divalproex sodium 125 mg
1 INDICATIONS AND USAGE Depakote Sprinkle Capsules are an anti-epileptic drug indicated for: 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 ( 1 ) 1.1 Epilepsy 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. Depakote Sprinkle Capsules 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. 1.2 Important Limitations 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 [see Warnings and Precautions ( 5.2 , 5.3 , 5.4 ) , Use in Specific Populations ( 8.1 ) , and Patient Counseling Information ( 17 ) ] . 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 Contraindications ( 4 ) ] .
AbbVie Inc.
CAPSULE BLUE THIS END UP DEPAKOTE SPRINKLE 125 mg
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16 HOW SUPPLIED/STORAGE AND HANDLING Depakote Sprinkle capsules (
DIVALPROEX SODIUM delayed release capsules), for oral use 125 mg, are white opaque and blue, and are supplied in bottles of 100 (NDC 0074-6114-13) and Unit Dose Packages of 100 (NDC 0074-6114-11). Recommended Storage: Store capsules below 77°F (25°C).
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