Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride
Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride Prescribing Information
Dosage and Administration, 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 in 0.9% sodium chloride injection is supplied in glass containers containing a premixed, ready to use dexmedetomidine hydrochloride solution in 0.9% sodium chloride in water. No further dilution of these preparations is necessary.
Warnings and Precautions, Hyperthermia or Pyrexia (
Dexmedetomidine may induce hyperthermia or pyrexia, which may be resistant to traditional cooling methods, such as administration of cooled intravenous fluids and antipyretic medications. Discontinue dexmedetomidine if drug-related hyperthermia or pyrexia is suspected and monitor patients until body temperature normalizes.
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a alpha
2-adrenergic receptor agonist indicated for:
- Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer dexmedetomidine hydrochloride in 0.9% sodium chloride injection by continuous infusion not to exceed 24 hours. (1.1)
- Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. (1.2)
- Individualize and titrate dexmedetomidine hydrochloride in 0.9% sodium chloride injection dosing to desired clinical effect. (2.1)
- Administer dexmedetomidine hydrochloride in 0.9% sodium chloride injection using a controlled infusion device. (2.1)
- The 80 mcg per 20 mL single-dose vial, 200 mcg per 50 mL, and 400 mcg per 100 mL single-dose bottles, do not require further dilution prior to administration. (2.4)
- For Adult Intensive Care Unit Sedation:Initiate at one mcg/kg over 10minutes, followed by a maintenance infusion of 0.2 mcg/kg/hourto 0.7 mcg/kg/hour. (2.2)
- For Adult Procedural Sedation:Initiate at one mcg/kg over 10minutes, followed by a maintenance infusion 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. (2.2)
- Alternative Doses:Recommended for patients over 65 years of age and awake fiberoptic intubation patients. (2.2)
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is a clear and colorless solution, ready to use. It is available as:
- Dexmedetomidine hydrochloride in 0.9% sodium chloride injection, 80 mcg per 20 mL (4 mcg per mL) single-dose vial.
- Dexmedetomidine hydrochloride in 0.9% sodium chloride injection, 200 mcg per 50 mL (4 mcg per mL) single-dose glass bottle.
- Dexmedetomidine hydrochloride in 0.9% sodium chloride injection, 400 mcg per 100 mL (4 mcg per mL) single-dose glass bottle.
- Geriatric Patients: Dose reduction should be considered. (2.2, 2.3, 5.2, 8.5)
- Hepatic Impairment: Dose reduction should be considered. (2.2, 2.3, 5.8, 8.6)
TM (dexmedetomidine hydrochloride in sodium chloride injection). However, due to Hospira, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
None.