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Dexmedetomidine (Monograph)

Brand names: Igalmi, Precedex
Drug class: alpha-Adrenergic Agonists

Medically reviewed by Drugs.com on Mar 10, 2024. Written by ASHP.

Introduction

Relatively selective α2-adrenergic agonist with sedative properties.1 2 3 4 5 6 7 8 13 33

Uses for Dexmedetomidine

Sedation in Critical Care Settings

IV dexmedetomidine is used for sedation of initially intubated and mechanically ventilated patients in an intensive care setting (i.e., ICU).1 800 801

May be used to provide mild to moderate levels of sedation, but not considered suitable for deep sedation.21 23 800 820

FDA-labeled for use only for short-term (<24 hours) sedation;1 however, has been used for prolonged sedation [off-label] in the intensive care setting.23 801 817 818 819 820

Produces sedation, anxiolysis, and analgesia without causing significant respiratory depression.24 801 817 818

Appears to be as effective as propofol and benzodiazepines (e.g., midazolam, lorazepam) for sedation in critically ill mechanically ventilated adults; however, because of some modest clinical benefits (e.g., reduced duration of mechanical ventilation, shorter time to extubation, reduced risk of delirium), nonbenzodiazepine sedatives (dexmedetomidine or propofol) are generally preferred to benzodiazepines.800 801 817 818 819 820

When selecting an appropriate sedative agent, consider patient's individual sedation goals in addition to specific drug-related (e.g., pharmacology, pharmacokinetics, adverse effects, availability, costs) and patient-related (e.g., comorbid conditions such as anxiety, seizures, or alcohol or benzodiazepine withdrawal) factors.23 24 800 801

Patients receiving dexmedetomidine are more arousable than those receiving other sedatives, which may be particularly useful for daily awakening trials.21 23 820

Because dexmedetomidine does not have a substantial respiratory depressant effect, infusions of the drug can be continued following extubation, if needed.1 801

Procedural Sedation

IV dexmedetomidine is used for sedation of nonintubated patients prior to and/or during surgical or other procedures.1 16 30 31 823

Comparative efficacy with other sedative agents not established.817 May be preferred in certain patients (e.g., those in whom respiratory compromise with benzodiazepines is a concern); consider risks versus benefits.817

Acute Agitation Associated with Schizophrenia or Bipolar Disorder

Sublingual/buccal dexmedetomidine is used for management of agitation associated with schizophrenia or bipolar I or II disorder in adults.33 34 35

Safety and efficacy not established beyond 24 hours from the first dose.33

Dexmedetomidine Dosage and Administration

General

Patient Monitoring

Dispensing and Administration Precautions

Administration

Administer by IV infusion or by sublingual or buccal administration depending on the dosage form.1 33

IV Administration

Administer by IV infusion.1

Commercially available as an injection concentrate (100 mcg/mL) that must be diluted to a concentration of 4 mcg/mL before administration or as premixed ready-to-use 4 mcg/mL solutions.1 16 32

Visually inspect solutions prior to administration; do not use if discoloration or precipitate matter is present.1 16 32

Do not infuse through the same IV line with blood or plasma because physical compatibility has not been established.1

Compatible with the following IV fluids: 5% dextrose injection, 0.9% sodium chloride injection, 20% mannitol, 100 mg/mL magnesum sulfate solution, 0.3% potassium chloride solution, and lactated Ringer's injection.1

Potential for adsorption of dexmedetomidine to some types of natural rubber; use of administration components made with synthetic or coated natural rubber gaskets is recommended.1

Rate of Administration

Administer by slow IV infusion via a controlled-infusion device.1

Rapid IV infusion associated with loss of α2-adrenergic selectivity1 and adverse cardiovascular effects.1 2 3 15

Standardize 4 Safety

Standardized concentrations for dexmedetomidine have been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care (see Table 1).249 250 Because recommendations from the S4S panels may differ from the manufacturer’s prescribing information, caution is advised when using concentrations that differ from labeling, particularly when using rate information from the label.249 250 For additional information on S4S (including updates that may be available), see [Web]

Table 1: Standardize 4 Safety Continuous Infusion Standards for Dexmedetomidine249250

