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Dexmedetomidine HCl

DEXMEDETOMIDINE HCL

Manufacturer: Hikma Pharmaceuticals USA Inc.

Score: 141.0

Quick Summary

Dexmedetomidine HCl is a relatively selective alpha 2-adrenergic agonist used for sedation of non-intubated patients prior to and/or during surgical and other procedures. It has a rapid distribution phase and a terminal elimination half-life of approximately 2 hours. The most common adverse reactions include hypotension, bradycardia, and dry mouth. Dosage should be individualized and titrated to desired clinical effect, with a recommended initial dose of 1 mcg/kg over 10 minutes, followed by a maintenance infusion of 0.6 mcg/kg/hour. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Sedation of non-intubated patients prior to and/or during surgical and other procedures
  • Relatively selective alpha 2-adrenergic agonist
  • Rapid distribution phase and terminal elimination half-life of approximately 2 hours

Important Safety Information

Warning

Hypotension, bradycardia, and dry mouth are common adverse reactions

Contraindications

Adverse Reactions

  • Hypotension
  • Bradycardia
  • Dry mouth
  • Respiratory depression
  • Hypertension
  • Tachycardia
  • Nausea
  • Hypoxia

Dosing Recommendations

General Guidance

Dosage should be individualized and titrated to desired clinical effect

Procedural sedation

Adult Dose

1 mcg/kg over 10 minutes, followed by a maintenance infusion of 0.6 mcg/kg/hour

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Category C
  • No adequate and well-controlled studies in pregnant women
  • Fetal exposure should be expected

Nursing Mothers

  • Caution should be exercised when administering to a nursing woman
  • Radio-labeled dexmedetomidine was excreted in milk in lactating female rats

Pediatric Use

  • Safety and efficacy have not been established
  • The use of dexmedetomidine for procedural sedation in pediatric patients has not been evaluated

Geriatric Use

  • A reduced loading dose of 0.5 mcg/kg given over 10 minutes is recommended
  • A reduction in the maintenance infusion should be considered for patients greater than 65 years of age

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