VALNEX CR-200/300/500(SODIUM VALPROATE TABLETS)

DESCRIPTION

Valproate sodium  is the sodium salt of valproic acid designated as sodium 2propylpentanoate. Valproate sodium has a molecular weight of 166.2. It occurs as an essentially white and odorless, crystalline, deliquescent powder.

DOSAGE

Use of Depacon for periods of more than 14 days has not been studied. Patients should be switched to oral valproate products as soon as it is clinically feasible. Depacon should be administered as a 60 minute infusion (but not more than 20 mg/min) with the same frequency as the oral products.

CLINICAL PHARMACOLOGY

Valproate sodium  exists as the valproate ion in the blood. The mechanisms by which valproate exerts its therapeutic effects have not been established. It has been suggested that its activity in epilepsy is related to increased brain concentrations of gamma-aminobutyric acid (GABA).

INDICATIONS

Valproate sodium  is  indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Depacon is also indicated for use as sole and adjunctive therapy in the treatment of patients with simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures.

CONTRA INDICATIONS

Valproate sodium  should not be administered to patients with hepatic disease or significant hepatic dysfunction. Depacon is contraindicated in patients known to have mitochondrial disorders caused by mutations in mitochondrial DNA polymerase  and children under two years of age who are suspected of having a POLG-related disorder. Depacon is contraindicated in patients with known hypersensitivity to the drug. Depacon is contraindicated in patients with known urea cycle disorders

SIDE EFFECTS

Hepatic failure, Birth defects, Pancreatitis, Hyperammonemic encephalopathy, Bleeding and other hematopoietic disorders, Hypothermia, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan hypersensitivity reactions.

DRUG INTERACTIONS

Drugs that affect the level of expression of hepatic enzymes, particularly those that elevate levels of glucuronosyltransferases (such as ritonavir), may increase the clearance of valproate. For example, phenytoin, carbamazepine, and phenobarbital (or primidone) can double the clearance of valproate.

AVAILABILITY

VALNEX CR-200/300/500 is available in strips  of  ten  capsules containing SODIUM VALPROATE TABLETS.