HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use PRECEDEX safely and effectively. See full prescribing information for PRECEDEX.
PrecedexTM (dexmedetomidine hydrochloride) Injection
For intravenous use.
PrecedexTM (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection
Initial U.S. Approval: 1999
INDICATIONS AND USAGE
Precedex is a relatively selective alpha2-adrenergic agonist indicated for:
DOSAGE AND ADMINISTRATION
For Adult Intensive Care Unit Sedation: Generally initiate at one mcg/kg over 10 minutes, followed by a maintenance infusion of 0.2 to 0.7 mcg/kg/hour. (2.2)
For Adult Procedural Sedation: 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. (2.2)
Alternative Doses: Recommended for patients over 65 years of age and awake fiberoptic intubation patients. (2.2)
DOSAGE FORMS AND STRENGTHS
Precedex Injection, 200 mcg/2 mL (100 mcg/mL) in a glass vial. To be used after dilution. (3)
Precedex in 0.9% Sodium Chloride Injection 80 mcg/20 mL (4 mcg/mL) in a 20 mL glass vial. Ready to use. (3)
Precedex in 0.9% Sodium Chloride Injection 200 mcg/50 mL (4 mcg/mL) in a 50 mL glass bottle. Ready to use. (3)
Precedex in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) in a 100 mL glass bottle. Ready to use. (3)
WARNINGS AND PRECAUTIONS
To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Anesthetics, Sedatives, Hypnotics, Opioids: Enhancement of pharmacodynamic effects. Reduction in dosage of Precedex or the concomitant medication may be required. (7.1)
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION.
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