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. It is indicated for adults and pediatric patients down to the age of 10 years. 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 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 and complex partial seizures: Start 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. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day. 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. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether 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. For conversion to monotherapy, concomitant antiepilepsy drug (AED) dosage can ordinarily be reduced by approximately 25% every 2 weeks.

Trial data not available in label.

The label contains a warning regarding fatal hepatic dysfunction. Because of the risk to the fetus of decreased IQ, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, 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. 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.

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 limited in women of childbearing potential and contraindicated in pregnancy for migraine prophylaxis. It offers an oral solution formulation for patients requiring alternative administration.