[+]Updated 2017 Mar 06 05:25 PM (ET)

International Formulary

See Brands below for prescribing information from United States, Canada, United Kingdom, Australia
 

Dosing & Indications

Adult Dosing

Cough, Fentanyl- or sufentanil-induced: 0.1 mcg/kg, 0.25 mcg/kg, or 0.5 mcg/kg IV over 5 minutes immediately
prior to sufentanil and 0.5 or 1 mcg/kg IV over 10 minutes immediately prior to fentanyl were used in clinical
trials
Cough, Fentanyl- or sufentanil-induced: (combination with midazolam) 0.6 mcg/kg IV over 10 minutes plus
midazolam 0.06 mg/kg IV over 5 seconds, administered 2 minutes prior to fentanyl, was used in a clinical trial
Premedication for anesthetic procedure, Nonintubated patients: Initial, loading infusion of 1 mcg/kg IV over 10
minutes; for less invasive procedures (ie, ophthalmic surgery), initial loading infusion of 0.5 mcg/kg IV over 10
minutes may be sufficient (FDA dosage)
Premedication for anesthetic procedure, Nonintubated patients: Maintenance, 0.6 mcg/kg/hr IV infusion
titrated to desired clinical effect with doses ranging from 0.2 to 1 mcg/kg/hr (FDA dosage)
Premedication for anesthetic procedure, Nonintubated patients: Awake, fiberoptic intubation: Initial, loading
infusion of 1 mcg/kg IV over 10 minutes, followed by maintenance infusion of 0.7 mcg/kg/hr until endotracheal
tube is secured (FDA dosage)
Premedication for anesthetic procedure, Nonintubated patients: 1 mcg/kg intranasally, diluted in NS to a total
volume of 0.8 mL and administered bilaterally (0.4 mL each nostril) (off-label dosage)
Sedation, Intubated/mechanically ventilated ICU patients for greater than 24 hours: 0.15 to 1.5 mcg/kg/hr
(study dosage)
Sedation, Intubated/mechanically ventilated ICU patients for less than 24 hours: Initial, loading infusion of 1
mcg/kg IV over 10 minutes; no loading dose required when converting from alternate sedative therapy
Sedation, Intubated/mechanically ventilated ICU patients for less than 24 hours: Maintenance, 0.2 to 0.7
mcg/kg/hr continuous IV infusion titrated to desired clinical effect for a MAX of 24 hours
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Pediatric Dosing

General Dosage Information: Safety and efficacy not established in pediatric patients
Premedication for anesthetic procedure: 0.5 to 2 mcg/kg intranasally 30 to 60 before induction or 45 to 60
minutes before surgery (study dosage)
Premedication for anesthetic procedure: 2.5 to 4 mcg/kg orally 40 to 60 minutes before induction of anesthesia
or 30 minutes before surgery (study dosage)
Premedication for anesthetic procedure: (1 to 12 years) 1.5 mcg/kg sublingually at least 45 minutes before
induction of anesthesia; undiluted injectable dexmedetomidine was used (study dosage) .
Premedication for anesthetic procedure, Nonintubated patients: (Mean age, 5.7 years) Nuclear medicine
imaging: 2 mcg/kg IV bolus over 10 minutes, then 1 mcg/kg/hour IV until completion of procedure (off-label
dosage)
Premedication for anesthetic procedure, Nonintubated patients: (Mean age, 5.6 years) EEG testing: 0.5 to 1
mcg/kg IV every 3 to 5 minutes (mean total dose, 2.1 mcg/kg; mean infusion rate, 1.5 mcg/kg/hr) (off-label
dosage)
Premedication for anesthetic procedure, Nonintubated patients: (Mean age, 3.5 years) EEG testing: Initial, 1 to
4.5 mcg/kg IM (mean dose, 2.6 mcg/kg); a second, lower dose (mean dose, 2 mcg/kg) was given if adequate
sedation was not achieved 10 minutes after first dose (off-label dosage)
Premedication for anesthetic procedure, Nonintubated patients: (1 to 8 years) Prior to anesthesia induction: 1
to 2 mcg/kg intranasally, administered bilaterally (off-label dosage)
 Premedication for anesthetic procedure, Nonintubated patients: (2 to 36 months) Prior to transthoracic ECG: 3
mcg/kg intranasally via atomiser or drops divided bilaterally in each nostril (off-label dosage)
Sedation, Intubated/mechanically ventilated ICU patients for less than 24 hours: Initial, 0.1 to 0.5 mcg/kg/hr
(off-label dosage)
Sedation, Intubated/mechanically ventilated ICU patients for less than 24 hours: Maintenance, 0.1 to 0.75
mcg/kg/hr (off-label dosage)
Sedation, Intubated/mechanically ventilated ICU patients for less than 24 hours: (Neonates) Up to 0.3
mcg/kg/hr continuous IV infusion; adjust based on age (particularly during first 2 weeks of life), total bypass
time, and presence of intracardiac right-to-left shunt. Loading doses were administered over 10 minutes and
continuous infusion for 4 to 24 hours (off-label dosage)
Sedation, Intubated/mechanically ventilated ICU patients for less than 24 hours: (Infants) Up to 0.75 mcg/kg/hr
continuous IV infusion; adjust based on total bypass time and presence of intracardiac right-to-left shunt.
Loading doses were administered over 10 minutes and continuous infusion for 4 to 24 hours (off-label dosage)
DRUGDEX® Subscribers: See additional details for DEXMEDETOMIDINE
Dose Adjustment

