VALPROATE SODIUM

Anticonvulsant

Brand names: Valproate Sodium, Depakote, Depakene

Intravenous

Mechanism of Action

12.1 Mechanism of Action 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

neurodevelopmental disorders

neural tube defects

and other major congenital malformations

which may occur very early in pregnancy

5.3

5.4 )

Contraindications

• e.g.
• 5.3
• 5.4 ) and Use in Specific Populations ( 8.1 )] . • Hepatic disease or significant hepatic dysfunction ( 4
• 5.1 ) • Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG) ( 4
• 5.1 ) • Suspected POLG-related disorder in children under two years of age ( 4

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Hepatotoxicity; evaluate high risk populations and monitor serum liver tests ( 5
1 Hepatotoxicity General Information on Hepatotoxicity Hepatic failure resulting in fatalities has occurred in patients receiving valproate
Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting
Patients on multiple anticonvulsants, children, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease may be at particular risk

Known Side Effects

7 documented side effects by frequency

Drug Not Working

>10%

Drowsiness

1-10%

Fever

1-10%

Vomiting

0.1-1%

Diarrhea

0.1-1%

Weight Gain

0.1-1%

Condition Worsened

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravenous