Veltila-500

Na valproate 333 mg, valproic acid 145 mg

Generalized epilepsy particularly w/ absence, clonic, tonic, myoclonic, tonic-clonic, atonic & mixed patterns of seizures, or specific syndromes (eg, West, Lennox-Gastaut); partial epilepsy w/ simple or complex & secondary generalized seizures. Treatment & prevention of mania associated w/ bipolar disorders.

May be given once or twice daily. Epilepsy Initially 10-15 mg/kg daily. Increase dosage successively at 2-3 day intervals to reach optimum dosage in about 1 wk. Adult 1,000-2,000 mg daily (20-30 mg/kg). May further increase to 2,500 mg daily or add another low dose anti-epileptic agent if adequate control is not achieved after 2 wk. Childn 20-30 mg/kg daily, may be increased to 35 mg/kg daily. Treatment & prevention of mania associated w/ bipolar disorders Initially 1,000 mg daily. May be increased to not >3,000 mg daily. Combination therapy May be necessary to raise dose by 5-10 mg/kg daily when used w/ anticonvulsants. Reduce dosage of barbiturates if sedation is observed.

Should be taken with food: Swallow whole, do not crush/chew.

Hypersensitivity. Active liver disease including acute & chronic hepatitis, personal or family history of hepatic dysfunction especially drug related, hepatic porphyria. Pregnancy.

Interrupt treatment in case of pancreatitis. Risk of wt gain at initiation of therapy; hyperammonemia. Patients w/ SLE; experiencing acute abdominal pain. Liver damage during 1st 6 mth of therapy. Non-specific symptoms usually of sudden onset eg, asthenia, anorexia, lethargy, drowsiness sometimes associated w/ repeated vomiting & abdominal pain. Recurrence of seizures in patients w/ epilepsy. Perform metabolic investigations prior to treatment when urea cycle enzymatic deficiency is suspected; biological investigations including prothrombin rate in patients w/ mild increased liver enzymes; LFTs before & periodically during the 1st 6 mth especially in patients at risk; blood tests (blood cell count, including platelet count, bleeding time & coagulation tests) prior to initiation of therapy or before surgery & in case of spontaneous bruising or bleeding. Mild increase in liver enzymes particularly at beginning of therapy. False +ve readings in urine testing of possible diabetics. May affect ability to drive & use machines. Renal insufficiency. Facial dysmorphia & multiple malformations particularly of limbs; induced neural tube defects, anencephaly, myelomeningocele & spina bifida during pregnancy. Start folate supplementation before pregnancy. Institute prenatal monitoring to detect possible occurrence of neural tube defect or another malformation. Lactation; consider cessation of therapy in lactating mothers w/ bipolar disorder. Haemorrhagic syndrome related to hypofibrinogenemia; afibrinogenemia in neonates whose mothers have taken Na valproate during pregnancy. Investigate platelet count, fibrinogen plasma level, coagulation tests & coagulation factors in neonates. Infant & young childn <3 yr w/ severe seizure disorders, particularly those w/ brain damage, mental retardation &/or congenital metabolic or degenerative disease. Avoid concomitant use w/ salicylates in childn <3 yr. Elderly.

Congenital & familial/genetic disorders eg, labial clefts & CV malformation, facial dysmorphia, haemorrhagic syndrome; nausea, gastralgia, diarrhoea; confusion, fine postural tremor & somnolence; hyperammonemia; thrombocytopenia, fibrinogen reduction or increased bleeding time; hair loss. SJS, TEN, erythema multiforme.

May potentiate effect of other psychotropics eg, neuroleptics, MAOIs, antidepressants & benzodiazepines. Increased plasma conc/levels of phenobarb; primidone; zidovudine. Decreased total plasma conc of phenytoin. May potentiate toxic effect of carbamazepine. May reduce metabolism & increase mean t_½ of lamotrigine. Antagonized anti-epileptic activity w/ antidepressants & neuroleptics. Decreased valproate serum conc w/ anti-epileptics w/ enzyme inducing effect (including phenytoin, phenobarb, carbamazepine); blood level w/ carbapenem antibiotics (eg, panipenem/meropenem). Increased valproate serum conc/levels w/ felbamate; cimetidine or erythromycin. Increased valproic acid metabolism w/ mefloquine. Lowered seizure threshold w/ chloroquine. Increased valproate free serum levels w/ highly protein bound agents (eg, aspirin). Increased anticoagulant effect of warfarin & other coumarin anticoagulants.

Anticonvulsants / Antipsychotics

N03AG01 - valproic acid ; Belongs to the class of fatty acid derivatives antiepileptic.

D