geriatric: (procedural sedation) a reduced loading dose of 0.5 mcg/kg IV over 10 minutes and a reduction in the
maintenance infusion is recommended
geriatric: (ICU sedation) consider a dose reduction of loading and maintenance dosages
hepatic impairment: consider a dose reduction of loading and maintenance dosages
concomitant use with anesthetics, sedatives, hypnotics, or opioids: a dosage reduction of either drug may be
required
DRUGDEX® Subscribers: See additional details for DEXMEDETOMIDINE
Indications

FDA-Labeled Indications
Premedication for anesthetic procedure, Nonintubated patients

Adult

FDA Approval: yes

Efficacy: Effective
Strength of Recommendation: Class IIb
Strength of Evidence: Category B
Pediatric

FDA Approval: no
Efficacy: Evidence favors efficacy
Strength of Recommendation: Class IIb
Strength of Evidence: Category B
Sedation, Intubated/mechanically ventilated ICU patients for less than 24 hours

Adult

FDA Approval: yes

Efficacy: Effective
Strength of Recommendation: Class IIb
Strength of Evidence: Category B
Pediatric

FDA Approval: no
Efficacy: Evidence favors efficacy
Strength of Recommendation: Class IIb
 Strength of Evidence: Category B
Non-FDA Labeled Indications
Anesthetics adverse reaction - Shivering

Adult

FDA Approval: no
Efficacy: Evidence favors efficacy
Strength of Recommendation: Class IIb
Strength of Evidence: Category B
Pediatric

FDA Approval: no
Cough, Fentanyl- or sufentanil-induced

Adult

FDA Approval: no
Efficacy: Evidence favors efficacy
Strength of Recommendation: Class IIb
Strength of Evidence: Category B
Pediatric

FDA Approval: no
General anesthesia; Adjunct

Adult

FDA Approval: no
Efficacy: Evidence favors efficacy
Strength of Recommendation: Class IIb
Strength of Evidence: Category B
Pediatric

FDA Approval: no
Efficacy: Evidence favors efficacy
Strength of Recommendation: Class IIb
Strength of Evidence: Category C
Premedication for anesthetic procedure

Adult

FDA Approval: no
Pediatric

FDA Approval: no
Efficacy: Evidence favors efficacy
Strength of Recommendation: Class IIb
Strength of Evidence: Category B
Sedation, During awake craniotomy

Adult
 FDA Approval: no
Efficacy: Evidence favors efficacy
Strength of Recommendation: Class IIb
Strength of Evidence: Category B
Pediatric

FDA Approval: no
Sedation, Intubated/mechanically ventilated ICU patients for greater than 24 hours

Adult

FDA Approval: no
Efficacy: Effective
Strength of Recommendation: Class IIb
Strength of Evidence: Category B
Pediatric

FDA Approval: no
Efficacy: Evidence favors efficacy
Strength of Recommendation: Class IIb
Strength of Evidence: Category C

Contraindications/Warnings

Contraindications

Specific contraindications have not been determined .

DRUGDEX® Subscribers: See additional details for DEXMEDETOMIDINE
Precautions

Cardiovascular: Sinus arrest, including fatal cases, have been reported .

