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Dexmedetomidine: Drug information

Dexmedetomidine: Drug information
(For additional information see "Dexmedetomidine: Patient drug information" and see "Dexmedetomidine: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Igalmi;
  • Precedex
Brand Names: Canada
  • Precedex
Pharmacologic Category
  • Alpha2-Adrenergic Agonist;
  • Sedative
Dosing: Adult

Note:

Medication safety: Errors have occurred due to clinician misinterpretation of dosing information and units. Maintenance dose is expressed as mcg/kg/hour (Ref).

Appropriate use: Does not provide adequate and reliable amnesia; therefore, use of additional agents with amnestic properties (eg, benzodiazepines, propofol) may be necessary.

Hemodynamic effects: Bradycardia and/or hypotension may occur with loading doses. Transient, paradoxical hypertension may also occur with loading doses; however, this is dependent on high peak plasma concentrations (eg, during rapid loading administration). Bradycardia and hypertension may occur with higher maintenance doses. Hypotension may also occur during titration, with dose escalations that occur more frequently than every 30 minutes (Ref).

Agitation associated with schizophrenia or bipolar I or II disorder

Agitation associated with schizophrenia or bipolar I or II disorder (alternative agent):

Note: Some experts recommend reserving use for patients with mild or moderate agitation who cannot tolerate first-line treatments (Ref). Monitor vital signs including orthostatic measures after each dose to prevent falls and syncope. Due to risk of hypotension, additional half-doses are not recommended in patients with systolic blood pressure (SBP) <90 mm Hg, diastolic blood pressure (DBP) <60 mm Hg, heart rate <60 beats per minute, or postural decrease in SBP ≥20 mm Hg or in DBP ≥10 mm Hg. Patients should not perform activities that require mental alertness (eg, operating machinery, driving) for at least 8 hours after administration.

Mild or moderate agitation: Sublingual film: Sublingual/Buccal: Initial: 120 mcg; if agitation persists, up to 2 additional doses of 60 mcg may be administered at least 2 hours apart. Maximum: 240 mcg/day.

Severe agitation: Sublingual film: Sublingual/Buccal: Initial: 180 mcg; if agitation persists, up to 2 additional doses of 90 mcg may be administered at least 2 hours apart. Maximum: 360 mcg/day.

General anesthesia, maintenance

General anesthesia, maintenance (adjunctive agent) (off-label use):

Note: May reduce sedative-hypnotic and/or opioid requirements of general anesthesia; may reduce postoperative opioid requirements (Ref).

Continuous IV infusion: Usual dosage range: 0.1 to 0.8 mcg/kg/hour; titrate to desired effect (Ref).

Mechanically ventilated patients in the ICU, sedation

Mechanically ventilated patients in the ICU, sedation:

Note: Used as a multimodal strategy (eg, combination of sedatives and analgesics) for ICU sedation and generally preferred over a benzodiazepine due to less risk of prolonged sedation and improved time to extubation; titrate to maintain a light level of sedation (eg, Richmond Agitation Sedation Scale score 0 to −2) or clinical effect (eg, ventilator synchrony). Deep sedation (eg, Richmond Agitation Sedation Scale score −5 to −4) is not achievable with dexmedetomidine monotherapy (Ref). May be used during the extubation period.

IV:

Loading dose (optional): Note: Generally not recommended due to concerns for hemodynamic compromise (eg, hypertension, hypotension, bradycardia) (Ref).

Initial: 1 mcg/kg over 10 minutes, followed by a continuous infusion.

Continuous infusion: Usual dosage range: 0.2 to 1.5 mcg/kg/hour; titrate by 0.2 mcg/kg/hour every 30 minutes to sedation goal or clinical effect (Ref).

Note: Although infusion rates as high as 2.5 mcg/kg/hour have been used, doses >1.5 mcg/kg/hour do not provide additional clinical efficacy (Ref). Manufacturer recommends that infusion duration not exceed 24 hours; however, randomized clinical trials have demonstrated efficacy and safety comparable to lorazepam and midazolam with longer-term infusions of up to ~14 days (Ref). Withdrawal symptoms (eg, hypertension, tachycardia, delirium, agitation) may be more likely to occur in patients with a history of hypertension or receiving continuous infusions for longer durations, with greater cumulative daily doses (eg, >12 mcg/kg/day), or with higher peak rates (eg, >0.8 mcg/kg/hour). In such patients, avoid abrupt discontinuation; carefully decrease dose, while monitoring for withdrawal symptoms (Ref).

Procedural sedation or monitored anesthesia care

Procedural sedation or monitored anesthesia care (including flexible scope intubation [awake]):

IV: Initial: Loading dose of 0.5 to 1 mcg/kg over 10 minutes (use lower range for less invasive procedures [eg, ophthalmic]), followed by a continuous infusion of 0.2 to 1 mcg/kg/hour; titrate to desired level of sedation.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, pharmacokinetics were not significantly different in patients with severe kidney impairment (CrCl <30 mL/minute).

Dosing: Hepatic Impairment: Adult

IV: There are no specific dosage adjustments provided in the manufacturer’s labeling; however, consider a dose reduction. Clearance is reduced in varying degrees based on the level of impairment.

Sublingual film: Agitation associated with schizophrenia or bipolar I or II disorder:

Note: Monitor vital signs, including orthostatic measures, after each dose to prevent falls and syncope. Due to risk of hypotension, additional half-doses are not recommended in patients with systolic blood pressure (SBP) <90 mm Hg, diastolic blood pressure (DBP) <60 mm Hg, heart rate <60 beats per minute, or postural decrease in SBP ≥20 mm Hg or in DBP ≥10 mm Hg. Patients should not perform activities that require mental alertness (eg, operating machinery, driving) for at least 8 hours after administration.

Mild or moderate hepatic impairment (Child-Pugh class A or B):

Mild or moderate agitation: Sublingual film: Sublingual/Buccal: Initial: 90 mcg; if agitation persists, up to 2 additional doses of 60 mcg may be administered at least 2 hours apart. Maximum: 210 mcg/day.

Severe agitation: Sublingual film: Sublingual/Buccal: Initial: 120 mcg; if agitation persists, up to 2 additional doses of 60 mcg may be administered at least 2 hours apart. Maximum: 240 mcg/day.

