The tolerability of Precedex (dexmedetomidine hydrochloride) was studied in one study in which healthy subjects were administered doses at and above the recommended dose of 0.2 to 0.7 mcg/kg/hr. The maximum blood concentration achieved in this study was approximately 13 times the upper boundary of the therapeutic range. The most notable effects observed in two subjects who achieved the highest doses were first degree atrioventricular block and second degree heart block. No hemodynamic compromise was noted with the atrioventricular block and the heart block resolved spontaneously within one minute.

Five patients received an overdose of Precedex (dexmedetomidine hydrochloride) in the intensive care unit sedation studies. Two of these patients had no symptoms reported; one patient received a 2 mcg/kg loading dose over 10 minutes (twice the recommended loading dose) and one patient received a maintenance infusion of 0.8 mcg/kg/hr. Two other patients who received a 2 mcg/kg loading dose over 10 minutes, experienced bradycardia and/or hypotension. One patient who received a loading bolus dose of undiluted Precedex (dexmedetomidine hydrochloride) (19.4 mcg/kg), had cardiac arrest from which he was successfully resuscitated.

None

Last reviewed on RxList: 11/15/2010
This monograph has been modified to include the generic and brand name in many instances.