Company:

Noven Therapeutics

Valproic acid 125mg, 250mg, 500mg; delayed-release caps.

Mania associated with bipolar disorder. Complex partial seizures. Absence seizures. Prophylaxis of migraine headaches.

Valproic acid dissociates into the valproate ion in the gastrointestinal tract. Although the exact mechanism of action is unknown, it is believed that valproate’s anti-epileptic activity is due to the increased brain concentration of gamma-aminobutyric acid (GABA).

Swallow whole. Give in 2–3 divided doses if total daily dose >250mg; max 60mg/kg per day. Mania: initially 750mg/day in divided doses. Complex partial seizures: <10years: not recommended. ≥10years: initially 10–15mg/kg per day; may increase at 1-week intervals by 5–10mg/kg per day. Conversion to monotherapy: see literature. Absence seizures: initially 15mg/kg per day; increase at 1-week intervals by 5–10mg/kg per day until seizures controlled or side effects occur. Migraine: initially 250mg twice daily; usual max 1g/day.

Hepatic disease. Significant hepatic dysfunction. Urea cycle disorders.

Discontinue if hepatic dysfunction, pancreatitis, thrombocytopenia, or hyperammonemia occurs. History of liver disease; monitor liver function and clinical symptoms (esp. for 1st 6 months). Evaluate for urea cycle disorders before starting therapy. Increased hepatotoxicity risk with congenital metabolic disorders, multiple AEDs, severe seizure disorders with mental retardation, organic brain disorders, in children <2 years of age. Avoid abrupt cessation. Monitor platelets, bleeding time (at baseline, before surgery, and in pregnancy); reevaluate periodically. May affect viral load in HIV or CMV infection (in vitro). Suicidal tendencies (monitor). Elderly (monitor fluid and nutritional intake, dehydration, somnolence, and others). Pregnancy (Cat.D): apprise female patients of childbearing potential of risks to fetus (eg, neural tube defects). Nursing mothers: not recommended.

Monitor levels of valproate, ethosuximide, other anticonvulsants, and when an enzyme inducer is added or withdrawn.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, carbapenem antibiotics. CNS depression with alcohol, other CNS depressants. Clonazepam may induce absence status in patients with absence seizures. Concomitant topiramate may cause hyperammonemia with or without encephalopathy. May interfere with urine ketone and thyroid tests. Others: see literature.

GI upset, headache, asthenia, somnolence, tremor, dizziness, vision changes, nystagmus, rash, ataxia, insomnia, alopecia, weight changes, emotional lability, abnormal thinking, tinnitus, blood dyscrasias, bone marrow suppression, hepatotoxicity, pancreatitis, thrombocytopenia, hyperammonemia, encephalopathy, hypothermia, metabolic abnormalities, others.

Register patients who become pregnant while taking valproic acid by calling (888) 233-2334.

Caps—100

8/29/08