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Dexmedetomidine

Medically reviewed by Drugs.com. Last updated on Jul 10, 2020.

Pronunciation

(deks MED e toe mi deen)

Index Terms

  • Dexmedetomidine HCl
  • Dexmedetomidine Hydrochloride

Dosage Forms

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

Precedex: Dexmedetomidine 200 mcg/50 mL in NaCl 0.9% (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/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)

Brand Names: U.S.

  • Precedex

Pharmacologic Category

  • Alpha2-Adrenergic Agonist
  • Sedative

Pharmacology

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.

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

Metabolism

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

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

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)

Time to Peak

Serum: Intranasal: Median: 38 minutes (range: 15 to 60 minutes) (Iirola 2011)

Duration of Action

Dose dependent: 60 to 120 minutes

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)

Protein Binding

~94%

Special Populations: Hepatic Function Impairment

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

Use: Labeled Indications

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.

Off Label Uses

General anesthesia, maintenance

Data from multiple controlled studies support the use of dexmedetomidine for general anesthesia in various procedures, including awake craniotomy. Use of dexmedetomidine may reduce requirements for other perioperative pharmacological interventions [Bakan 2015], [Dutta 2019], [Goettel 2016], [Le Guen 2014], [Shen 2013], [Shin 2019].

Contraindications

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

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

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 (ISMP 2018; ISMP 2020).

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

Note: 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 (Ebert 2000; Gerlach 2009; Gerlach 2016; Tan 2010; Zhang 2016).

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 (Davy 2017; Shin 2019).

Continuous IV infusion: Usual dosage range: 0.1 to 0.8 mcg/kg/hour; titrate to desired effect (Bakan 2015; Dutta 2019; Le Guen 2014; Patel 2012; Shin 2019).

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 (Gerlach 2011; SCCM [Devlin 2018]). 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) (Jakob 2012; Shehabi 2019).

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 (Gerlach 2009; Jakob 2012; Riker 2009; Shehabi 2004; Shehabi 2019).

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 (Venn 2003). 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 (Jakob 2012; Shehabi 2019). 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 (Bouajram 2019; Flieller 2019; Salah 2020).

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: Geriatric

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: 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.

Reconstitution

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.

Administration

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).

Storage

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.

Drug Interactions

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. 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. Consider therapy modification

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

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

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

Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. 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. Consider therapy modification

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

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

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

Bromperidol: Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Bromperidol may diminish the hypotensive effect of Blood Pressure Lowering Agents. 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. Consider therapy modification

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

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

Fexinidazole [INT]: Bradycardia-Causing Agents may enhance the arrhythmogenic effect of Fexinidazole [INT]. Avoid combination

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

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

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

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

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

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

Midodrine: May enhance the bradycardic effect of Bradycardia-Causing Agents. 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. Consider therapy modification

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

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

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

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

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. 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. Consider therapy modification

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

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

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

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

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

Serotonin/Norepinephrine Reuptake Inhibitors: May diminish the antihypertensive effect of Alpha2-Agonists. 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. Consider therapy modification

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

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

Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. 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. Consider therapy modification

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. 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

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 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).

• Transient, paradoxical hypertension: Has been primarily observed during 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 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.

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]).

Pregnancy Risk Factor C Pregnancy Considerations

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

Patient Education

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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.