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Precedex ®

Indications and Safety Information

Precedex is indicated for sedation in nonintubated patients prior to and during surgical and other procedures and in intubated and mechanically ventilated patients during treatment in an intensive care setting.

Precedex should be administered by continuous infusion not to exceed 24 hours.

Caution should be exercised when administering Precedex to patients with advanced heart block and/or severe ventricular dysfunction.

Clinically significant episodes of bradycardia, sinus arrest and hypotension have been associated with Precedex infusion and may necessitate medical intervention.

Please see a more complete description of these and other Warnings and Precautions in the full prescribing information.

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Safety

Clinically significant episodes of bradycardia, sinus arrest and hypotension have been associated with Precedex infusion and may necessitate medical intervention.

Moderate blood pressure and heart rate reductions should be anticipated when initiating sedation with Precedex.

Overall, the most common treatment-emergent adverse reactions occurring in >2% of patients in both ICU and procedural sedation studies include1:

  • Hypotension
  • Bradycardia
  • Dry mouth

Transient hypertension has been observed primarily during loading infusion; treatment has generally not been necessary, though reducing the loading dose or administration rate may be necessary.1

Some patients receiving Precedex have been observed to be arousable and alert when stimulated. This alone should not be considered as evidence of lack of efficacy in the absence of other clinical signs and symptoms.1

Coadministration 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. Therefore, a decrease in the dosage of Precedex or the concomitant agent may be required in patients already sedated with other anesthetics, sedatives or opioid analgesics. Also, in patients already sedated with other agents, a loading dose may not be necessary.1