Miscellaneous anxiolytics, sedatives and hypnotics
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Precedex Dosage

Drug Detail:Precedex (Dexmedetomidine [ dex-med-e-toe-mi-deen ])

Generic Name: DEXMEDETOMIDINE HYDROCHLORIDE 4ug in 1mL

Dosage Form: injection, solution

Drug Class: Miscellaneous anxiolytics, sedatives and hypnotics

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

Administration Instructions

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PRECEDEX dosing should be individualized and titrated to desired clinical response.
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PRECEDEX is not indicated for infusions lasting longer than 24 hours.
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PRECEDEX should be administered using a controlled infusion device.

Recommended Dosage

Table 1: Recommended Dosage in Adult Patients

INDICATION

DOSAGE AND ADMINISTRATION

Initiation of Intensive Care Unit Sedation

For adult patients: a loading infusion of one mcg/kg over 10 minutes.

For adult patients being converted from alternate sedative therapy: a loading dose may not be required.

For patients over 65 years of age: Consider a dose reduction [see Use in Specific Populations (8.5)].

For adult patients with impaired hepatic function: Consider a dose reduction [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Maintenance of Intensive Care Unit Sedation

For adult patients: a maintenance infusion of 0.2 to 0.7 mcg/kg/hour. The rate of the maintenance infusion should be adjusted to achieve the desired level of sedation.

For patients over 65 years of age: Consider a dose reduction [see Use in Specific Populations (8.5)].

For adult patients with impaired hepatic function: Consider a dose reduction [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)]

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 in adult 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 (8.5)].

For adult patients with impaired hepatic function: Consider a dose reduction [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Maintenance of Procedural Sedation

For adult patients: the maintenance infusion is generally 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. Adjust the rate of the maintenance infusion to achieve the targeted level of sedation.

For awake fiberoptic intubation in adult patients: a maintenance infusion of 0.7 mcg/kg/hour is recommended until the endotracheal tube is secured.

For patients over 65 years of age: Consider a dose reduction [see Use in Specific Populations (8.5)].

For adult patients with impaired hepatic function: Consider a dose reduction [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
Table 2: Recommended Dosage in Pediatric Patients

INDICATION

DOSAGE AND ADMINISTRATION

Initiation of Sedation During Non‑invasive Procedures

For pediatric patients:

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1 month to less than 2 years: a loading infusion of 1.5 mcg/kg over 10 minutes.
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2 to less than 18 years: a loading infusion of 2 mcg/kg over 10 minutes.

Consider a reduction in dosage if clinically indicated.

Maintenance of Sedation During Non-invasive Procedures

For pediatric patients:

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1 month to less than 18 years: the maintenance infusion is generally initiated at 1.5 mcg/kg/hour and titrated to achieve desired clinical effect with dosage ranging from 0.5 to 1.5 mcg/kg/hour.

As clinically warranted, titrate the maintenance dose to individual patient clinical response.

Dosage Adjustment

Due to possible pharmacodynamic interactions, a reduction in dosage of PRECEDEX or other concomitant anesthetics, sedatives, hypnotics or opioids may be required when co-administered [see Drug Interactions (7.1)].

Dosage reductions may need to be considered for adult patients with hepatic impairment, and geriatric patients [see Warnings and Precautions (5.8), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

Preparation of Solution

Strict aseptic technique must always be maintained during handling of PRECEDEX.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. ​Do not use if product is discolored or if precipitate matter is present.

PRECEDEX in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg/mL) and 400 mcg/100 mL (4 mcg/mL)

PRECEDEX in 0.9% Sodium Chloride Injection is supplied in glass containers containing a premixed, ready to use dexmedetomidine hydrochloride solution in 0.9% sodium chloride in water. No further dilution of this preparation is necessary.

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:

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

Compatibility with Natural Rubber

Compatibility studies have demonstrated the potential for absorption of PRECEDEX to some types of natural rubber. Although PRECEDEX is dosed to effect, it is advisable to use administration components made with synthetic or coated natural rubber gaskets.

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