Patient Population

Concentration Standard

Dosing Units

Pediatric patients (<50 kg)

4 mcg/mL

mcg/kg/hour

Adults

4 mcg/mL

mcg/kg/hour

Sublingual/Buccal Administration

Dexmedetomidine sublingual film is intended for sublingual or buccal administration. 33 Prepare and administer under supervision of a clinician.33

Commercially available films contain 120 or 180 mcg of dexmedetomidine; the 120 or 180 mcg films may be cut in half to obtain doses of 60 or 90 mcg, respectively.33

Keep films in foil pouch until ready to use; administer immediately once pouch is opened and dose is prepared.33

To prepare dose, open sealed foil pouch by tearing straight across at notch.33 If a half-dose (60 or 90 mcg) will be administered, remove film from pouch with clean, dry hands and cut strip in half between the dots with clean, dry scissors.33 Discard unused half in a waste container and place half film for administration back into pouch.33

Immediately give pouch containing appropriate dose (full or half film) to patient.33 Instruct patient to remove film from pouch with clean, dry hands and to place under the tongue (sublingual administration) or behind lower lip (buccal administration), close the mouth, and allow film to dissolve.33 Film will stick in place and should not be chewed or swallowed.33 Patients should avoid eating or drinking for ≥15 minutes or ≥1 hour following sublingual or buccal administration, respectively.33

Dosage

Available as dexmedetomidine hydrochloride; dosage is expressed in terms of dexmedetomidine.1 33

Dosage reductions may be needed in patients concomitantly receiving other anesthetics, sedatives, hypnotics, or opiates.1

Pediatric Patients

Procedural Sedation
IV

Initiation of sedation in pediatric patients 1 month to <2 years of age undergoing noninvasive procedures: 1.5 mcg/kg as a loading infusion over 10 minutes.1 Consider a reduction in dosage if clinically indicated.1

Initiation of sedation in pediatric patients 2 to <18 years of age undergoing noninvasive procedures: 2 mcg/kg as a loading infusion over 10 minutes.1 Consider a reduction in dosage if clinically indicated.1

Maintenance of sedation in pediatric patients 1 month to <18 years of age undergoing noninvasive procedures: Initiate maintenance infusion at a rate of 1.5 mcg/kg per hour; adjust rate within range of 0.5–1.5 mcg/kg per hour to achieve desired level of sedation.1 Titrate maintenance dose to individual patient clinical response as clinically warranted. 1

Adults

Sedation in Critical Care Settings
IV

Initiation of sedation: 1 mcg/kg as a loading infusion over 10 minutes.1 Because of risk of adverse hemodynamic effects, many clinicians do not recommend a loading dose; if a loading dose is used, caution is advised, particularly in patients with bradycardia, heart block, or hemodynamic instability.21 22 25 801 817 Manufacturer states loading dose may not be required in patients converting from an alternative sedative agent.1

Maintenance of sedation: Continuous IV infusion at a rate of 0.2–0.7 mcg/kg per hour recommended.1 Adjust infusion rate to desired level of sedation;1 in most cases, a light rather than deep level of sedation is recommended in critically ill, mechanically ventilated patients.801 Assess depth and quality of sedation using a validated and reliable assessment tool.800 801 Adjust dosage slowly to reduce risk of hypotension and other adverse effects.24 817

Evidence from clinical studies supports use of infusion rates up to 1.5 mcg/kg per hour.23 24 801 817 818 819 820

Manufacturer states that continuous IV infusion of dexmedetomidine should not exceed 24 hours.1 817 However, the drug has been used for prolonged (>24 hours) sedation in the ICU.817 818 819 820

Procedural Sedation
IV

Initiation of sedation: 1 mcg/kg as a loading infusion over 10 minutes.1 A loading infusion of 0.5 mcg/kg over 10 minutes may be suitable for less invasive procedures (e.g., ophthalmic surgery).1 For awake fiberoptic intubation, a loading infusion of 1 mcg/kg over 10 minutes is recommended.1

Maintenance of sedation: Initiate maintenance infusion at a rate of 0.6 mcg/kg per hour; adjust rate within range of 0.2–1 mcg/kg per hour to achieve desired level of sedation.1 For awake fiberoptic intubation in adults, a maintenance infusion of 0.7 mcg/kg per hour is recommended until endotracheal tube is secured.1

