{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "sodium valproate",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Epilepsy Complex Partial Seizures in Adults and Children 10 years of age or older: Initial dose is 10 to 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/day to achieve optimal clinical response.",
        "source": "US FDA label for valproate sodium (Valproate Sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/sodium-valproate.json",
        "verbatim": true
      },
      {
        "text": "Maximum recommended dose is 60 mg/kg/day ( 2.1 ).",
        "source": "US FDA label for valproate sodium (Valproate Sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/sodium-valproate.json",
        "verbatim": true
      },
      {
        "text": "Simple and Complex Absence Seizures: Initial dose is 10 to 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/day to achieve optimal clinical response.",
        "source": "US FDA label for valproate sodium (Valproate Sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/sodium-valproate.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Experience with oral valproate has indicated that pediatric patients under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those with the aforementioned conditions [see BOXED WARNING ]. The safety of Valproate Sodium Injection has not been studied in individuals below the age of 2 years.",
        "source": "US FDA label for valproate sodium (Valproate Sodium), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/sodium-valproate.json",
        "verbatim": true
      },
      {
        "text": "Valproate Sodium Injection is intended for intravenous use only. Epilepsy Complex Partial Seizures in Adults and Children 10 years of age or older: Initial dose is 10 to 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/day to achieve optimal clinical response. Maximum recommended dose is 60 mg/kg/day ( 2.1 ).",
        "source": "US FDA label for valproate sodium (Valproate Sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/sodium-valproate.json",
        "verbatim": true
      },
      {
        "text": "Epilepsy Complex Partial Seizures in Adults and Children 10 years of age or older: Initial dose is 10 to 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/day to achieve optimal clinical response.",
        "source": "US FDA label for valproate sodium (Valproate Sodium), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/sodium-valproate.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 valproate sodium (Valproate Sodium), retrieved 2026-08-29",
        "cached_file": "labels/sodium-valproate.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "Valproate-induced acute liver failure and liver-related deaths have been reported in patients with hereditary neurometabolic syndromes caused by mutations in the gene for mitochondrial DNA polymerase γ (POLG) (e.g., Alpers- Huttenlocher Syndrome) at a higher rate than those without these syndromes.",
        "source": "US FDA label for valproate sodium (Valproate Sodium), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/sodium-valproate.json",
        "verbatim": true
      },
      {
        "text": "Most of the reported cases of liver failure in patients with these syndromes have been identified in children and adolescents.",
        "source": "US FDA label for valproate sodium (Valproate Sodium), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/sodium-valproate.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), including Valproate Sodium Injection, during pregnancy.",
        "source": "US FDA label for valproate sodium (Valproate Sodium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/sodium-valproate.json",
        "verbatim": true
      },
      {
        "text": "Encourage women who are taking Valproate Sodium Injection during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling toll free 1-888-233-2334 or visiting the website, http://www.aedpregnancyregistry.org/.",
        "source": "US FDA label for valproate sodium (Valproate Sodium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/sodium-valproate.json",
        "verbatim": true
      },
      {
        "text": "This must be done by the patient herself.",
        "source": "US FDA label for valproate sodium (Valproate Sodium), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/sodium-valproate.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Risk Summary Valproate is excreted in human milk.",
        "source": "US FDA label for valproate sodium (Valproate Sodium), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/sodium-valproate.json",
        "verbatim": true
      },
      {
        "text": "Data in the published literature describe the presence of valproate in human milk (range: 0.4 mcg/mL to 3.9 mcg/mL), corresponding to 1% to 10% of maternal serum levels.",
        "source": "US FDA label for valproate sodium (Valproate Sodium), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/sodium-valproate.json",
        "verbatim": true
      },
      {
        "text": "Valproate serum concentrations collected from breastfed infants aged 3 days postnatal to 12 weeks following delivery ranged from 0.7 mcg/mL to 4 mcg/mL, which were 1% to 6% of maternal serum valproate levels.",
        "source": "US FDA label for valproate sodium (Valproate Sodium), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/sodium-valproate.json",
        "verbatim": true
      }
    ]
  }
}