Severe hepatic impairment (Child-Pugh class C):

Mild or moderate agitation: Sublingual film: Sublingual/Buccal: Initial: 60 mcg; if agitation persists, up to 2 additional doses of 60 mcg may be administered at least 2 hours apart. Maximum: 180 mcg/day.

Severe agitation: Sublingual film: Sublingual/Buccal: Initial: 90 mcg; if agitation persists, up to 2 additional doses of 60 mcg may be administered at least 2 hours apart. Maximum: 210 mcg/day.

Dosing: Pediatric

(For additional information see "Dexmedetomidine: Pediatric drug information")

Note: Errors have occurred due to misinterpretation of dosing information. Maintenance dose expressed as mcg/kg/hour. Individualize and titrate to desired clinical effect.

ICU sedation

ICU sedation: Limited data available:

Infants, Children, and Adolescents:

Loading dose (Optional): IV: 0.5 to 1 mcg/kg/dose over 10 minutes; use of loading dose is dependent upon concomitant sedation agents and patient's current and desired level of sedation (Ref).

Maintenance dose: Note: Although the manufacturer recommends limiting continuous infusions to ≤24 hours in adult patients, duration in pediatric patients has been reported from 2 hours to 103 days; weaning of dexmedetomidine and/or replacement strategies have been recommended (Ref).

Continuous IV infusion: Initial: 0.2 to 0.5 mcg/kg/hour; increase dose by 0.1 to 0.3 mcg/kg/hour to achieve desired level of sedation; usual dose range: 0.2 to 2.5 mcg/kg/hour (Ref). Note: Infants may require higher maintenance infusion rates than either neonates or older children (Ref).

Junctional ectopic tachycardia, postoperative; prevention

Junctional ectopic tachycardia, postoperative; prevention : Limited data available; dosing regimens variable; optimal dose not established:

Infants, Children, and Adolescents (very limited data for adolescents) (Ref):

Loading dose: 0.5 to 1 mcg/kg as a single dose over 15 to 20 minutes; infusion should be completed 10 minutes prior to anesthesia induction.

Continuous IV infusion: 0.5 to 0.75 mcg/kg/hour; administer immediately following loading dose and continue intraoperatively and postoperatively for 48 hours.

Sedation/anesthesia, noninvasive procedures

Sedation/anesthesia, noninvasive procedures: Limited data available:

Infants, Children, and Adolescents:

Loading dose: IV: 0.5 to 2 mcg/kg/dose over 10 minutes; may be repeated if sedation is not adequate (Ref).

Maintenance dose: Continuous IV infusion: Usual initial dose: 0.5 to 1 mcg/kg/hour; an initial dose up to 2 mcg/kg/hour has been reported; titrate to desired level of sedation; dosing based on multiple studies evaluating IV dexmedetomidine administered prior to noninvasive procedures (eg, electroencephalogram, MRI, nuclear medicine studies) (Ref).

Sedation, nonpainful or minimally painful diagnostic procedures

Sedation, nonpainful or minimally painful diagnostic procedures: Limited data available; reported dosing regimens variable and ideal dose not established:

Infants and Children (very limited data in children >10 years): Intranasal: Usual dose: 2 to 3 mcg/kg as a single dose 30 to 60 minutes prior to procedure; reported dose range: 1 to 4 mcg/kg; dosing based on multiple studies evaluating intranasal dexmedetomidine administered prior to procedures (eg, CT, MRI, transesophageal echocardiography, ophthalmic exams, audio brainstem response exams) (Ref).

Sedation, pre-anesthetic

Sedation, pre-anesthetic: Limited data available:

Intranasal:

Children and Adolescents (very limited data available in patients >9 years): Intranasal: 1 to 2 mcg/kg as a single dose 30 to 60 minutes prior to induction of anesthesia. Higher-end doses (2 mcg/kg) are recommended for older children (≥5 years) and adolescents (Ref).

Oral: Dosing regimens variable; optimal dose not established:

Children and Adolescents (very limited data available in adolescents): Oral: 1 to 4 mcg/kg as a single dose 45 minutes prior to induction of anesthesia; dosing based on three retrospective studies and one prospective study (Ref). Note: A dose of 1 mcg/kg has not been shown to decrease the incidence of emergence delirium (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Parenteral: There are no dosage adjustments provided in the manufacturer's labeling; however, pharmacokinetics were not significantly different in adult patients with severe renal impairment (CrCl <30 mL/minute).

Dosing: Hepatic Impairment: Pediatric

Parenteral: There are no specific dosage adjustments provided in the manufacturer's labeling; however, clearance is reduced in varying degrees based on the level of hepatic impairment; adult data suggest a dosage adjustment.

Dosing: Older Adult

Agitation associated with schizophrenia or bipolar I or II disorder:

Note: Monitor vital signs including orthostatic measures after each dose to prevent falls and syncope. Due to risk of hypotension, additional half-doses are not recommended in patients with systolic blood pressure (SBP) <90 mm Hg, diastolic blood pressure (DBP) <60 mm Hg, heart rate <60 beats per minute, or postural decrease in SBP ≥20 mm Hg or in DBP ≥10 mm Hg. Patients should not perform activities that require mental alertness (eg, operating machinery, driving) for at least 8 hours after administration.

Mild, moderate, or severe agitation: Sublingual film: Sublingual/Buccal: Initial: 120 mcg; if agitation persists, up to 2 additional doses of 60 mcg may be administered at least 2 hours apart. Maximum: 240 mcg/day.

Mechanically ventilated patients in the ICU, sedation: IV: Refer to adult dosing. Consider dosage reduction. No specific guidelines available. Dose selections should be cautious, at the low end of dosage range; titration should be slower, allowing adequate time to evaluate response.

Procedural sedation or monitored anesthesia care (including flexible scope intubation [awake]): IV: Refer to adult dosing: Initial: Loading dose of 0.5 mcg/kg over 10 minutes; Maintenance infusion: Dosage reduction should be considered.

Dosing: Obesity: Adult

The recommendations for dosing in patients with obesity are based upon the best available evidence and clinical expertise. Senior Editorial Team: Jeffrey F. Barletta, PharmD, FCCM; Manjunath P. Pai, PharmD, FCP; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC.

