Precedex Warnings, Precautions, Pregnancy, Nursing, Abuse - Dexmedetomidine hydrochloride

Precedex Warnings, Precautions, Pregnancy, Nursing, Abuse - Dexmedetomidine hydrochloride

WARNINGS

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

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

Some patients receiving PRECEDEX have been observed to be arousable and alert when stimulated. This alone should not be considered an evidence of lack of efficacy in the absence of other clinical signs and symptoms.

Reports of hypotension and bradycardia have been associated with PRECEDEX infusion. If medical intervention is required, treatment may include decreasing or stopping the infusion of PRECEDEX, increasing the rate of IV 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, atropine) should be considered to modify vagal tone. In clinical trials, atropine or glycopyrrolate 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.

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.

PRECEDEX infusion should not be coadministered through the same IV catheter with blood or plasma since physical compatibility has not been established. Safety and effectiveness of dexmedetomidine have not been evaluated in infusions over 24 hours. Dexmedetomidine is not indicated for infusions lasting over 24 hours (see INDICATIONS AND USAGE, DOSAGE AND ADMINISTRATION).

Although not specifically studied, if PRECEDEX is administered chronically and stopped abruptly, withdrawal symptoms similar to those reported for another alpha-2-adrenergic agent, clonidine, may result. These symptoms may include nervousness, agitation, and headaches, accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma. PRECEDEX should not be administered for greater than 24 hours (see INDICATIONS AND USAGE, DOSAGE AND ADMINISTRATION).

Dexmedetomidine had no effect on ACTH-stimulated cortisol release in dogs after a single dose; however, after the subcutaneous infusion of dexmedetomidine for one week, the cortisol response to ACTH was diminished by approximately 40%.

Since dexmedetomidine clearance decreases with severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function (see CLINICAL PHARMACOLOGY, Pharmacokinetics, DOSAGE AND ADMINISTRATION).