Agitation in Patients with Schizophrenia or Bipolar Disorder
Buccal/Sublingual

Mild or moderate agitation: Initial dose of 120 mcg administered sublingually or bucally; optional second and third doses of 60 mcg each given ≥2 hours apart if agitation persists.33 The maximum recommended total daily dosage is 240 mcg.33

Severe agitation: Initial dose of 180 mcg administered sublingually or bucally; optional second and third doses of 90 mcg given ≥2 hours apart if agitation persists.33 The maximum recommended total daily dosage is 360 mcg.33

Assess vital signs, including orthostatic measurements, prior to administration of a second or third dose.33 Due to risk of hypotension, additional doses not recommended in patients with systolic BP <90 mm Hg, diastolic BP <60 mm Hg, heart rate <60 beats per minute, or a postural decrease in systolic BP of ≥20 mm Hg or in diastolic BP of ≥10 mm Hg.33

Special Populations

Hepatic Impairment

IV Dexmedetomidine:Consider dosage reduction in patients with impaired hepatic function.1

Buccal/Sublingual Dexmedetomidine:Dosage reduction of sublingual or buccal dexmedetomidine for agitation is recommended in patients with hepatic impairment.33 Recommended dosage is based on severity of hepatic impairment and severity of agitation. 33 (See Table 2).

Table 2. Recommended Buccal/Sublingual Dosage of Dexmedetomidine in Patients with Hepatic Impairment33

Severity of Hepatic Impairment

Severity of Agitation

Initial Dose

Optional Second/Third Dose

Maximum Total Daily Dosage

Mild or moderate

Mild or moderate

90 mcg

60 mcg

210 mcg

Mild or moderate

Severe

120 mcg

60 mcg

240 mcg

Severe

Mild or moderate

60 mcg

60 mcg

180 mcg

Severe

Severe

90 mcg

60 mcg

210 mcg

Renal Impairment

Manufacturers make no special dosage recommendations.1 33

Geriatric Patients

IV Dexmedetomidine: For initiation and maintenance of ICU sedation in geriatric patients >65 years of age, consider dosage reduction.1 For procedural sedation in geriatric patients, reduce IV loading dose to 0.5 mcg/kg over 10 minutes; consider dosage reduction for maintenance of procedural sedation.1

Buccal/Sublingual Dexmedetomidine:Dosage reduction recommended.33 In adults ≥65 years of age with mild, moderate, or severe agitation, an initial dose of 120 mcg is recommended.33 Optional second and third doses of 60 mcg each may be given ≥2 hours apart, for a maximum recommended daily dosage of 240 mcg.33

Cautions for Dexmedetomidine

Contraindications

Warnings/Precautions

Administration Precautions

To minimize risk of adverse effects, follow recommendations for administration and monitoring of dexmedetomidine therapy.1

IV dexmedetomidine should be administered by individuals skilled in the management of patients in the intensive care or operating room setting.1

Continuously monitor patients while receiving IV dexmedetomidine.1

Cardiovascular Effects

Bradycardia and sinus arrest reported following IV infusion of dexmedetomidine in young, healthy adults with high vagal tone; also associated with other methods of administration, including rapid IV administration.1

Hypotension and/or bradycardia reported frequently with IV infusion; although intervention rarely required, some cases resulted in fatality.1 8 9 21 23 818 820 May be more pronounced in geriatric patients or those with hypovolemia, diabetes mellitus, or chronic hypertension.1 If treatment is required, consider slowing or stopping dexmedetomidine infusion, increasing IV fluids, elevating lower extremities, and/or use of vasopressors; consider IV anticholinergic agents (e.g., atropine sulfate, glycopyrrolate) to modify vagal tone.1 More advanced resuscitative measures may be necessary in patients with significant cardiovascular dysfunction.1

Transient hypertension reported with IV loading dose; treatment generally not required, although reduction in the loading dose infusion rate may be desirable.1

Supraventricular and ventricular tachycardia, atrial fibrillation, extrasystoles, and cardiac arrest reported during postmarketing experience with IV infusion.1 15