Class 1, 2, or 3 obesity (BMI ≥30 kg/m2):

IV: Use adjusted body weight for initial weight-based dose calculations, then titrate to clinical effect (Ref). Clinicians should not change dosing weight from one weight metric to another during therapy (ie, adjusted body weight to/from actual body weight) (Ref). Refer to adult dosing for indication-specific doses.

Rationale for recommendations:

There are limited data on the effects of obesity on dexmedetomidine dosing or pharmacokinetics. Pharmacokinetic studies evaluating dexmedetomidine, a lipophilic compound, have shown a meaningful correlation between both fat free mass (FFM) and lean body weight (LBW) with clearance, but not between actual body weight and clearance (Ref). For Vd, defining the most descriptive weight metric is less clear, but dexmedetomidine appears to have a small additive volume above FFM and LBW (Ref).

Some data suggest using LBW for initial weight-based dosing of dexmedetomidine (Ref); however, there are concerns with calculation errors when using the complex LBW and FFM formula, especially in critical situations (Ref). In addition, if LBW is used, underdosing may occur in clinical situations where faster sedation is indicated (eg, procedural sedation, induction of anesthesia, ICU sedation) (Ref). Using actual body weight in weight-based dosing calculations for bolus doses or continuous infusions may lead to excessive concentrations resulting in adverse effects (Ref). Use of an alternative size descriptor (ie, adjusted body weight) is recommended for dosing in patients with class 1, 2, or 3 obesity (BMI ≥30 kg/m2) (Ref).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Film, Sublingual, as hydrochloride:

Igalmi: 120 mcg (10 ea); 180 mcg (10 ea) [contains fd&c blue #1 (brilliant blue)]

Solution, Intravenous:

Generic: 400 mcg/4 mL (4 mL); 1000 mcg/10 mL (10 mL)

Solution, Intravenous, as hydrochloride:

Generic: 200 mcg/2 mL (2 mL); Dexmedetomidine 200 mcg/50 mL in NaCl 0.9% (50 mL); Dexmedetomidine 400 mcg/100 mL in NaCl 0.9% (100 mL)

Solution, Intravenous, as hydrochloride [preservative free]:

Precedex: 200 mcg/2 mL (2 mL); Dexmedetomidine 400 mcg/100 mL in NaCl 0.9% (100 mL) [additive free, latex free]

Precedex: 80 mcg/20 mL (20 mL); Dexmedetomidine 200 mcg/50 mL in NaCl 0.9% (50 mL); Dexmedetomidine 400 mcg/100 mL in NaCl 0.9% (100 mL) [latex free]

Precedex: 80 mcg/20 mL (20 mL); 1000 mcg/250 mL (250 mL); Dexmedetomidine 200 mcg/50 mL in NaCl 0.9% (50 mL)

Generic: 80 mcg/20 mL (20 mL); 200 mcg/2 mL (2 mL); Dexmedetomidine 200 mcg/50 mL in Dextrose 5% (50 mL); Dexmedetomidine 200 mcg/50 mL in NaCl 0.9% (50 mL); Dexmedetomidine 400 mcg/100 mL in Dextrose 5% (100 mL); Dexmedetomidine 400 mcg/100 mL in NaCl 0.9% (100 mL)

Generic Equivalent Available: US

May be product dependent

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous:

Precedex: 4 mcg/mL (20 mL, 50 mL, 100 mL)

Generic: 4 mcg/mL (50 mL, 100 mL)

Solution, Intravenous, as hydrochloride:

Precedex: 200 mcg/2 mL (2 mL)

Generic: 200 mcg/2 mL (2 mL)

Administration: Adult

IV: Administer using a controlled infusion device. Advisable to use administration components made with synthetic or coated natural rubber gaskets. If loading dose used, administer over 10 minutes; may extend to 20 minutes to further reduce vasoconstrictive effects. Titration no more frequently than every 30 minutes may reduce the incidence of hypotension when used for ICU sedation (Ref).

Sublingual film: For sublingual or buccal administration. Keep in foil pouch until ready to administer; administer immediately after pouch is open and dose is prepared. Remove from pouch with clean, dry hands. For half-doses, cut film in half between the dots with clean, dry scissors; discard the unused half in a waste container. For 60 mcg dose, cut 120 mcg film in half; for 90 mcg dose, cut 180 mcg film in half. For sublingual administration, place film under the tongue; for buccal administration place film behind the lower lip. Allow the film to dissolve; do not chew or swallow. Do not eat or drink for at least 15 minutes after sublingual administration, or at least one hour after buccal administration. Monitor vital signs. Patients should sit or lie down until vital signs are within normal range; if unable to remain seated or lying down, precautions should be taken to reduce the risks of falls. Ensure patient is alert and not experiencing symptomatic hypotension or orthostatic hypotension before resuming ambulation.

Administration: Pediatric

Parenteral: IV: Concentrated solution (100 mcg/mL) must be diluted prior to administration; premixed IV solution (4 mcg/mL) is available. Administer using a controlled infusion device. Infuse loading dose over 10 minutes; may extend up to 20 minutes in neonatal patients or when needed to further reduce vasoconstrictive effects; rapid infusions are associated with severe side effects (Ref). Dexmedetomidine may adhere to natural rubber; use administration components made with synthetic or coated natural rubber gaskets.

Intranasal: Administer undiluted (100 mcg/mL) or dilute in a small volume of NS (eg, to a total volume of 1 or 1.5 mL). Divide dose and give half in each nostril by slowly dripping from a needleless syringe onto the nasal mucosa while in a recumbent position (Ref). Some recommend using a nasal atomizer such as the MAD Nasal Drug delivery device (Ref).

Oral: Administer parenteral formulation undiluted (100 mcg/mL) or diluted in ~5 mL of apple juice or honey (avoid use of honey in infants) (Ref).

Usual Infusion Concentrations: Adult

IV infusion: 200 mcg in 50 mL (concentration: 4 mcg/mL) of NS

Usual Infusion Concentrations: Pediatric

Note: Premixed solutions available.

