Precedex
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Precedex
INDICATIONS
Intensive Care Unit Sedation
Precedex (dexmedetomidine hydrochloride) ® is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Precedex (dexmedetomidine hydrochloride) should be administered by continuous infusion not to exceed 24 hours.
Precedex (dexmedetomidine hydrochloride) has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Precedex (dexmedetomidine hydrochloride) prior to extubation.
Procedural Sedation
Precedex (dexmedetomidine hydrochloride) is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.
DOSAGE AND ADMINISTRATION
Dosing Guidelines
Precedex (dexmedetomidine hydrochloride) dosing should be individualized and titrated to desired clinical response.
Precedex (dexmedetomidine hydrochloride) is not indicated for infusions lasting longer than 24 hours
Precedex (dexmedetomidine hydrochloride) should be administered using a controlled infusion device.
Dosage Information
Table 1: Dosage Information
| INDICATION | DOSAGE AND ADMINISTRATION |
| Initiation of Intensive Care Unit Sedation | For adult patients: a loading infusion of up to one mcg/kg over
10 minutes. For patients being converted from alternate sedative therapy: a loading dose may not be required [see DOSAGE AND ADMINISTRATION : Maintenance of Intensive Care Unit Sedation]. For patients over 65 years of age: a dose reduction should be considered [see Use In Specific Populations]. For patients with impaired hepatic function: a dose reduction should be considered [see Use in Specific Populations, CLINICAL PHARMACOLOGY]. |
| Maintenance of Intensive Care Unit Sedation | For adult patients: a maintenance infusion of 0.2 to 0.7 mcg/kg/hr.
The rate of the maintenance infusion should be adjusted to achieve the
desired level of sedation. For patients over 65 years of age: a dose reduction should be considered [see Use in Specific Populations]. For patients with impaired hepatic function: a dose reduction should be considered [see Use in Specific Populations, CLINICAL PHARMACOLOGY]. |
| Initiation of Procedural Sedation | For adult patients: a loading infusion of one mcg/kg over 10
minutes. For less invasive procedures such as ophthalmic surgery, a loading
infusion of 0.5 mcg/kg given over 10 minutes may be suitable. For awake fiberoptic intubation patients: a loading infusion of one mcg/kg over 10 minutes. For patients over 65 years of age: a loading infusion of 0.5 mcg/kg over 10 minutes [see Use In Specific Populations]. For patients with impaired hepatic function:: a dose reduction should be considered [see Use in Specific Populations, CLINICAL PHARMACOLOGY]. |
| Maintenance of Procedural Sedation | For adult patients: the maintenance infusion is generally 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. The rate of the maintenance infusion
should be adjusted to achieve the targeted level of sedation. For awake fiberoptic intubation patients: a maintenance infusion of 0.7 mcg/kg/hr is recommended until the endotracheal tube is secured. For patients over 65 years of age: a dose reduction should be considered [see Use in Specific Populations]. For patients with impaired hepatic function: a dose reduction should be considered [see Use in Specific Populations, CLINICAL PHARMACOLOGY]. |
Dosage Adjustment
Due to possible pharmacodynamic interactions, a reduction in dosage of Precedex (dexmedetomidine hydrochloride) or other concomitant anesthetics, sedatives, hypnotics or opioids may be required when co-administered. [see DRUG INTERACTIONS].
Dosage reductions may need to be considered for patients with hepatic impairment, and geriatric patients [see WARNINGS AND PRECAUTIONS, Use in Specific Populations, CLINICAL PHARMACOLOGY].
Preparation of Solution
Precedex (dexmedetomidine hydrochloride) 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 (dexmedetomidine hydrochloride) .
To prepare the infusion, withdraw 2 mL of Precedex (dexmedetomidine hydrochloride) 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 (dexmedetomidine hydrochloride) infusion should not be co-administered through the same intravenous catheter with blood or plasma because physical compatibility has not been established.
Precedex (dexmedetomidine hydrochloride) has been shown to be incompatible when administered with the following drugs: amphotericin B, diazepam.
Precedex (dexmedetomidine hydrochloride) 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
Compatibility with Natural Rubber
Compatibility studies have demonstrated the potential for absorption of Precedex (dexmedetomidine hydrochloride) to some types of natural rubber. Although Precedex (dexmedetomidine hydrochloride) is dosed to effect, it is advisable to use administration components made with synthetic or coated natural rubber gaskets.
HOW SUPPLIED
Dosage Forms And Strengths
200 mcg/2 mL (100 mcg/mL) in a glass vial
Storage And Handling
Precedex (dexmedetomidine hydrochloride) injection, 200 mcg/2 mL (100 mcg/mL) is available in 2 mL clear glass vial. Vials are intended for single use only.
Store at controlled room temperature, 25°C (77°F) with excursions allowed from 15 to 30°C (59 to 86°F). [See USP.]
Manufactured and Distributed by: Hospira, Inc. Lake Forest, IL 60045 USA. Licensed from: Orion Corporation Espoo, Finland. Revised: 09/2010
Last reviewed on RxList: 11/15/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Precedex Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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