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Dexmedetomidine

    Brands

    DEA Class;  Rx

    Common Brand Names; Precedex, Igalmi

    • Sedatives

    Relatively selective alpha2-adrenergic agonist sedative
    IV form used for procedural and intensive care sedation; sublingual formulation used for acute agitation due to bipolar I or II disorder or schizophrenia in adults
    Produces arousable sedation, limited effects on respiratory drive, and reduced analgesic/anesthetic requirements; hypotension and bradycardia are dose-related

    Indicated for sedation induction and sedation maintenance of mechanically ventilated intensive care patients.

    For procedural sedation of non-intubated patients prior to and/or during surgical and other procedures.
    For the treatment of acute agitation associated with schizophrenia or bipolar I or II disorder in adults.
    For preanesthesia sedation.

    –

    • Hypotension (25-28%)
    • Hypertension (12-16%)
    • Nausea (9-11%)
    • Bradycardia (5-7%)
    • Pyrexia (4-5%)
    • Atrial fibrillation (4%)
    • Dry mouth (3-4%)
    • Vomiting (3-4%)
    • Hypoxia (2-4%)
    • Hypovolemia (3%)
    • Atelectasis (3%)
    • Tachycardia (2-3%)
    • Postprocedural hemorrhage (2-3%)
    • Anemia (2-3%)
    • Agitation (2%)
    • Hyperthermia (2%)
    • Pain (2%)
    • Hyperglycemia (2%)
    • Chills or rigors (2%)
    • Hyperglycemia (2%)
    • Oliguria (2%)
    • Thirst (2%)
    • Acidosis (1-2%)
    • Pleural effusion (1-2%)
    • Pulmonary edema (1%)
    • Hypocalcemia (1%)
    • Urine output decreased (1%)
    • Sinus tachycardia (1%)
    • Ventricular tachycardia
    • Wheezing
    • Peripheral edema

    Continuously monitor patients while on therapy; IV should only be administered only by persons skilled in managing patients in the intensive care or operating room setting

    Bradycardia and sinus arrest have occurred in young healthy volunteers with high vagal tone or with different routes of administration, including rapid IV bolus administration

    Caution with advanced heart block and/or severe ventricular dysfunction; because dexmedetomidine decreases sympathetic nervous system activity, hypotension and/or bradycardia may more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension, and in older patients

    Transient hypertension reported primarily during loading dose; consider reduction in loading infusion rate

    Prolongs QT interval; avoid use in patients at risk of torsades de pointes or sudden death including those with known QT prolongation, a history of other arrhythmias, symptomatic bradycardia, hypokalemia, or hypomagnesemia, and in patients receiving other drugs known to prolong the QT interval

    May cause somnolence; advise patients not to perform activities requiring mental alertness (eg, operating a motor vehicle, operating hazardous machinery) for at least 8 hr after administering

    Withdrawal symptoms after discontinuation reported when administered for longer than 6 hr; most common events reported include nausea, vomiting, and agitation

    Use of another dexmedetomidine product administered IV beyond 24 hr has been associated with tolerance and tachyphylaxis and a dose-related increase in adverse reactions

    Not studied for >24 hr after first dose

    Available data from published randomized controlled trials and case reports over several decades of use with intravenously administered dexmedetomidine during pregnancy have not identified a drug-associated risk of major birth defects and miscarriage

    Presence of dexmedetomidine reported in human milk following IV administration

    There is no information regarding effects of dexmedetomidine on breastfed children or the effects on milk production

    Adults

    1 mcg/kg IV loading dose and 1.5 mcg/kg/hour continuous IV infusion; 180 mcg as initial single dose maximum and do not exceed 360 mcg/day total for sublingual film.

    Geriatric

    1 mcg/kg IV loading dose and 1.5 mcg/kg/hour continuous IV infusion; 120 mcg as initial single dose maximum and do not exceed 240 mcg/day total for sublingual film.

    Adolescents

    Safety and efficacy have not been established; however, loading doses up to 2 mcg/kg IV (for procedural sedation) and infusions up to 2.5 mcg/kg/hour IV (for ICU sedation) have been reported.

    Children

    Safety and efficacy have not been established; however, loading doses up to 2 mcg/kg IV (for procedural sedation) and infusions up to 2.5 mcg/kg/hour IV (for ICU sedation) have been reported.

    Infants

    Safety and efficacy have not been established; however, loading doses up to 1 mcg/kg IV and infusions up to 2.5 mcg/kg/hour IV have been reported.

    Neonates

    Term Neonates: Safety and efficacy have not been established; however, loading doses up to 0.5 mcg/kg IV and infusions up to 2.5 mcg/kg/hour IV have been reported.
    Premature Neonates: Safety and efficacy have not been established; however, loading doses up to 0.5 mcg/kg IV and infusions up to 1.2 mcg/kg/hour IV have been reported.

    Dexmedetomidine Hydrochloride

    injectable solution

    • 200mcg/2mL (100mcg/mL) single-dose glass vial
    • Requires further dilution before administering

    ready-to-use injectable solution

    • 80mcg/20mL 0.9% NaCl (4mcg/mL)
    • 200mcg/50mL 0.9% NaCl (4mcg/mL)
    • 400mcg/100mL 0.9% NaCl (4mcg/mL)

    film, sublingual

    • 120mg
    • 180mg