Drug administration1

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 arrest1

Clinically significant episodes of bradycardia and sinus arrest have been reported with Precedex administration in young, healthy 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. If medical intervention is required, treatment may include:

1. Decreasing or stopping Precedex infusion
2. Increasing rate of IV fluid administration
3. Elevation of the lower extremities
4. 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 (such as glycopyrrolate or atropine) should be considered to modify vagal tone.

• In clinical trials, glycopyrrolate or atropine was 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 situations where other vasodilators or negative chronotropic agents are administered, coadministration of Precedex could have an additive pharmacodynamic effect and should be administered with caution.

Transient hypertension1

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.

Arousability1

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.