Divalproex Sodium

DIVALPROEX SODIUM

Manufacturer: Aphena Pharma Solutions - Tennessee, LLC

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