Use IV dexmedetomidine with caution in patients with (or at risk of) advanced heart block and/or severe ventricular dysfunction, and in patients receiving concomitant drugs that slow cardiac conduction.1 817

Dose-dependent hypotension, orthostatic hypotension, and bradycardia reported following use of transmucosal (buccal or sublingual) dexmedetomidine.33 May be more pronounced in geriatric patients or those with hypovolemia, diabetes mellitus, or chronic hypertension.33

Avoid use of sublingual/buccal dexmedetomidine in patients with hypotension, orthostatic hypotension, advanced heart block, severe ventricular dysfunction, or history of syncope.33 After transmucosal administration, patients should be adequately hydrated and should sit or lie down until vital signs are within normal range.33 If a patient is unable to remain seated or lying down, take precautions to reduce the risk of falls.33 Ensure that patient is alert and not experiencing orthostatic hypotension or symptomatic hypotension prior to resumption of ambulation.33

QT-interval prolongation reported with transmucosal dexmedetomidine.33 Avoid use of transmucosal dexmedetomidine 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 those receiving other drugs known to prolong QT interval.33

Somnolence

Somnolence reported in patients receiving transmucosal dexmedetomidine.33

Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or operating hazardous machinery, for at least 8 hours after receiving transmucosal dexmedetomidine.33

Arousability

Some patients receiving IV dexmedetomidine can be arousable and alert when stimulated; should not be considered as evidence of lack of efficacy in the absence of other signs and symptoms.1

Withdrawal Effects

Abrupt withdrawal of IV dexmedetomidine may result in clonidine-like withdrawal symptoms.1 Withdrawal-related events (e.g., nausea, vomiting, agitation, tachycardia, hypertension) reported following discontinuance of therapy in some patients after prolonged (up to 7 days) infusion for ICU sedation.1 Withdrawal symptoms not reported with short-term (<6 hours) infusions for procedural sedation.1

Mild transient withdrawal symptoms (emergence delirium or agitation) reported following discontinuance of short‑term (<2 hours) infusions of dexmedetomidine in pediatric patients.1

Use of transmucosal dexmedetomidine not studied for >24 hours after first dose.33 Potential risk of physical dependence and a withdrawal syndrome if transmucosal dexmedetomidine used in manner other than indicated.33

Tolerance and Tachyphylaxis

Use of IV dexmedetomidine for durations >24 hours associated with tolerance, tachyphylaxis, and dose-related increase in adverse effects.1

Use of transmucosal dexmedetomidine not studied for >24 hours after first dose.33 Potential risk of tolerance and tachyphylaxis if transmucosal dexmedetomidine used in manner other than indicated.33

Hyperthermia or Pyrexia

Risk of hyperthermia or pyrexia, which may be resistant to traditional cooling methods (e.g., administration of cooled IV fluids and antipyretic medications).1

Discontinue dexmedetomidine if drug-related hyperthermia or pyrexia is suspected; monitor patients until body temperature normalizes.1

Specific Populations

Pregnancy

Drug-associated risk of major birth defects and miscarriage not observed with exposure to IV dexmedetomidine after first trimester.1 Most exposures occurred at the time of caesarean section delivery; adverse effects on maternal outcomes or infant Apgar scores not observed.1

Fetal and developmental toxicity observed in animal studies.1

No data available on sublingual/buccal use of dexmedetomidine in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal effects.33

Lactation

Distributed into human milk following IV infusion.1 Potential effects of IV or sublingual/buccal dexmedetomidine on the breast-fed infant or on milk production not known.1 33

Consider developmental and health benefits of breast-feeding along with the mother's need for dexmedetomidine and any potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.1 33 Advise nursing women to monitor the breast-fed infant for irritability.1 33

Pediatric Use

Safety and efficacy of IV dexmedetomidine for ICU sedation not established in pediatric patients <18 years of age.1 However, the drug has been used in pediatric patients undergoing sedation in the ICU or other settings to facilitate mechanical ventilation or other procedures (e.g., radiologic imaging).25 26 27 Additional study is needed to evaluate the drug's safety in this population.21 25 26

