dexmedetomidine hydrochloride - Precedex®
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Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]
|Preparation of Solution
Precedex must be diluted in 0.9% sodium chloride solution to achieve required concentration (4 mcg/mL) prior to administration. Preparation of solutions is the same, whether for the loading dose or maintenance infusion.
Strict aseptic technique must always be maintained during handling of Precedex.
To prepare the infusion, withdraw 2 mL of Precedex and add to 48 mL of 0.9% sodium chloride injection to a total of 50 mL. Shake gently to mix well.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Administration with Other Fluids
Precedex has been shown to be incompatible when administered with the following drugs: amphotericin B, diazepam.
Precedex has been shown to be compatible when administered with the following intravenous fluids:
Supplied: 200 mcg/2 mL (100 mcg/mL) in a glass vial
Stability / Miscellaneous
| EXP: 24 hours (RT/REF). May be given undiluted by IV bolus.
INDICATIONS AND USAGE
Mechanism of Action
DOSAGE AND ADMINISTRATION
For 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/hr.
For Procedural Sedation: Generally initiate at one mcg/kg over 10 minutes, followed by a maintenance infusion initiated at 0.6 mcg/kg/hr and titrated to achieve desired clinical effect with doses ranging from 0.2 to 1 mcg/kg/hr.
Alternative doses recommended for patients over 65 years of age and awake fiberoptic intubation patients.
WARNINGS AND PRECAUTIONS
Bradycardia and sinus arrest: Have occurred in young healthy volunteers with high vagal tone or with different routes of administration, e.g., rapid intravenous or bolus administration.
Hypotension and bradycardia: May necessitate medical intervention. May be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension, and in the elderly. Use with caution in patients with advanced heart block or severe ventricular dysfunction.
Co-administration with other vasodilators or negative chronotropic agents: Use with caution due to additive pharmacodynamic effects.
Transient hypertension: Observed primarily during the loading dose. Consider reduction in loading infusion rate.
Arousability: Patients can become aroused/alert with stimulation; this alone should not be considered as lack of efficacy
Prolonged exposure to dexmedetomidine beyond 24 hours may be associated with tolerance and tachyphylaxis and a dose-related increase in adverse events
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.
USE IN SPECIFIC POPULATIONS
DOSAGE FORMS AND STRENGTHS
Store at controlled room temperature, 25°C (77°F) with excursions allowed from 15 to 30°C (59 to 86°F). [See USP.]
Source: Package insert
Manufactured and Distributed by:
Printed in USA EN-2680