dexmedetomidine hydrochloride - Precedex®

Usual Diluents

Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]

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 infusion should not be co-administered through the same intravenous catheter with blood or plasma because physical compatibility has not been established.

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:

• 0.9% sodium chloride in water
• 5% dextrose in water
• 20% mannitol
• Lactated Ringer's solution
• 100 mg/mL magnesium sulfate solution
• 0.3% potassium chloride solution

Supplied: 200 mcg/2 mL (100 mcg/mL) in a glass vial

Stability / Miscellaneous

INDICATIONS AND USAGE
Precedex is a relatively selective alpha2-adrenergic agonist indicated for:
-Sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Administer Precedex by continuous infusion not to exceed 24 hours.
-Sedation of non-intubated patients prior to and/or during surgical and other procedures.

Mechanism of Action
Precedex is a relatively selective alpha2-adrenergic agonist with sedative properties. Alpha2 selectivity is observed in animals following slow intravenous infusion of low and medium doses (10-300 mcg/kg). Both alpha1 and alpha2 activity is observed following slow intravenous infusion of high doses (≥1000 mcg/kg) or with rapid intravenous administration.

DOSAGE AND ADMINISTRATION
Individualize and titrate Precedex dosing to desired clinical effect.
Administer Precedex using a controlled infusion device.
Dilute vial contents in 0.9% sodium chloride solution to achieve required concentration (4 mcg/mL) prior to 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.

CONTRAINDICATIONS
None

WARNINGS AND PRECAUTIONS
Monitoring: Continuously monitor patients while receiving Precedex.

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

ADVERSE REACTIONS
The most common adverse reactions (incidence greater than 2%) are hypotension, bradycardia, and dry mouth.
Adverse reactions associated with infusions greater than 24 hours in duration include ARDS, respiratory failure, and agitation.

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.

DRUG INTERACTIONS
Anesthetics, sedatives, hypnotics, opioids: Enhancement of pharmacodynamic effects. Reduction in dosage of Precedex or the concomitant medication may be required.

USE IN SPECIFIC POPULATIONS
Geriatric patients: Dose reduction should be considered
Hepatic impairment: Dose reduction should be considered
Pregnancy: Based on animal data, may cause fetal harm
Nursing Mothers: Caution should be exercised when administered to a nursing woman

DOSAGE FORMS AND STRENGTHS
200 mcg/2 mL (100 mcg/mL) in a glass vial

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:

Hospira, Inc.
Lake Forest, IL 60045 USA

Licensed from:
Orion Corporation
Espoo, Finland

Printed in USA EN-2680
Hospira, Inc., Lake Forest, IL 60045 USA