The tolerability and safety of valproate sodium injection given as an intravenous infusion

Abstract

Patients with epilepsy may sometimes require antiepileptic drugs (AEDs) parenterally. This study assessed the safety and tolerability of valproate sodium injection (IV valproate) (Depacon, Abbott Laboratories, Abbott Park, IL), given by intravenous infusion, as replacement therapy for oral valproate in a placebo-controlled trial involving stable epilepsy inpatients on steady doses of divalproex sodium (DVPX). Thirty-four patients received IV valproate and oral placebo, and 17 received IV placebo and oral DVPX (Depakote, Abbott Laboratories) every 6 hours for 4 days. The dose of IV valproate was the same (milligram for milligram) as that of previous oral DVPX. Concomitant AEDs were continued as usual. No serious adverse events were observed with IV valproate, nor were any clinically significant differences found between study groups for changes in average, minimum, or maximum systolic or diastolic blood pressure or heart rate. Positional changes caused no significant group differences in these variables, and no evidence of either acute or cumulative cardiotoxicity was found. The only changes found in laboratory values were increased SGOT and SGPT levels in the IV valproate group, compared with decreases in the control group ( P = 0.014 and 0.001, respectively). In conclusion, intravenous sodium valproate appears to be a well-tolerated substitute for an equivalent dose of oral valproate.