Heart Rate & Blood Pressure Effects
In two pivotal Phase III clinical trials of ICU patients treated with Precedex, the largest mean decrease in heart rate was approximately 7% and the largest mean decreases in systolic and diastolic blood pressures were 10% and 11%, respectively.13
Precedex has been studied in two pivotal Phase III clinical trials of nonintubated patients receiving monitored anesthesia care (MAC) sedation for a variety of surgical procedures as well as in patients undergoing awake fiberoptic intubation.1
The table below shows the frequency at which Precedex-sedated patients undergoing MAC sedation may experience hypotension or bradycardia and the frequency at which certain types of interventions may be needed to manage these adverse events.
Incidence and interventions for hypotension, bradycardia in patients undergoing procedural sedation15
Treatment options for drug-induced bradycardia or hypotension
In Precedex clinical trials, atropine, glycopyrrolate and ephedrine 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.1,15
Glycopyrrolate dosing for drug-induced bradycardia or hypotension
Glycopyrrolate Injection may be used during surgery to counteract drug-induced or vagal reflexes and their associated arrhythmias (e.g., bradycardia). It should be administered intravenously as single doses of 0.1 mg (
Atropine dosing for drug-induced bradycardia or hypotension
Initial single doses in adults vary from around 0.5 to
When the recurrent use of atropine is essential in patients with coronary artery disease, the total dose should be restricted to 2 to
Ephedrine dosing for drug-induced bradycardia or hypotension
Ephedrine is indicated to counteract the hypotensive effects of spinal or other types of nontopical conduction anesthesia. Depending on the clinical circumstances, Ephedrine Sulfate Injection may be given subcutaneously, intramuscularly or intravenously. Usual adult dose: 25 to
Precedex Indications and UsagePrecedex is 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.
Precedex 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: 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 as 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.
- The most common adverse reactions (incidence > 2%) are hypotension, bradycardia, and dry mouth.