Dosing & Uses
Dosage Forms & Strengths
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)
ICU Sedation
Indicated for sedation of initially intubated and mechanically ventilated patients in ICU setting
Load: 1 mcg/kg IV over 10 minutes; loading dose may not be required for adults converted from other sedative therapy
Maintenance 0.2-0.7 mcg/kg/hr continuous IV infusion; not to exceed 24 hr
Dexmedetomidine has been continuously infused in mechanically ventilated patients before, during, and after extubation; it is not necessary to discontinue dexmedetomidine before extubation
Procedural Sedation
Indicated for sedation of nonintubated patients before and/or during surgical and other procedures
Load: 1 mcg/kg IV over 10 minutes
Maintenance 0.6 mcg/kg/hr IV titrate to effect (usually 0.2-1 mcg/kg/hr)
Awake fiberoptic Intubation
Dosage Modifications
Dose reduction may be required if coadministered with other concomitant anesthetics, sedatives, hypnotics, or opioids
Consider dose reduction in patients with hepatic impairment or aged ≥65 yr; clearance decreases with increasing severity of hepatic impairment
Renal impairment: No dosage adjustment required
Safety and efficacy not established
ICU Sedation
Indicated for sedation of initially intubated and mechanically ventilated patients in ICU setting; not to exceed 24 hr
Consider dose reduction: Higher incidence of bradycardia and hypotension was observed following administration in patients aged >65 yr
Dexmedetomidine has been continuously infused in mechanically ventilated patients before, during, and after extubation; it is not necessary to discontinue dexmedetomidine before extubation
Procedural sedation
Indicated for sedation of nonintubated patients before and/or during surgical and other procedures
Reduced loading dose recommended: 0.5 mcg/kg IV over 10 minutes
Maintenance: Consider reduced maintenance infusion
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
>10%
Hypotension (25-28%)
Hypertension (12-16%)
Nausea (9-11%)
1-10%
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%)
<1%
Ventricular tachycardia
Wheezing
Peripheral edema
Postmarketing Reports
Blood and lymphatic system disorders: Anemia
Cardiac disorders: Arrhythmia, atrial fibrillation, atrioventricular block, bradycardia, cardiac arrest, cardiac disorder, extrasystoles, myocardial infarction, supraventricular tachycardia, tachycardia, ventricular arrhythmia, ventricular tachycardia
Eye disorders: Photopsia, visual impairment
Gastrointestinal disorders: Abdominal pain, diarrhea, nausea, vomiting
General: Chills, hyperpyrexia, pain, pyrexia, thirst
Investigations: AST/ALT increased, blood alkaline phosphatase increased, blood urea increased, EKG T wave inversion, GGT increased, QT prolonged
Metabolism and nutrition disorders: Acidosis, hyperkalemia, hypoglycemia, hypovolemia, hypernatremia
Nervous system disorders: Convulsion, dizziness, headache, neuralgia, neuritis, speech disorder
Psychiatric disorders: Agitation, confusional state, delirium, hallucination, illusion
Renal and urinary disorders: Oliguria, polyuria
Respiratory, thoracic, and mediastinal disorders: Apnea, bronchospasm, dyspnea, hypercapnia, hypoventilation, hypoxia, pulmonary congestion, respiratory acidosis
Skin and subcutaneous tissue disorders: Hyperhidrosis, pruritus, rash, urticaria
Surgical and medical procedures: Light anesthesia
Vascular disorders: Blood pressure fluctuation, hemorrhage, hypertension, hypotension
Warnings
Contraindications
None
Cautions
Continuously monitor patients while on therapy; therapy should be administered only by persons skilled in the management of 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 be expected to be 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
Patients can become aroused/alert with stimulation; this alone should not be considered as lack of efficacy
Prolonged exposure to dexmedetomidine beyond 24 hours may be associated with tolerance and tachyphylaxis and a dose-related increase in adverse events (eg, ARDS, respiratory failure, agitation)
