DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

Manufacturer: Sandoz Inc.

Score: 141.0

Quick Summary

Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a centrally acting alpha-2 adrenergic agonist used for sedation in adult patients. It is 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 recommended dosage is individualized and titrated to the desired clinical effect, with specific dosing recommendations for intensive care unit sedation and procedural sedation. Important safety considerations include hypotension, bradycardia, and respiratory depression, and the drug is not recommended for use in patients with severe hepatic impairment.

Key Clinical Findings and Indications

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

Important Safety Information

Warning

Hypotension, bradycardia, and respiratory depression can occur with use of dexmedetomidine hydrochloride in 0.9% sodium chloride injection

Contraindications

Adverse Reactions

Hypotension
Bradycardia
Dry mouth
Respiratory depression
Hypoxia

Dosing Recommendations

General Guidance

Dose reductions may be necessary for patients with hepatic impairment, geriatric patients, and patients with renal impairment

Intensive Care Unit Sedation

Adult Dose

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

Pediatric Dose

Not established

Procedural Sedation

Adult Dose

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 mcg/kg/hour to 1 mcg/kg/hour

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Available data from published randomized controlled trials and case reports have not identified a drug-associated risk of major birth defects and miscarriage