Dexmedetomidine

DEXMEDETOMIDINE- dexmedetomidine hydrochloride injection, solution, concentrate
Mylan Institutional LLC

1 INDICATIONS AND USAGE

1.1 Intensive Care Unit Sedation

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

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

1.2 Procedural Sedation

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

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Guidelines

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Dexmedetomidine injection dosing should be individualized and titrated to desired clinical response.

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Dexmedetomidine injection is not indicated for infusions lasting longer than 24 hours.

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Dexmedetomidine injection should be administered using a controlled infusion device.

2.2 Dosage Information

Table 1: Dosage Information

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: a dose reduction should be considered [see Use in Specific Populations (8.5)]. For adult patients with impaired hepatic function: a dose reduction should be considered [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: a dose reduction should be considered [see Use in Specific Populations (8.5)]. For adult patients with impaired hepatic function: a dose reduction should be considered [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: a dose reduction should be considered [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. The rate of the maintenance infusion should be adjusted 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: a dose reduction should be considered [see Use in Specific Populations (8.5)]. For adult patients with impaired hepatic function: a dose reduction should be considered [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

2.3 Dosage Adjustment

Due to possible pharmacodynamic interactions, a reduction in dosage of dexmedetomidine injection 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)].

2.4 Preparation of Solution

Strict aseptic technique must always be maintained during handling of dexmedetomidine injection.

​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.

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

Dexmedetomidine injection 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 dexmedetomidine injection, and add to 48 mL of 0.9% sodium chloride injection to a total of 50 mL. Shake gently to mix well.

Discard unused portion.

2.5 Administration with Other Fluids

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

Dexmedetomidine injection has been shown to be incompatible when administered with the following drugs: amphotericin B, diazepam.

Dexmedetomidine injection 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 dexmedetomidine injection to some types of natural rubber. Although dexmedetomidine injection is dosed to effect, it is advisable to use administration components made with synthetic or coated natural rubber gaskets.