Safety and efficacy of IV dexmedetomidine established in pediatric patients 1 month to <18 years of age for sedation during noninvasive procedures.1 Increased frequency of bradypnea, bradycardia, hypertension, and hypotension observed in pediatric patients; however, overall safety profile consistent with known safety profile in adults.1 Safety and efficacy for procedural sedation not established in pediatric patients <1 month of age.1

Safety and efficacy of transmucosal dexmedetomidine not established in pediatric patients.33

Geriatric Use

Hypotension and/or bradycardia may be more pronounced.1 Consider dosage reduction for IV dexmedetomidine.1 A reduced loading dose of IV dexmedetomidine is recommended in geriatric patients receiving the drug for procedural sedation.1

Dosage reduction of dexmedetomidine transmucosal strips recommended in geriatric patients.33

Not known whether efficacy of transmucosal dexmedetomidine differs in geriatric patients compared with younger adults.33

Hepatic Impairment

Clearance may be reduced.1 33 Consider dosage reduction of IV dexmedetomidine.1 Dosage reduction of sublingual/buccal dexmedetomidine recommended in patients with hepatic impairment.33

Renal Impairment

Pharmacokinetics in patients with severe renal impairment (Clcr <30 mL/minute) and healthy individuals are similar.1

Common Adverse Effects

Most common adverse effects (>2%) in adults receiving IV dexmedetomidine: hypotension, bradycardia, dry mouth.1

Most common adverse effects (>5%) in pediatric patients 1 month to <17 years of age receiving IV dexmedetomidine: bradypnea, bradycardia, hypertension, hypotension.1

Most common adverse effects (≥5%) in adults receiving sublingual/buccal dexmedetomidine: somnolence, oral paresthesia or oral hypoesthesia, dizziness, dry mouth, hypotension, orthostatic hypotension.33

Drug Interactions

Metabolized by CYP isoenzymes, principally CYP2A6.1 However, no evidence of clinically important CYP-mediated drug interactions in vitro.1

Drugs that Prolong QT Interval

Potential pharmacodynamic interaction (increased risk of QT-interval prolongation and arrhythmia).33 Avoid concomitant use.33

Drugs with Negative Chronotropic Effects

Potential pharmacodynamic interaction (additive pharmacodynamic effects).1 Use with caution.1

Protein-bound Drugs

Pharmacokinetic interaction unlikely.1

Specific Drugs

Drug

Interaction

Comments

Anesthetics

Additive pharmacologic effects1 8 33

May require reduction in dosage of dexmedetomidine or concomitant drug1 8 33

Digoxin

Negligible change in dexmedetomidine protein binding in vitro; negligible displacement of digoxin from protein binding sites in vitro1

Possible additive hypotensive and bradycardic effects1 25

Caution is advised1

Fentanyl

Negligible change in dexmedetomidine protein binding in vitro1

Ibuprofen

Negligible displacement of ibuprofen from protein binding sites in vitro1

Ketorolac

Negligible change in dexmedetomidine protein binding in vitro1

Lidocaine

Negligible change in dexmedetomidine protein binding in vitro1

Neuromuscular blocking agents

Increased plasma rocuronium concentrations1 12

No clinically important effect on neuromuscular blockade1 12

Opiate agonists

Additive pharmacologic effects1 8 33

May require reduction in dosage of dexmedetomidine or concomitant drug1 8 33

Phenytoin

Negligible displacement of phenytoin from protein binding sites in vitro1

Propranolol

Negligible displacement of propranolol from protein binding sites in vitro1

Sedatives/hypnotics

Additive pharmacologic effects1 8 33

May require reduction in dosage of dexmedetomidine or concomitant drug1 8 33

Theophylline

Negligible change in dexmedetomidine protein binding in vitro; negligible displacement of theophylline from protein binding sites in vitro1

Vasodilators

Possible additive hypotensive effects1

Use with caution1

Warfarin

Negligible displacement of warfarin from protein binding sites in vitro1

Dexmedetomidine Pharmacokinetics

Absorption

Bioavailability

Mean time for dexmedetomidine to dissolve in mouth is approximately 6–8 minutes or 18 minutes following sublingual or buccal administration, respectively.33 Dexmedetomidine generally is quantifiable in plasma within 5–20 minutes after transmucosal administration.33

