Valpros Pedia

Monotherapy or adjunctive therapy of complex partial seizures &/or simple or complex absence seizures, including petit mal & is useful in primary generalized seizures w/ tonic-clonic manifestations. Adjunctive therapy of multiple seizure types including absence seizures or tonic-clonic seizures. Manic episodes, maintenance & prophylactic treatment of bipolar disorder.

Epilepsy Monotherapy in adult Initially 600 mg/day increasing by 200/day at 3-day intervals until control is achieved. Dose range: 1,000-2,000 mg/day (ie, 20-30 mg/kg/day). When adequate control is not achieved, may be further increased to max of 2,500 mg/day (in divided doses). Childn >20 kg Initially 400 mg/day (irrespective of wt) w/ spaced increases until control is achieved (dose range: 20-30 mg/kg/day), if adequate control of seizure is not achieved, may be increased to 35 mg/kg/day, <20 kg 20 mg/kg/day, may be increased in severe cases, but only in patient w/ monitored plasma valproate levels. Combined therapy in patient already on other anticonvulsants Taper dose slowly. Used in combination w/ anticonvulsants which induce liver enzyme activity (eg, phenytoin, phenobarb & carbamazepine) Initiate gradually w/ target dose being reached after about 2 wk. May increase dose by 5-10 mg/kg/day if necessary when used in combination w/ anticonvulsants. Bipolar disorder Adult ≥18 yr Initially 600 mg/day in 2-3 divided doses. Day 2: Increase dose as rapidly as possible to achieve the lowest therapeutic dose. Dose range: 1,000-2,000 mg/day (ie, 20-30 mg/kg/day). If adequate control is not achieved, may increase dose to max of 2,500 mg/day.

Should be taken with food.

Hypersensitivity. Patients w/ preexisting, acute or chronic hepatic dysfunction or history of severe hepatic dysfunction, especially drug-related. Patients known to have mitochondrial disorders caused by mutations in mitochondrial DNA polymerase-γ gene & childn <2 yr suspected of having a POLG-related disorder; urea cycle disorders. Porphyria. Pregnancy & lactation.

May cause major congenital malformations eg, neural tube defects. Cases of life-threatening pancreatitis. Hepatotoxicity may occur; increased risk of developing fatal hepatotoxicity in childn <2 yr. Patients w/ hereditary neurometabolic syndromes. Risk of transient drowsiness. Women of childbearing potential. Pregnancy & lactation.

Pain, peripheral edema; chest pain, vasodilation, vasculitis, wt gain, hyperammonemia, hyponatremia; headache, dizziness, nervousness, sedation, ataxia, paresthesia, hypesthesia, Parkinsonism, tremor, reversible dementia, somnolence, hallucinations, encephalopathy, coma, lethargy, confusion, abnormal gait, aggression, increased alertness, hyperactivity, behavioral deterioration; abdominal pain, diarrhea, nausea, vomiting, pancreatitis; thrombocytopenia, anemia, leukopenia, pancytopenia, bone marrow suppression, red cell hypoplasia, agranulocytosis; hepatic dysfunction & failure, increased liver enzymes; pharyngitis, pneumonia; hearing loss, taste perversion; amenorrhea, irregular menses, breast enlargement; TEN, SJS, erythema multiforme.

May potentiate CNS depressant activity of alcohol. May increase free-valproate conc & inhibit metabolism of valproate w/ aspirin. May enhance effects of vit K-dependent factor anticoagulants (eg, coumarin, warfarin). Decreased blood levels when co-administered w/ carbapenems (eg, ertapenem, imipinem, meropenem) & rifampicin. Inhibited metabolism by fluoxetine & chlorpromazine & increased metabolism w/ mefloquine & chloroquine. Increased risk of adverse events associated w/ olanzapine. May inhibit metabolism of carbamazepine & diazepam; ethosuximide. Increased plasma levels w/ cimetidine or erythromycin. Increased serum conc w/ felbamate. May increase toxicity of lamotigrine. Increased plasma levels w/ cimetidine or erythromycin. May increase phenobarb plasma conc & primidone plasma levels. May be associated w/ hyperammonemia w/ or w/o encephalopathy w/ topiramate; induce absence status in patients w/ history of absence type seizure in concomitant use w/ clonazepam. May decrease plasma clearance of lorazepam, zidovudine & temozolomide. Decreased absorption w/ cholestyramine.

Anticonvulsants

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

Rx