divalproex sodium 125 MG Delayed Release Oral Capsule
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) ].
American Health Packaging
CAPSULE BLUE ZA66 125 mg
ZA66 125 mg CAPSULE BLUE
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16 HOW SUPPLIED/STORAGE AND HANDLING
DIVALPROEX SODIUM Delayed-Release capsules, USP equivalent to 125 mg of valproic acid are white to off-white free flowing pellets filled in size '0' hard gelatin capsules with blue colored cap printed with "ZA66" in black ink and white body printed with "125mg" in black ink and are supplied as follows: Unit dose packages of 50 (5 x 10) NDC 68084-313-65 Unit dose packages of 100 (10 x10) NDC 68084-313-01 Storage: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.
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