Sodium Valproate

DRUG INFORMATION

  ADULT
    - 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
    - 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
    - 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

  CHILD
    - 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
    - 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
    - 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

  RENAL IMPAIRMENT
    - 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

  HEPATIC IMPAIRMENT
    - 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
    - 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

  PREGNANCY
    - 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
    - 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
    - This must be done by the patient herself.
      Source: US FDA label for valproate sodium (Valproate Sodium), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Risk Summary Valproate is excreted in human milk.
      Source: US FDA label for valproate sodium (Valproate Sodium), section 'nursing
      mothers', retrieved 2026-08-29
    - 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
    - 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