FDA Approves Dexmedetomidine Hydrochloride for ICU and Procedural Sedation in Adults

Dexmedetomidine is an alpha-2 adrenergic receptor agonist.

Dexmedetomidine is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting, and for sedation of non-intubated adult patients prior to and/or during surgical and other procedures.

Administer intravenously using a controlled infusion device. Duration should not exceed 24 hours. For ICU sedation: loading infusion of 1 mcg/kg over 10 minutes, followed by maintenance infusion of 0.2 to 0.7 mcg/kg/hour. For procedural sedation: loading infusion of 1 mcg/kg over 10 minutes (0.5 mcg/kg for patients over 65 or less invasive procedures), followed by maintenance infusion initiated at 0.6 mcg/kg/hour, titrated to effect (range 0.2 to 1 mcg/kg/hour). Dose reduction should be considered in patients over 65 years and those with hepatic impairment. Dexmedetomidine Injection must be diluted prior to administration; Dexmedetomidine in 5% Dextrose Injection single-dose bags do not require dilution. Continuously monitor blood pressure, heart rate, and oxygen levels during administration.

Not reported in label.

Not reported in label.

Dexmedetomidine provides sedation for ICU and procedural settings, particularly useful when respiratory depression is a concern. It is an alternative to other sedatives and should be administered only by healthcare providers skilled in ICU or operating room patient management.