Cardiovascular: Bradycardia and hypotension, including fatal cases, have been reported and are more
pronounced in the elderly and patients with hypovolemia, diabetes mellitus, or chronic hypertension; dosage
reduction or interruption may be necessary .
Cardiovascular: Use caution with advanced heart block or severe ventricular dysfunction .
Cardiovascular: Transient hypertension has been reported, primarily during the loading dose; reduced loading
infusion rate may be necessary .
Hepatic: Hepatic impairment; dosage adjustment may be necessary
Neurologic: Arousability and alertness when stimulated have been reported and should not be interpreted as a
lack of efficacy in the absence of other clinical signs and symptoms .
Prolonged use: Tolerance, tachyphylaxis, and dose-related increases in adverse events have been reported with
use beyond 24 hours .
Withdrawal: Withdrawal symptoms (eg, nausea, vomiting, agitation, hypertension, tachycardia) have been
reported within 48 hours after discontinuation .
DRUGDEX® Subscribers: See additional details for DEXMEDETOMIDINE
Pregnancy Category

Dexmedetomidine: C (FDA) - Either studies in animals have revealed adverse effects on the fetus (teratogenic
or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not
available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
DRUGDEX® Subscribers: See additional details for DEXMEDETOMIDINE
Breast Feeding
 Dexmedetomidine: Micromedex: Infant risk cannot be ruled out.
DRUGDEX® Subscribers: See additional details for DEXMEDETOMIDINE

Drug Interactions

Drug-Drug Interactions

Drugs: Severity: Documentation: Summary:

Concurrent use of
TAPENTADOL and
TAPENTADOL -- SEDATIVES Major Fair SEDATIVES may result in an
increase in CNS and
respiratory depression.

Concurrent use of
OXYCODONE and SEDATIVES
OXYCODONE -- SEDATIVES Major Fair may result in an increase in
CNS or respiratory
depression.

Concurrent use of ZOLPIDEM

and SEDATIVES OR
ZOLPIDEM -- SEDATIVES OR
Major Fair HYPNOTICS may result in an
HYPNOTICS
increase in CNS depressant
effects.

Concurrent use of
HYDROMORPHONE and
HYDROMORPHONE --
Major Fair SEDATIVES may result in an
SEDATIVES
increase in CNS or respiratory
depression.

Concurrent use of MECLIZINE

MECLIZINE -- CNS and CNS DEPRESSANTS may
Major Fair
DEPRESSANTS result in an increase in CNS or
respiratory depression.

Concurrent use of
CARBINOXAMINE -- CNS CARBINOXAMINE and CNS
Major Fair
DEPRESSANTS DEPRESSANTS may result in
additive CNS effects.

Concurrent use of FENTANYL

FENTANYL -- CNS and CNS DEPRESSANTS may
Major Fair
DEPRESSANTS result in increased risk of CNS
depression.

Concurrent use of
HYDROCODONE and CNS
DEPRESSANTS may result in
HYDROCODONE -- CNS
Major Fair increased risk of CNS
DEPRESSANTS
depression (ie, respiratory
depression, profound
sedation, coma).
SODIUM OXYBATE [All Concurrent use of SODIUM
Routes] -- OXYBATE and SELECTED
Major Fair
DEXMEDETOMIDINE ANESTHETICS may result in
HYDROCHLORIDE [Systemic] increased CNS depression.

Concurrent use of
BUPRENORPHINE and CNS
BUPRENORPHINE -- CNS
Major Fair DEPRESSANTS may result in
DEPRESSANTS
increased risk of respiratory
depression.

Concurrent use of
OXYMORPHONE and CNS
OXYMORPHONE -- CNS DEPRESSANTS may result in
Major Fair
DEPRESSANTS increased risk of respiratory
depression, profound
sedation, coma, and death.

Concurrent use of MORPHINE

MORPHINE -- CNS and CNS DEPRESSANTS may
Major Fair
DEPRESSANTS result in increased risk of CNS
depression.

Concurrent use of
METHADONE and CNS
METHADONE -- CNS
Major Fair DEPRESSANTS may result in
DEPRESSANTS
increased risk of CNS
depression.