IV infusion: 4 mcg/mL, 12 mcg/mL, 20 mcg/mL.

Use: Labeled Indications

Agitation associated with schizophrenia or bipolar I or II disorder: Treatment of acute agitation associated with schizophrenia or bipolar I or II disorder in adults.

Limitations of use: Safety and effectiveness have not been established beyond 24 hours from the first dose.

Mechanically ventilated patients in the ICU, sedation: Sedation of intubated, mechanically ventilated patients in the ICU; sedation during extubation and post extubation in the ICU.

Procedural sedation or monitored anesthesia care (including flexible scope intubation [awake]): Procedural sedation prior to and/or during awake fiberoptic intubation; sedation prior to and/or during surgical or other procedures of nonintubated patients.

Use: Off-Label: Adult

General anesthesia, maintenance

Medication Safety Issues
Sound-alike/look-alike issues:

DexmedeTOMIDine may be confused with dexAMETHasone.

Precedex may be confused with Peridex.

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.

Administration issues:

Errors have occurred due to misinterpretation of dosing information; use caution. Maintenance dose expressed as mcg/kg/hour.

Adverse Reactions (Significant): Considerations
Cardiovascular effects

Dexmedetomidine has been associated with hypotension and/or bradycardia (Ref). Hypertension, although less common, may also occur (Ref). Bradycardia, hypotension, and hypertension have occurred in pediatric patients (Ref). Dexmedetomidine has been associated with cardiac arrest/asystole in case reports (Ref). Bradycardia, hypotension, and hypertension are all more common with the IV formulation.

Mechanism: Dexmedetomidine can cause a biphasic blood pressure response (a short hypertensive phase with hypotension thereafter). These effects are related to alpha-2 adrenergic receptor subtypes: Alpha-2B (responsible for hypertensive effects) and alpha-2A (responsible for hypotension) (Ref). In addition, dexmedetomidine decreases sinus and atrioventricular nodal function in pediatric patients (Ref).

Onset: Hypotension and/or bradycardia: Rapid. In one study, the median time to first hypotensive episode was 5 hours (range: ~3 to 13 hours) (Ref). Another study reported a median time of ~4 hours for hemodynamic instability, with more than two-thirds of patients developing hypotension and/or bradycardia within 24 hours (Ref). An additional study showed a median onset of 17 hours for the first hemodynamic event (hypotension or bradycardia) (Ref).

Risk factors:

• Hypotension and/or bradycardia:

- Low baseline arterial blood pressure (Ref)

- Increased age (Ref)

- Increased severity of illness (Ref)

- Loading dose (risk for hypotension in neurosurgical patients or risk for bradycardia in general ICU patients) (Ref)

- Inotrope use (cardiac ICU patients) (Ref)

- Coronary artery disease (Ref)

- Lack of adjuvant sedatives (Ref)

- Titration of infusion < every 30 minutes (Ref)

- Infusion >6 hours (pediatric patients) (Ref)

• Hypertension:

- Loading dose and higher peak plasma concentrations (risk for transient hypertension) (Ref)

• Cardiac arrest/asystole:

- Bradycardia or acute hypotension (Ref)

Tolerance, tachyphylaxis, and withdrawal

Prolonged use of dexmedetomidine use may lead to drug tolerance, tachyphylaxis, loss of sedation control, increased adverse reactions, and withdrawal syndrome (Ref). Withdrawal symptoms may occur in both adult and pediatric patients and may include hypertension, tachycardia, diaphoresis, anxiety, fever, and delirium (Ref). The incidence of withdrawal has been reported in ∼30% of patients (Ref).

Mechanism: Dose- and time-related; related to alpha-2 receptor affinity, binding, and upregulation after prolonged use (Ref).

Onset: Rapid; typically occurs with prolonged use (eg, >24 hours) (Ref).

Risk factors:

• Dose: Higher cumulative daily doses (eg, >12 mcg/kg/day) or with higher peak rates (eg, >0.8 mcg/kg/hour) (Ref)

• Duration (Ref)

• History of hypertension (Ref)

• Opioid duration prior to discontinuation (Ref)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency dependent upon dose, duration, and indication. Reported adverse reactions are for IV dexmedetomidine in adults unless otherwise noted.

>10%:

Cardiovascular: Bradycardia (IV: 5% to 42%; sublingual: 2%) (table 1), hypertension (IV: 11% to 16%; sublingual: 5%) (table 2), hypotension (IV: 24% to 56%; sublingual: 5%) (table 3), tachycardia (25%)

Dexmedetomidine: Adverse Reaction: Bradycardia

Drug (Dexmedetomidine)

Comparator

Placebo

Dose

Dosage Form

Indication

Number of Patients (Dexmedetomidine)

Number of Patients (Comparator)

Number of Patients (Placebo)

2%

N/A

0%

180 mcg

Sublingual film

Acute treatment of agitation associated with schizophrenia or bipolar I or II disorder

252

N/A

252

2%

N/A

0%

120 mcg

Sublingual film

Acute treatment of agitation associated with schizophrenia or bipolar I or II disorder

255

N/A

252

7%

N/A

3%

N/A

IV

Intensive care unit sedation

387

N/A

379

5%

Propofol: 0%

3%

0.5 mcg/kg/hour (range: 0.1 to 6 mcg/kg/hour)

IV

Intensive care unit sedation

798

188

400

42%

Midazolam: 19%

N/A

N/A

IV

Long-term intensive care unit sedation

244

122

N/A

14%

N/A

4%

1.3 mcg/kg/hour (range: 0.3 to 6.1 mcg/kg/hour)

IV

Procedural sedation

318

N/A

113

Dexmedetomidine: Adverse Reaction: Hypertension

Drug (Dexmedetomidine)

Comparator

Placebo

Dose

Dosage Form

Indication

Number of Patients (Dexmedetomidine)

Number of Patients (Comparator)

Number of Patients (Placebo)

16%

N/A

18%

N/A

IV

Intensive care unit sedation

387

N/A

379

13%

Propofol: 4%

19%

0.5 mcg/kg/hour (range: 0.1 to 6 mcg/kg/hour)

