Valproate Sodium

VALPROATE SODIUM

Manufacturer: Fresenius Kabi USA, LLC

Score: 144.0

Quick Summary

Valproate Sodium Injection is used for the treatment of epilepsy, including complex partial seizures, simple and complex absence seizures, and as an adjunctive therapy in patients with multiple seizure types that include absence seizures. It is also used in the prophylaxis of migraine headaches. However, its use is contraindicated in pregnancy due to the risk of birth defects and other serious adverse effects. The drug has several important safety warnings, including the risk of hepatotoxicity, teratogenicity, and pancreatitis. Dosing recommendations vary based on the condition being treated and the age of the patient, with careful monitoring required for dose adjustments and potential interactions with other medications. Special considerations are needed for use in pregnancy, nursing mothers, pediatric patients, and geriatric patients due to increased risks of adverse effects.

Key Clinical Findings and Indications

Treatment of epilepsy, including complex partial seizures and simple and complex absence seizures
Adjunctive therapy in patients with multiple seizure types that include absence seizures
Prophylaxis of migraine headaches

Important Safety Information

Warning

Valproate Sodium Injection can cause serious and potentially life-threatening liver damage, birth defects, and pancreatitis.

Contraindications

Hepatic disease or significant hepatic dysfunction
Known hypersensitivity to the drug
Pregnancy and women of childbearing potential not using effective contraception

Adverse Reactions

Hepatotoxicity
Teratogenicity
Pancreatitis
Bleeding and other hematopoietic disorders
Hyperammonemic encephalopathy

Dosing Recommendations

General Guidance

Dose adjustments may be necessary based on patient response, serum concentrations, and potential interactions with other medications.

Epilepsy

Adult Dose

10 to 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/day

Pediatric Dose

10 to 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/day

Special Population Considerations

Pregnancy

Valproate Sodium Injection is contraindicated in pregnancy due to the risk of birth defects and other serious adverse effects.
Women of childbearing potential should use effective contraception.

Nursing Mothers

Valproate is excreted in human milk, and nursing mothers should be cautious when using the drug.

Pediatric Use

The safety of Valproate Sodium Injection has not been studied in individuals below the age of 2 years.
Pediatric patients may require larger maintenance doses to attain targeted total and unbound valproate concentrations.

Geriatric Use

No unique safety concerns were identified in geriatric patients receiving Valproate Sodium Injection.
Geriatric patients may require dose adjustments due to decreased renal function and other age-related factors.