PRECEDEX Highlights

PRECEDEX is a alpha2-adrenergic receptor agonist indicated for:

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Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer PRECEDEX by continuous infusion not to exceed 24 hours. (1.1)

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Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2)

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Sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures. (1.2)

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Individualize and titrate PRECEDEX dosing to desired clinical effect. (2.1)

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Administer PRECEDEX using a controlled infusion device. (2.1)

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Dilute the 200 mcg/2 mL (100 mcg/mL) vial contents in 0.9% sodium chloride solution to achieve required concentration (4 mcg/mL) prior to administration. (2.4)

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The 80 mcg/20 mL single-dose vial, and 200 mcg/50 mL, 400 mcg/100 mL, and 1,000 mcg/250 mL single-dose bottles do not require further dilution prior to administration. (2.4)

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For Adult Intensive Care Unit Sedation: Initiate at one mcg/kg over 10 minutes, followed by a maintenance infusion of 0.2 to 0.7 mcg/kg/hour. (2.2)

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For Adult Procedural Sedation: Initiate at one mcg/kg over 10 minutes, followed by a maintenance infusion initiated at 0.6 mcg/kg/hour and titrated to achieve desired clinical effect with doses ranging from 0.2 to 1 mcg/kg/hour. (2.2)

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For Sedation of Pediatric Patients During Non-invasive Procedures: Patients 1 month to less than 2 years old initiate at 1.5 mcg/kg over 10 minutes followed by a maintenance infusion of 1.5 mcg/kg/hourand titrated to achieve desired clinical effect with dosage ranging from 0.5 to 1.5 mcg/kg/hour; patients 2 to less than 18 years old initiate at 2.0 mcg/kg over 10 minutes followed by a maintenance infusion of 1.5 mcg/kg/hourand titrated to achieve desired clinical effect with dosage ranging from 0.5 to 1.5 mcg/kg/hour. (2.2)

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Alternative Doses: Recommended for patients over 65 years of age and awake fiberoptic intubation patients. (2.2)

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PRECEDEX Injection, 200 mcg/2 mL (100 mcg/mL) in a single-dose vial. To be used after dilution. (3)

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PRECEDEX in 0.9% Sodium Chloride Injection, 80 mcg/20 mL (4 mcg/mL) in a single-dose vial. Ready to use. (3)

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PRECEDEX in 0.9% Sodium Chloride Injection, 200 mcg/50 mL, 400 mcg/100 mL, and 1,000 mcg/250 mL (4 mcg/mL) in single-dose glass bottles. Ready to use. (3)

None. (4)

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Monitoring: Continuously monitor patients while receiving PRECEDEX. (5.1)

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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. (5.2)

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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. (5.2)

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Co-administration with Other Vasodilators or Negative Chronotropic Agents: Use with caution due to additive pharmacodynamic effects. (5.2)

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Transient Hypertension: Observed primarily during the loading dose. Consider reduction in loading infusion rate. (5.3)

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Arousability: Patients can become aroused/alert with stimulation; this alone should not be considered as lack of efficacy. (5.4)

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Tolerance and Tachyphylaxis: Prolonged exposure to dexmedetomidine beyond 24 hours may be associated with tolerance and tachyphylaxis and a dose-related increase in adverse events. (5.6)

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The most common adverse reactions (incidence >2%) in adults are hypotension, bradycardia, and dry mouth. (6.1)

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The most common adverse reactions (incidence >5%) in pediatric patients aged 1 month to less than 17 years are bradypnea, bradycardia, hypertension, and hypotension. (6.1)

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Adverse reactions in adults, associated with infusions >24 hours in duration include ARDS, respiratory failure, and agitation. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch.

Anesthetics, Sedatives, Hypnotics, Opioids: Enhancement of pharmacodynamic effects. Reduction in dosage of PRECEDEX or the concomitant medication may be required. (7.1)

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Geriatric Patients: Dose reduction should be considered. (2.2, 2.3, 5.2, 8.5)

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Hepatic Impairment: Dose reduction should be considered. (2.2, 2.3, 5.8, 8.6)