IV

Intensive care unit sedation

798

188

400

11%

Midazolam: 15%

N/A

N/A

IV

Long-term intensive care unit sedation

244

122

N/A

13%

N/A

24%

1.3 mcg/kg/hour (range: 0.3 to 6.1 mcg/kg/hour)

IV

Procedural sedation

318

N/A

113

Dexmedetomidine: Adverse Reaction: Hypotension

Drug (Dexmedetomidine)

Comparator

Placebo

Dose

Dosage Form

Indication

Number of Patients (Dexmedetomidine)

Number of Patients (Comparator)

Number of Patients (Placebo)

5%

N/A

0%

180 mcg

Sublingual film

Acute treatment of agitation associated with schizophrenia or bipolar I or II disorder

252

N/A

252

5%

N/A

0%

120 mcg

Sublingual film

Acute treatment of agitation associated with schizophrenia or bipolar I or II disorder

255

N/A

252

28%

N/A

13%

N/A

IV

Intensive care unit sedation

387

N/A

379

24%

Propofol: 13%

12%

0.5 mcg/kg/hour (range: 0.1 to 6 mcg/kg/hour)

IV

Intensive care unit sedation

798

188

400

56%

Midazolam: 56%

N/A

N/A

IV

Long-term intensive care unit sedation

244

122

N/A

54%

N/A

30%

1.3 mcg/kg/hour (range: 0.3 to 6.1 mcg/kg/hour)

IV

Procedural sedation

318

N/A

113

Gastrointestinal: Constipation (6% to 14%), nausea (IV: 3% to 11%; sublingual: 3%)

Nervous system: Agitation (5% to 14%), drowsiness (including fatigue and lethargy: sublingual: 22% to 23%)

Respiratory: Respiratory depression (37%)

1% to 10%:

Cardiovascular: Atrial fibrillation (2% to 9%), edema (2%), orthostatic hypotension (sublingual: 3% to 5%), peripheral edema (3% to 7%)

Endocrine & metabolic: Hyperglycemia (7%), hypocalcemia (1%), hypoglycemia (5%), hypokalemia (9%), hypomagnesemia (1%), hypovolemia (3%), increased thirst (2%)

Gastrointestinal: Abdominal distress (sublingual: 2%), oral hypoesthesia (sublingual: ≤7%), xerostomia (IV: 3%; sublingual: 4% to 7%)

Genitourinary: Decreased urine output (1%), oliguria (2%)

Hematologic & oncologic: Anemia (3%)

Nervous system: Anxiety (5% to 9%), dizziness (sublingual: 4% to 6%), paresthesia (sublingual: ≤7%), withdrawal syndrome (ICU sedation; 3% to 5%)

Renal: Acute kidney injury (2% to 3%)

Respiratory: Acute respiratory distress syndrome (1% to 9%), pleural effusion (2%), respiratory failure (2% to 10%), wheezing (1%)

Miscellaneous: Fever (5% to 7%)

Postmarketing:

Cardiovascular: Acute myocardial infarction, atrioventricular block, cardiac arrhythmia, extrasystoles, inversion T wave on ECG, prolonged QT interval on ECG (IV, sublingual), sinoatrial arrest, supraventricular tachycardia, ventricular arrhythmia, ventricular tachycardia

Dermatologic: Hyperhidrosis, pruritus, skin rash, urticaria

Endocrine & metabolic: Acidosis, hyperkalemia, hypernatremia, increased gamma-glutamyl transferase, respiratory acidosis

Gastrointestinal: Abdominal pain, diarrhea, gastrointestinal pseudo-obstruction (Alkaissi 2021), vomiting

Hematologic & oncologic: Hemorrhage

Hepatic: Abnormal liver function, hyperbilirubinemia, increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase

Nervous system: Anesthesia (light), chills, confusion, delirium, hallucination, headache, hyperpyrexia, illusion, neuralgia, neuritis, pain, seizure, speech disturbance

Ophthalmic: Photopsia, visual disturbance

Renal: Increased blood urea nitrogen, polyuria

Respiratory: Apnea, bronchospasm, dyspnea, hypercapnia, hypoventilation, hypoxia, pulmonary congestion

Miscellaneous: Drug tolerance (use >24 hours) (Tobias 2010), tachyphylaxis (use >24 hours)

Contraindications

There are no contraindications listed in the US manufacturer's labeling.

Canadian labeling: Hypersensitivity to dexmedetomidine or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Cardiovascular effects: Episodes of bradycardia, hypotension, and sinus arrest have been associated with rapid IV administration (eg, loading administration) or when given to patients with high vagal tone. Bradycardia and hypertension may also occur with higher IV maintenance doses. When used for ICU sedation, use of a loading dose is optional; for the maintenance infusion, titration no more frequently than every 30 minutes may reduce the incidence of hypotension (Ebert 2000; Gerlach 2009; Gerlach 2016; Tan 2010; Zhang 2016). If medical intervention is required, treatment may include stopping or decreasing the infusion, increasing the rate of IV fluid administration, use of pressor agents, and elevation of the lower extremities. At low concentrations, mean arterial pressure (MAP) may be reduced without changes in other hemodynamic parameters (eg, pulmonary artery occlusion pressure [PAOP]); however, at higher concentrations (>1.9 ng/mL), MAP, central venous pressure, PAOP, pulmonary vascular resistance, and systemic vascular resistance increase (Ebert 2000).

• Hyperthermia/pyrexia: Hyperthermia or pyrexia, which may be resistant to traditional cooling methods (eg, cooled IV fluids, antipyretics), may occur. Discontinue therapy for suspected drug-related hyperthermia, and monitor patients until body temperature returns to normal.

• Transient, paradoxical hypertension: Has been primarily observed during IV loading dose administration and high peak plasma concentrations and is associated with the initial peripheral vasoconstrictive effects of dexmedetomidine (Ebert 2000). Treatment is generally unnecessary; however, reduction of infusion rate may be required.

Disease-related concerns:

• Cardiovascular disease: Use IV formulation with caution in patients with heart block, bradycardia, severe ventricular dysfunction, hypovolemia, or chronic hypertension. In a scientific statement from the American Heart Association, dexmedetomidine has been determined to be an agent that may exacerbate underlying myocardial dysfunction (magnitude: moderate) (AHA [Page 2016]). Avoid use of the sublingual film in patients with hypotension, orthostatic hypotension, advanced heart block, severe ventricular dysfunction, history of syncope or other arrhythmias, symptomatic bradycardia, hypokalemia or hypomagnesemia, in patients at risk of torsades de pointes or sudden death, including those with known QT prolongation, and in patients receiving other drugs known to prolong the QT interval.

