Precedex (Dexmedetomidine hydrochloride) Drug Information: Overdosage and Contraindications

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May 27, 2012

Precedex

Sleep Disorder Drugs »

Sleep disorder drugs (hypnotic and sedative drugs) overview

Insomnia, a disorder of sleep, occurs occasionally in most people but usually lasts only a few days. The body then "corrects" itself naturally, and people return to a normal pattern of sleep. Insomnia may be short-term (less than three weeks) or chronic, lasting longer than three weeks. Contributing factors include, but are not limited to, poor sleeping habits, stress, jet lag, medications, disease, and depression. Chronic insomnia may warrant the use of sedative/hypnotics medications; however, it is important that the treating physician perform a complete diagnostic evaluation as well as take medication and substance abuse histories, to exclude secondary insomnia due to other conditions.

Hypnotics/sedatives medications (henceforth referred to as hypnotics) work, in general, by increasing the activity of gamma-aminobutyric acid (GABA), a neurotransmitter in the brain. Neuro...

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Precedex

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OVERDOSE

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.