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Dexmeto

Dexmeto Special Precautions

dexmedetomidine

Manufacturer:

Fahrenheit
Full Prescribing Info
Special Precautions
Reports of hypotension and bradycardia have been associated with dexmedetomidine infusion. If medical intervention is required, treatment may include decreasing or stopping the infusion of dexmedetomidine, increasing the rate of IV fluid administration, elevation of the lower extremities, and use of pressor agents. Because dexmedetomidine has the potential to augment bradycardia induced by vagal stimuli, clinicians should be prepared to intervene. The intravenous administration of anticholinergic agents (e.g., atropine) should be considered to modify vagal tone. Atropine or glycopyrrolate were effective in the treatment of most episodes of dexmedetomidine induced bradycardia. However, in some patients with significant cardiovascular dysfunction, more advanced resuscitative measures were required.
Caution should be exercised when administering dexmedetomidine to patients with advanced heart block and/or severe ventricular dysfunction. Because dexmedetomidine decreases sympathetic nervous system activity, hypotension and/or bradycardia may be expected to be more pronounced in hypovolemic patients and in those with diabetes mellitus or chronic hypertension and in the elderly.
In situations where other vasodilators or negative chronotropic agents are administered, co-administration of dexmedetomidine could have an additive pharmacodynamic effect and should be administered with caution.
Treatment of the transient hypertension has generally not been necessary, although reduction of the loading infusion rate may be desirable.
Dexmedetomidine infusion should not be co-administered through the same IV catheter with blood or plasma because physical compatibility has not been evaluated in infusions over 24 hours.
Dexmedetomidine is not indicated for infusions lasting over 24 hours (see Indications, Dosage & Administration).
Withdrawal: If dexmedetomidine is administered chronically and stopped abruptly, withdrawal symptoms similar to those reported for another alpha-2-adrenergic agent, clonidine, may result. These symptoms include nervousness, agitation, and headaches, accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma.
Dexmedetomidine should not be administered for greater than 24 hours (see Indications, Dosage & Administration).
Drug Abuse and Dependence: Dexmedetomidine (dexmedetomidine hydrochloride) is not a controlled substance.
The dependence potential of dexmedetomidine has not been studied in humans. However, dexmedetomidine exhibits pharmacologic actions similar to those of clonidine, it is possible that dexmedetomidine may produce a clonidine-like withdrawal syndrome upon abrupt discontinuation (see withdrawal as previously mentioned).
Hepatic Impairment: Since dexmedetomidine clearance decreases with severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function (see Pharmacology under Actions, Dosage & Administration).
Use in Children: There have been no clinical studies to establish the safety and efficacy of dexmedetomidine in pediatric patients below 18 years of age. Therefore, dexmedetomidine is not recommended for use in this population.
Use in the Elderly: A dose reduction may be considered in patients over 65 years of age.
Dexmedetomidine is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in elderly patients, and it may be useful to monitor renal function.
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