FDA Approves Valproic Acid Oral Solution (valproic acid) for Monotherapy and Adjunctive Therapy of Complex Partial and Absence Seizures

Not reported in label.

Valproic Acid Oral Solution 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. It is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures. For complex partial seizures, it is indicated for adults and pediatric patients down to the age of 10 years. Because of fetal risks, valproate should not be used to treat women with epilepsy who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. Valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable.

Valproic acid oral solution is intended for oral administration. For simple and complex absence seizures, therapy starts at 10 to 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/week until seizure control or limiting side effects. For complex partial seizures in adults and children 10 years of age or older, monotherapy (initial therapy) starts at 10 to 15 mg/kg/day, increased by 5 to 10 mg/kg/week to achieve optimal clinical response, typically below 60 mg/kg/day. Conversion to monotherapy follows the same titration, with concomitant antiepilepsy drug (AED) dosage ordinarily reduced by approximately 25% every 2 weeks. Adjunctive therapy is added at 10 to 15 mg/kg/day and increased by 5 to 10 mg/kg/week. If the total daily dose exceeds 250 mg, it should be given in divided doses. Safety of doses above 60 mg/kg/day is not established. Plasma levels can be measured to determine if they are in the usually accepted therapeutic range (50 to 100 mcg/mL). The probability of thrombocytopenia increases significantly at total trough valproate plasma concentrations above 110 mcg/mL in females and 135 mcg/mL in males.

trial data not available in label

Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, valproate should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. Valproate should not be administered to a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. For prophylaxis of migraine headaches, valproate is contraindicated in women who are pregnant and in women of childbearing potential who are not using effective contraception. See Warnings and Precautions for statement regarding fatal hepatic dysfunction.

Valproic Acid Oral Solution is indicated for monotherapy and adjunctive therapy of complex partial seizures and for sole and adjunctive therapy of simple and complex absence seizures. Its use is subject to significant restrictions in women who are pregnant or of childbearing potential due to established teratogenic risks.