Dexmedetomidine

Pharmacologic Category

Alpha2-Adrenergic Agonist; Sedative

Dosing: Adult

Note: Errors have occurred due to misinterpretation of dosing information. Maintenance dose expressed as mcg/kg/hour. Individualized and titrated to desired clinical effect. At recommended doses, dexmedetomidine does not provide adequate and reliable amnesia (when necessary); therefore, use of additional agents with amnestic properties (eg, benzodiazepines) may be necessary (Ebert 2000).

ICU sedation: IV: Initial: Loading infusion (optional; see "Note" below) of 1 mcg/kg over 10 minutes, followed by a maintenance infusion (see "Note" below) of 0.2 to 0.7 mcg/kg/hour; adjust rate to desired level of sedation; titration no more frequently than every 30 minutes may reduce the incidence of hypotension (Gerlach 2009)

Note: Loading infusion: The loading dose may be omitted for this indication if patient is either being converted from another sedative and patient is adequately sedated or there are concerns for hemodynamic compromise. Maintenance infusion: Dosing ranges between 0.2 to 1.5 mcg/kg/hour have been reported during randomized controlled clinical trials (Pandharipande 2007; Riker 2009). Although infusion rates as high as 2.5 mcg/kg/hour have been used, it is thought that doses >1.5 mcg/kg/hour do not add to clinical efficacy (Venn 2003). Manufacturer recommends duration of infusion should 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 ~5 days (Pandharipande 2007; Riker 2009).

Procedural sedation: IV: Initial: Loading infusion of 1 mcg/kg (or 0.5 mcg/kg for less invasive procedures [eg, ophthalmic]) over 10 minutes, followed by a maintenance infusion of 0.6 mcg/kg/hour, titrate to desired effect; usual range: 0.2 to 1 mcg/kg/hour

Fiberoptic intubation (awake): IV: Initial: Loading infusion of 1 mcg/kg over 10 minutes, followed by a maintenance infusion of 0.7 mcg/kg/hour until endotracheal tube is secured (Bergese 2010).

Craniotomy (awake) (off-label use): IV: Initial: Loading infusion of 0.5 to 1 mcg/kg over 10 to 20 minutes, followed by a maintenance infusion of 0.5 mcg/kg/hour, titrate to desired effect (Bekker 2001; Bekker, 2008; Piccioni 2008; Shen 2013); usual range: 0.1 to 0.7 mcg/kg/hour (Piccioni 2008).

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

* See Dosage and Administration in AHFS Essentials for additional information.

Dosing: Geriatric

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: IV: Refer to adult dosing: Initial: Loading infusion of 0.5 mcg/kg over 10 minutes; Maintenance infusion: Dosage reduction should be considered.

Dosing: Renal Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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.

Dosing: Pediatric

Note: Errors have occurred due to misinterpretation of dosing information. Maintenance dose expressed as mcg/kg/hour. Individualize and titrate to desired clinical effect. At recommended doses, dexmedetomidine does not provide adequate and reliable amnesia (when necessary); therefore, use of additional agents with amnestic properties (eg, benzodiazepines) may be necessary (Ebert 2000).

ICU sedation: Infants, Children, and Adolescents: Limited data available:

Loading dose (Optional): IV: 0.5 to 1 mcg/kg/dose over 10 minutes (Chrysostomou 2009; Walker 2006); use of loading dose is dependent upon concomitant sedation agents and patient's current and desired level of sedation.

Maintenance dose: Continuous IV infusion: Initial: 0.2 to 0.5 mcg/kg/hour; adjust dose to desired level of sedation. Dosing based on multiple retrospective studies, case reports, and a few prospective studies. Most reported increasing by 0.1 to 0.3 mcg/kg/hour as needed. Reported maintenance dose variable, usual reported range was 0.4 to 0.7 mcg/kg/hour (Bejian 2009; Carroll 2008; Chrysostomou 2006; Chrysostomou 2009; Czaja 2009; Hosokawa 2010; Tobias 2004; Walker 2006; Whalen 2014). In general, infants may require higher maintenance infusion rates than either neonates or older children (Chrysostomou 2006; Chrysostomou 2009; Tobias 2004). Maximum reported doses varied; most utilized doses <1 mcg/kg/hour; however, doses as high as 2.5 mcg/kg/hour in intubated patients have been described (Carroll 2008). Although the manufacturer recommends duration of infusion should not exceed 24 hours, most studies reported use beyond this time period; most patients received infusion for ≤72 hours; however, one patient received dexmedetomidine for 103 days (Whalen 2014). Prolonged infusions should not be abruptly discontinued and are generally tapered over several days to prevent withdrawal symptoms.

