{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "phenytoin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "For Status Epilepticus and Non-emergent Loading Dose: Adult loading dose is 10 to 15 mg/kg at a rate not exceeding 50 mg/min.",
        "source": "US FDA label for phenytoin (Phenytoin Sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/phenytoin.json",
        "verbatim": true
      },
      {
        "text": "( 2.2 , 2.3 ) 2.1 General Dosing Information Because of the increased risk of adverse cardiovascular reactions associated with rapid administration, intravenous administration should not exceed 50 mg per minute in adults.",
        "source": "US FDA label for phenytoin (Phenytoin Sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/phenytoin.json",
        "verbatim": true
      },
      {
        "text": "Treatment with Phenytoin Sodium Injection can be initiated either with a loading dose or an infusion: Loading Dose: A loading dose of parenteral Phenytoin Sodium Injection should be injected slowly, not exceeding 50 mg per minute in adults and 1 to 3 mg/kg/min (or 50 mg per minute, whichever is slower) in pediatric patients.",
        "source": "US FDA label for phenytoin (Phenytoin Sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/phenytoin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "A loading dose of 15 to 20 mg/kg of Phenytoin Sodium Injection intravenously will usually produce serum concentrations of phenytoin within the generally accepted serum total concentrations between 10 and 20 mcg/mL (unbound phenytoin concentrations of 1 to 2 mcg/mL).",
        "source": "US FDA label for phenytoin (Phenytoin Sodium), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/phenytoin.json",
        "verbatim": true
      },
      {
        "text": "For Status Epilepticus and Non-emergent Loading Dose: Adult loading dose is 10 to 15 mg/kg at a rate not exceeding 50 mg/min. ( 2.2 ) Pediatric loading dose is 15 to 20 mg/kg at a rate not exceeding 1 to 3 mg/kg/min or 50 mg/min, whichever is slower. ( 2.8 ) Continuous monitoring of the electrocardiogram, blood pressure, and respiratory function is essential.",
        "source": "US FDA label for phenytoin (Phenytoin Sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/phenytoin.json",
        "verbatim": true
      },
      {
        "text": "For Status Epilepticus and Non-emergent Loading Dose: Adult loading dose is 10 to 15 mg/kg at a rate not exceeding 50 mg/min.",
        "source": "US FDA label for phenytoin (Phenytoin Sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/phenytoin.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 phenytoin (Phenytoin Sodium), retrieved 2026-08-29",
        "cached_file": "labels/phenytoin.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "Because there is approximately an 8% increase in drug content with the free acid form over that of the sodium salt, dosage adjustments and serum level monitoring may be necessary when switching from a product formulated with the free acid to a product formulated with the sodium salt and vice versa.",
        "source": "US FDA label for phenytoin (Phenytoin Sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/phenytoin.json",
        "verbatim": true
      },
      {
        "text": "( 5.11 , 8.1 ) Renal and/or Hepatic Impairment or Hypoalbuminemia: Monitor unbound phenytoin concentrations in these patients.",
        "source": "US FDA label for phenytoin (Phenytoin Sodium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/phenytoin.json",
        "verbatim": true
      },
      {
        "text": "Lower or less frequent dosing may be required [see Dosage and Administration (2.6) ]. 8.6 Renal and/or Hepatic Impairment or Hypoalbuminemia The liver is the site of biotransformation.",
        "source": "US FDA label for phenytoin (Phenytoin Sodium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/phenytoin.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "P regnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as Phenytoin Sodium Injection, during pregnancy.",
        "source": "US FDA label for phenytoin (Phenytoin Sodium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/phenytoin.json",
        "verbatim": true
      },
      {
        "text": "Physicians are advised to recommend that pregnant patients taking phenytoin enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.",
        "source": "US FDA label for phenytoin (Phenytoin Sodium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/phenytoin.json",
        "verbatim": true
      },
      {
        "text": "This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves.",
        "source": "US FDA label for phenytoin (Phenytoin Sodium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/phenytoin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Malformations (including craniofacial, cardiovascular, neural, limb, and digit abnormalities) were observed in rats, rabbits, and mice at doses as low as 100, 75, and 12.5 mg/kg, respectively. 8.2 Lactation Risk Summary Phenytoin is secreted in human milk.",
        "source": "US FDA label for phenytoin (Phenytoin Sodium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/phenytoin.json",
        "verbatim": true
      },
      {
        "text": "The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Phenytoin Sodium Injection and any potential adverse effects on the breastfed infant from Phenytoin Sodium Injection or from the underlying maternal condition.",
        "source": "US FDA label for phenytoin (Phenytoin Sodium), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/phenytoin.json",
        "verbatim": true
      }
    ]
  }
}