(dexmedetomidine hydrochloride injection)

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Administration Instructions

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

2.2 Recommended Dosage

Table 1: Recommended Dosage in Adult Patients
INDICATIONDOSAGE 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 mcg/kg/hour 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 mcg/kg/hour 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 mcg/kg/hour to 1.5 mcg/kg/hour.

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

2.3 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 (5.9), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

2.4 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 Presentations Requiring Dilution:

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PRECEDEX Injection, 200 mcg/2 mL (100 mcg/mL)

PRECEDEX must be diluted with 0.9% sodium chloride injection to achieve required concentration (4 mcg/mL) prior to administration. Preparation of solutions is the same, whether for the loading dose or maintenance infusion.

To prepare the infusion, withdraw 2 mL of PRECEDEX Injection, and add to 48 mL of 0.9% sodium chloride injection to a total of 50 mL. Shake gently to mix well.

PRECEDEX Presentations that are Ready to Use:

PRECEDEX in 0.9% Sodium Chloride Injection is supplied in glass containers and flexible containers:

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80 mcg/20 mL (4 mcg/mL) in glass vials
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200 mcg/50 mL (4 mcg/mL) in glass bottles and flexible containers
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400 mcg/100 mL (4 mcg/mL) in glass bottles and flexible containers
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1,000 mcg/250 mL (4 mcg/mL) in glass bottles and flexible containers

These presentations contain a premixed, ready to use dexmedetomidine hydrochloride solution in 0.9% sodium chloride in water. No further dilution of these preparations is necessary.

Instructions for Use for Flexible Containers:

1.
Tear outer wrap at the notch and remove solution container.
2.
Check the container for minute leaks by squeezing it firmly. If leaks are found, or if the seal is not intact, discard the solution as the sterility may be compromised.
3.
Do not use if the solution is cloudy or a precipitate is present.
4.
Use aseptic technique.

Preparation for Administration:

1.
Close flow control clamp of administration set.
2.
Remove twist-off cap from administration port at bottom of flexible container.
3.
Insert spike of administration set into administration port with a twisting motion until the spike is firmly seated. NOTE: See full directions on administration set carton.
4.
Suspend container from hanger.
5.
Squeeze and release drip chamber to establish proper fluid level in chamber during infusion.
6.
Open flow control clamp to expel air from set. Close clamp.
7.
Regulate rate of administration with flow control clamp.

2.5 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

2.6 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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