Sedation/anesthesia, noninvasive procedures: Limited data available:

Loading dose: Infants, Children, and Adolescents: IV: 0.5 to 2 mcg/kg/dose over 10 minutes; may be repeated if sedation is not adequate (Ahmed 2014; Berkenbosch 2005; Koroglu 2006; Mason 2013; Siddappa 2011).

Maintenance dose: Infants, Children, and Adolescents: Continuous IV infusion: 0.5 to 1 mcg/kg/hour (Ahmed 2014; Berkenbosch 2005; Koroglu 2006; Mason 2013; Siddappa 2011). Dosing based on multiple retrospective and prospective studies in over 800 pediatric patients receiving dexmedetomidine (± other sedatives) for noninvasive procedures (eg, EEG, MRI, PET scan). In the largest, a retrospective study, 669 patients (age: 0.1 to 22.5 years) undergoing nuclear medicine imaging received dexmedetomidine for sedation. A bolus of 2 mcg/kg was administered over 10 minutes; this dose could be repeated up to 2 additional times if the predefined sedation score was not achieved; in addition, patients also received a maintenance infusion of 1 mcg/kg/hour. The mean time to achieve adequate sedation for all patients was 8.6 ± 4.6 minutes (range: 1 to 40 minutes). Hypotension, hypertension, and bradycardia occurred in 58.7%, 2.1% and 4.3% of patients, respectively; no patient required pharmacologic treatment. Hypotension and bradycardia were noted to be age related; risk of hypotension increased by 25% with each 5 year age increment increase and bradycardia occurred more often in children 3 to 12 years than any other age group. The authors concluded that the drug was well tolerated (Mason 2013).

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

Infants ≥6 months 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) (Cao 2017; Ghai 2017; Gyanesh 2014; Ibrahim 2014; Li 2014; Li 2020; Reynolds 2016; Sulton 2020; Yuen 2019).

Sedation, pre-anesthetic: Limited data available: 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 (Talon 2009; Yuen 2012). Dosing based on multiple prospective studies (Akin 2012; Cimen 2013; Talon 2009; Wang 2014; Yuen 2012).

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

Dosing: Renal Impairment: Pediatric

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

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 suggests a dosage adjustment.

Calculations

• Dexmedetomidine

Use: Labeled Indications

Intensive care unit sedation: Sedation of initially-intubated and mechanically-ventilated patients during treatment in an intensive care setting

Procedural sedation: Procedural sedation prior to and/or during awake fiberoptic intubation; sedation prior to and/or during surgical or other procedures of nonintubated patients

* See Uses in AHFS Essentials for additional information.

Use: Off-Label: Adult

​Sedation during awake craniotomyLevel of Evidence [B]

Data from controlled studies indicate that dexmedetomidine can be used successfully to provide sedation during awake craniotomy and may help reduce length of stay as well as the need for other perioperative pharmacological interventions. Additional trials may be necessary to further define the role of dexmedetomidine in this condition. Access Full Off-Label Monograph

Level of Evidence Definitions

​Level of Evidence Scale

Clinical Practice Guidelines

Critical Care:

ACCM/SCCM, "Clinical Practice Guidelines for the Management of Pain, Agitation, and Delirium in Adult Patients in the Intensive Care Unit,” January 2013

ACCM/SCCM, “Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU,” August 2018

Usual Infusion Concentrations: Pediatric

IV infusion: 4 mcg/mL

Usual Infusion Concentrations: Adult

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

Administration: 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 (Gerlach 2009).

