divalproex 125 mg
1 INDICATIONS AND USAGE Divalproex sodium delayed-release 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 Divalproex sodium delayed-release 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. Divalproex sodium delayed-release 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)].
alembic pharmaceuticals inc.
CAPSULE BLUE THIS END UP D9
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16 HOW SUPPLIED/STORAGE AND HANDLING
DIVALPROEX SODIUM delayed-release capsules, USP, for oral use 125 mg, are transparent blue cap/opaque white body hard gelatin capsule size “1” having imprinting “↑ THIS END UP ↑” on cap with black ink and “D9” on body with black ink filled with white to off white pellets. Bottle of 100 capsules with child-resistant closure, NDC 62332-821-31 Bottle of 1000 capsules, NDC 62332-821-91 Unit Dose Package of 100 capsules, NDC 62332-821-10 Recommended Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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