Valparin XR 500

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

Epilepsy Adult 600 mg daily in 2 divided doses. May be increased by 200 mg every 3 days to 1-2 g daily (20-30 mg/kg daily) up to max 2.5 g daily if adequate control has not been achieved. Childn 20-30 mg/kg daily. May be increased to 40 mg/kg daily in severe cases but only w/ monitored plasma levels. Patient on other anticonvulsants (phenytoin, phenobarb, & carbamazepine) Initiation therapy should be gradual, w/ target dose being reached after about 2 wk, to raise dose by 5-10 mg/kg daily. Bipolar Initial dose: 20 mg/kg/day. Maintenance dose: 1,000-2,000 mg daily. Max dose: 3,000 mg daily.

Should be taken with food.

Hypersensitivity. Acute & chronic hepatitis, family history of severe hepatitis, drug-induced hepatitis, porphyria. Patients known to have mitochondrial disorders caused by mutations in the nuclear gene encoding mitochondrial enzyme polymerase γ.

Reports of liver damage resulting in fatalities. Patients most-at-risk, especially in cases of multiple anticonvulsant therapy, are infants & young childn <3 yr w/ severe seizure disorders. Perform LFTs before beginning treatment & periodic monitoring during the 1st 6 mth, especially in at-risk patients. Reports of pancreatitis; determine serum amylase level before deciding on surgery. Blood tests (including cell count, platelet count, bleeding time & coagulation tests) are recommended prior to initiation of therapy & surgery, & in case of spontaneous bruising or bleeding. Caution in patients w/ SLE. Discontinue therapy if ammonia is increased. Reports of hypothermia. Monitor for signs of suicidal ideation & behaviors. May lead to false interpretation of urine ketone test. Do not use concurrently salicylates in childn <3 yr. Women of childbearing potential must use effective contraception during treatment. Do not use in childn, female adolescents, women of childbearing potential & pregnant women unless alternative treatments are ineffective or not tolerated. Discontinue breast-feeding or discontinue/abstain from therapy taking into account the benefit of breast-feeding for the child & of therapy for woman.

Confusion or convulsions; GI disturbances eg, nausea, gastric pain; transient dose-dependent adverse effects eg, hair loss, fine postural tremor; wt gain, amenorrhea & menstrual disturbances; dose-related rise in bleeding time, decrease in fibrinogen; thrombocytopenia; isolated hyperammonaemia.

Generalized convulsions may be promoted by imipramine antidepressants. Increased plasma conc of phenobarb. Decreased plasma conc of total phenytoin. Increased plasma levels of primidone w/ enhanced adverse effects (sedation). Reports of clinical toxicity w/ carbamazepine. May reduce metabolism of lamotrigine. May decrease mean clearance of felbamate. May raise plasma conc of zidovudine. Increased metabolism w/ mefloquine & chloroquine. Clinically significant reduction in serum conc w/ carbapenems. Absorption may be decreased w/ colestyramine. Blood levels may be decreased w/ rifampicin. Risk of encephalopathy &/or hyperammonaemia w/ topiramate. Free serum levels may be increased w/ highly protein-bound drugs (eg, aspirin); cimetidine or erythromycin. Perform close monitoring of prothrombin time in concomitant use w/ vit K-dependent anticoagulant.

Anticonvulsants

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

Rx