pediatric patients with asthma 6 to 14 years of age.
      Safety and efficacy profiles in this age group are similar to those seen in adults
      [see Adverse Reactions (6.1) , Clinical Pharmacology , Special Populations (12.3)
      , and Clinical Studies (14.1 , 14.2 ) ] .
      Source: US FDA label for montelukast (MONTELUKAST SODIUM), section 'pediatric
      use', retrieved 2026-08-29
    - Administration (by indications): • Asthma ( 2.1 ): Once daily in the evening for
      patients 12 months and older. • Acute prevention of EIB ( 2.2 ): One tablet at
      least 2 hours before exercise for patients 6 years of age and older. • Seasonal
      allergic rhinitis ( 2.3 ): Once daily for patients 2 years and older. • Perennial
      allergic rhinitis ( 2.3 ): Once daily for patients 6 months and older. Dosage (by
      age) ( 2 ): • 15 years and older: one 10-mg tablet.
      Source: US FDA label for montelukast (MONTELUKAST SODIUM), section 'dosage and
      administration', retrieved 2026-08-29
    - Safety and effectiveness in pediatric patients younger than 6 months of age with
      perennial allergic rhinitis have not been established. 2.4 Asthma and Allergic
      Rhinitis Patients with both asthma and allergic rhinitis should take only one
      montelukast sodium dose daily in the evening.
      Source: US FDA label for montelukast (MONTELUKAST SODIUM), section 'dosage and
      administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - No dosage adjustment in the elderly is required. 8.6 Hepatic Insufficiency No
      dosage adjustment is required in patients with mild-to-moderate hepatic
      insufficiency [see Clinical Pharmacology (12.3) ] . 8.7 Renal Insufficiency No
      dosage adjustment is recommended in patients with renal insufficiency [see
      Clinical Pharmacology (12.3) ] .
      Source: US FDA label for montelukast (MONTELUKAST SODIUM), section 'use in
      specific populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No dosage adjustment in the elderly is required. 8.6 Hepatic Insufficiency No
      dosage adjustment is required in patients with mild-to-moderate hepatic
      insufficiency [see Clinical Pharmacology (12.3) ] . 8.7 Renal Insufficiency No
      dosage adjustment is recommended in patients with renal insufficiency [see
      Clinical Pharmacology (12.3) ] .
      Source: US FDA label for montelukast (MONTELUKAST SODIUM), section 'use in
      specific populations', retrieved 2026-08-29

  PREGNANCY   [ CAUTION ]
    The label allows it only when the benefit is judged to outweigh the risk. Read the
      quote below.
    - Pregnancy Category B: There are no adequate and well-controlled studies in
      pregnant women.
      Source: US FDA label for montelukast (MONTELUKAST SODIUM), section 'pregnancy',
      retrieved 2026-08-29
    - Because animal reproduction studies are not always predictive of human response,
      montelukast sodium should be used during pregnancy only if clearly needed.
      Source: US FDA label for montelukast (MONTELUKAST SODIUM), section 'pregnancy',
      retrieved 2026-08-29
    - Teratogenic Effect: No teratogenicity was observed in rats and rabbits at doses
      approximately 100 and 110 times, respectively, the maximum recommended daily oral
      dose in adults based on AUCs [see Nonclinical Toxicology (13.2) ] .
      Source: US FDA label for montelukast (MONTELUKAST SODIUM), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Studies in rats have shown that montelukast is excreted in milk.
      Source: US FDA label for montelukast (MONTELUKAST SODIUM), section 'nursing
      mothers', retrieved 2026-08-29
    - It is not known if montelukast is excreted in human milk.
      Source: US FDA label for montelukast (MONTELUKAST SODIUM), section 'nursing
      mothers', retrieved 2026-08-29
    - Because many drugs are excreted in human milk, caution should be exercised when
      montelukast sodium is given to a nursing mother.
      Source: US FDA label for montelukast (MONTELUKAST SODIUM), section 'nursing
      mothers', retrieved 2026-08-29