Generic Name and Formulations:
Valproic acid 250mg; soft-gel caps.
Indications for DEPAKENE:
Monotherapy or adjunct in complex partial seizures; simple or complex absence seizures. Adjunct in multiple seizure types.
Adults and Children:
Swallow caps whole. Partial seizures: <10yrs: not recommended. ≥10yrs: Initially 10–15mg/kg per day. Absence seizures: Initially 15mg/kg per day. Both: may increase weekly by 5–10mg/kg per day; max 60mg/kg per day; give in divided doses if total daily dose >250mg. Elderly: reduce initial dose and titrate slowly; monitor. Concomitant rufinamide: initiate at a low dose and titrate; see full labeling.
Hepatic disease or significant hepatic dysfunction. Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG). Suspected POLG-related disorder in children <2yrs of age. Urea cycle disorders.
Life-threatening adverse reactions (eg, hepatotoxicity, fetal risk, pancreatitis).
Increased risk of hepatotoxicity in patients with congenital metabolic disorders, multiple AEDs, severe seizure disorders with mental retardation, organic brain disorders, esp. in children <2yrs of age. Increased risk of major congenital malformations (eg, spina bifida) and decreased IQ scores. Discontinue if hepatic dysfunction, pancreatitis, thrombocytopenia, hyperammonemia, hypothermia, or DRESS/multi-organ hypersensitivity reactions occur. History of liver disease; monitor liver function and clinical symptoms prior to therapy and at frequent intervals (esp. for 1st 6 mos). Avoid abrupt cessation. Evaluate for urea cycle disorders. May affect viral load in HIV or CMV infection. Monitor motor and cognitive functions routinely. Monitor CBCs, coagulation tests (esp. if used in pregnancy). 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; avoid, if treatment necessary, use effective contraception. Nursing mothers.
Monitor levels of valproate, ethosuximide, other anticonvulsants, and when an enzyme inducer is added or withdrawn.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, propofol, rufinamide. Potentiated by aspirin, felbamate. Efficacy reduced by rifampin, phenytoin, carbamazepine, phenobarbital, carbapenems, estrogen-containing hormonal contraceptives; monitor serum valproate concentrations. CNS depression with alcohol, other CNS depressants. Clonazepam may induce absence status in patients with absence seizures. Concomitant topiramate may cause hyperammonemic encephalopathy, hypothermia. Separate dosing of cholestyramine by 3hrs. May interfere with urine ketone and thyroid tests. Others: see full labeling.
Abdominal pain, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspepsia, dyspnea, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rhinitis, somnolence, abnormal thinking, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss; hepatotoxicity, birth defects, pancreatitis, hyperammonemia, hypothermia.