which results in [36:<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 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 Off Label Uses Sedation during awake craniotomy 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. Additional Off-Label Uses Treatment of shivering Contraindications There are no contraindications listed in the U.S. manufacturer's labeling. Canadian labeling: Hypersensitivity to dexmedetomidine or any component of the formulation. 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) 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 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 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. 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 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. Consider therapy modification 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. Exceptions: Levobunolol; Metipranolol. 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 Bretylium: May enhance the bradycardic effect of Bradycardia-Causing Agents. Bretylium may also enhance atrioventricular (AV) blockade in patients receiving AV blocking agents. Monitor therapy Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy 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. Avoid combination CYP2A6 Inhibitors (Moderate): May decrease the metabolism of CYP2A6 Substrates (High risk with Inhibitors). Monitor therapy CYP2A6 Inhibitors (Strong): May decrease the metabolism of CYP2A6 Substrates (High risk with Inhibitors). 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 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 Iobenguane I 123: Alpha2-Agonists may diminish the therapeutic effect of Iobenguane I 123. Avoid combination 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: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa. Monitor therapy Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering 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 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. Consider therapy modification 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 (Limited to 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 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. 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 patients: Monitor depth of sedation with either the Richmond Agitation-Sedation Scale (RASS) or Sedation-Agitation Scale (SAS) (Barr 2013) Pregnancy Risk Factor C Pregnancy Considerations 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). Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience nausea. Have patient report immediately to prescriber severe dizziness, passing out, difficulty breathing, slow breathing, shallow breathing, bradycardia, abnormal heartbeat, agitation, severe anxiety, headache, confusion, constipation, diarrhea, salt cravings, abdominal pain, sweating a lot, weakness, or weight loss (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Interactions Print this page Add to My Med List More about dexmedetomidine Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: miscellaneous anxiolytics, sedatives and hypnotics Consumer resources Dexmedetomidine Professional resources Dexmedetomidine Hydrochloride (AHFS Monograph) Dexmedetomidine Hydrochloride Injection (FDA) Dexmedetomidine hydrochloride Injection, Concentrate (FDA) Other brands: Precedex Related treatment guides Sedation ]} Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Dexmedetomidine Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Manufacturers Akorn, Inc. Mylan Pharmaceuticals Inc. Sandoz Inc. Teva Pharmaceuticals USA, Inc. Sun Pharmaceutical Industries Inc. Fresenius Kabi USA, LLC More... Drug Class Miscellaneous anxiolytics, sedatives and hypnotics Related Drugs miscellaneous anxiolytics, sedatives and hypnotics zolpidem , Ambien , hydroxyzine , melatonin , buspirone , diphenhydramine Sedation trazodone , promethazine , lorazepam , hydroxyzine , Ativan , fentanyl , Vistaril , Phenergan , phenobarbital , Atarax , Desyrel , butabarbital , Precedex , Luminal , Promethegan , Talwin , pentazocine , Sublimaze , Nembutal , pentobarbital , chloral hydrate , Seconal , amobarbital , Phenadoz , More...} } different
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