FDA Approves Precedex (dexmedetomidine) for Pediatric Procedural Sedation

Precedex is an alpha-2 adrenergic receptor agonist.

Precedex is indicated for sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting (continuous infusion not to exceed 24 hours). It is also indicated for sedation of non-intubated adult patients prior to and/or during surgical and other procedures. Additionally, Precedex is indicated for sedation of non-intubated pediatric patients aged 1 month to less than 18 years prior to and during non-invasive procedures.

Dosing should be individualized and titrated to desired clinical effect. Administer using a controlled infusion device. For adult ICU sedation: loading infusion of 1 mcg/kg over 10 minutes, then maintenance infusion of 0.2 to 0.7 mcg/kg/hour. For adult procedural sedation: loading infusion of 1 mcg/kg over 10 minutes (0.5 mcg/kg for less invasive procedures or patients over 65), then maintenance infusion initiated at 0.6 mcg/kg/hour and titrated (range 0.2 to 1 mcg/kg/hour). For pediatric procedural sedation (1 month to <2 years): loading infusion of 1.5 mcg/kg over 10 minutes, then maintenance infusion of 1.5 mcg/kg/hour (range 0.5 to 1.5 mcg/kg/hour). For pediatric procedural sedation (2 to <18 years): loading infusion of 2 mcg/kg over 10 minutes, then maintenance infusion of 1.5 mcg/kg/hour (range 0.5 to 1.5 mcg/kg/hour). Consider dose reduction in patients over 65 years and those with impaired hepatic function.

Not reported in label.

Not reported in label.

Precedex provides sedation with minimal respiratory depression, making it a valuable option for procedural sedation in both adults and pediatric patients. Its use in the ICU is limited to 24 hours of continuous infusion.