In a randomized clinical trial the sedative effect of Valium injectable emulsion and Valium injection solution was compared at three different dose levels (0.04, 0.10 and 0.20 mg/kg b.w.). Approximately the same extent of sedation was observed with the two formulations indicating that the same dosing recommendations should apply. The data for Valium injectable emulsion were suggestive of a slightly lower bioavailability for diazepam in females compared to males given this formulation, and in younger patients (age 20-55), a relative potency for females compared to males of roughly 2/3. Twenty-three percent of the patients given Valium injection solution experienced pain at the site of injection compared to none in the diazepam injectable emulsion group. However, other comparative studies of Valium injectable emulsion administered intravenously have reported local pain in a range of 0 to 14% and injection site thrombohlebitis in a range of 0 to 6%, suggesting that intravenous administration of Valium injectable emulsion may be associated with some risk of such reactions.
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