Dexmedetomidine Hydrochloride

Sedation

Approved for sedation of intubated, mechanically ventilated adult patients in an intensive care setting (infusion limited to 24 hours), sedation of non-intubated adult patients before and/or during surgical or other procedures, and procedural (non-invasive) sedation of pediatric patients aged 1 month to less than 18 years. (2)

Anesthesia adjunct

Used as part of an anesthesia/sedation plan for certain procedures, providing sedation and pain relief while reducing the amount of other anesthetic or sedative agents needed, always administered and monitored by a healthcare professional. (2)

Hypotension

Incidence: Adults: ~25% (per FDA label, incidence >2% population); Pediatric (1 month-<17 years): ~25%

Bradycardia

Incidence: Adults: ~5% (per FDA label, incidence >2% population); Pediatric (1 month-<17 years): ~62%

Dry mouth

Incidence: Adults: ~4% (per FDA label, incidence >2% population)

Hypertension

Incidence: Pediatric (1 month-<17 years): ~38% (per FDA label); reported in adults as well, frequency not separately quantified

Bradypnea (slowed breathing)

Incidence: Pediatric (1 month-<17 years): ~67% (per FDA label)

Hypoxia (low blood oxygen)

Incidence: Pediatric (1 month-<17 years): ~8% (per FDA label)

Nausea

Incidence: Reported in the clinician-authored database; frequency not separately quantified in the FDA label excerpt reviewed

Respiratory depression

Incidence: Reported in the clinician-authored database; frequency not separately quantified in the FDA label excerpt reviewed

Atrial fibrillation

Incidence: Reported in the clinician-authored database; frequency not separately quantified in the FDA label excerpt reviewed

Signs of very slow heart rate, fainting, or severe drowsiness while receiving the infusion

Incidence: Monitored continuously by the care team; report promptly if noticed

May cause significant low blood pressure and slow heart rate — serious

Symptoms: May cause significant low blood pressure and slow heart rate. Use with caution in patients with heart conduction problems. Dose adjustments required in liver impairment. Not approved for long-term sedation outside monitored settings. Monitor for withdrawal symptoms if stopped abruptly.

Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)

The FDA label lists no absolute contraindications for dexmedetomidine — serious

Symptoms: The FDA label lists no absolute contraindications for dexmedetomidine. It should be used with particular caution, under continuous clinician monitoring, in patients with hypersensitivity to dexmedetomidine or its components, advanced heart block (unless paced), severe ventricular dysfunction, bradycardia, hypotension, hepatic impairment, or volume depletion. Elderly patients and those with cardiac conduction abnormalities require closer monitoring, and the clinical team typically uses a lower starting dose in patients over 65.

Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)

Pregnancy

Available human data (from cesarean-delivery studies) have not identified a fetal risk from dexmedetomidine exposure after the first trimester; animal studies showed fetal toxicity only at doses that were also toxic to the mother. Because dexmedetomidine is a hospital-administered, clinician-controlled infusion, any use in pregnancy is a decision for the treating obstetric and anesthesia/ICU team, weighing the clinical need against the limited data. (2)

Breastfeeding

Dexmedetomidine has been detected in human breast milk for up to about 12 hours after an infusion, with a milk-to-plasma ratio of roughly 0.53-0.95 and an estimated relative infant dose of about 0.02%-0.098% (low). The care team can advise on breastfeeding timing around a dexmedetomidine infusion based on the individual clinical situation. (2)

Children

Dexmedetomidine IS approved for procedural (non-invasive) sedation in pediatric patients aged 1 month to less than 18 years, using a weight-based regimen determined by the treating clinician: for ages 1 month to under 2 years, a loading dose of 1.5 mcg/kg over 10 minutes followed by a maintenance infusion of 0.5-1.5 mcg/kg/hour; for ages 2 to under 18 years, a loading dose of 2 mcg/kg over 10 minutes followed by a maintenance infusion of 0.5-1.5 mcg/kg/hour. It is NOT an approved or established sedative for pediatric ICU/mechanical-ventilation sedation, which remains an adult-only indication; close specialist monitoring is required for any pediatric use. (2)

Renal_impairment

Hepatic impairment: dose reduction should be considered, since clearance is reduced with worsening liver disease (roughly 74% of normal clearance in mild impairment, 64% in moderate, and 53% in severe impairment). Renal impairment: no specific dose adjustment is required; pharmacokinetics were not significantly different in patients with severe renal impairment compared with healthy subjects. Elderly patients (over 65 years): a lower starting/loading dose (about 0.5 mcg/kg versus the standard 1 mcg/kg) is generally used because of a higher incidence of bradycardia and hypotension in this group. (2)

Hepatic_impairment

Hepatic impairment: dose reduction should be considered, since clearance is reduced with worsening liver disease (roughly 74% of normal clearance in mild impairment, 64% in moderate, and 53% in severe impairment). Renal impairment: no specific dose adjustment is required; pharmacokinetics were not significantly different in patients with severe renal impairment compared with healthy subjects. Elderly patients (over 65 years): a lower starting/loading dose (about 0.5 mcg/kg versus the standard 1 mcg/kg) is generally used because of a higher incidence of bradycardia and hypotension in this group. (2)

United States

• Precedex4 ug/mL, 100 ug/mL · hospira, inc.
• Dexmedetomidine in Dextrose4 ug/mL · wg critical care, llc
• IGALMI120 ug, 180 ug · bioxcel therapeutics, inc.

Canada

• PRECEDEX