Monograph Details
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Central Nervous System
> Seizure disorders
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DEPAKENE SYRUP |
| Manufacturer |
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Abbott Laboratories |
| Legal Classification |
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Rx
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| Generic Name |
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Valproic acid (as sodium salt) 250mg/5mL. |
| Also |
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• DEPAKENE
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| Indications |
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Monotherapy or adjunct in complex partial seizures; simple or complex absence seizures. Adjunct in multiple seizure types. |
| Adults and Children |
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Swallow whole. Partial seizures: <10yrs: not recommended. ≥10yrs: Initially 10–15mg/kg per day, may increase by 5–10mg/kg per week. Conversion to monotherapy: see literature. Absence seizures: Initially 15mg/kg per day; may increase weekly by 5–10mg/kg per day. All: give in divided doses if total daily dose >250mg; max 60mg/kg per day. |
| Contraindications |
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Hepatic disease or significant hepatic dysfunction. Urea cycle disorders. |
| Precautions |
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Discontinue if hepatic dysfunction, pancreatitis, thrombocytopenia, or hyperammonemia occurs. History of liver disease; monitor liver function and clinical symptoms (esp. for 1st 6 months). Reevaluate periodically. Avoid abrupt cessation. Evaluate for urea cycle disorders. Increased risk of hepatotoxicity in patients with congenital metabolic disorders, multiple AEDs, severe seizure disorders with mental retardation, organic brain disorders, in children <2 years of age. Monitor platelets, bleeding time (at baseline, before surgery, and in pregnancy); reevaluate periodically. May affect viral load in HIV or CMV infection. Suicidal tendencies (monitor). Elderly (monitor fluid and nutritional intake, and for dehydration, somnolence, tremor, other adverse reactions). Pregnancy (Cat.D): apprise female patients of childbearing potential of risks to fetus (eg, neural tube defects). Nursing mothers. |
| Interactions |
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Monitor levels of valproate, ethosuximide, other anticonvulsants, and when 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 absence seizures. Concomitant topiramate may cause hyperammonemic encephalopathy. May interfere with urine ketone and thyroid tests. Others: see literature. |
| Adverse Reactions |
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GI upset, headache, asthenia, somnolence, tremor, dizziness, vision changes, ataxia, alopecia, weight changes, amnesia, tinnitus, infection, blood dyscrasias, bone marrow suppression, hepatotoxicity, acute pancreatitis, thrombocytopenia, hyperammonemia, metabolic abnormalities, others; rare: Fanconi's syndrome in children, Stevens-Johnson syndrome, multiorgan hypersensitivity reaction. |
| How Supplied |
Caps—100
Syrup—pt |
| Additional Resources |
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• Related Prescribing Note |
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