Valproate Sodium

What it is and how it works

Mechanism of Action Valproate sodium exists as the valproate ion in the blood. The mechanisms by which valproate exerts its therapeutic effects have not been established. It has been suggested that its activity in epilepsy is related to increased brain concentrations of gamma-aminobutyric acid (GABA).

Indications

Valproate sodium injection is indicated as an intravenous alternative in patients in whom oral administration of valproate products is temporarily not feasible in the following conditions: • Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures Epilepsy Valproate sodium injection is indicated as an intravenous alternative in patients for whom oral administration of valproate products is temporarily not feasible in the following conditions: Valproate sodium injection is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Valproate sodium injection is also indicated for use as sole and adjunctive therapy in the treatment of patients with simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures.

Dosage and administration (summary)

Valproate sodium injection is intended for intravenous use only. • Epilepsy o 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 . o 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. Maximum recommended dose is 60 mg/kg/day . Epilepsy Valproate sodium injection is for intravenous use only. Use of valproate sodium injection for periods of more than 14 days has not been studied.

Contraindications

• Valproate sodium injection should not be administered to patients with hepatic disease or significant hepatic dysfunction . • Valproate sodium injection is contraindicated in patients known to have mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG; e.g., Alpers-Huttenlocher Syndrome) and children under two years of age who are suspected of having a POLG-related disorder .

Warnings and precautions

• Hepatotoxicity; evaluate high risk populations and monitor serum liver tests • Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure; should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable ( 5.2 , 5.3 , 5.4 ) • Pancreatitis; valproate sodium should ordinarily be discontinued • Bleeding and other hematopoietic disorders.

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), including Valproate sodium, during pregnancy.

Storage and supply

Valproate Sodium Injection, equivalent to 100 mg of valproic acid per mL, is a clear, colorless solution supplied as: Manufacturer Product Number Unit of Sale Strength Each Unit PRX439405 NDC 63323-494-16 Available in trays of 10 vials. 500 mg per 5 mL (100 mg per mL) NDC 63323-494-41 5 mL Single-dose Vial Store at 20°C to 25°C (68°F to 77°F) .

Source: Valproate Sodium (Valproate Sodium) — US FDA prescribing information, 2024-12-15, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.