Administration: Pediatric

Parenteral: IV: 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. 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 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 (Akin 2012; Cimen 2013; Ghai 2017; Gyanesh 2014; Wang 2014). Some recommend using a nasal atomizer such as the MAD Nasal Drug delivery device (Cao 2017; Talon 2009).

Storage/Stability

Bottles: Store at room temperature.

Vials: Store unopened vials (single-dose and multi-dose) at room temperature. Diluted solutions using multi-dose vials may be stored for up to 4 hours at room temperature or up to 24 hours at 2°C to 8°C (35°F to 46°F) prior to use.

Preparation for Administration: Adult

Concentrated solution (100 mcg/mL): Must dilute in NS to achieve the required concentration (4 mcg/mL) prior to administration. Add 2 mL (200 mcg) of dexmedetomidine to 48 mL of NS for a total volume of 50 mL (4 mcg/mL) or 4 mL (400 mcg) of dexmedetomidine to 96 mL of NS for a total volume of 100 mL. Shake gently to mix.

Preparation for Administration: Pediatric

Parenteral: IV: Dexmedetomidine injection concentrate (100 mcg/mL) must be diluted prior to administration. Dilute 200 mcg (2 mL) in 48 mL NS to achieve a final concentration of 4 mcg/mL. Shake gently to mix.

Compatibility

See Trissel’s IV Compatibility Database

Open Trissel's IV Compatibility

Medication Patient Education with HCAHPS Considerations

What is this drug used for?

• It is used to cause sleep during a procedure.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Severe dizziness

• Passing out

• Trouble breathing

• Slow breathing

• Shallow breathing

• Slow heartbeat

• Fast heartbeat

• Abnormal heartbeat

• Agitation

• Anxiety

• Headache

• Confusion

• Constipation

• Diarrhea

• Salt cravings

• Abdominal pain

• Sweating a lot

• Weakness

• Weight loss

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Medication Safety Issues

​Sound-alike/look-alike issues:

​High alert medication:

​Administration issues:

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, bolus administration) or when given to patients with high vagal tone. 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 (Gerlach 2009). 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, CVP, PAOP, PVR, and SVR increase (Ebert 2000).

• Transient hypertension: Has been primarily observed during loading dose administration and is associated with the initial peripheral vasoconstrictive effects of dexmedetomidine. Treatment is generally unnecessary; however, reduction of infusion rate may be required.

Disease-related concerns:

• Cardiovascular disease: Use 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]).

• 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:

• Elderly: Use with caution in the elderly; 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. This alone should not be considered as lack of efficacy in the absence of other clinical signs/symptoms.

• Experienced personnel: 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 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.

* See Cautions in AHFS Essentials for additional information.

Pregnancy Risk Factor

C

Pregnancy Considerations

Dexmedetomidine is expected to cross the placenta. Information related to use during pregnancy is limited (El-Tahan 2012).

Breast-Feeding Considerations

It is not known if dexmedetomidine is excreted in breast milk. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Briggs' Drugs in Pregnancy & Lactation

• Dexmedetomidine

Adverse Reactions

Frequency dependent upon dose, duration, and indication.

>10%:

Cardiovascular: Hypotension (24% to 56%), bradycardia (5% to 42%), systolic hypertension (28%), tachycardia (25%), hypertension (diastolic; 12%), hypertension (11%)

Central nervous system: Agitation (5% to 14%)

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

Respiratory: Respiratory depression (37%; placebo 32%)

1% to 10%:

Cardiovascular: Atrial fibrillation (2% to 9%), peripheral edema (3% to 7%), hypovolemia (3%), edema (2%)

Central nervous system: Anxiety (5% to 9%)

Endocrine & metabolic: Hypokalemia (9%), hyperglycemia (7%), hypoglycemia (5%), increased thirst (2%), hypocalcemia (1%), hypomagnesemia (1%)

Gastrointestinal: Xerostomia (3% to 4%)

Genitourinary: Oliguria (2%)

Hematologic & oncologic: Anemia (3%)

Renal: Acute renal failure (2% to 3%), decreased urine output (1%)

