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HomeEfficacyEfficacyIntensive Care Unit SedationProcedural SedationAdult PatientsPediatric PatientsSafetyDosing and AdministrationDosing and
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Prescribing Information Indication
Intensive Care Unit SedationThe efficacy of PRECEDEX was studied in two randomized, double-blind, parallel-group, placebo-controlled, multicenter clinical trials and one controlled clinical trial vs midazolam for ICU sedation.¹Study 1 - Description

In a randomized, double-blind, parallel-group, placebo-controlled, multicenter clinical trial, 175 adult patients treated in a surgical intensive care unit received placebo and 178 received PRECEDEX by intravenous infusion at a dose of 0.4 mcg/kg/hr (with allowed adjustment between 0.2 mcg/kg/hr and 0.7 mcg/kg/hr) following an initial loading infusion of 1 mcg/kg intravenous over 10 minutes. All patients were initially intubated and received mechanical ventilation. The study drug infusion rate was adjusted to maintain a Ramsay Sedation Scale score of ≥3. Patients were allowed to receive rescue midazolam as needed to augment the study drug infusion. In addition, morphine sulfate was administered for pain as needed. The primary outcome measure for this study was the total amount of rescue medication (midazolam) needed to maintain sedation as specified while intubated.

 Study 1: Midazolam Use as Rescue Medication During Intubation (ITT) to evaluate total amount of rescue medication (midazolam) needed to maintain sedation as specified while intubated¹

The primary outcome measure for this study was the total amount of rescue medication (midazolam) needed to maintain sedation as specified while intubated. Patients randomized to placebo received significantly more midazolam than patients randomized to PRECEDEX.

 Midazolam Use as Rescue Medication During Intubation (ITT) Study One

ITT (intent-to-treat) population includes all randomized patients.
*ANOVA model with treatment center.
†Chi-square.

  • A prospective secondary analysis assessed the dose of morphine sulfate administered to adult patients in the PRECEDEX and placebo groups. On average, PRECEDEX-treated patients received less morphine sulfate for pain than placebo-treated patients (0.47 versus 0.83 mg/h). In addition, 44% (79 of 178 patients) of PRECEDEX patients received no morphine sulfate for pain versus 19% (33 of 175 patients) in the placebo group.
Study 2 - Description

In a randomized, double-blind, parallel-group, placebo-controlled, multicenter clinical trial, 198 adult patients treated in a surgical intensive care unit received placebo and 203 received PRECEDEX by intravenous infusion at a dose of 0.4 mcg/kg/hr (with allowed adjustment between 0.2 mcg/kg/hr and 0.7 mcg/kg/hr) following an initial loading infusion of 1 mcg/kg intravenous over 10 minutes. All patients were initially intubated and received mechanical ventilation. The study drug infusion was adjusted to maintain a Ramsay Sedation Scale score of ≥3. Patients were allowed to receive rescue propofol as needed to augment the study drug infusion. In addition, morphine sulfate was administered as needed for pain. The primary outcome measure for this study was the total amount of rescue medication (propofol) needed to maintain sedation as specified while intubated.

 Study 2: Propofol Use as Rescue Medication During Intubation (ITT) to evaluate total amount of rescue medication (propofol) needed to maintain sedation as specified while intubated¹

Patients on PRECEDEX received significantly less propofol to maintain sedation during intubation compared with placebo.

 Propofol Use as Rescue Medication During Intubation (ITT) Study Two

*ANOVA model with treatment center.
†Chi-square.

