Uses

Divalproex sodium extended-release tablets are indicated for the acute treatment of manic or mixed episodes in bipolar disorder, monotherapy and adjunctive therapy of complex partial seizures and absence seizures, and prophylaxis of migraine headaches.

Do not use if

Contraindicated in patients with hepatic disease or significant hepatic dysfunction, known urea cycle disorders, known mitochondrial disorders caused by POLG mutations, and in children under 2 years suspected of having POLG-related disorders. Contraindicated in pregnancy for migraine prophylaxis.

Side effects

Common adverse effects include nausea, vomiting, diarrhea, weight gain, tremor, alopecia, and thrombocytopenia. Serious adverse effects include hepatotoxicity (potentially fatal), pancreatitis, hyperammonemic encephalopathy, and teratogenicity (neural tube defects, decreased IQ in offspring).

Warnings

BLACK BOX WARNING: Fatal hepatotoxicity has occurred, usually within the first 6 months; monitor LFTs closely. Valproate causes major congenital malformations and decreased cognitive function in children born to mothers treated during pregnancy — avoid in pregnancy if alternatives exist. Fatal pancreatitis has been reported.

How it works

Divalproex sodium dissociates in the gastrointestinal tract to the valproate ion. Valproate's antiepileptic mechanism is not fully elucidated but is believed to involve increasing brain GABA concentrations, inhibiting voltage-gated sodium channels, and modulating T-type calcium channels, thereby stabilizing neuronal membranes.

Storage

Store at room temperature (20–25°C). Keep in a dry place away from moisture and excessive heat.