{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "isoniazid",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Adults over 30 Kg: 300 mg per day in a single dose.",
        "source": "US FDA label for isoniazid (isoniazid), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/isoniazid.json",
        "verbatim": true
      },
      {
        "text": "In situations where adherence with daily preventative therapy cannot be assured, 20 mg/kg to 30 mg/kg (not to exceed 900 mg) twice weekly under the direct observation of a health care worker at the time of administration 8 .",
        "source": "US FDA label for isoniazid (isoniazid), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/isoniazid.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Infants and Children 10 mg/kg (up to 300 mg daily) in a single dose.",
        "source": "US FDA label for isoniazid (isoniazid), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/isoniazid.json",
        "verbatim": true
      },
      {
        "text": "In situations where adherence with daily preventative therapy cannot be assured, 20 mg/kg to 30 mg/kg (not to exceed 900 mg) twice weekly under the direct observation of a health care worker at the time of administration 8 .",
        "source": "US FDA label for isoniazid (isoniazid), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/isoniazid.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 isoniazid (isoniazid), retrieved 2026-08-29",
        "cached_file": "labels/isoniazid.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 isoniazid (isoniazid), retrieved 2026-08-29",
        "cached_file": "labels/isoniazid.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Teratogenic Effects Pregnancy Category C Isoniazid has been shown to have an embryocidal effect in rats and rabbits when given orally during pregnancy.",
        "source": "US FDA label for isoniazid (isoniazid), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/isoniazid.json",
        "verbatim": true
      },
      {
        "text": "Isoniazid was not teratogenic in reproduction studies in mice, rats and rabbits.",
        "source": "US FDA label for isoniazid (isoniazid), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/isoniazid.json",
        "verbatim": true
      },
      {
        "text": "There are no adequate and well-controlled studies in pregnant women.",
        "source": "US FDA label for isoniazid (isoniazid), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/isoniazid.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "The small concentrations of isoniazid in breast milk do not produce toxicity in the nursing newborn; therefore, breast feeding should not be discouraged.",
        "source": "US FDA label for isoniazid (isoniazid), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/isoniazid.json",
        "verbatim": true
      },
      {
        "text": "However, because levels of isoniazid are so low in breast milk, they can not be relied upon for prophylaxis or therapy of nursing infants.",
        "source": "US FDA label for isoniazid (isoniazid), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/isoniazid.json",
        "verbatim": true
      }
    ]
  }
}