{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "hydroxocobalamin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "( 2.1 ) Dosing : The starting dose of CYANOKIT for adults is 5 g, administered by intravenous infusion over 15 minutes.",
        "source": "US FDA label for hydroxocobalamin (Cyanokit), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/hydroxocobalamin.json",
        "verbatim": true
      },
      {
        "text": "One 5 g vial is a complete starting dose.",
        "source": "US FDA label for hydroxocobalamin (Cyanokit), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/hydroxocobalamin.json",
        "verbatim": true
      },
      {
        "text": "( 2.2 ) Depending upon the severity of the poisoning and the clinical response, a second dose of 5 g may be administered by intravenous infusion for a total dose of 10 g.",
        "source": "US FDA label for hydroxocobalamin (Cyanokit), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/hydroxocobalamin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and effectiveness of CYANOKIT have not been established in this population. In non-US marketing experience, a dose of 70 mg/kg has been used to treat pediatric patients.",
        "source": "US FDA label for hydroxocobalamin (Cyanokit), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/hydroxocobalamin.json",
        "verbatim": true
      },
      {
        "text": "In non-US marketing experience, a dose of 70 mg/kg has been used to treat pediatric patients.",
        "source": "US FDA label for hydroxocobalamin (Cyanokit), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/hydroxocobalamin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "No adjustment of dose is required in elderly patients. 8.6 Renal Impairment The safety and effectiveness of CYANOKIT have not been studied in patients with renal impairment.",
        "source": "US FDA label for hydroxocobalamin (Cyanokit), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/hydroxocobalamin.json",
        "verbatim": true
      },
      {
        "text": "( 5.2 ) Risk of Renal Injury : Acute renal failure with acute tubular necrosis, renal impairment and urine calcium oxalate crystals have been reported following CYANOKIT therapy.",
        "source": "US FDA label for hydroxocobalamin (Cyanokit), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/hydroxocobalamin.json",
        "verbatim": true
      },
      {
        "text": "Allergic reactions including angioneurotic edema have also been reported in postmarketing experience. 5.3 Risk of Renal Injury Cases of acute renal failure with acute tubular necrosis, renal impairment, and urine calcium oxalate crystals have been reported.",
        "source": "US FDA label for hydroxocobalamin (Cyanokit), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/hydroxocobalamin.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "Hydroxocobalamin and cyanocobalamin are eliminated unchanged by the kidneys. 8.7 Hepatic Impairment The safety and effectiveness of CYANOKIT have not been studied in patients with hepatic impairment.",
        "source": "US FDA label for hydroxocobalamin (Cyanokit), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/hydroxocobalamin.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Available data from cases reported in the published literature and postmarketing surveillance with CYANOKIT use in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal and fetal outcomes.",
        "source": "US FDA label for hydroxocobalamin (Cyanokit), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/hydroxocobalamin.json",
        "verbatim": true
      },
      {
        "text": "There are risks to the pregnant woman and fetus associated with untreated cyanide poisoning (see Clinical Considerations) .",
        "source": "US FDA label for hydroxocobalamin (Cyanokit), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/hydroxocobalamin.json",
        "verbatim": true
      },
      {
        "text": "In animal studies, hydroxocobalamin administered to pregnant rats and rabbits during the period of organogenesis caused skeletal and soft tissue abnormalities, including alterations in the central nervous system, at exposures similar to human exposures at the therapeutic dose (see Data) .",
        "source": "US FDA label for hydroxocobalamin (Cyanokit), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/hydroxocobalamin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Treatment should not be withheld due to pregnancy ( 8.1 ) Lactation : Breastfeeding not recommended ( 8.2 ) 8.1 Pregnancy Risk Summary Available data from cases reported in the published literature and postmarketing surveillance with CYANOKIT use in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal and fetal outcomes.",
        "source": "US FDA label for hydroxocobalamin (Cyanokit), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/hydroxocobalamin.json",
        "verbatim": true
      },
      {
        "text": "It is unknown if similar findings would be observed in rats and rabbits if CYANOKIT was administered as a single dose during any critical period of development. 8.2 Lactation Risk Summary Breastfeeding is not recommended during treatment with CYANOKIT.",
        "source": "US FDA label for hydroxocobalamin (Cyanokit), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/hydroxocobalamin.json",
        "verbatim": true
      },
      {
        "text": "Hydroxocobalamin and Vitamin B12 (which is formed when hydroxocobalamin combines with cyanide) are present in human milk.",
        "source": "US FDA label for hydroxocobalamin (Cyanokit), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/hydroxocobalamin.json",
        "verbatim": true
      }
    ]
  }
}