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Precedex ®

Indications and Safety Information

Precedex is indicated for sedation in nonintubated patients prior to and during surgical and other procedures and in intubated and mechanically ventilated patients during treatment in an intensive care setting.

Precedex should be administered by continuous infusion not to exceed 24 hours.

Caution should be exercised when administering Precedex to patients with advanced heart block and/or severe ventricular dysfunction.

Clinically significant episodes of bradycardia, sinus arrest and hypotension have been associated with Precedex infusion and may necessitate medical intervention.

Please see a more complete description of these and other Warnings and Precautions in the full prescribing information.

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Dosing in Special Patient Populations

Geriatric use

Precedex 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.1

Hepatic impairment

Since Precedex clearance decreases with severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function.1

Renal impairment

Precedex pharmacokinetics (Cmax, Tmax, AUC, t½, CL, and Vss) were not significantly different in patients with severe renal impairment (creatinine clearance <30 mL/min) compared to healthy subjects. However, the pharmacokinetics of the metabolites of Precedex have not been evaluated in patients with impaired renal function. Since the majority of metabolites are excreted in the urine, it is possible that the metabolites may accumulate upon long-term infusions in patients with impaired renal function.1

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Precedex should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.1

Labor and delivery

The safety of Precedex during labor and delivery has not been studied. Therefore, Precedex is not recommended during labor and delivery including cesarean section deliveries.1

Nursing mothers

It is not known whether Precedex is excreted in human milk. Radio-labeled Precedex administered subcutaneously to lactating female rats was excreted in milk. Because many drugs are excreted in human milk, caution should be exercised when Precedex is administered to a nursing woman.1

Pediatric use

There have been no clinical studies to establish the safety and efficacy of Precedex in pediatric patients below 18 years of age. Therefore, Precedex should not be used in this population.1