FDA Approves Depakote Sprinkle Capsules (valproate) for Monotherapy and Adjunctive Therapy of Complex Partial and Absence Seizures.

Not reported in label.

Depakote Sprinkle Capsules are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years 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 that 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.

Depakote Sprinkle Capsules may be swallowed whole or the contents may be sprinkled on soft food and swallowed immediately (avoid chewing). For complex partial seizures, therapy should be initiated at 10 to 15 mg/kg/day, increasing at 1-week intervals by 5 to 10 mg/kg/day to achieve optimal clinical response. For absence seizures, start at 15 mg/kg/day, increasing at 1-week intervals by 5 to 10 mg/kg/day until seizure control or limiting side effects. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day. Safety of doses above 60 mg/kg/day is not established. If the total daily dose exceeds 250 mg, it should be given in divided doses. If satisfactory clinical response is not achieved, plasma levels should be measured; the usually accepted therapeutic range is 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. When converting to monotherapy, concomitant antiepilepsy drug (AED) dosage can ordinarily be reduced by approximately 25% every 2 weeks.

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, which may occur very early in pregnancy, 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.

Depakote Sprinkle Capsules are indicated for monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures. The label provides specific dosing regimens for initiation and titration in these seizure types. It also provides guidance for conversion to monotherapy from other AEDs and for adjunctive therapy. The label emphasizes the significant teratogenic risks, limiting its use in women of childbearing potential.