Use with caution in hepatic impairment; consider dose reduction
Hypotension and bradycardia may necessitate medical intervention; may be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension, and in the elderly; use with caution in patients with advanced heart block or severe ventricular dysfunction
Withdrawal symptoms after discontinuation reported when administered for longer than 6 hr; most common events reported include nausea, vomiting, and agitation
Tachycardia and hypertension reported, requiring intervention 48 hr following study drug discontinuation; if tachycardia and/or hypertension occurs after discontinuation, supportive therapy is indicated
Drug interaction overview
- Caution if coadministered with other vasodilators or negative chronotropic agents owing to additive pharmacodynamic effects
- Coadministration with anesthetics, sedatives, hypnotics, and opioids is likely to lead to an enhancement of pharmacodynamic effects
Pregnancy & Lactation
Pregnancy
There are no adequate and well-controlled studies of use in pregnant women
In an in vitro human placenta study, placental transfer of dexmedetomidine occurred
Animal studies
- In pregnant rats, dexmedetomidine placental transfer observed when radiolabeled dexmedetomidine was administered SC
- Thus, fetal exposure should be expected in humans; use during pregnancy only if potential benefits justify potential fetal risk
Lactation
Unknown if excreted in human milk
Radio-labeled dexmedetomidine administered SC to lactating female rats was excreted in milk
Because many drugs are excreted in human milk, caution should be exercised when administered to breastfeeding women
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Centrally acting alpha2-adrenoceptor agonist that has sedative and anesthetic properties possibly by activating G-proteins in the brainstem, which results in the inhibition of norepinephrine release
Pharmacokinetics
Half-life, elimination: 6 min; 2 hr (terminal)
Peak plasma: 0.3-1.5 ng/mL
Protein bound: 94%
Vd: 118 L
Metabolism: Liver, including glucuronidation and CYP2A6
Metabolites: 3-hydroxy, 3-carboxy, 3-hydroxy N-methyl, 3-carboxy N-methyl, and N-methyl O-glucuronide dexmedetomidine
Total body clearance: 39 L/hr
Excretion: Urine (95%); feces (4%)
Administration
IV Incompatibilities
Y-site: amphotericin B, diazepam
IV Compatibilities
Solution: D5W, LR, 0.9% NaCl, mannitol 20%, MgSO4 100 mg/mL, KCl 0.3%
Y-site (partial list): amiodarone, cefepime, cefoperazone, ceftriaxone, chlorpromazine, ciprofloxacin, clindamycin, digoxin, diphenhydramine, dobutamine, dopamine, epinephrine, fluconazole, furosemide, heparin, hydroxyzine, labetalol, lidocaine, linezolid, lorazepam, meperidine, metoclopramide, MgSO4, metronidazole, KCl, nitroglycerin, prochlorperazine, promethazine, NaHCO3, Na-nitroprusside, TMP-SMX, vancomycin, verapamil
Not specified: atracurium, atropine, etomidate, fentanyl, glycopyrrolate, midazolam, mivacurium, morphine, pancuronium, phenylephrine, succinylcholine, thiopental, vecuronium
IV Preparation
200 mcg/2 mL (100 mcg/mL) vial
- Must be diluted with 0.9% NaCl to achieve required concentration (4 mcg/mL) before
- Preparation of solutions is the same, whether for the loading dose or maintenance infusion
- Withdraw 2 mL of 100 mcg/mL dexmedetomidine and add to 48 mL of 0.9% NaCl to a total of 50 mL
- Shake gently to mix well
IV Administration
Use controlled infusion device; use components made with synthetic or coated natural rubber gaskets
Infuse loading dose over 10 min
Maintenance dose: Administer by IV continuous infusion at recommended rate; individualized infusion rte and adjust rate to desired clinical response
Storage
Controlled room temperature of 25ºC (77ºF); excursions allowed from 15-30ºC (59-86ºF)
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Patient Handout
Formulary
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