Dexmedetomidine Hydrochloride

DEXMEDETOMIDINE HYDROCHLORIDE- dexmedetomidine hydrochloride injection, solution, concentrate
DEXMEDETOMIDINE HYDROCHLORIDE- dexmedetomidine hydrochloride injection
WG Critical Care, LLC

1 INDICATIONS AND USAGE

1.1 Intensive Care Unit Sedation

Dexmedetomidine Hydrochloride Injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Dexmedetomidine Hydrochloride Injection should be administered by continuous infusion not to exceed 24 hours.

Dexmedetomidine Hydrochloride Injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Dexmedetomidine Hydrochloride Injection prior to extubation.

1.2 Procedural Sedation

Dexmedetomidine Hydrochloride Injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

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Dexmedetomidine HCl Injection, 400 mcg in 4 mL and 100 mcg in 10 mL vial must be diluted prior to administration. Dexmedetomidine HCl Injection, 200 mcg/50 mL and 400mcg/100mL single-dose bags do not require further dilution prior to administration [see Dosage and Administration (2.6)].

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Dexmedetomidine HCl Injection should be administered only by health care providers skilled in the management of patients in the intensive care or operating room setting.

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Administer by continuous intravenous infusion using a controlled infusion device.

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Administration duration should not exceed 24 hours [see Warnings and Precautions (5.5, 5.6)].

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Continuously monitor blood pressure, heart rate and oxygen levels during the use of Dexmedetomidine HCl Injection and as clinically appropriate after discontinuation.

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Use administration components made with synthetic or coated natural rubber gaskets. Dexmedetomidine HCl Injection has the potential for absorption into some types of natural rubber.

2.2 Recommended Dosage

Dexmedetomidine HCl Injection must be diluted prior to administration [see Dosage and Administration (2.6)]. Table 1 displays the recommended loading and maintenance dosage of Dexmedetomidine HCl Injection in various procedures. Individualize dosages and titrate to desired sedation.

Table 1: Recommended Dosage for Dexmedetomidine HCl Injection

Initiation of Intensive Care Unit Sedation
Procedure	Recommended Loading Infusion Dosage
ICU Sedation	•1 mcg/kg over 10 minutes •For adult patients being converted from alternate sedative therapy, a loading dose may not be required [see Dosage and Administration (2.2) ].
Maintenance of Intensive Care Unit Sedation
Procedure	Recommended Maintenance Infusion Dosage
Maintenance	•0.2 to 0.7 mcg/kg/hour. •Adjust the maintenance infusion rate to achieve the targeted level of sedation.
Initiation of Procedural Sedation
Procedure	Recommended Loading Infusion Dosage
For more invasive procedures or for awake fiberoptic intubation	1 mcg/kg over 10 minutes
For less invasive procedures such as ophthalmic surgery	0.5 mcg/kg over 10 minutes
Maintenance of Procedural Sedation
Procedure	Recommended Maintenance Infusion Dosage
For all procedures except awake fiberoptic intubation	• Generally, initiate the maintenance infusion at 0.6 mcg/kg/hour and titrate to achieve desired clinical effect with dosages ranging from 0.2 mcg/kg/hour to 1 mcg/kg/hour. • Adjust the maintenance infusion rate to achieve the targeted level of sedation.
For awake fiberoptic intubation	Administer 0.7 mcg/kg/hour until the endotracheal tube is secured.

2.3 Dosage Modifications in Geriatric Patients

For patients over 65 years of age, for ICU sedation, a dose reduction may be considered. For procedural sedation, the recommended intravenous loading infusion dosage of Dexmedetomidine HCl Injection for initiation of procedural sedation is 0.5 mcg/kg infused over 10 minutes. Consider dosage reduction for maintenance of procedural sedation [see Use in Specific Populations (8.5)].

2.4 Dosage Modifications in Patients with Hepatic Impairment

In patients with hepatic impairment, consider dosage reduction of Dexmedetomidine HCl Injection [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

2.5 Dosage Modifications due to Drug Interactions

When co-administered with anesthetics, sedatives/hypnotics, or opioids, consider dosage reduction of Dexmedetomidine HCl Injection [see Drug Interactions (7.1)].

2.6 Preparation of Diluted Dexmedetomidine HCl Solution for Administration

Dexmedetomidine HCL Injection, 400 mcg in 4 mL and 1000 mcg in 10 mL (100 mcg/mL)

Dexmedetomidine HCl Injection must be diluted prior to administration to a final concentration of 4 mcg/mL by adding:

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2 mL of Dexmedetomidine HCl Injection to 48 mL of 0.9% Sodium Chloride Injection to a total volume of 50 mL or

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4 mL of Dexmedetomidine HCl Injection to 96 mL of 0.9% Sodium Chloride Injection to a total of volume of 100 mL

Gently shake and mix well. Prior to administration, visually inspect the diluted dexmedetomidine HCl solution for particulate matter and discoloration (the diluted solution should be a clear, colorless solution).

Prior to use, may store the diluted dexmedetomidine HCl solution for up to 4 hours at room temperature or up to 24 hours at 2^o to 8^o C.

Discard unused portion.

Dexmedetomidine HCL Injection, 200 mcg/50 mL and 400 mcg/100 mL (4 mcg/mL) flexible plastic infusion bag

Dexmedetomidine HCL Injection is supplied in a flexible plastic infusion bag containing a premixed, ready-to-use dexmedetomidine solution in 5% dextrose in water. No further dilution of these preparations are necessary.

2.7 Drug Compatibility

Diluted dexmedetomidine HCl solution for administration is compatible with and may be co-administered with:

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0.9% Sodium Chloride in Water Injection

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5% Dextrose in Water Injection

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Mannitol Injection (20%)

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Lactated Ringer’s Injection

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Magnesium Sulfate Injection (100 mg/mL)

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Potassium Chloride Injection (0.3%)

Diluted dexmedetomidine HCl solution is not compatible for co-administration through the same intravenous catheter with:

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Amphotericin B or diazepam

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Blood or plasma because physical compatibility has not been established.