Absolute bioavailability approximately 72 or 82% following sublingual or buccal administration, respectively.33

Early water intake (as early as 15 minutes postdose) has minimal effects on rate or extent of absorption following sublingual administration.33 Effects of early water intake (i.e., <2 hours postdose) on absorption following buccal administration not evaluated.33

Mean maximal plasma concentrations of dexmedetomidine reached approximately 2 hours after sublingual or buccal administration of the transmucosal strips.33

Distribution

Extent

Rapidly distributed.1 Rapidly crosses blood-brain barrier.25

Crosses the placenta and is distributed into human milk.1

Plasma Protein Binding

Approximately 94%.1

Elimination

Metabolism

Undergoes almost complete biotransformation by direct glucuronidation, aliphatic hydroxylation by CYP2A6, and N-methylation.1 15

Elimination Route

Excreted in urine (95%) and feces (4%).1

Half-life

Terminal elimination half-life is approximately 2 hours following IV infusion.2 3 6

Terminal elimination half-life is approximately 2.8 hours following sublingual or buccal administration of dexmedetomidine strips.33

Special Populations

Clearance decreases with increasing severity of hepatic impairment.1 In adult subects with mild, moderate, or severe hepatic impairment, mean clearance values were 74, 64, or 53%, respectively, of those in healthy individuals.1

Pharmacokinetics in patients with severe renal impairment (Clcr <30 mL/minute) not substantially altered.1

Stability

Storage

Buccal/Sublingual

Sublingual Film

20–25°C (excursions permitted to 15–30°C).33 Store films in foil pouch until ready to administer.33

Parenteral

Premixed Injection in 0.9% Sodium Chloride Injection

20–25°C (excursions permitted to 15–30°C).1

Premixed Injection in 5% Dextrose

20–25°C; protect from light and freezing.32

Actions

Advice to Patients

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Dexmedetomidine Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection Concentrate, for IV Infusion

100 mcg (of dexmedetomidine) per mL*

Dexmedetomidine Hydrochloride Injection

Sublingual (Intrabuccal)

Sublingual Film

120 mcg (of dexmedetomidine)

Igalmi

BioXcel

180 mcg (of dexmedetomidine)

Igalmi

BioXcel

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Dexmedetomidine Hydrochloride in Sodium Chloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for IV infusion

4 mcg (of dexmedetomidine) per mL (80, 200, 400, or 1000 mcg) in sodium chloride 0.9%*

Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection

Precedex

Hospira

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Dexmedetomidine Hydrochloride in Dextrose

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for IV infusion

4 mcg (of dexmedetomidine) per mL (200 or 400 mcg) in 5% dextrose*

Dexmedetomidine Hydrochloride in 5% Dextrose Injection

AHFS DI Essentials™. © Copyright 2024, Selected Revisions March 10, 2024. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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3. Kamibayashi T, Harasawa K, Maze M. Alpha-2 adrenergic agonists. Can J Anaesth. 1997; 44:R13-R18. http://www.ncbi.nlm.nih.gov/pubmed/9196836?dopt=AbstractPlus

4. Peden CJ, Prys-Roberts C. Dexmedetomidine—a powerful new adjunct to anaesthesia? Br J Anaesth. 1992; 68:123-5. Editorial.

5. Shipton EA. Alpha-adrenergic agonists in anaesthesia and analgesia. S Afr Med J. 1991; 79:578-80. http://www.ncbi.nlm.nih.gov/pubmed/1674173?dopt=AbstractPlus

6. Jalonen J, Hynynen M, Kuitunen A et al. Dexmedetomidine as an anesthetic adjunct in coronary artery bypass grafting. Anesthesiology. 1997; 86:331-45. http://www.ncbi.nlm.nih.gov/pubmed/9054252?dopt=AbstractPlus

7. Aho M, Lehtinen A-M, Erkola O et al. The effect of intravenously administered dexmedetomidine on perioperative hemodynamics and isoflurane requirements in patients undergoing abdominal hysterectomy. Anesthesiology. 1991; 74:997-1002. http://www.ncbi.nlm.nih.gov/pubmed/1675042?dopt=AbstractPlus

