Do not administer IM. Risk of severe liver damage in infants & young childn <3 yr w/ severe epilepsy & epilepsy associated w/ brain disorders, psychomotor retardation &/or congenital metabolic or degenerative disease. Assess liver function prior to start of therapy, & then periodically during the 1st 6 mth of therapy. Discontinue use if abnormally low prothrombin time is confirmed, & pancreatitis occurs. Closely monitor for signs of suicidal ideation & behavior. Concomitant use w/ divalproate, valpromide; lamotrigine & penems. Patients w/ strict Na diet; urea cycle enzyme deficiency; systemic lupus erythematosus. Haemotological exam (CBC including platelets, bleeding time & coagulation test) prior to initiation of therapy, then after 15 days & at the end of therapy, & prior to surgery is recommended in case of spontaneous haematoma or bleeding. Avoid concomitant use of salicylates especially in childn. Renal insufficiency. Perform metabolic investigations (fasting & post-prandial serum ammon) prior to treatment in childn w/ history of unexplained hepatic or digestive disorders, lethargy or coma, mental retardation or family history of neonatal death or death in childhood metabolic investigations, in particular fasting & post-prandial serum ammonia. Risk of wt gain. False positive result of urine ketones in diabetics. Risk of rhabdomyolysis in patients w/ type II carnitine palmitoyltransferase deficiency. Alcohol intake during treatment is not recommended. May affect ability to drive or use machinery. Female adolescent, women of childbearing potential, pregnancy. Women of childbearing age should use effective contraception during treatment. Perform coagulation investigation including platelet count, fibrinogen, assay & clotting time in pregnant woman before delivery. Neonates. Lactation.