Concurrent use of
BROMAZEPAM and CNS
BROMAZEPAM -- CNS
Major Fair DEPRESSANTS may result in
DEPRESSANTS
increased risk of respiratory
or cardiovascular depression.

FLIBANSERIN [Oral Concurrent use of

(systemic)] -- FLIBANSERIN and CNS
Major Fair
DEXMEDETOMIDINE DEPRESSANTS may result in
HYDROCHLORIDE [Systemic] additive CNS depression.

Concurrent use of
PERICIAZINE and CNS
PERICIAZINE -- CNS
Major Fair DEPRESSANTS may result in
DEPRESSANTS
risk of enhanced CNS
depression.

Concurrent use of
BROMOPRIDE and
BROMOPRIDE -- SEDATIVES Major Fair SEDATIVES may result in
potentiation of sedative
effects .

Concurrent use of
MEPERIDINE and CNS
DEPRESSANTS may result in
MEPERIDINE -- CNS
Major Fair increased risk of CNS
DEPRESSANTS
 depression (ie, respiratory
depression, profound
sedation, coma).

Concurrent use of
BUTORPHANOL and CNS
DEPRESSANTS may result in
BUTORPHANOL -- CNS
Major Fair increased risk of CNS
DEPRESSANTS
depression (ie, respiratory
depression, profound
sedation, coma).

Concurrent use of
REMIFENTANIL and CNS
DEPRESSANTS may result in
REMIFENTANIL -- CNS
Major Fair increased risk of CNS
DEPRESSANTS
depression (ie, respiratory
depression, profound
sedation, coma).

Concurrent use of
TRAMADOL and CNS
DEPRESSANTS may result in
TRAMADOL -- CNS
Major Fair increased risk of CNS
DEPRESSANTS
depression (ie, respiratory
depression, profound
sedation, coma).

Concurrent use of
PENTAZOCINE and CNS
DEPRESSANTS may result in
PENTAZOCINE -- CNS increased risk of CNS
Major Fair depression (ie, respiratory
DEPRESSANTS
depression, profound
sedation, coma).

Concurrent use of
DIHYDROCODEINE and CNS
DEPRESSANTS may result in
DIHYDROCODEINE -- CNS
Major Fair increased risk of CNS
DEPRESSANTS
depression (ie, respiratory
depression, profound
sedation, coma).

Concurrent use of
SUFENTANIL and CNS
DEPRESSANTS may result in
SUFENTANIL -- CNS
Major Fair increased risk of CNS
DEPRESSANTS
depression (ie, respiratory
depression, profound
sedation, coma).

Concurrent use of
DOXYLAMINE and CNS
DOXYLAMINE -- CNS
Major Fair DEPRESSANTS may result in
DEPRESSANTS
 increased risk of CNS
depression.

Concurrent use of LOXAPINE

and CNS DEPRESSANTS may
result in potentiation of
LOXAPINE -- CNS impaired cognitive function
Moderate Fair
DEPRESSANTS and motor skills and an
increased risk of respiratory
depression, hypotension,
oversedation, and syncope.

Drug-FOOD Interactions (None found)

Drug-ETHANOL Interactions (None found)

Drug-LAB Interactions (None found)

Drug-TOBACCO Interactions (None found)

Definitions

Severity: Contraindicated Major Moderate Minor Unknown

Documentation: Excellent Good Fair Unknown  

DRUGDEX® Subscribers: See additional details for DEXMEDETOMIDINE

Adverse Effects

Common

Cardiovascular: Hypertension (12% to 16% )

Gastrointestinal: Nausea (3% to 11% ), Vomiting (3% to 4% ), Xerostomia (3% to 4% )
Hematologic: Anemia (3% )
Other: Fever (4% to 5% )
Serious

Cardiovascular: Atrial fibrillation (4% ), Bradyarrhythmia (5% to 14% ), Hypotension (25% to 54% ), Sinus arrest,
Tachycardia (2% to 5% ), Transient hypertension, Ventricular tachycardia (Less than 1% )
Respiratory: Acidosis (1% to 2% ), Hypoxia (2% to 4% ), Pulmonary edema (1% ), Respiratory depression (37%)
DRUGDEX® Subscribers: See additional details for DEXMEDETOMIDINE