  • A prospective secondary analysis assessed the dose of morphine sulfate administered to adult patients in the PRECEDEX and placebo groups. On average, PRECEDEX-treated patients received less morphine sulfate for pain than placebo-treated patients (0.43 versus 0.89 mg/h). In addition, 41% (83 of 203 patients) of PRECEDEX patients received no morphine sulfate for pain versus 15% (30 of 198 patients) in the placebo group.
 Controlled clinical trial vs midazolam¹
  • In a controlled clinical trial, PRECEDEX was compared to midazolam for ICU sedation exceeding 24 hours duration.
  • PRECEDEX was not shown to be superior to midazolam for the primary efficacy endpoint, the percent of time patients were adequately sedated (81% vs 81%). In addition, administration of PRECEDEX for longer than 24 hours was associated with tolerance, tachyphylaxis, and a dose-related increase in adverse events.
ICU=intensive care unit.ReferencePRECEDEX [prescribing information]. Lake Forest, IL: Hospira Inc., December 2022.Efficacy Review Hanging Instructions for PRECEDEX Hanging Instructions Loading Learn more about PRECEDEX with these additional resources Additional Resources Loading

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PP-PDX-USA-0121
INDICATIONS AND USAGEIntensive Care Unit Sedation
 
  • PRECEDEX is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. PRECEDEX should be administered by continuous infusion not to exceed 24 hours.
  • PRECEDEX has been continuously infused in mechanically ventilated adult patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue PRECEDEX prior to extubation.
Procedural Sedation
 
  • PRECEDEX is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures.
  • PRECEDEX is indicated for sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures.
Please see full Prescribing Information.
Important Safety Information Monitoring: Continuously monitor patients while receiving PRECEDEX. Bradycardia and Sinus Arrest: Clinically significant episodes of bradycardia and sinus arrest have occurred in young healthy volunteers with high vagal tone or with different routes of administration, e.g., rapid intravenous or bolus administration. Hypotension and Bradycardia: Reports of hypotension and bradycardia have been associated with PRECEDEX infusion. Some of these cases have resulted in fatalities. May necessitate medical intervention. May be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension and in the elderly. Use with caution in patients with advanced heart block or severe ventricular dysfunction. Co-administration with other Vasodilators or Negative Chronotropic Agents: Use with caution due to additive pharmacodynamic effects. Transient Hypertension: Observed primarily during the loading dose. Consider reduction in loading infusion rate. Arousability: Patients can become aroused/alert with stimulation; this alone should not be considered lack of efficacy. Tolerance and Tachyphylaxis: Prolonged exposure to dexmedetomidine beyond 24 hours may be associated with tolerance and tachyphylaxis and a dose-related increase in adverse events. Withdrawal Intensive Care Unit Sedation: With administration up to 7 days, regardless of dose, 12 (5%) PRECEDEX adult subjects experienced at least 1 event related to withdrawal within the first 24 hours after discontinuing study drug and 7 (3%) PRECEDEX adult subjects experienced at least 1 event 24 to 48 hours after the end of study drug. The most common events were nausea, vomiting, and agitation. In adult subjects, tachycardia and hypertension requiring intervention in the 48 hours following study drug discontinuation occurred at frequencies of <5%. If tachycardia and/or hypertension occurs after discontinuation of PRECEDEX, supportive therapy is indicated. Procedural Sedation: In adult subjects, withdrawal symptoms were not seen after discontinuation of short-term infusions of PRECEDEX (<6 hours). In pediatric patients, mild transient withdrawal symptoms of emergence delirium or agitation were seen after discontinuation of short-term infusions. Specific Populations Dosage reductions should be considered for adult patients with hepatic impairment and for geriatric patients. Adverse Reactions The most common adverse reactions: (Incidence greater than 2%) in adults are hypotension, bradycardia, and dry mouth. (Incidence greater than 5%) in pediatrics aged 1 month to less than 17 years are bradypnea, bradycardia, hypertension, and hypotension. Adverse reactions associated with infusions greater than 24 hours in duration include acute respiratory distress syndrome, respiratory failure, and agitation. Drug Interactions 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 Precedex 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. IndicationsIntensive Care Unit Sedation
  • PRECEDEX is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. PRECEDEX should be administered by continuous infusion not to exceed 24 hours.
  • PRECEDEX has been continuously infused in mechanically ventilated adult patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue PRECEDEX prior to extubation.
Procedural Sedation
  • PRECEDEX is indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures.
  • PRECEDEX is indicated for sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures.
Please see full Prescribing Information.