Home About
Back to Search

Divalproex Sodium

DIVALPROEX SODIUM

Manufacturer: A-S Medication Solutions

Score: 148.0

Quick Summary

Divalproex sodium is an anti-epileptic drug used for the treatment of manic episodes associated with bipolar disorder, as monotherapy and adjunctive therapy for complex partial seizures and simple and complex absence seizures, and for the prophylaxis of migraine headaches. It has a boxed warning for hepatotoxicity, fetal risk, and pancreatitis. The initial dose for mania is 750 mg daily, and for epilepsy, the dose is 10 to 15 mg/kg/day. Special considerations are needed for pregnant women, nursing mothers, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

  • Treatment of manic episodes associated with bipolar disorder
  • Monotherapy and adjunctive therapy for complex partial seizures and simple and complex absence seizures
  • Prophylaxis of migraine headaches

Important Safety Information

Warning

Hepatotoxicity, fetal risk, and pancreatitis

Contraindications

  • Hepatic disease or significant hepatic dysfunction
  • Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG)
  • Known hypersensitivity to the drug
  • Urea cycle disorders
  • Pregnant women and women of childbearing potential who are not using effective contraception

Adverse Reactions

  • Nausea
  • Somnolence
  • Dizziness
  • Vomiting
  • Accidental injury
  • Asthenia
  • Abdominal pain
  • Dyspepsia

Dosing Recommendations

General Guidance

Dose adjustments may be necessary based on patient response and tolerability

Mania

Adult Dose

750 mg daily

Pediatric Dose

Not recommended

Epilepsy

Adult Dose

10 to 15 mg/kg/day

Pediatric Dose

10 to 15 mg/kg/day

Special Population Considerations

Pregnancy

  • Valproate can cause major congenital malformations, particularly neural tube defects
  • Valproate should not be used in pregnant women unless other medications have failed to provide adequate symptom control

Nursing Mothers

  • Valproate is excreted in breast milk
  • Caution should be exercised when valproate is administered to a nursing mother

Pediatric Use

  • Pediatric patients under the age of 2 years are at a higher risk of developing fatal hepatotoxicity
  • Valproate should be used with extreme caution in pediatric patients

Geriatric Use

  • The starting dose should be reduced in geriatric patients
  • Dose adjustments may be necessary based on patient response and tolerability
Back to Search