IV Compatibility

Solutions

Solution Compatibility

  Compatible
D5W-Dextrose 5%
Compatible

Lactated Ringer's Injection Compatible

Normal saline- Sodium chloride 0.9% Compatible

Y-Site

Y-Site Compatibility

Dexrazoxane Compatible

Diazepam Incompatible

Digoxin Compatible

Diltiazem hydrochloride Compatible

Diphenhydramine hydrochloride Compatible

Dobutamine hydrochloride Compatible

Docetaxel Compatible

Dolasetron mesylate Compatible

Dopamine hydrochloride Compatible

Doxacurium chloride Compatible

Doxorubicin hydrochloride Compatible

Doxorubicin hydrochloride liposomal Compatible

Doxycycline hyclate Compatible

Droperidol Compatible

Enalaprilat Compatible

Ephedrine sulfate Compatible

Epinephrine hydrochloride Compatible

Ertapenem sodium Compatible

Erythromycin lactobionate Compatible

Esmolol hydrochloride Compatible

Etomidate Compatible

Etoposide Compatible

Etoposide phosphate Compatible

Famotidine Compatible

Fenoldopam mesylate Compatible

Fentanyl citrate Compatible

Fluconazole Compatible

Fludarabine phosphate Compatible

Fluorouracil Compatible

Foscarnet sodium Compatible

Fosphenytoin sodium Compatible

Furosemide Compatible

Gallium nitrate Compatible

Ganciclovir sodium Compatible

Garenoxacin Mesylate Incompatible

Gatifloxacin Compatible

Gemcitabine hydrochloride Compatible

Gemtuzumab ozogamicin Incompatible

Gentamicin sulfate Compatible

Glycopyrrolate Compatible
Granisetron hydrochloride Compatible

Haloperidol lactate Compatible

Heparin sodium Compatible

Hetastarch 6% (Hextend) Compatible

Hydrocortisone sodium phosphate Compatible

Hydrocortisone sodium succinate Compatible

Hydromorphone hydrochloride Compatible

Hydroxyzine hydrochloride Compatible

Idarubicin hydrochloride Compatible

Ifosfamide Compatible

Imipenem-cilastatin sodium Compatible

Inamrinone lactate Compatible

Insulin, regular Compatible

Irinotecan hydrochloride Incompatible

Isoproterenol hydrochloride Compatible

Ketorolac tromethamine Compatible

Labetalol hydrochloride Compatible

Lepirudin Compatible

Leucovorin calcium Compatible

Levofloxacin Compatible

Levorphanol tartrate Compatible

Lidocaine hydrochloride Compatible

Linezolid
Compatible

Lorazepam Compatible

Magnesium sulfate Compatible

Mannitol Compatible

Mechlorethamine hydrochloride Compatible

Meperidine hydrochloride Compatible

Meropenem Compatible

Mesna Compatible

Methadone hydrochloride Compatible

Methohexital sodium Compatible

Methotrexate sodium Compatible

Methylprednisolone sodium succinate Compatible

Metoclopramide hydrochloride Compatible

Metoprolol tartrate Compatible

Metronidazole Compatible

Midazolam hydrochloride Compatible

Milrinone lactate Compatible

Mitomycin Compatible

Mitoxantrone hydrochloride Compatible

Mivacurium chloride Compatible

Morphine sulfate Compatible

Moxifloxacin hydrochloride Compatible

Mycophenolate mofetil hydrochloride
Compatible

Nalbuphine hydrochloride Compatible

Naloxone hydrochloride Compatible

Nesiritide Compatible

Nicardipine hydrochloride Compatible

Nitroglycerin Compatible

Nitroprusside sodium Compatible

Norepinephrine bitartrate Compatible

Octreotide acetate Compatible

Ofloxacin Compatible

Ondansetron hydrochloride Compatible

Oritavancin Compatible

Oxaliplatin Compatible

Oxytocin Compatible

Paclitaxel (solvent/surfactant) Compatible

Palonosetron hydrochloride Compatible

Pamidronate disodium Compatible

Pancuronium bromide Compatible

Pantoprazole sodium Incompatible

Pemetrexed disodium Compatible

Pentamidine isethionate Compatible

Pentobarbital sodium Compatible

Phenobarbital sodium
Compatible

Phenylephrine hydrochloride Compatible

Phenytoin sodium Incompatible

Piperacillin sodium Compatible

Piperacillin sodium-tazobactam sodium Compatible

Potassium acetate Compatible

Potassium chloride Compatible

Potassium phosphates Compatible

Procainamide hydrochloride Compatible

Prochlorperazine edisylate Compatible

