{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "montelukast",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "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",
        "cached_file": "labels/montelukast.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "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",
        "cached_file": "labels/montelukast.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/montelukast.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/montelukast.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "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",
        "cached_file": "labels/montelukast.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "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",
        "cached_file": "labels/montelukast.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/montelukast.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/montelukast.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/montelukast.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "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",
        "cached_file": "labels/montelukast.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/montelukast.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/montelukast.json",
        "verbatim": true
      }
    ]
  },
  "verdicts": {
    "pregnancy": {
      "level": "caution",
      "line": "The label allows it only when the benefit is judged to outweigh the risk. Read the quote below.",
      "set_by": "Set from the label's own words, not from a reading of them: 'should be used during pregnancy only if'."
    }
  }
}