{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "midazolam",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Dosing Recommendations for Continuous Intravenous Infusion in Adult, Pediatric, and Neonatal Patients ADULT PATIENTS If a loading dose is necessary to rapidly initiate sedation, 0.01 mg/kg to 0.05 mg/kg (approximately 0.5 mg to 4 mg for a typical adult) may be given slowly or infused over several minutes.",
        "source": "US FDA label for midazolam (Midazolam in Sodium Chloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/midazolam.json",
        "verbatim": true
      },
      {
        "text": "DOSING AND ADMINISTRATION For intravenous injection only. Avoid intra-arterial injection or extravasation. ( 2.1 ) Individualize dosing and titrate to desired clinical response, taking into account patient age, clinical status, and concomitant use of other CNS depressants. ( 2.1 ) See Full Prescribing Information for complete dosage and administration information.",
        "source": "US FDA label for midazolam (Midazolam in Sodium Chloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/midazolam.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and efficacy of midazolam for sedation/anxiolysis/amnesia following continuous infusion have been established in pediatric and neonatal patients. UNLIKE ADULT PATIENTS, PEDIATRIC PATIENTS GENERALLY RECEIVE INCREMENTS OF MIDAZOLAM ON A MG/KG BASIS. As a group, pediatric patients generally require higher dosages of midazolam (mg/kg) than do adults.",
        "source": "US FDA label for midazolam (Midazolam in Sodium Chloride), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/midazolam.json",
        "verbatim": true
      },
      {
        "text": "DOSING AND ADMINISTRATION For intravenous injection only. Avoid intra-arterial injection or extravasation. ( 2.1 ) Individualize dosing and titrate to desired clinical response, taking into account patient age, clinical status, and concomitant use of other CNS depressants. ( 2.1 ) See Full Prescribing Information for complete dosage and administration information.",
        "source": "US FDA label for midazolam (Midazolam in Sodium Chloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/midazolam.json",
        "verbatim": true
      },
      {
        "text": "Dosing Recommendations for Continuous Intravenous Infusion in Adult, Pediatric, and Neonatal Patients ADULT PATIENTS If a loading dose is necessary to rapidly initiate sedation, 0.01 mg/kg to 0.05 mg/kg (approximately 0.5 mg to 4 mg for a typical adult) may be given slowly or infused over several minutes.",
        "source": "US FDA label for midazolam (Midazolam in Sodium Chloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/midazolam.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "No kidney-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for midazolam (Midazolam in Sodium Chloride), retrieved 2026-08-29",
        "cached_file": "labels/midazolam.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "No liver-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for midazolam (Midazolam in Sodium Chloride), retrieved 2026-08-29",
        "cached_file": "labels/midazolam.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Neonates born to mothers using benzodiazepines, including midazolam, late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see Warnings and Precautions (5.10 ), and Clinical Considerations ] .",
        "source": "US FDA label for midazolam (Midazolam in Sodium Chloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/midazolam.json",
        "verbatim": true
      },
      {
        "text": "Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see Data) .",
        "source": "US FDA label for midazolam (Midazolam in Sodium Chloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/midazolam.json",
        "verbatim": true
      },
      {
        "text": "Available data from randomized controlled trials, cohort studies and case reports over several decades with midazolam use in pregnant women for anesthesia have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.",
        "source": "US FDA label for midazolam (Midazolam in Sodium Chloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/midazolam.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Lactation: A lactating woman may pump and discard breast milk for 4 to 8 hours after treatment with midazolam.",
        "source": "US FDA label for midazolam (Midazolam in Sodium Chloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/midazolam.json",
        "verbatim": true
      },
      {
        "text": "Pregnant rats were administered midazolam using intravenous doses of 0.2, 1, and 4 mg/kg/day (0.09, 0.46, and 1.85 times the human induction dose of 0.35 mg/kg based on body surface area comparisons) during late gestation and through lactation (Gestation Day 15 through Lactation Day 21).",
        "source": "US FDA label for midazolam (Midazolam in Sodium Chloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/midazolam.json",
        "verbatim": true
      },
      {
        "text": "The clinical significance of these findings is not clear; however, studies in juvenile animals suggest neuroapoptosis correlates with long-term cognitive deficits [see Warnings and Precautions (5.8 ), Use in Specific Populations (8.4 ), Nonclinical Pharmacology (13.2) ]. 8.2 Lactation Risk Summary There are reports of sedation, poor feeding, and poor weight gain in infants exposed to benzodiazepines through breast milk.",
        "source": "US FDA label for midazolam (Midazolam in Sodium Chloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/midazolam.json",
        "verbatim": true
      }
    ]
  }
}