Promethazine hydrochloride Compatible

Propofol Compatible

Propranolol hydrochloride Compatible

Quinupristin-Dalfopristin Compatible

Ranitidine hydrochloride Compatible

Rapacuronium bromide Compatible

Remifentanil hydrochloride Compatible

Rocuronium bromide Compatible

Sodium acetate Compatible

Sodium bicarbonate Compatible

Sodium phosphates Compatible

Succinylcholine chloride Compatible

Sufentanil citrate
Compatible

Sulfamethoxazole-trimethoprim Compatible

Tacrolimus Compatible

Teniposide Compatible

Theophylline Compatible

Thiopental sodium Compatible

Thiotepa Compatible

Ticarcillin disodium Compatible

Ticarcillin disodium-clavulanate potassium Compatible

Tigecycline Compatible

Tirofiban hydrochloride Compatible

Tobramycin sulfate Compatible

Topotecan hydrochloride Compatible

Vancomycin hydrochloride Compatible

Vasopressin Compatible

Vecuronium bromide Compatible

Verapamil hydrochloride Compatible

VinBLAStine sulfate Compatible

VinCRIStine sulfate Compatible

Vinorelbine tartrate Compatible

Voriconazole Compatible

Zidovudine Compatible
 Zoledronic acid
Compatible

Admixture

Admixture Compatibility

Mannitol Compatible

Definitions

Caution:
Compatible Incompatible Inconsistent Uncertain Not Tested
Data

Class/US Availability

DRUGDEX® Subscribers: See additional details for DEXMEDETOMIDINE

Generic Name

Dexmedetomidine Hydrochloride
US Trade Names

Precedex
Synonyms

None Found
Class

Alpha-2 Adrenergic Agonist

Sedative
Regulatory Status

RX
Generic Availability

Yes

Mechanism of Action/Pharmacokinetics

Mechanism of Action

Dexmedetomidine is a relatively selective alpha-2 adrenergic agonist with sedative characteristics. Selectivity
may be dependent upon the dose and the rate of infusion .
DRUGDEX® Subscribers: See additional details for DEXMEDETOMIDINE
Pharmacokinetics

Absorption
 Bioavailability, Intranasal: 82%
Distribution
Protein binding: 94%
Vd: 118 to 152 L
Vd, hypoalbuminemia: 151 L
Vd, severe renal impairment: 161.2 L
Vd, obesity: unchanged by increases in fat mass .
Metabolism
Liver: extensive via direct glucuronidation and cytochrome P450-mediated metabolism
Substrate of CYP2A6 and to a lesser extent, CYP1A2, CYP2E1, CYP2D6, and CYP2C19
Excretion
Fecal: 4%
Renal: 95% changed
Renal clearance: 0.82 L/min
Total body clearance: 39 L/hr to 57 L/hr
Total body clearance, elderly ICU patients: 42.2 L/hr
Total body clearance, hepatic impairment: 53% to 74% of healthy subjects
Total body clearance, severe renal impairment: 1.1 L/min
Total body clearance, obesity: Decreased with increasing fat mass .
Elimination Half-life
Healthy adults, 2 to 2.67 hours
Elderly, 155 minutes
Hypoalbuminemia, 140 minutes
Renal impairment, 113.4 min
DRUGDEX® Subscribers: See additional details for DEXMEDETOMIDINE

Administration/Monitoring

Administration

Intravenous: dexmedetomidine concentrate, 200 mcg/2 mL: dilute 2 mL (200 mcg) of dexmedetomidine with
48 mL of NS (50 mL total) to achieve required concentration of 4 mcg/mL prior to administration; shake gently
to mix
Intravenous: dexmedetomidine 200 mcg/50 mL and 400 mcg/100 mL: already at required concentration of 4
mcg/mL; no further dilution is necessary
Intravenous: administer using a controlled infusion device; do not coadminister in the same IV catheter with
blood or plasma products
Monitoring

attenuation of heart rate and blood pressure increases in response to endotracheal intubation and a decrease
in anesthetic/opioid requirements are indicative of a therapeutic response to dexmedetomidine when given as
an anesthetic adjunct
patients may be arousable and alert when stimulated; this alone should not be considered as indicative of lack
of efficacy
blood pressure, heart rate, respiratory rate, and oxygen levels; continuously during dexmedetomidine infusion
and after discontinuation, as clinically necessary
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How Supplied
Generic

