Sole & adjunctive therapy in the treatment of simple & complex absence seizures & adjunctively in multiple seizure types including absence seizures in adults & childn ≥10 yr.
View Depakene overdosage for action to be taken in the event of an overdose.
Administration
May be taken with or without food: May be taken w/ meals if GI discomfort occurs.
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; systemic primary carnitine deficiency w/ uncorrected hypocarnitinemia; urea cycle disorders (UCD); porphyria. Treatment of epilepsy or mania & prophylaxis of migraine attacks in pregnancy & women of childbearing potential.
Multi-organ hypersensitivity reactions. Not to be used for prophylaxis of post-traumatic seizures in patients w/ acute head trauma. Hepatotoxicity. Suicidal behavior & ideation. Discontinue if pancreatitis occurs; ammonia is increased; suspected or apparent signs of brain atrophy are present. Patients w/ hereditary neurometabolic syndromes caused by mutations in the gene for mitochondrial DNA polymerase γ (POLG) (eg, Alpers-Huttenlocher syndrome). 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. Hypothermia. Risk of rhabdomyolysis in patients w/ underlying carnitine palmitoyltransferase type II deficiency. Aggravated convulsions. Patients w/ DM. Not to be taken by patients w/ fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. May be harmful to the teeth. 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. Not to be abruptly discontinued in prevention of major seizures. Not recommended in concomitant use w/ carbapenems. Concomitant use w/ pivalate-conjugated medicines or other antiepileptics; topiramate. False interpretation of urine ketone test. Altered thyroid function test. May affect ability to drive or operate machinery. Hepatic dysfunction. Women of childbearing potential must use effective contraception w/o interruption during entire treatment. May impair fertility in men. Pregnancy & lactation. Childn <2 yr; female childn experiencing menarche. Elderly >65 yr.
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