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PRECEDEX Drug Abuse and Dependence (dexmedetomidine hydrochloride injection)

9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

PRECEDEX (dexmedetomidine hydrochloride) is not a controlled substance.

9.3 Dependence

The dependence potential of PRECEDEX has not been studied in humans. However, since studies in rodents and primates have demonstrated that PRECEDEX exhibits pharmacologic actions similar to those of clonidine, it is possible that PRECEDEX may produce a clonidine-like withdrawal syndrome upon abrupt discontinuation [see Warnings and Precautions (5.5)].

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