Intravenous Solution: 100 MCG/1 ML

Branded

Dexmedetomidine HCl Novaplus

Intravenous Solution: 100 MCG/1 ML
Precedex
Intravenous Solution: 100 MCG/1 ML
PremierPro Rx Dexmedetomidine HCl
Intravenous Solution: 100 MCG/1 ML

Toxicology

Clinical Effects

DEXMEDETOMIDINE : USES: Indicated for short term (24 hours or less) sedation of patients requiring
intubation and mechanical ventilation in an intensive care setting. It is also used for sedating non-intubated
patients either before and/or during surgical and non-surgical procedures. Multiple studies have utilized
dexmedetomidine for greater than 24 hours; therefore, it may be a safe and effective sedative when used for
longer than 24 hours. PHARMACOLOGY: Dexmedetomidine is a specific and selective alpha-2 adrenoceptor
agonist. It has a significantly higher alpha-2/alpha-1 selectivity ratio than does clonidine. TOXICOLOGY: It is
anticipated that dexmedetomidine can produce hypotension and bradycardia induced by vagal stimuli and
sympathetic outflow. EPIDEMIOLOGY: Overdose is rare. OVERDOSE: Limited data exists on overdose. It is
anticipated that overdose events may be an extension of the adverse events observed. Overdose may result in
oversedation, bradycardia and hypotension. In a series of 3 inadvertent overdoses, deep hypnosis developed,
which resolved within one hour of drug discontinuation. First and second degree AV block have been reported.
Cardiac arrest developed in one patient receiving a bolus loading dose of undiluted dexmedetomidine (19.4
mcg/kg); recovery was uneventful. ADVERSE EVENTS: COMMON: The most frequently reported adverse events
include: hypotension (28%), hypertension (16%) {associated with loading dose administration}, bradycardia
(7%), tachycardia (3%) and hypoxia (4%). Dexmedetomidine decreases sympathetic nervous system activity,
therefore bradycardia and hypotension may be profound in some patients including the elderly, hypovolemic
patients or patients with significant comorbidity (e.g., diabetes mellitus or chronic hypertension). Other events
include atrial fibrillation (4%), fever (5%), vomiting (4%), hemorrhage (3%), and anemia (3%). Respiratory
depression is rare, despite doses that produce marked sedation. INFREQUENT EVENTS: Hyperpyrexia, pain,
hyperglycemia, acidosis, pleural effusion, oliguria and thirst may develop. WITHDRAWAL SYNDROME:
Withdrawal symptoms may occur following abrupt dose reduction or sudden cessation of therapy, similar to
clonidine and other centrally acting antihypertensive agents. Symptoms include, but are not limited to, nausea,
vomiting, agitation, palpitations, and hypertension.
Treatment

DEXMEDETOMIDINE: Support: MANAGEMENT OF MILD TO MODERATE TOXICITY: Treatment is symptomatic

and supportive. Manage mild hypotension with IV fluids. Transient hypertension may develop after exposure;
treatment is usually not indicated. MANAGEMENT OF SEVERE TOXICITY: Treatment is symptomatic and
supportive. Treat severe hypotension with IV 0.9% NaCl at 10 to 20 mL/kg. Add dopamine or norepinephrine if
unresponsive to fluids. Symptomatic bradycardia can be treated with atropine.
DEXMEDETOMIDINE: Decontamination: Not indicated. Drug administered via the intravenous route.
DEXMEDETOMIDINE: Airway management: A decrease in respiratory function is generally not anticipated with
dexmedetomidine when given alone, but it may produce significant respiratory depression when combined with
centrally acting depressant agents (eg, opioids). Assess respiratory rate and effort closely following exposure;
administer oxygen, assist ventilation and intubate if clinically indicated.
DEXMEDETOMIDINE: Antidote: None.
 DEXMEDETOMIDINE: Monitoring of patient: Monitor vital signs and pulse oximetry. Hypotension, bradycardia
and respiratory depression may develop. Institute continuous cardiac monitoring and obtain an ECG. Monitor
neurologic function. Specific laboratory tests are not necessary following inadvertent exposure, unless
otherwise clinically indicated.
DEXMEDETOMIDINE: Enhanced elimination procedure: Hemodialysis is UNLIKELY to be of value because of the
high degree of protein binding and large volume of distribution.
DEXMEDETOMIDINE: Patient disposition: HOME CRITERIA: There is no data to support home management;
dexmedetomidine is generally only used in the hospital setting. OBSERVATION CRITERIA: Patients who are
symptomatic should be observed with frequent monitoring of vital signs. HOSPITAL ADMISSION: Patients with
dysrhythmias or severe respiratory distress require ICU admission. CONSULT CRITERIA: Consult a poison
center or medical toxicologist for assistance in managing patients with severe toxicity or in whom the
diagnosis is not clear.
Range of Toxicity

