Adverse event information is derived from the placebo-controlled, continuous infusion trials of dexmedetomidine for sedation in the ICU setting in which 387 patients received Precedex®. Overall, the most frequently observed treatment-emergent adverse events included hypotension, hypertension, nausea, bradycardia, fever, vomiting, hypoxia, tachycardia and anemia (see Table 5).

Table 5: Treatment-Emergent Adverse Events Occurring in > 1% of All Dexmedetomidine-Treated Patients in the Randomized Placebo-controlled Continuous Infusion ICU Sedation Studies

The treatment-emergent adverse events in Table 6 were reported in ≤ 1% of all dexmedetomidine-treated patients that are potentially clinically relevant.

Table 6: Potentially Clinically Relevant Treatment-Emergent Adverse Events to Dexmedetomidine Reported in ≤ 1% of Patients in the Continuous Infusion ICU Sedation Trials

Drug Abuse And Dependence

Precedex® (dexmedetomidine hydrochloride) is not a controlled substance.

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

General

In vitro studies in human liver microsomes demonstrated no evidence of cytochrome P450 mediated drug interactions that are likely to be of clinical relevance.

Anesthetics/Sedatives/Hypnotics/Opioids

Co-administration of Precedex® with anesthetics, sedatives, hypnotics, and opioids is likely to lead to an enhancement of effects. Specific studies have confirmed these effects with sevoflurane, isoflurane, propofol, alfentanil, and midazolam. No pharmacokinetic interactions between dexmedetomidine and isoflurane, propofol, alfentanil and midazolam have been demonstrated. However, due to possible pharmacodynamic interactions, when co-administered with Precedex®, a reduction in dosage of Precedex® or the concomitant anesthetic, sedative, hypnotic or opioid may be required.

Neuromuscular Blockers

In one study of 10 healthy volunteers, administration of Precedex® for 45 minutes at a plasma concentration of 1 (one) ng/mL resulted in no clinically meaningful increases in the magnitude of neuromuscular blockade associated with rocuronium administration.

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