Dexmedetomidine: Pediatric drug information

Copyright 1978-2018 Lexicomp, Inc. All rights reserved.

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

For abbreviations and symbols that may be used in Lexicomp (show table)
• Brand Names: US Precedex
• Brand Names: Canada Precedex
• Therapeutic Category Adrenergic Agonist Agent; Alpha-
Adrenergic Agonist; Sedative
Dosing: Neonatal 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: Limited data available:
Loading dose (Optional): IV: 0.1 to 0.5 mcg/kg/dose over 10 to 20 minutes.
Use of loading dose is dependent upon concomitant sedation
agents and patient’s current and desired level of sedation
(Chyrsostomou 2014; O’Mara 2012; Su 2016)
Maintenance dose: Continuous IV infusion: Initial: 0.1 to 0.3 mcg/kg/hour,
adjust dose to desired level of sedation; reported titration was
variable; however, many increased by 0.1 mcg/kg/hour as needed
to desired level of sedation. Reported dose variable, usual
reported range: 0.2 to 0.6 mcg/kg/hour. Maximum dose: 1.5 mcg/
kg/hour (Bejian 2009; Chrysosotomou 2009; Chysosotomou 2014;
O’Mara 2009; O’Mara 2012; Su 2016). Dosing based on two
prospective pharmacokinetic studies, three retrospective studies,
and a case report. In the largest retrospective study, 24 neonates
(GA: 25.5 ± 1.7 weeks) received a loading dose of 0.5 mcg/kg
followed by a continuous infusion of 0.3 mcg/kg/hour, doses were
titrated by 0.1 mcg/kg/hour every 12 hours to desired sedation.
Mean rate required was 0.6 mcg/kg/hour (range: 0.3 to 1.2 mcg/
kg/hour). When compared to a historical case-controlled cohort,
neonates who received dexmedetomidine required less adjunctive
sedation compared to neonates who received fentanyl, and there
was no difference in hemodynamic parameters between the
groups (O’Mara 2012). A prospective, multicenter,
pharmacokinetic study evaluated the safety and efficacy of
escalating dose levels of dexmedetomidine in 42 neonates
(preterm: n=18, GA: 28 to <36 weeks; term: n=24, GA: 36 to 44
weeks). Patients in each group were sequentially assigned to 1 of
3 escalating dose levels. Level 1 received a loading dose of 0.05
mcg/kg, then maintenance infusion of 0.05 mcg/kg/hour. Level 2
 received a loading dose of 0.1 mcg/kg, then a maintenance
infusion of 0.1 mcg/kg/hour. Level 3 received a loading dose of 0.2
mcg/kg, then a maintenance infusion of 0.2 mcg/kg/hour. Loading
doses were administered over 10 to 20 minutes. Sedation was
demonstrated at each dose but several patients in the Level 1
group had undetectable serum concentrations (Chrysostomou
2014). Reported incidence of adverse effects has been variable;
although many studies report no occurrence of adverse events, a
few studies have reported cases of hypotension and bradycardia
leading to discontinuation of dexmedetomidine and in some cases
requiring resuscitation measures (Chrysostomou 2009; Su 2106).
Dosing: Pediatric
(For additional information see "Dexmedetomidine: 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. 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, 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).
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.
Dosing: Adult
(For additional information see "Dexmedetomidine: Drug information")
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)
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.
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 [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)
Generic: 200 mcg/2 mL (2 mL)
Generic Availability (US) Yes
Administration
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; Wang 2014). Some
recommend using a nasal atomizer such as the MAD Nasal Drug delivery
device (Talon 2009).
Usual Infusion Concentrations: Pediatric IV infusion: 4 mcg/
mL
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.
Use Sedation of initially intubated and mechanically ventilated patients
during treatment in an intensive care setting (FDA approved in adults);
sedation of nonintubated patients prior to and/or during surgical or other
procedures (FDA approved in adults)
Medication Safety Issues
Sound-alike/look-alike issues:
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
Cardiovascular: Atrial fibrillation, bradycardia, edema, hypertension,
hypertension (diastolic), hypotension, hypovolemia, peripheral edema,
systolic hypertension, tachycardia
Central nervous system: Agitation, anxiety
Endocrine & metabolic: Hyperglycemia, hypocalcemia, hypokalemia,
hypoglycemia, hypomagnesemia, increased thirst
Gastrointestinal: Constipation, nausea, xerostomia
Genitourinary: Oliguria
Hematologic & oncologic: Anemia
Renal: Acute renal failure, decreased urine output
Respiratory: Pleural effusion, respiratory depression, wheezing
Miscellaneous: Fever, withdrawal syndrome (ICU sedation)
Rare but important or life-threatening: 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 Q-T 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
Contraindications
There are no contraindications listed in the U.S. 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.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist,
requiring dose or frequency adjustment, additional monitoring, and/or
selection of alternative therapy. Consult drug interactions database for
more detailed information.
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.
Metabolism/Transport Effects Substrate of CYP2A6 (major);
Note: Assignment of Major/Minor substrate status based on clinically
relevant drug interaction potential
Drug Interactions
(For additional information: Launch drug interactions program)