DEXMEDETOMIDINE: TOXICITY: Limited data. Three patients received an inadvertent overdose in the
perioperative setting: one patient received a dose of 192 mcg (2.6 times the prescribed dose) over 20 minutes;
one received 4 and 2 mcg/kg/hr instead of 0.4 and 0.2 mcg/kg/hr and the third patient received 0.5
mcg/kg/min rather than 0.5 mcg/kg/hr. The major clinical effect in all three was oversedation, which resolved
with the discontinuation of the infusion. In a study of healthy subjects receiving doses approximately 13 times
the upper limit of therapeutic range, transient AV block (first and second degree) developed which resolved
spontaneously. One patient receive a bolus dose of 19.4 mcg/kg undiluted dexmedetomidine and had a cardiac
arrest from which he was successfully resuscitated. THERAPEUTIC DOSE: For sedation,
intubated/mechanically ventilated ICU patients: ADULT: Initial dose: 1 mcg/kg over 10 min; Maintenance: 0.2 to
0.7 mcg/kg/hr infusion for a maximum of 24 hours. Procedural sedation: ADULT: Initial dose: 0.5 to 1 mcg/kg
over 10 min; Maintenance: 0.6 mcg/kg/hr initially and adjust to 0.2 to 1 mcg/kg/hr for a maximum of 24 hours.
PEDIATRIC: Safety and efficacy in children less than 18 years of age have not been established.

References

General References Used

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may not be sold, redistributed, or otherwise used for commercial purposes.
Last Modified

February 09, 2017

Strength of Recommendation Classes

Class I - Recommended. The given test or treatment has been proven to be useful, and should be performed or
administered.
Class IIa - Recommended, In Most Cases. The given test, or treatment is generally considered to be useful, and
is indicated in most cases
Class IIb - Recommended, In Some Cases. The given test, or treatment may be useful, and is indicated in some,
but not most, cases.
Class III - Not Recommended. The given test, or treatment is not useful, and should be avoided.
Strength of Evidence Categories

Category A evidence is based on data derived from: Meta-analyses of randomized controlled trials with
homogeneity with regard to the directions and degrees of results between individual studies. Multiple, well-
done randomized clinical trials involving large numbers of patients.
Category B evidence is based on data derived from: Meta-analyses of randomized controlled trials with
conflicting conclusions with regard to the directions and degrees of results between individual studies.
Randomized controlled trials that involved small numbers of patients or had significant methodological flaws
 (e.g., bias, drop-out rate, flawed analysis, etc.). Nonrandomized studies (e.g., cohort studies, case-control
studies, observational studies).
Category C evidence is based on data derived from: Expert opinion or consensus, case reports or case series.
No Evidence.

Brands

United States Brands

generic dexmedetomidine available

Precedex
see also dexmedetomidine in DailyMed
Canadian Brands

Precedex
see also Health Canada Drug Product Database (DPD)
United Kingdom Brands

generic dexmedetomidine available

Dexdor
see also dexmedetomidine in electronic Medicines Compendium (eMC)
Australian Brands

Precedex Concentrate for infusion (see MIMS Online)

How to cite

National Library of Medicine, or "Vancouver style" (International Committee of Medical Journal Editors):
Truven Health Analytics. DynaMed Plus [Internet]. Ipswich (MA): EBSCO Information Services. 1995 - . Record
No. 232763, Dexmedetomidine; [updated 2014 Jan 10, cited place cited date here]; [about 6 screens].
Available from http://www.dynamed.com/login.aspx?direct=true&site=DynaMed&id=232763. Registration and
login required.