DEXMEDETOMIDINE HYDROCHLORIDE- dexmedetomidine hydrochloride injection, solution
Accord Healthcare Inc.
Dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.
- Dexmedetomidine hydrochloride injection dosing should be individualized and titrated to desired clinical response.
- Dexmedetomidine hydrochloride injection is not indicated for infusions lasting longer than 24 hours.
- Dexmedetomidine hydrochloride injection should be administered using a controlled infusion device.
Table 1: Dosage Information
|INDICATION||DOSAGE AND ADMINISTRATION|
|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
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) ].
|Maintenance of Procedural Sedation||For adult
patients: the maintenance
infusion is generally initiated at 0.6 mcg/kg/
and titrated to achieve desired clinical effect
with doses ranging from 0.2 to 1 mcg/kg/
rate of the maintenance infusion should be
adjusted to achieve the targeted level of
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) ].
Due to possible pharmacodynamic interactions, a reduction in dosage of dexmedetomidine hydrochloride 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 (5.7), Use in Specific Populations (8.6), Clinical Pharmacology (12.3) ].
Strict aseptic technique must always be maintained during handling of dexmedetomidine hydrochloride injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Dexmedetomidine hydrochloride injection, 200 mcg/2 mL (100 mcg/mL)
Dexmedetomidine hydrochloride 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 hydrochloride injection, and add to 48 mL of 0.9% sodium chloride injection to a total of 50 mL. Shake gently to mix well.
Dexmedetomidine hydrochloride infusion should not be co-administered through the same intravenous catheter with blood or plasma because physical compatibility has not been established.
Dexmedetomidine hydrochloride injection has been shown to be incompatible when administered with the following drugs: amphotericin B, diazepam.
Dexmedetomidine hydrochloride injection 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
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