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.

Concomitant Medications

In this section:

Opioid sparing in ICU patients
Opioid sparing in nonintubated patients
Titration to effect
Phase III studies

Precedex reduces the need for opioids without compromising patient comfort in the ICU1-3

Key Findings

Less than half the number of patients on Precedex (28%) required morphine to manage postoperative pain vs 63% of patients on propofol.
The mean dose of morphine required to provide adequate analgesia was four times less in patients sedated with Precedex vs those sedated with propofol.

Precedex-based vs propofol-based sedation3

Results from a randomized, open-label multicenter trial of 295 adults undergoing CABG surgery.
At sternal closure, patients received either Precedex at 1 mcg/kg over 20 minutes followed by maintenance dosages of 0.2 to 0.7 mcg/kg/hr or propofol.
Precedex and propofol were titrated to maintain a Ramsay sedation score ≥3 during intubation and ≥2 after extubation.
If a patient was unable to achieve the targeted level of sedation on Precedex alone, propofol could be administered.

Percent of patients requiring opioids to manage postoperative pain3

Mean hourly morphine dosages (when required) to maintain adequate analgesia for first 6 hours postextubation3

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Precedex reduces the need for opioids without compromising patient comfort during surgical or other procedures4

Key Finding

Compared to the placebo matching saline infusion ± rescue midazolam group, the Precedex group required significantly lower doses of fentanyl to maintain adequate analgesia during a variety of surgical procedures.

Results from 326 nonintubated patients requiring MAC sedation for elective surgeries or other procedures.
To maintain adequate patient comfort, fentanyl 25 mcg IV boluses were administered as needed for pain.
Patients received fentanyl for pain if they expressed a pain score of ≥3 during the procedure or ≥4 in the PACU.
Pain was measured on a scale of 0 to 10, where 0 = no pain and 10 = worst pain ever experienced.

Fentanyl dosages required to maintain adequate analgesia during surgical procedures4

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Titrate Precedex and concomitant medications to effect

Coadministration of Precedex with anesthetics, sedatives, hypnotics and opioids can enhance the pharmacodynamic effects of these agents. Specific studies have confirmed these effects with sevoflurane, isoflurane, propofol, alfentanil and midazolam. A decrease in the dosage of Precedex or the concomitant agent may be required.1

These effects have been demonstrated in pharmacodynamic studies of healthy subjects and in patients undergoing sedation while taking the medications listed below.

These clinical trials are of different designs in a variety of patient populations. Because clinical trials are conducted under widely varying conditions, rates observed may not be directly compared to other trials and may not always reflect the rates observed in practice.

^aSevoflurane. Dexmedetomidine 0.7 ng/mL decreased the MAC of sevoflurane by 17% in patients undergoing elective surgery.7
^bIsoflurane. Low- and high-dose infusions of dexmedetomidine decreased the end-tidal isoflurane concentration by 31%-50%, respectively, necessary to elicit the desired response in 50% of healthy subjects.8
^cIsoflurane. Dexmedetomidine decreased the MAC of isoflurane by 47% in patients who also received thiopental and alfentanil as induction agents.9
^dMidazolam. In healthy subjects, the effect of midazolam in combination with dexmedetomidine on sedation was synergistic, with greater degrees of synergy occurring at lower levels of sedation. At higher degrees of sedation, the augmentation of the effect of dexmedetomidine on midazolam was less pronounced.8
^ePropofol. In healthy subjects, dexmedetomidine reduced the propofol concentrations required for sedation and suppression of motor response by approximately one half. Propofol doses required for sedation and induction of anesthesia may have to be reduced in the presence of dexmedetomidine.10
^fMorphine. A single IV dose of 1 mcg/kg dexmedetomidine given 10 minutes before induction reduced postoperative morphine consumption by 28% at identical pain scores to control.11
^gAlfentanil. In the presence of dexmedetomidine, less alfentanil is needed to produce the same degree of pain relief.8

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Phase III studies

In Phase III placebo-controlled pivotal trials, patients were administered the study drug as well as a rescue sedative as needed to achieve an equivalent depth of sedation. Patients also received concomitant morphine or fentanyl as needed to control pain. Differences in coadministered dosages of rescue sedative and analgesics are shown in the following table for patients receiving Precedex and patients in the placebo control group.

Mean total dosages of coadministered sedatives and/or morphine in three placebo-controlled Phase III pivotal trials of Precedex in surgical ICU patients and patients undergoing MAC sedation.1,12

Patients in each study were titrated to achieve an equivalent level of sedation, either a Ramsay sedation score ≥3 or an OAA/S score ≤4.1 Patients received either morphine or fentanyl as needed to maintain adequate analgesia.1,12

*Two Precedex strengths were used in the trial (1 mcg/kg loading dose and 0.5 mcg/kg loading dose, respectively, over 10 minutes and titrated to effect).

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