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

Miscellaneous: Fever (5% to 7%), withdrawal syndrome (ICU sedation; 3% to 5%)

Postmarketing and/or case reports: Abdominal pain, acidosis, apnea, atrioventricular block, bronchospasm, cardiac arrhythmia, cardiac disease, chills, confusion, convulsions, decreased visual acuity, delirium, diaphoresis, diarrhea, dizziness, drug tolerance (use >24 hours), dyspnea, extrasystoles, hallucination, headache, heart block, hemorrhage, hepatic insufficiency, hyperbilirubinemia, hypercapnia, hyperkalemia, hypernatremia, hyperpyrexia, hypoventilation, hypoxia, illusion, increased blood urea nitrogen, increased gamma-glutamyl transferase, increased serum alkaline phosphatase, increased serum ALT, increased serum AST, inversion T-wave on ECG, myocardial infarction, neuralgia, neuritis, pain, photopsia, polyuria, prolonged QT interval on ECG, pulmonary congestion, respiratory acidosis, rigors, seizure, sinoatrial arrest, speech disturbance, supraventricular tachycardia, tachyphylaxis (use >24 hours), variable blood pressure, ventricular arrhythmia, ventricular tachycardia, visual disturbance, vomiting

* See Cautions in AHFS Essentials for additional information.

Allergy and Idiosyncratic Reactions

• DexmedeTOMIDine Allergy

Metabolism/Transport Effects

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

Drug Interactions Open Interactions

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 amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Risk D: Consider therapy modification

Amisulpride (Oral): May enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor therapy

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

Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. 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. Exceptions: Levobunolol; Metipranolol. 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. Exceptions are discussed in separate monographs. 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 [INT]: Bradycardia-Causing Agents may enhance the arrhythmogenic effect of Fexinidazole [INT]. Risk X: Avoid combination

Herbs (Hypotensive Properties): 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

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. 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

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

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

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

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

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

Ruxolitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Management: Ruxolitinib Canadian product labeling recommends avoiding use with bradycardia-causing agents to the extent possible. Risk C: Monitor therapy

Serotonin/Norepinephrine Reuptake Inhibitors: May diminish the antihypertensive 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. Risk D: Consider therapy modification

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

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

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

Tricyclic Antidepressants: May diminish the antihypertensive effect of Alpha2-Agonists. Management: Consider avoiding this combination. If used, monitor for decreased effects of the alpha2-agonist. Exercise great caution if discontinuing an alpha2-agonist in a patient receiving a TCA. Risk D: Consider therapy modification

Genes of Interest

• Cytochrome P450 2D6

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]).

Advanced Practitioners Physical Assessment/Monitoring

Sedation of initially intubated and mechanically ventilated patients, do not exceed 24 hours of infusion, may lead to tolerance and tachyphylaxis and a dose related increase in adverse events. Administration should be managed by professionals experienced in anesthesia or critical care. Dosage and rate of administration should be individualized and titrated to the desired effect. Continuous monitoring of vital signs, cardiac and respiratory status, and level of sedation is mandatory during infusion and until full consciousness is regained. Safety precautions must be maintained until patient is fully alert. Dexmedetomidine is a sedative; pain must be treated with appropriate analgesic agents. Do not discontinue abruptly (may result in rapid awakening associated with anxiety, agitation, and resistance to mechanical ventilation). Titrate infusion rate so patient awakes slowly. Monitor fluid levels (intake and output) during and following infusion. Reposition patient and provide appropriate skin, mouth, and eye care every 2 to 3 hours, while sedated. Provide appropriate emotional and sensory support (auditory and environmental). Monitor for bradycardia, sinus arrest, or hypotension during administration. May occur more frequently in patients with hypovolemia, diabetes, chronic hypertension, or in the elderly. Possible transient hypertension can occur with a loading dose. Caution coadministration with other vasodilators or negative chronotropic agents. Baseline LFTs to determine liver function; use with caution in patients with hepatic impairment. Use with caution in the elderly; reduce the dosage. Monitor blood sugars and electrolytes closely in diabetics receiving dexmedetomidine.

