The tolerability of Precedex® was noted 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 AV block and second degree heart block. No hemodynamic compromise was noted with the AV block and the heart block resolved spontaneously within one minute.

Five patients received an overdose of Precedex® in the ICU 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® (19.4 mcg/kg), had cardiac arrest from which he was successfully resuscitated.

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