{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "ipratropium bromide",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "The usual starting dosage of ATROVENT HFA is two inhalations four times a day. Patients may take additional inhalations as required; however, the total number of inhalations should not exceed 12 in 24 hours. ATROVENT HFA is a solution aerosol that does not require shaking. However, as with any other metered-dose inhaler, some coordination is required between actuating the canister and inhaling the medication.",
        "source": "US FDA label for ipratropium bromide (Atrovent HFA), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/ipratropium-bromide.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and effectiveness in the pediatric population have not been established.",
        "source": "US FDA label for ipratropium bromide (Atrovent HFA), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/ipratropium-bromide.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 ipratropium bromide (Atrovent HFA), retrieved 2026-08-29",
        "cached_file": "labels/ipratropium-bromide.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 ipratropium bromide (Atrovent HFA), retrieved 2026-08-29",
        "cached_file": "labels/ipratropium-bromide.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Ipratropium is negligibly absorbed systemically following oral inhalation; therefore, maternal use is not expected to result in fetal exposure to the drug [ see Clinical Pharmacology (12.3) ].",
        "source": "US FDA label for ipratropium bromide (Atrovent HFA), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/ipratropium-bromide.json",
        "verbatim": true
      },
      {
        "text": "There is limited experience with ipratropium bromide use in pregnant women.",
        "source": "US FDA label for ipratropium bromide (Atrovent HFA), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/ipratropium-bromide.json",
        "verbatim": true
      },
      {
        "text": "Published literature, including cohort studies, case control studies and case series, over several decades have not identified a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.",
        "source": "US FDA label for ipratropium bromide (Atrovent HFA), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/ipratropium-bromide.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "This effect is not considered relevant to human use due to the large doses at which it was observed and the difference in route of administration. 8.2 Lactation Risk Summary There are no data on the presence of ipratropium in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.",
        "source": "US FDA label for ipratropium bromide (Atrovent HFA), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/ipratropium-bromide.json",
        "verbatim": true
      },
      {
        "text": "Although lipid-insoluble quaternary cations pass into breast milk, ipratropium concentrations in plasma after inhaled therapeutic doses are low, therefore, ipratropium levels in human breast milk are expected to be low [ see Clinical Pharmacology (12.3) ].",
        "source": "US FDA label for ipratropium bromide (Atrovent HFA), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/ipratropium-bromide.json",
        "verbatim": true
      },
      {
        "text": "The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ATROVENT HFA and any potential adverse effects on the breastfed child from ATROVENT HFA or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness in the pediatric population have not been established.",
        "source": "US FDA label for ipratropium bromide (Atrovent HFA), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/ipratropium-bromide.json",
        "verbatim": true
      }
    ]
  }
}