AHFS Class:

12:12.04 alpha-Adrenergic Agonists

Generic Name

• DexmedeTOMIDine Hydrochloride

Dexmedetomidine hydrochloride is available as a 100-mcg/mL concentrate for injection in 2-mL single-use, preservative-free vials.²⁸⁴⁸; ³¹⁸⁰ Each mL of the concentrate for injection contains dexmedetomidine 100 mcg as the hydrochloride and sodium chloride 9 mg in water for injection.²⁸⁴⁸; ³¹⁸⁰ Some formulations may also contain sodium acetate trihydrate and glacial acetic acid.³¹⁸⁰ The concentrate for injection must be diluted in sodium chloride 0.9% to a final dexmedetomidine concentration of 4 mcg/mL prior to administration.²⁸⁴⁸; ³¹⁸⁰ To prepare a 4-mcg/mL solution, 2 mL of the concentrate should be added to 48 mL of sodium chloride 0.9% and shaken gently to mix.²⁸⁴⁸; ³¹⁸⁰

Dexmedetomidine hydrochloride 100-mcg/mL concentrate for injection also is available in 4- and 10-mL multiple-use vials (WG Critical Care).³¹⁷⁹ Each mL of the concentrate contains dexmedetomidine 100 mcg as the hydrochloride, methylparaben 1.6 mg, propylparaben 0.2 mg, and sodium chloride 9 mg in water for injection.³¹⁷⁹ The concentrate for injection must be diluted in sodium chloride 0.9% to a final dexmedetomidine concentration of 4 mcg/mL prior to administration.³¹⁷⁹ To prepare a 4-mcg/mL solution, 2 or 4 mL of the concentrate should be added to 48 or 96 mL, respectively, of sodium chloride 0.9% and shaken gently to mix.³¹⁷⁹

Dexmedetomidine hydrochloride also is available as a premixed, ready-to-use solution containing dexmedetomidine 4 mcg/mL as the hydrochloride in sodium chloride 0.9% in single-use, preservative-free 20-mL vials and 50-, 100-, and 250-mL glass bottles for intravenous infusion.²⁸⁴⁸ Some formulations also may contain sodium acetate trihydrate and acetic acid³⁸⁴⁰ or L-methionine 1 mg/mL.³⁸⁴¹

Dexmedetomidine hydrochloride also is available as a premixed, ready-to-use solution containing dexmedetomidine 4 mcg/mL as the hydrochloride in dextrose 5% in 50- and 100-mL flexible plastic containers.³¹⁷⁹

Tonicity

Dexmedetomidine hydrochloride concentrate for injection and premixed, ready-to-use solutions in sodium chloride 0.9% or dextrose 5% are isotonic.²⁸⁴⁸; ³¹⁷⁹; ³¹⁸⁰

Equivalency

Dexmedetomidine hydrochloride 118 mcg is equivalent to 100 mcg of dexmedetomidine as the base.²⁸⁴⁸; ³¹⁷⁹; ³¹⁸⁰

pH

Dexmedetomidine hydrochloride concentrate for injection has a pH ranging from 4.5 to 7.²⁸⁴⁸; ³¹⁷⁹; ³¹⁸⁰

The premixed, ready-to-use solution in sodium chloride 0.9% has a pH ranging from 4.5 to 8.²⁸⁴⁸; ³⁸⁴⁰; ³⁸⁴¹ The premixed, ready-to-use solution in dextrose 5% has a pH ranging from 4.5 to 7.³¹⁷⁹

Trade Name(s)

Precedex

Dexmedetomidine hydrochloride is administered by intravenous infusion using a controlled infusion device over periods not exceeding 24 hours.²⁸⁴⁸; ³¹⁷⁹; ³¹⁸⁰ The concentrate for injection must be diluted in sodium chloride 0.9% to a concentration of 4 mcg/mL prior to administration;²⁸⁴⁸; ³¹⁷⁹; ³¹⁸⁰ premixed, ready-to-use solutions do not require further dilution.²⁸⁴⁸

Dexmedetomidine hydrochloride concentrate for injection and premixed, ready-to-use solutions should be clear and colorless.²⁸⁴⁸; ³¹⁷⁹; ³¹⁸⁰ Intact containers of the concentrate and the premixed, ready-to-use solutions should be stored at controlled room temperature;²⁸⁴⁸; ³¹⁷⁹; ³¹⁸⁰ consult specific labeling for additional storage details.

Diluted solutions of dexmedetomidine hydrochloride (WG Critical Care) prepared from multiple-use vials of the concentrate for injection may be stored for up to 4 hours at room temperature or 24 hours at 2 to 8°C prior to administration.³¹⁷⁹ Any unused portion of the solution should be discarded.³¹⁷⁹

Dexmedetomidine hydrochloride solutions should be visually inspected for particulate matter and discoloration prior to administration.²⁸⁴⁸; ³¹⁷⁹; ³¹⁸⁰

Syringes

The stability of dexmedetomidine hydrochloride concentrate (Hospira) after dilution to a concentration of 4 mcg/mL in sodium chloride 0.9% and packaged as 25 mL in 60-mL natural rubber-free polypropylene syringes (Becton Dickinson) was evaluated at ambient room temperature with light exposure and under refrigeration in the dark.²⁸⁴⁹ No changes in color or clarity occurred.²⁸⁴⁹ Samples stored at 20 to 25°C in light exhibited a loss of less than 10% over 48 hours; those stored at 5°C in the dark exhibited a loss of less than 5% over 14 days.²⁸⁴⁹

Sorption

Dexmedetomidine hydrochloride is known to undergo sorption to some types of natural rubber.²⁸⁴⁸; ³¹⁷⁹; ³¹⁸⁰ Although the drug is dosed to effect, the manufacturer recommends the use of administration equipment with synthetic rubber or coated natural rubber gaskets.²⁸⁴⁸; ³¹⁷⁹; ³¹⁸⁰

Standardize 4 Safety

One or more standardized concentrations for this drug have been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care. (See Standardize 4 Safety in Users Guide.) Recommendations developed to date through this initiative are available at www.ashp.org/pharmacy-practice/standardize-4-safety-initiative.

Table 1. Standardize 4 Safety Continuous IV Infusion Standard Concentrations for Dexmedetomidine³⁶³⁵; ³⁶³⁶

Solution Compatibility

Y-Site Injection Compatibility (1:1 Mixture)

Additional Compatibility Information

Infusion Solutions

Manufacturers state that dexmedetomidine hydrochloride is compatible when administered with dextrose 5% or Ringer’s injection, lactated.²⁸⁴⁸; ³¹⁷⁹; ³¹⁸⁰

For a list of references cited in the text of this monograph, search the monograph titled References.

ASHP^® Injectable Drug Information^TM. Selected Revisions March 7, 2025. © Copyright, 2025. American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.