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HomeEfficacyEfficacyIntensive Care Unit SedationProcedural SedationAdult PatientsPediatric PatientsSafetyDosing and AdministrationDosing and
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Prescribing Information Indication

For additional safety information see full Prescribing Information.

Safety InformationClinical trial experience¹
Adult ICU Sedation Population
Adverse reactions with an incidence of >2%-adult ICU sedation population <24 hours*

Adult Procedural Sedation Population
Adverse reactions with an incidence of >2%

 ICU=intensive care unit; SpO2=oxygen saturation.26 subjects in the all PRECEDEX group and 10 subjects in the randomized PRECEDEX group had exposure for greater than 24 hours.Hypotension was defined in absolute and relative terms as Systolic blood pressure of <80 mmHg or ≤30% lower than pre-study drug infusion value, or Diastolic blood pressure of <50 mmHg.Respiratory depression was defined in absolute and relative terms as respiratory rate (RR) <8 beats per minute or >25% decrease from baseline.Bradycardia was defined in absolute and relative terms as <40 beats per minute or ≤30% lower than pre-study drug infusion value. Subjects in Study 2 were pretreated with glycopyrrolate 0.1 mg intravenously before receiving study drug.Hypertension was defined in absolute and relative terms as Systolic blood pressure >180 mmHg or ≥30% higher than pre-study drug infusion value or Diastolic blood pressure of >100 mmHg.Tachycardia was defined in absolute and relative terms as >120 beats per minute or ≥30% greater than pre-study drug infusion value.Hypoxia was defined in absolute and relative terms as SpO2 <90% or 10% decrease from baseline.The most common adverse reactions (incidence >5%) in pediatric patients aged 1 month to less than 17 years are bradypnea, bradycardia, hypertension, and hypotension

Pediatric patients during non-invasive procedure
Treatment-emergent adverse events with incidence >5%

 HR=heart rate.Bradypnea was defined as respiratory rate <1st centile of the age-adjusted normal range.Bradycardia was defined as a decrease in HR of 30% from baseline or absolute HR ≤1st centile of the age-adjusted normal range.For pediatric patients 1 month to less than 1 year old, hypertension was defined as supine systolic blood pressure ≥104 mmHg and/or diastolic blood pressure ≥56 mmHg measurements. For pediatric patients 1 to less than 17 years old: hypertension was defined as supine systolic blood pressure and/or diastolic blood pressure measurements ≥95th percentile for gender, age, and height.Hypotension was defined as a decrease in systolic blood pressure ≥30% from baseline.Hypoxia was defined as oxygen saturation <90% for any duration.Warnings and precautions for use¹Drug Administration

PRECEDEX should be administered only by persons skilled in the management of patients in the intensive care or operating room setting. Due to the known pharmacological effects of PRECEDEX, patients should be continuously monitored while receiving PRECEDEX.

Hypotension, Bradycardia, and Sinus Arrest

Clinically significant episodes of bradycardia and sinus arrest have been reported with PRECEDEX administration in young, healthy adult volunteers with high vagal tone or with different routes of administration including rapid intravenous or bolus administration.

Reports of hypotension and bradycardia have been associated with PRECEDEX infusion. Some of these cases have resulted in fatalities. If medical intervention is required, treatment may include decreasing or stopping the infusion of PRECEDEX, increasing the rate of intravenous fluid administration, elevation of the lower extremities, and use of pressor agents. Because PRECEDEX has the potential to augment bradycardia induced by vagal stimuli, clinicians should be prepared to intervene. The intravenous administration of anticholinergic agents (eg, glycopyrrolate, atropine) should be considered to modify vagal tone. In clinical trials, glycopyrrolate or atropine were effective in the treatment of most episodes of PRECEDEX-induced bradycardia. However, in some patients with significant cardiovascular dysfunction, more advanced resuscitative measures were required.

Caution should be exercised when administering PRECEDEX to patients with advanced heart block and/or severe ventricular dysfunction. Because PRECEDEX decreases sympathetic nervous system activity, hypotension and/or bradycardia may be expected to be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension and in elderly patients.

In clinical trials where other vasodilators or negative chronotropic agents were co-administered with PRECEDEX an additive pharmacodynamic effect was not observed. Nonetheless, caution should be used when such agents are administered concomitantly with PRECEDEX.

Transient Hypertension

Transient hypertension has been observed primarily during the loading dose in association with the initial peripheral vasoconstrictive effects of PRECEDEX. Treatment of the transient hypertension has generally not been necessary, although reduction of the loading infusion rate may be desirable.

Arousability

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.

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 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%.

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 of PRECEDEX (<2 hours).

Tolerance and Tachyphylaxis

Use of dexmedetomidine beyond 24 hours has been associated with tolerance and tachyphylaxis and a dose-related increase in adverse reactions.

Hyperthermia or Pyrexia

PRECEDEX may induce hyperthermia or pyrexia, which may be resistant to traditional cooling methods, such as administration of cooled intravenous fluids and antipyretic medications. Discontinue PRECEDEX if drug-related hyperthermia or pyrexia is suspected and monitor patients until body temperature normalizes.

Hepatic Impairment

Since PRECEDEX clearance decreases with severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function.

Special considerations for particular types of patient groups when using PRECEDEX¹Geriatric patients

Intensive Care Unit Sedation

A dose reduction may be considered in patients over 65 years of age.

Procedural Sedation

A reduced loading dose of 0.5 mcg/kg given over 10 minutes is recommended and a reduction in the maintenance infusion should be considered for patients greater than 65 years of age.

Patients with hepatic impairment

Dose reduction should be considered in patients with impaired hepatic function.

ARDS=acute respiratory distress syndrome.
HR=heart rate.

Please see full Prescribing Information for PRECEDEX.ReferencePRECEDEX [prescribing information]. Lake Forest, IL: Hospira Inc., December 2022. 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.