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IMPORTANT SAFETY INFORMATION AND INDICATIONS

IMPORTANT SAFETY INFORMATION

Monitoring: Continuously monitor patients while receiving Precedex®.

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.

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).

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%) are hypotension, bradycardia, and dry mouth. 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.

INDICATIONS

Precedex® (dexmedetomidine hydrochloride) is a relatively selective alpha2-adrenergic agonist indicated for:

  • Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Administer Precedex® by continuous infusion not to exceed 24 hours.
  • Sedation of non-intubated patients prior to and/or during surgical and other procedures.