• Diabetes: Use with caution in patients with diabetes mellitus; cardiovascular adverse events (eg, bradycardia, hypotension) may be more pronounced.

• Hepatic impairment: Use with caution in patients with hepatic impairment; dosage reductions recommended.

Special populations:

• Older adults: Use with caution in older adults; cardiovascular events (eg, bradycardia, hypotension) may be more pronounced. Dose reduction may be necessary.

Other warnings/precautions:

• Arousability: Patients may be arousable and alert when stimulated with use of the IV formulation. This alone should not be considered as lack of efficacy in the absence of other clinical signs/symptoms.

• Experienced personnel: IV formulation should be administered only by persons skilled in management of patients in intensive care setting or operating room. Patients should be continuously monitored.

• Tolerance and tachyphylaxis: Use of infusions >24 hours has been associated with tolerance and tachyphylaxis and dose-related increase in adverse reactions.

• Withdrawal: When IV treatment is withdrawn abruptly in patients who have received >24 hours of therapy, withdrawal symptoms may result (eg, hypertension, tachycardia, nervousness, nausea, vomiting, agitation, headaches). Use for >24 hours is not recommended by the manufacturer.

Metabolism/Transport Effects

Substrate of CYP2A6 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider therapy modification

Androgens: Hypertension-Associated Agents may enhance the hypertensive effect of Androgens. Risk C: Monitor therapy

Beta-Blockers: Alpha2-Agonists may enhance the AV-blocking effect of Beta-Blockers. Sinus node dysfunction may also be enhanced. Beta-Blockers may enhance the rebound hypertensive effect of Alpha2-Agonists. This effect can occur when the Alpha2-Agonist is abruptly withdrawn. Management: Closely monitor heart rate during treatment with a beta blocker and clonidine. Withdraw beta blockers several days before clonidine withdrawal when possible, and monitor blood pressure closely. Recommendations for other alpha2-agonists are unavailable. Risk D: Consider therapy modification

Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy

Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Bromperidol: May diminish the hypotensive effect of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Risk X: Avoid combination

Ceritinib: Bradycardia-Causing Agents may enhance the bradycardic effect of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Risk D: Consider therapy modification

CNS Depressants: May enhance the CNS depressant effect of DexmedeTOMIDine. Management: Monitor for increased CNS depression during coadministration of dexmedetomidine and CNS depressants, and consider dose reductions of either agent to avoid excessive CNS depression. Risk D: Consider therapy modification

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Risk C: Monitor therapy

Fexinidazole: Bradycardia-Causing Agents may enhance the arrhythmogenic effect of Fexinidazole. Risk X: Avoid combination

Fingolimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Fingolimod. Management: Consult with the prescriber of any bradycardia-causing agent to see if the agent could be switched to an agent that does not cause bradycardia prior to initiating fingolimod. If combined, perform continuous ECG monitoring after the first fingolimod dose. Risk D: Consider therapy modification

Herbal Products with Blood Pressure Lowering Effects: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy

Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Risk C: Monitor therapy

Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Risk C: Monitor therapy

Levodopa-Containing Products: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Containing Products. Risk C: Monitor therapy

Levoketoconazole: QT-prolonging Agents (Indeterminate Risk - Avoid) may enhance the QTc-prolonging effect of Levoketoconazole. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Midodrine: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Mirtazapine: May diminish the antihypertensive effect of Alpha2-Agonists. Management: Consider avoiding concurrent use. If the combination cannot be avoided, monitor for decreased effects of alpha2-agonists if mirtazapine is initiated/dose increased, or increased effects if mirtazapine is discontinued/dose decreased. Risk D: Consider therapy modification

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Risk C: Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider therapy modification

Ozanimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Ponesimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Ponesimod. Management: Avoid coadministration of ponesimod with drugs that may cause bradycardia when possible. If combined, monitor heart rate closely and consider obtaining a cardiology consult. Do not initiate ponesimod in patients on beta-blockers if HR is less than 55 bpm. Risk D: Consider therapy modification

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Avoid) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Serotonin/Norepinephrine Reuptake Inhibitors: May diminish the therapeutic effect of Alpha2-Agonists. Risk C: Monitor therapy

Siponimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Siponimod. Management: Avoid coadministration of siponimod with drugs that may cause bradycardia. If combined, consider obtaining a cardiology consult regarding patient monitoring. Risk D: Consider therapy modification

Solriamfetol: May enhance the hypertensive effect of Hypertension-Associated Agents. Risk C: Monitor therapy

Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Pregnancy Considerations

Dexmedetomidine crosses the placenta.

Placental transfer was demonstrated following IV infusion in patients undergoing cesarean delivery (Eskandr 2018; Wang 2017; Yu 2015). Based on data from human placental perfusion studies, dexmedetomidine may be retained in the placenta, partially limiting the total amount that could be transferred to the fetus (Ala-Kokko 1997).

Bradycardia is reported with dexmedetomidine use. Fetal bradycardia was noted following a maternal IV bolus dose administered during surgery to a patient on dexmedetomidine infusion for a percutaneous balloon mitral valvuloplasty at 27 weeks' gestation (Weiner 2014).

IV and intrathecal dexmedetomidine have been evaluated for use during spinal anesthesia in patients undergoing cesarean delivery (Bao 2017; Liu 2019; Shen 2020; Sun 2020; Wang 2019). Data from available meta-analyses of randomized controlled studies found no adverse effects of exposure on 1- and 5-minute Apgar scores or umbilical cord blood gases (Lee 2021; Shen 2020; Sun 2020; Zhang 2017). Decreased maternal shivering, nausea, and vomiting have been observed in some studies; dexmedetomidine may also improve the onset to anesthesia compared to some other agents (Bao 2017; Liu 2019; Shen 2020; Sun 2020; Wang 2019; Zhang 2017).