8. Aho MS, Erkola OA, Scheinin H et al. Effect of intravenously administered dexmedetomidine on pain after laparoscopic tubal ligation. Anesth Analg. 1991; 73:112-8. http://www.ncbi.nlm.nih.gov/pubmed/1854025?dopt=AbstractPlus

9. Lawrence CJ, De Lange S. Effects of a single pre-operative dexmedetomidine dose on isoflurane requirements and peri-operative haemodynamic stability. Anaesthesia. 1997; 52:736-44. http://www.ncbi.nlm.nih.gov/pubmed/9291757?dopt=AbstractPlus

10. Talke P, Li J, Jain U et al. Effects of perioperative dexmedetomidine infusion in patients undergoing vascular surgery. Anesthesiology. 1995; 82:620-33. http://www.ncbi.nlm.nih.gov/pubmed/7879930?dopt=AbstractPlus

11. Jaakola M-L, Ali-Melkkila T, Kanto J et al. Dexmedetomidine reduces intraocular pressure, intubation responses and anaesthetic requirements in patients undergoing ophthalmic surgery. Br J Anaesth. 1992; 68:570-5. http://www.ncbi.nlm.nih.gov/pubmed/1351736?dopt=AbstractPlus

12. Talke PO, Caldwell JE, Richardson CA et al. The effects of dexmedetomidine on neuromuscular blockade in human volunteers. Anesth Analg. 1999; 88:633-9. http://www.ncbi.nlm.nih.gov/pubmed/10072019?dopt=AbstractPlus

13. Khan ZP, Munday IT, Jones RM et al. Effects of dexmedetomidine on isoflurane requirements in healthy volunteers. 1. Pharmacodynamic and pharmacokinetic interactions. Br J Anaesth. 1999; 83:372-80. http://www.ncbi.nlm.nih.gov/pubmed/10655905?dopt=AbstractPlus

14. Aho M, Erkola O, Kallio A et al. Dexmedetomidine infusion for maintenance of anesthesia in patients undergoing abdominal hysterectomy. Anesth Analg. 1992; 75:940-6. http://www.ncbi.nlm.nih.gov/pubmed/1359809?dopt=AbstractPlus

15. Abbott, Abbott Park, IL: Personal communication.

16. Akorn. Dexmedetomidine hydrochloride injection prescribing information. Gurnee, IL; 2022 Jul.

21. Keating GM. Dexmedetomidine: A Review of Its Use for Sedation in the Intensive Care Setting. Drugs. 2015; 75:1119-30. http://www.ncbi.nlm.nih.gov/pubmed/26063213?dopt=AbstractPlus

22. Mo Y, Zimmermann AE. Role of dexmedetomidine for the prevention and treatment of delirium in intensive care unit patients. Ann Pharmacother. 2013; 47:869-76. http://www.ncbi.nlm.nih.gov/pubmed/23719785?dopt=AbstractPlus

23. MacLaren R, Krisl JC, Cochrane RE et al. A case-based approach to the practical application of dexmedetomidine in critically ill adults. Pharmacotherapy. 2013; 33:165-86. http://www.ncbi.nlm.nih.gov/pubmed/23386596?dopt=AbstractPlus

24. Reardon DP, Anger KE, Adams CD et al. Role of dexmedetomidine in adults in the intensive care unit: an update. Am J Health Syst Pharm. 2013; 70:767-77. http://www.ncbi.nlm.nih.gov/pubmed/23592359?dopt=AbstractPlus

25. McMorrow SP, Abramo TJ. Dexmedetomidine sedation: uses in pediatric procedural sedation outside the operating room. Pediatr Emerg Care. 2012; 28:292-6. http://www.ncbi.nlm.nih.gov/pubmed/22391930?dopt=AbstractPlus

26. Grant MJ, Schneider JB, Asaro LA et al. Dexmedetomidine Use in Critically Ill Children With Acute Respiratory Failure. Pediatr Crit Care Med. 2016; 17:1131-1141. http://www.ncbi.nlm.nih.gov/pubmed/27654816?dopt=AbstractPlus

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