FDA Approves Valproic Acid Capsules (valproic acid) for monotherapy and adjunctive therapy of complex partial seizures and absence seizures.

Not reported in label.

Valproic Acid Capsules are 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. They are also 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. Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present. The drug is approved for adults and pediatric patients down to the age of 10 years.

Valproic Acid Capsules are intended for oral administration and should be swallowed whole without chewing to avoid local irritation. For simple and complex absence 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. For complex partial seizures in monotherapy or conversion to monotherapy, initiate at 10 to 15 mg/kg/day and increase by 5 to 10 mg/kg/week to achieve optimal clinical response, typically below 60 mg/kg/day. For adjunctive therapy, add at 10 to 15 mg/kg/day and increase similarly. If 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 should be measured if response is unsatisfactory, with therapeutic range usually 50 to 100 mcg/mL.

Trial data not available in label.

Because of the risk to the fetus of decreased IQ, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition. The probability of thrombocytopenia increases significantly at total trough valproate plasma concentrations above 110 mcg/mL in females and 135 mcg/mL in males.

Valproic Acid Capsules are used as monotherapy and adjunctive therapy for complex partial seizures and absence seizures, providing an option for oral administration in epilepsy management. They may interact with other antiepileptic drugs such as clonazepam, diazepam, ethosuximide, lamotrigine, tolbutamide, phenobarbital, carbamazepine, and phenytoin, affecting their concentrations, so periodic plasma concentration monitoring is recommended. Concomitant AED dosage can be reduced by approximately 25% every 2 weeks when converting to monotherapy, with close monitoring for increased seizure frequency.