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Migraine: The recommended starting dose is 500 mg/day for 1 week, thereafter increasing to 1,000 mg/day (2.3) Dosage Forms and Strengths Tablets : 250 mg (3) Contraindications Hepatic disease or significant hepatic dysfunction (4, 5.1) Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase (POLG) (4, 5.1) Suspected POLG-related disorder in children under two years of age (4, 5.1) Known hypersensitivity to the drug (4, 5.12) Urea cycle disorders (4, 5.6) Prophylaxis of migraine headaches: Pregnant women, women of childbearing potential not using effective contraception (4, 8.1) Warnings and Precautions Birth defects, decreased IQ, and neurodevelopmental disorders following in utero exposure: Should not be used to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant or to treat a woman of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable (5.2, 5.3, 5.4) Pancreatitis: Divalproex sodium extended-release tablets should ordinarily be discontinued (5.5) Suicidal behavior or ideation: Antiepileptic drugs, including divalproex sodium extended-release tablets, increase the risk of suicidal thoughts or behavior (5.7) Bleeding and other hematopoietic disorders: Monitor platelet counts and coagulation tests (5.8) Hyperammonemia and hyperammonemic encephalopathy: Measure ammonia level if unexplained lethargy and vomiting or changes in mental status, and also with concomitant topiramate use

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