Dexmedetomidine

PRECEDEX is a alpha 2 -adrenergic receptor agonist indicated for: • 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. • Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. • Sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures.

PRECEDEX is a relatively selective centrally acting alpha 2 -adrenergic agonist with sedative properties. Alpha 2 selectivity is observed in animals following slow intravenous infusion of low and medium doses (10-300 mcg/kg). Both alpha 1 and alpha 2 activity is observed following slow intravenous infusion of high doses (≥1,000 mcg/kg) or with rapid intravenous administration.

• Individualize and titrate PRECEDEX dosing to desired clinical effect. • Administer PRECEDEX using a controlled infusion device. • The 200 mcg/50 mL, and 400 mcg/100 mL single-dose bottles do not require further dilution prior to administration. • 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. • 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.

None. None.

• Monitoring: Continuously monitor patients while receiving PRECEDEX. • 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. • 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. • Co-administration with Other Vasodilators or Negative Chronotropic Agents: Use with caution due to additive pharmacodynamic effects. • Transient Hypertension: Observed primarily during the loading dose. Consider reduction in loading infusion rate.

The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypotension, bradycardia and sinus arrest • Transient hypertension • The most common adverse reactions (incidence >2%) in adults are hypotension, bradycardia, and dry mouth. • The most common adverse reactions (incidence >5%) in pediatric patients aged 1 month to less than 17 years are bradypnea, bradycardia, hypertension, and hypotension. • Adverse reactions in adults, associated with infusions >24 hours in duration include ARDS, respiratory failure, and agitation.

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

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).