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Dosage Forms and Strengths Tablets: 125 mg, 250 mg and 500 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 divalproex sodium, sodium valproate, or valproic acid (4, 5.12, 5.13, 5.14) 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: Depakote should ordinarily be discontinued (5.5) Suicidal behavior or ideation: Antiepileptic drugs, including Depakote, 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

Durukan, E

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R.VarmaS.CasanovaR.DammerE.PletnikovaO.et al

& Nicolazzo, J

Higher serum trimethylamine-N-oxide levels are associated with increased abdominal aortic calcification in hemodialysis patients