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
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
Bretylium: May enhance the bradycardic effect of Bradycardia-Causing
Agents. Bretylium may also enhance atrioventricular (AV) blockade in
patients receiving AV blocking agents. Risk C: Monitor therapy
Brimonidine (Topical): May enhance the hypotensive effect of Blood
Pressure Lowering Agents. Risk C: 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. 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 X: Avoid combination
CYP2A6 Inhibitors (Moderate): May decrease the metabolism of CYP2A6
Substrates (High risk with Inhibitors). Risk C: Monitor therapy
CYP2A6 Inhibitors (Strong): May decrease the metabolism of CYP2A6
Substrates (High risk with Inhibitors). 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
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
Iobenguane I 123: Alpha2-Agonists may diminish the therapeutic effect of
Iobenguane I 123. Risk X: Avoid combination
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: Blood Pressure Lowering Agents may enhance the hypotensive
effect of Levodopa. Risk C: Monitor therapy
Lormetazepam: May enhance the hypotensive effect of Blood Pressure
Lowering 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
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. Risk D: Consider therapy modification
Pregnancy Risk Factor C (show table)
Pregnancy Implications Adverse effects have been observed in
some animal reproduction studies. Dexmedetomidine is expected to cross
the placenta. Information related to use during pregnancy is limited (El-
Tahan 2012).
Monitoring Parameters Level of sedation, heart rate, respiration,
ECG, blood pressure, pain control
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 (Adult data unless noted)
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.
Additional Information In a prospective, cohort study of pediatric
patients undergoing cardiothoracic surgery for congenital heart disease,
patients received perioperative sedation with either dexmedetomidine
(n=32, median age: 4.8 months, range: ~1 week to 16.5 years) or standard
therapy. Patients receiving dexmedetomidine were noted to have
significantly fewer postoperative arrhythmias (0% vs 25% for ventricular
arrhythmias, p=0.01; 6% vs 25% for supraventricular arrhythmias, p=0.05)
(Chrysostomou 2011). Further studies are needed.
Pricing: US
Solution (Dexmedetomidine HCl Intravenous)
200 mcg/2 mL (2 mL): $22.91
400MCG/4ML (4 mL): $94.74
1000MCG/10ML (10 mL): $233.94
Solution (Precedex Intravenous)
80 mcg/20 mL (20 mL): $31.50
200 mcg/2 mL (2 mL): $50.40
200 mcg/50 mL (50 mL): $55.44
400 mcg/100 mL (100 mL): $100.80
Disclaimer: The pricing data provide a representative AWP and/or AAWP
price from a single manufacturer of the brand and/or generic product,
respectively. The pricing data should be used for benchmarking purposes
only, and as such should not be used to set or adjudicate any prices for
reimbursement or purchasing functions. Pricing data is updated monthly.
• Brand Names: International Cepedex (AT); Demesynt (CR,
DO, GT, HN, PA, SV); Demsynt (NI); Detomax IV (BD); Dexdomitor
(AT); Dexdor (AT, DK, ES, HR, HU, IE, LT, LV, MT, NL, PL, RO, TR,
UA); Dexem (LK); Meproxidina (CR, DO, GT, HN, NI, PA, SV);
Precedex (AE, AR, AU, BH, BR, CR, CZ, DO, GT, HK, HN, ID, JO, KR,
KW, LB, MX, MY, NI, NZ, PA, PE, PH, QA, SA, SG, SV, TH, TW, UY,
VN); Sedadex (AT)
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