Monotherapy & adjunctive therapy in the treatment of complex partial seizures that occur either in isolation or in association w/ other types of seizures in adults & childn ≥10 yr. Sole & adjunctive therapy in the treatment of simple & complex absence seizures & adjunctively in multiple seizure types that include absence seizures in adults & childn ≥10 yr. Acute manic or mixed episodes associated w/ bipolar disorder. Prophylaxis of migraine headaches.
Should be taken with food: Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity. Not to be administered to patients w/ hepatic disease or significant hepatic dysfunction. Mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG; eg, Alpers-Huttenlocher syndrome) & childn <2 yr suspected of having POLG-related disorder; urea cycle disorders (UCD); porphyria. Treatment of epilepsy or mania & prophylaxis of migraine attacks in pregnancy & women of childbearing potential.
Hepatotoxicity. Suicidal behavior & ideation. Discontinue if pancreatitis occurs; ammonia is increased; suspected or apparent signs of brain atrophy is present. Thrombocytopenia. Evaluate for UCD in patients w/ history of unexplained encephalopathy or coma, encephalopathy associated w/ protein load, pregnancy & postpartum, unexplained mental retardation, history of elevated plasma ammonia or glutamine; cyclical vomiting & lethargy, episodic extreme irritability, ataxia, low BUN, protein avoidance; family history of UCD or unexplained infant deaths (particularly males); other signs or symptoms of UCD. Patients w/ inborn errors of metabolism or reduced hepatic mitochondrial activity may be at increased risk for hyperammonemia w/ or w/o encephalopathy. Increased risk for symptomatic hypocarnitinemia in patients w/ metabolic disorders including mitochondrial disorders related to carnitine. Can seriously harm an unborn baby. Always use effective contraception during the treatment. Hypothermia. Risk of rhabdomyolysis in patients w/ underlying carnitine palmitoyltransferase type II deficiency. Check plasma levels in patients w/ medication residue in the stool. Aggravated convulsions. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not to be used for prophylaxis of post-traumatic seizures in patients w/ acute head trauma. Perform LFTs prior to therapy & at frequent intervals thereafter especially during the 1st 6 mth. Monitor platelet count & coagulation parameters prior to surgery, before initiating therapy & at periodic intervals. Concomitant use w/ carbapenem antibiotics (not recommended) & topiramate. False interpretation of urine ketone test. Altered thyroid function test. May affect ability to drive or operate machinery. Hepatic dysfunction. Use effective contraception w/o interruption during entire treatment in women of childbearing potential. Pregnancy & lactation. Childn <2 yr. Elderly >65 yr.
Sign Out
