Monograph Details
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Central Nervous System
> Mood disorders
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DEPAKOTE ER |
| Manufacturer |
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Abbott Laboratories |
| Legal Classification |
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Rx
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| Generic Name |
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Divalproex sodium 250mg, 500mg; ext-rel tabs. |
| Also |
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• DEPAKOTE
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| Indications |
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Acute manic or mixed episodes in bipolar disorder. |
| Children |
Not recommended.
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| Adults |
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Take once daily. Swallow whole. Initially 25mg/kg per day, max 60mg/kg per day. |
| Contraindications |
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Hepatic disease. Significant hepatic dysfunction. Urea cycle disorders. |
| Precautions |
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Discontinue if hepatic dysfunction, pancreatitis, thrombocytopenia, or hyperammonemic encephalopathy occurs. History of liver disease. Increased hepatotoxicity risk with congenital metabolic disorders, multiple AEDs, severe seizure disorders with mental retardation, organic brain disorders, in children <2 years of age. Monitor liver function and symptoms (esp. 1st 6 months). Follow-up if symptoms of hyperammonemia occur. Suicidal tendencies (monitor). Depakote ER is not bioequivalent to delayed-release tabs on mg/mg basis. Avoid abrupt cessation. Monitor platelets, bleeding time (at baseline, before surgery, and in pregnancy); reevaluate periodically. May affect HIV or CMV viral load (in vitro). Elderly (monitor fluid and nutritional intake, and for somnolence). Pregnancy (Cat.D): apprise females of childbearing potential of risks to fetus (eg, neural tube defects). Nursing mothers: not recommended. |
| Interactions |
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Monitor levels of valproate, ethosuximide, other anticonvulsants, and whenever an enzyme inducer is added or withdrawn. Potentiates carbamazepine, diazepam, ethosuximide, lamotrigine, phenobarbital, phenytoin, tolbutamide, warfarin, zidovudine, amitriptyline, nortriptyline. Potentiated by aspirin, felbamate. Levels reduced by rifampin, phenytoin, carbamazepine, phenobarbital. CNS depression with alcohol, other CNS depressants. Clonazepam may induce absence status in patients with history of absence seizures. May interfere with urine ketone and thyroid tests. Others: see literature. |
| Adverse Reactions |
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Dizziness, headache, GI upset, CNS effects (esp. somnolence), rash, cardiovascular effects, arthralgia, liver failure, acute pancreatitis, clotting abnormalities, thrombocytopenia, hyperammonemia, others. |
| How Supplied |
Tabs 125mg—100
Tabs 250mg, 500mg—100, 500
ER 250mg—60
ER 250mg, 500mg—100, 500 |
| Additional Resources |
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• Related Prescribing Note |
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