Dexmedetomidine (in combination with other agents) has also been evaluated for use in patient-controlled analgesia following cesarean delivery (Liu 2021; Nie 2018; Zhang 2021).

Breastfeeding Considerations

Dexmedetomidine is present in breast milk.

• A study to test a method of detecting dexmedetomidine in breast milk presented data collected following administration to 4 women undergoing cesarean delivery. Dexmedetomidine IV was given at 6 mcg/kg/hour for 10 minutes, followed by 0.2 to 0.7 mcg/kg/hour until closure of the peritoneal incision. Dexmedetomidine was present in maternal serum of all patients at the end of the infusion (range: 390.3 to 744 pg/mL). Breast milk and maternal serum were sampled 6 and 24 hours after the infusion stopped. Breast milk concentrations at 6 hours ranged from less than the level of detection (<3 pg/mL) to 30.4 pg/mL and all breast milk samples obtained at 24 hours were less than the level of detection. Using the data collected at 6 hours, authors of the study calculated the relative infant dose (RID) of dexmedetomidine to be <1% of the weight-adjusted maternal dose (range: 0.040% to 0.098%) (Nakanishi 2017).

• Dexmedetomidine was evaluated in the colostrum of 10 patients following cesarean delivery. Patients received dexmedetomidine 6 mcg/kg/hour over 10 minutes following removal of the neonate followed by a maintenance dose of 0.7 mcg/kg/hour until closure of the peritoneal incision (mean dose: 63 9 mcg over 21 ± 5 minutes). Maternal serum levels at the end of the infusion ranged from 293.5 to 744 pg/mL. Six hours following dexmedetomidine administration, breast milk concentrations ranged from below the limit of detection to 30.4 pg/mL. Only 1 sample had detectable concentrations at 12 hours (13.6 pg/mL) and dexmedetomidine was not measurable in any breast milk sample 24 hours after the dose. Authors of this study calculated the RID at 6 hours to be <1% of the weight-adjusted maternal dose (range: 0.023% to 0.098%). Breastfeeding was adequate for all neonates at 3 and 5 days, except for 1 infant at 3 days (Yoshimura 2017).

• The presence of dexmedetomidine in breast milk was evaluated in patients receiving patient-controlled IV analgesia (PCIA) following cesarean delivery. Following a bolus dose of 0.5 mcg/kg, pumps were programed to deliver dexmedetomidine 0.03 mcg/kg/hour (n = 29), 0.05 mcg/kg/hour (n = 29), or 0.08 mcg/kg/hour (n = 28) in combination with butorphanol. The basal infusion rate and bolus doses were the same for each study group. Breast milk was collected for 48 hours once lactation started. Dexmedetomidine was present at all doses evaluated. The highest concentrations were observed in patients receiving 0.08 mcg/kg/hour. Actual concentrations were not presented; however, authors of the study calculated the RID of dexmedetomidine to be <1% of the weight-adjusted maternal dose. In addition, the 0.05 mcg/kg/hour dose was found to be most effective for maternal analgesia (Liu 2021).

• A case report describes dexmedetomidine breast milk concentrations in a patient who underwent an awake left frontal craniotomy at 4 weeks postpartum. Dexmedetomidine 45 mcg was administered as a bolus injection followed by an infusion of 0.7 to 1 mcg/kg/hour during surgery. Breast milk was collected twice during surgery and twice after. Concentrations of dexmedetomidine in breast milk were 88 pg/mL ~2 hours after surgery was initiated, and 50 pg/mL ~4 hours into surgery (following a pause in the infusion). Following surgery, breast milk samples obtained in the recovery room were 89 pg/mL (48 minutes after discontinuation of infusion) and 15 pg/mL (4 hours after the dexmedetomidine infusion was stopped) (Dodd 2021).

• In general, breastfeeding is considered acceptable when the RID of a medication is <10% (Anderson 2016; Ito 2000).

A randomized, prospective, double-blind study was conducted to evaluate the effect of dexmedetomidine on breastfeeding outcomes. Patients who planned to exclusively breastfeed for ≥3 months following an elective cesarean delivery were eligible. Dexmedetomidine was initiated following cutting of the umbilical cord with a loading dose of 0.5 mc/kg, followed by 0.5 mcg/kg/hour until surgery ended. Patients were then connected to a PCIA pump and given dexmedetomidine 2 mcg/kg in combination with sufentanil and dolasetron (n = 72). Outcomes were compared to patients receiving similar care, with the exception of dexmedetomidine (n = 72). The mean GA at delivery was 39.34 weeks and 39.03 for the dexmedetomidine and standard care groups, respectively (p = 0.038). The 1- and 5-minute Apgar scores and duration of surgery were similar for both groups. The time to first lactation was shorter and the probability of exclusively breastfeeding within 6 weeks postpartum was greater in the dexmedetomidine group. Milk volumes were similar on the first day postpartum, but greater on the second day in patients in the dexmedetomidine group. A neonatal behavioral neurological assessment conducted on days 1 and 2 of life showed no differences in neonatal outcomes (Wang 2020).

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Breastfeeding infants should be monitored for adverse events (eg, irritability), particularly following high maternal doses used for prolonged periods of time (Mitchell 2020; Mitchell 2021).

Monitoring Parameters

Level of sedation; heart rate, respiration, rhythm, blood pressure; pain control. Note: Dexmedetomidine causes minimal respiratory depression, inhibits salivation, and is analgesic-sparing.

Critically ill mechanically ventilated ICU patients: Assess and adjust sedation according to scoring system (Richmond Agitation-Sedation Scale [RASS] or Sedation-Agitation Scale [SAS]) (SCCM [Devlin 2018]).

Mechanism of Action

Selective alpha2-adrenoceptor agonist with anesthetic and sedative properties thought to be due to activation of G-proteins by alpha2a-adrenoceptors in the brainstem resulting in inhibition of norepinephrine release; peripheral alpha2b-adrenoceptors are activated at high doses or with rapid IV administration resulting in vasoconstriction.

Pharmacokinetics

Onset of action:

IV loading dose: 5 to 10 minutes.

Intranasal:

Neonates (PMA: Median: 40.1 weeks): Median: 10 minutes (Bua 2018).

