Dexmedetomidine
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Dosing in liver impairment
Hepatic Impairment Since dexmedetomidine clearance decreases with increasing severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function [see Dosage and Administration ( 2.2 , 2.3 ), Clinical Pharmacology].
| 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 mcg/kg/ hourto 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 minutesmay 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/ hourand titrated to achieve desired clinical effect with doses ranging from 0.2 mcg/kg/ hourto 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/ houris 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: Considera dose reduction [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)]. |
Preparation and administration
Administration Instructions
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection dosing should be individualized and titrated to desired clinical response.
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is not indicated for infusions lasting longer than 24 hours.
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection should be administered using a controlled infusion device.
Preparation of Solution Strict aseptic technique must always be maintained during handling of dexmedetomidine hydrochloride in 0.9% sodium chloride 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 Hydrochloride Presentations that are Ready to Use: Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is supplied in glass containers: 80 mcg/20 mL (4 mcg/mL) in glass vials 200 mcg/50 mL (4 mcg/mL) in glass bottles 400 mcg/100 mL (4 mcg/mL) in glass bottles 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.
Administration with Other Fluids Dexmedetomidine hydrochloride in 0.9% sodium chloride injection infusion should not be co-administered through the same intravenous catheter with blood or plasma because physical compatibility has not been established. Dexmedetomidine hydrochloride in 0.9% sodium chloride injection has been shown to be incompatible when administered with the following drugs: amphotericin B, diazepam.
Dexmedetomidine hydrochloride in 0.9% sodium chloride 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
Compatibility with Natural Rubber Compatibility studies have demonstrated the potential for absorption of dexmedetomidine hydrochloride in 0.9% sodium chloride injection to some types of natural rubber. Although dexmedetomidine hydrochloride in 0.9% sodium chloride injection is dosed to effect, it is advisable to use administration components made with synthetic or coated natural rubber gaskets.
| 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 mcg/kg/ hourto 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 minutesmay 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/ hourand titrated to achieve desired clinical effect with doses ranging from 0.2 mcg/kg/ hourto 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/ houris 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: Considera dose reduction [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)]. |
| INDICATION | DOSAGE AND ADMINISTRATION |
| Initiation of Sedation During Non-invasive Procedures | For pediatric patients:1 month to less than 2 years: a loading infusion of 1.5 mcg/kg over 10 minutes.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:1 month to less than 18 years: the maintenance infusion is generally initiated at 1.5 mcg/kg/ hourand titrated to achieve desired clinical effect with dosage ranging from 0.5 mcg/kg/ hourto 1.5 mcg/kg/ hour.As clinically warranted, titrate the maintenance dose to individual patient clinical response. |