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HIGHLIGHTS OF PRESCRIBING INFORMATION |
These highlights do not include all the information needed to use Depakote safely and effectively. See full prescribing information for Depakote.
Depakote (divalproex sodium) Capsule for Oral use
Initial U.S. Approval: 1989
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WARNING: LIFE THREATENING ADVERSE REACTIONS
See full prescribing information for complete boxed warning.
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Hepatotoxicity, including fatalities, usually during first 6 months of treatment. Children under the age of two years are at considerably higher risk of fatal hepatotoxicity. Monitor patients closely, and perform liver function tests prior to therapy and at frequent intervals thereafter (5.1)
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Teratogenicity, including neural tube defects (5.2)
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Pancreatitis, including fatal hemorrhagic cases (5.3)
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RECENT MAJOR CHANGES
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Warnings and Precautions (5.5) 4/2009
Warnings and Precautions (5.2) 11/2009
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INDICATIONS AND USAGE
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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)
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DOSAGE AND ADMINISTRATION
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Depakote Sprinkle Capsules may be swallowed whole or the contents may be sprinkled on soft food. The drug/food mixture should be swallowed immediately (avoid chewing)
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Safety of doses above 60 mg/kg/day is not established (2.1, 2.2)
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Complex Partial Seizures: Start at 10 to 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/day to achieve optimal clinical response; if response is not satisfactory, check valproate plasma level; see full prescribing information for conversion to monotherapy (2.1)
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Absence Seizures: Start at 15 mg/kg/day, increasing at 1 week intervals by 5 to 10 mg/kg/day until seizure control or limiting side effects (2.1)
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DOSAGE FORMS AND STRENGTHS
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Capsules: 125 mg (3)
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CONTRAINDICATIONS
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Hepatic disease or significant hepatic dysfunction (4, 5.1)
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Known hypersensitivity to the drug (4, 5.10)
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Urea cycle disorders (4, 5.4)
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WARNINGS AND PRECAUTIONS
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Hepatotoxicity; monitor liver function tests (5.1)
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Teratogenic effects; weigh Depakote Sprinkle Capsules benefits against risk to the fetus (5.2)
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Pancreatitis; Depakote Sprinkle Capsules should ordinarily be discontinued (5.3)
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Suicidal behavior or ideation; Antiepileptic drugs, including Depakote increase the risk of suicidal thoughts or behavior (5.5)
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Thrombocytopenia; monitor platelet counts and coagulation tests (5.6)
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Hyperammonemia and hyperammonemic encephalopathy; measure ammonia level if unexplained lethargy and vomiting or changes in mental status (5.7, 5.8)
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Hypothermia; Hypothermia has been reported during valproate therapy with or without associated hyperammonemia. This adverse reaction can also occur in patients using concomitant topiramate (5.9)
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Multi-organ hypersensitivity reaction; discontinue Depakote Sprinkle Capsules (5.10)
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Somnolence in the elderly can occur. Depakote Sprinkle capsules dosage should be increased slowly and with regular monitoring for fluid and nutritional intake (5.12)
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ADVERSE REACTIONS
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