Infants: Median: 10 minutes (Yu 2017).

Children ≤12 years: Within 10 to 20 minutes (Miller 2018; Yu 2017).

Adults: 45 to 60 minutes (Yuen 2007).

Peak effect:

IV loading dose: 15 to 30 minutes.

IV continuous infusion: 60 minutes (Barr 2013).

Intranasal: 90 to 105 minutes (Yuen 2007).

Duration, post-continuous infusion (dose dependent): 60 to 240 minutes (Ebert 2000; Hall 2000; Ramsay 2004).

Distribution: IV: Vss:

Preterm Neonates (28 to <36 weeks GA): Median: 2.7 L/kg (range: 2.5 to 5.9 L/kg) (Chrysostomou 2014).

Term Neonates (36 to ≤44 weeks GA): Median: 3.9 L/kg (range: 0.1 to 10.9 L/kg) (Chrysostomou 2014). Neonates ≥36 weeks undergoing therapeutic hypothermia for hypoxic ischemic encephalopathy may have a larger volume of distribution (McAdams 2020).

Infants and Children <2 years: Median: 3.8 L/kg (range: 1.9 to 4.6 L/kg) (Vilo 2008).

Children 2 to 11 years: Median: 2.2 L/kg (range: 1.3 to 2.8 L/kg) (Vilo 2008).

Adults: ~118 L; rapid.

Bioavailability:

Intranasal: Variable: Median: 65% (range: 35% to 93%) (Iirola 2011).

Oral: 16% (range: 12% to 20%) (Anttila 2003).

Sublingual: 72%.

Buccal: 82%.

Protein binding: IV: ~94%.

Metabolism: Hepatic via N-glucuronidation, N-methylation, and CYP2A6.

Half-life elimination:

IV:

Preterm Neonates (28 to <36 weeks GA): Terminal: Median: 7.6 hours (range: 3 to 9.1 hours) (Chrysostomou 2014).

Term Neonates (36 to ≤44 weeks GA): Terminal: Median: 3.2 hours (range: 1 to 9.4 hours) (Chrysostomou 2014). Neonates ≥36 weeks undergoing therapeutic hypothermia for hypoxic ischemic encephalopathy may have a longer elimination half-life (McAdams 2020).

Infants and Children <2 years: Terminal: Median: 2.3 hours (range: 1.5 to 3.3 hours) (Vilo 2008).

Children 2 to 11 years: Terminal: Median: 1.6 hours (range: 1.2 to 2.3 hours) (Vilo 2008).

Adults: Distribution: ~6 minutes; Terminal: Approximately up to 3 hours (Venn 2002); significantly prolonged in patients with severe hepatic impairment (Cunningham 1999).

Sublingual/Buccal: 2.8 hours.

Time to peak, serum: Intranasal: Median: 38 minutes (range: 15 to 60 minutes) (Iirola 2011); Sublingual/Buccal: 2 hours.

Excretion: IV: Urine (95%); feces (4%).

Clearance: IV:

Note: Clearance following cardiac surgery was reduced by 27% in pediatric patients aged 1 week to 14 years (Potts 2009).

Preterm Neonates (28 to <36 weeks GA): Median: 0.3 L/hour/kg (0.2 to 0.4 L/hour/kg) (Chrysostomou 2014).

Term Neonates (36 to ≤44 weeks GA): Median: 0.9 L/hour/kg (0.2 to 1.5 L/hour/kg) (Chrysostomou 2014). Neonates ≥36 weeks undergoing therapeutic hypothermia for hypoxic ischemic encephalopathy may have lower clearance (McAdams 2020).

Infants and Children <2 years: Median: 1 L/hour/kg (0.85 to 1.66 L/hour/kg) (Vilo 2008).

Children 2 to 11 years: Median: 1 L/hour/kg (0.56 to 1.35 L/hour/kg) (Vilo 2008).

Adults: ~39 L/hour; Hepatic impairment (Child-Pugh class A, B, or C): Mean clearance values were 74%, 64%, and 53% respectively, of those observed in healthy adults.

Pharmacokinetics: Additional Considerations

Hepatic function impairment: Clearance and plasma protein binding are decreased in patients with hepatic impairment.

Pricing: US

Film (Igalmi Sublingual)

120 mcg (per each): $126.00

180 mcg (per each): $126.00

Solution (Dexmedetomidine HCl in NaCl Intravenous)

80 mcg/20 mL (per mL): $1.63 - $1.71

200 mcg/50 mL (per mL): $0.33 - $1.08

400 mcg/100 mL (per mL): $0.30 - $1.00

Solution (Dexmedetomidine HCl Intravenous)

200 mcg/2 mL (per mL): $2.40 - $38.52

400MCG/4ML (per mL): $23.69

1000MCG/10ML (per mL): $15.99

Solution (Dexmedetomidine HCl-Dextrose Intravenous)

200MCG/50ML -5% (per mL): $0.46

400MCG/100ML -5% (per mL): $0.43

Solution (Precedex Intravenous)

80 mcg/20 mL (per mL): $1.59

200 mcg/2 mL (per mL): $25.45

200 mcg/50 mL (per mL): $0.67

400 mcg/100 mL (per mL): $0.60

1000MCG/250ML (per mL): $1.02

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Alphadex (IN);
  • Cepedex (AT);
  • Demesynt (CR, DO, GT, HN, PA, SV);
  • Demsynt (NI);
  • Detomax IV (BD);
  • Dexdomitor (AT);
  • Dexdor (AT, BE, CH, DE, DK, ES, FI, FR, GB, GR, HR, HU, IE, LT, LV, MT, NL, NO, PL, RO, SE, TR, UA);
  • Dexem (IN, LK);
  • Dexretin (AR);
  • Extodin (BR);
  • Meproxidina (CR, DO, GT, HN, MX, NI, PA, SV);
  • Precedex (AE, AR, AU, BH, BR, CR, DO, EG, GT, HK, HN, ID, JO, JP, KR, KW, LB, MY, NI, NZ, PA, PE, PH, SA, SG, SV, TH, TW, UY, VE, VN);
  • Sedadex (AT);
  • Xamdex (IN)


For country code abbreviations (show table)
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  13. Based on expert opinion.
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