Depakote

[Divalproex]

In some patients with somnolence (approximately one-half), there was associated reduced nutritional intake and weight loss. There was a trend for the patients who experienced these events to have a lower baseline albumin concentration, lower valproate clearance, and a higher BUN. In elderly patients, dosage should be increased more slowly and with regular monitoring for fluid and nutritional intake, dehydration, somnolence, and other adverse events. Dose reductions or discontinuation of valproate should be considered in patients with decreased food or fluid intake and in patients with excessive somnolence (see DOSAGE AND ADMINISTRATION).

Thrombocytopenia

The frequency of adverse effects (particularly elevated liver enzymes and thrombocytopenia [see PRECAUTIONS]) may be dose-related. In a clinical trial of DEPAKOTE (divalproex sodium) as monotherapy in patients with epilepsy, 34/ 126 patients (27%) receiving approximately 50 mg/ kg/ day on average, had at least one value of platelets < 75 x 10 9 /L.
Approximately half of these patients had treatment discontinued, with return of platelet counts to normal.

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In the remaining patients, platelet counts normalized with continued treatment. In this study, the probability of thrombocytopenia appeared to increase significantly at total valproate concentrations of > 110 µg/ mL (females) or > 135 µg/ mL (males). The therapeutic benefit which may accompany the higher doses should therefore be weighed against the possibility of a greater incidence of adverse effects.

DOSAGE AND ADMINISTRATION

DEPAKOTE ER is an extended-release product intended for once-a-day oral administration.

DEPAKOTE ER tablets should be swallowed whole and should not be crushed or chewed.

Migraine

DEPAKOTE ER is indicated for prophylaxis of migraine headaches in adults. The recommended starting dose is 500 mg once daily for 1 week, thereafter increasing to 1000 mg once daily. Although doses other than 1000 mg once daily of DEPAKOTE ER have not been evaluated in patients with migraine, the effective dose range of DEPAKOTE (divalproex sodium delayed-release tablets) in these patients is 500-1000 mg/ day. As with other valproate products, doses of DEPAKOTE ER should be individualized and dose adjustment may be necessary. If a patient requires smaller dose adjustments than that available with DEPAKOTE ER, DEPAKOTE should be used instead.

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