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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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Hemodynamic Profile

Cardiovascular response2

  • Moderate blood pressure and heart rate reductions should be anticipated with Precedex, consistent with alpha2-adrenoceptor agonist effects.
  • Caution should be exercised when administering Precedex to patients with advanced heart block and/or severe ventricular dysfunction.
  • Clinically significant episodes of bradycardia and sinus arrest have been associated with Precedex administration in young, healthy volunteers with high vagal tone or with different routes of administration including rapid intravenous or bolus administration.
  • Overall, the most frequently observed treatment-emergent adverse events include hypotension, bradycardia and dry mouth.
  • Transient hypertension has been observed primarily during loading infusion; treatment has generally not been necessary, though reducing the loading infusion may be necessary.

Largest mean changes in heart rate*
(as observed from baseline in patients in Phase II/III continuous infusion sedation studies)13

*Largest mean changes observed at 10 min in the Precedex group and 7 hr in the placebo group.

Largest mean changes in blood pressure
(as observed from baseline in patients in Phase II/III continuous infusion sedation studies13

Largest mean changes observed at 12 hr in the Precedex group and 30 min (SBP) and 20 min (DBP) in the placebo group.

Heart rate and blood pressure effects of Precedex and propofol for 24 hours of administration

Effects of Precedex and propofol on heart rate14

Systolic and diastolic blood pressure effects: Precedex vs propofol14