Nursing Physical Assessment/Monitoring

Continuous monitoring of vital signs, cardiac and respiratory status, and level of sedation is mandatory during infusion and until full consciousness is regained. Safety precautions must be maintained until patient is fully alert. Dexmedetomidine is a sedative; pain must be treated with appropriate analgesic agents. Do not discontinue abruptly (may result in agitation, anxiety, resistance to mechanical ventilation, headache, hypertension). Titrate infusion rate so patient awakes slowly. Monitor fluid levels (intake and output) during and following infusion. Reposition patient and provide appropriate skin, mouth, and eye care every 2 to 3 hours, while sedated. Provide appropriate emotional and sensory support (auditory and environmental). Monitor for bradycardia, sinus arrest, and hypotension. Monitor for transient hypertension with a large loading dose.

Dosage Forms: US

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

Solution, Intravenous:

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

Solution, Intravenous, as hydrochloride [preservative free]:

Precedex: 400 mcg/100 mL (100 mL); 200 mcg/2 mL (2 mL) [additive free, latex free]

Precedex: 200 mcg/50 mL (50 mL) [latex free]

Precedex: 80 mcg/20 mL (20 mL); 1000 mcg/250 mL (250 mL)

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

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)

Solution, Intravenous, as hydrochloride:

Precedex: 200 mcg/2 mL (2 mL)

Generic: 200 mcg/2 mL (2 mL)

Anatomic Therapeutic Chemical (ATC) Classification

• N05CM18

Generic Available (US)

Yes

Pricing: US

Solution (Dexmedetomidine HCl in NaCl Intravenous)

80 mcg/20 mL (per mL): $1.56

200 mcg/50 mL (per mL): $1.03 - $1.07

400 mcg/100 mL (per mL): $0.96 - $0.98

Solution (Dexmedetomidine HCl Intravenous)

200 mcg/2 mL (per mL): $3.25 - $38.52

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

1000MCG/10ML (per mL): $23.39

Solution (Dexmedetomidine HCl-Dextrose Intravenous)

200MCG/50ML -5% (per mL): $0.87

400MCG/100ML -5% (per mL): $0.64

Solution (Precedex Intravenous)

80 mcg/20 mL (per mL): $1.58

200 mcg/2 mL (per mL): $25.20

200 mcg/50 mL (per mL): $1.11

400 mcg/100 mL (per mL): $1.01

1000MCG/250ML (per mL): $1.01

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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.

Pharmacodynamics/Kinetics

Onset of action:

IV loading dose: 5 to 10 minutes

Intranasal: 45 to 60 minutes (Yuen 2007), may be faster in pediatric patients when administered via an atomizing device (Talon 2009)

Peak effect:

IV loading dose: 15 to 30 minutes

Intranasal: 90 to 105 minutes (Yuen 2007)

Duration (dose dependent): 60 to 120 minutes

Distribution: Vss:

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

Term neonates (36 to ≤44 weeks GA): 3.9 L/kg (range: 0.1 to 10.9 L/kg) (Chrysostomou 2014)

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)

Protein binding: ~94%

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

Half-life elimination:

Preterm Neonates (28 to <36 weeks GA): Terminal: 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)

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: ~up to 3 hours (Venn 2002); significantly prolonged in patients with severe hepatic impairment (Cunningham 1999)

Time to peak, serum: Intranasal: Median: 38 minutes (range: 15 to 60 minutes) (Iirola 2011)

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

Clearance:

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): 0.3 L/hour/kg (0.2 to 0.4 L/hour/kg) (Chrysostomou 2014)

Term Neonates (36 to ≤44 weeks GA): 0.9 L/hour/kg (0.2 to 1.5 L/hour/kg)

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

Pharmacodynamics/Kinetics: Additional Considerations

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

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Xerostomia and changes in salivation (normal salivary flow resumes upon discontinuation)

Effects on Bleeding

No information available to require special precautions

Related Information

• Moderate Sedation

Index Terms

Dexmedetomidine HCl; Dexmedetomidine Hydrochloride

FDA Approval Date

December 17, 1999

References

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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)

Last Updated 10/13/20