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Dexmedetomidine Hydrochloride

DEXMEDETOMIDINE HYDROCHLORIDE

Manufacturer: Fresenius Kabi USA, LLC

Score: 145.0

Quick Summary

Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a relatively selective alpha 2-adrenergic agonist indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting and for sedation of non-intubated patients prior to and/or during surgical and other procedures. The drug has a rapid distribution phase with a distribution half-life of approximately 6 minutes and a terminal elimination half-life of approximately 2 hours. Dexmedetomidine exhibits linear pharmacokinetics in the dosage range of 0.2 to 0.7 mcg/kg/hr when administered by intravenous infusion for up to 24 hours. The most common adverse reactions include hypotension, bradycardia, and dry mouth. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be administered using a controlled infusion device and the dosage should be individualized and titrated to desired clinical response.

Key Clinical Findings and Indications

  • Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting
  • Sedation of non-intubated patients prior to and/or during surgical and other procedures

Important Safety Information

Warning

Hypotension, bradycardia, and sinus arrest have been reported with the use of dexmedetomidine hydrochloride in 0.9% sodium chloride injection

Contraindications

Adverse Reactions

  • Hypotension
  • Bradycardia
  • Dry mouth
  • Respiratory depression
  • Hypoxia

Dosing Recommendations

General Guidance

Dosage reductions may need to be considered for adult patients with hepatic impairment and geriatric patients

Intensive Care Unit Sedation

Adult Dose

Generally initiate at one mcg/kg over 10 minutes, followed by a maintenance infusion of 0.2 to 0.7 mcg/kg/hour

Pediatric Dose

Not established

Procedural Sedation

Adult Dose

Generally 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

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • There are no adequate and well-controlled studies of dexmedetomidine hydrochloride in 0.9% sodium chloride injection use in pregnant women
  • Dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be used during pregnancy only if the potential benefits justify the potential risk to the fetus

Nursing Mothers

  • It is not known whether dexmedetomidine is excreted in human milk
  • Caution should be exercised when dexmedetomidine hydrochloride in 0.9% sodium chloride injection is administered to a nursing woman

Pediatric Use

  • Safety and efficacy have not been established for Procedural or ICU Sedation in pediatric patients

Geriatric Use

  • A higher incidence of bradycardia and hypotension was observed following administration of dexmedetomidine hydrochloride in 0.9% sodium chloride injection in patients greater than 65 years of age
  • A dose reduction may be considered in patients over 65 years of age

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