pharmacopeia
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/api/v1/drug/dexmedetomidine

Mechanism of action

Sourced from openFDA

Dexmedetomidine is a relatively selective centrally acting alpha 2 -adrenergic agonist with sedative properties. Alpha 2 selectivity was observed in animals following slow intravenous infusion of low and medium doses (10 mcg/kg to 300 mcg/kg).

Indications

Sourced from openFDA
  • Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection is a alpha 2 adrenergic receptor agonist indicated for: • Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection by continuous infusion not to exceed 24 hours.

Contraindications

Sourced from openFDA
  • None. None.contraindicated

Dosage & administration

Sourced from openFDA

• Individualize and titrate dosing to desired clinical effect. (2.1) • Administration duration should not exceed 24 hours. (2.1) • Administer intravenously using a controlled infusion device. (2.1) • Dexmedetomidine Injection must be diluted prior to administration. (2.1) • Dexmedetomidine Injection in 5% Dextrose 200 mcg/50 mL and 400 mcg/100 mL single-dose bags, do not require dilution prior to administration. (2.1) • To be administered only by health care providers skilled in management of patients in the intensive care or operating room setting. (2.1) • Continuously monitor blood pressure, heart rate, and oxygen levels during administration and as clinically appropriate after discontinuation. (2.1) • It is not necessary to discontinue Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection prior to extubation. • For Adult Intensive Care Unit Sedation : • Initiate at one mcg/kg over 10 minutes , followed by a maintenance infusion of 0.2 to 0.7 mcg/kg/ hour . (2.2) • For Adult Procedural Sedation : Initiate at one mcg/kg over 10 minutes , followed by a maintenance infusion initiated at 0.6 mcg/kg/ hour and titrated to achieve desired clinical effect with doses ranging from 0.2 to 1 mcg/kg/ hour . (2.2) • Alternative Doses : Recommended for patients over 65 years of age and awake fiberoptic intubation patients. (2.2) • See full prescribing information for recommended dosage, reconstitution, dilution, and administration instructions.

Warnings & precautions

Sourced from openFDA

• Monitoring: Continuously monitor patients while receiving dexmedetomidine. (5.1) • Bradycardia and Sinus Arrest: Have occurred in young healthy volunteers with high vagal tone or with different routes of administration, e.g., rapid intravenous or bolus administration. (5.2) • Hypotension and Bradycardia: May necessitate medical intervention. May be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension, and in the elderly. Use with caution in patients with advanced heart block or severe ventricular dysfunction. (5.2) • Co-administration with Other Vasodilators or Negative Chronotropic Agents: Use with caution due to additive pharmacodynamic effects. (5.2) • Transient Hypertension: Observed primarily during the loading dose. Consider reduction in loading infusion rate. (5.3) • Arousability: Patients can become aroused/alert with stimulation; this alone should not be considered as lack of efficacy. (5.4) • Tolerance and Tachyphylaxis: Prolonged exposure to dexmedetomidine beyond 24 hours may be associated with tolerance and tachyphylaxis and a dose-related increase in adverse events. (5.7) 5.1 Drug Administration Dexmedetomidine should be administered only by persons skilled in the management of patients in the intensive care or operating room setting. Due to the known pharmacological effects of dexmedetomidine, patients should be continuously monitored while receiving dexmedetomidine.

Adverse reactions

Sourced from openFDA

The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypotension, bradycardia and sinus arrest [see Warnings and Precautions (5.2)] • Transient hypertension [see Warnings and Precautions (5.3)] • The most common adverse reactions (incidence >2%) in adults are hypotension, bradycardia, and dry mouth. (6.1) • Adverse reactions in adults, associated with infusions >24 hours in duration include ARDS, respiratory failure, and agitation. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact WG Critical Care at 1-866-562-4708 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most common treatment-emergent adverse reactions, occurring in greater than 2% of adult patients in both Intensive Care Unit and procedural sedation studies include hypotension, bradycardia and dry mouth. Intensive Care Unit Sedation Adverse reaction information is derived from the continuous infusion trials of dexmedetomidine for sedation in the Intensive Care Unit setting in which 1,007 adult patients received dexmedetomidine. The mean total dose was 7.4 mcg/kg (range: 0.8 to 84.1), mean dose per hour was 0.5 mcg/kg/hr (range: 0.1 to 6.0) and the mean duration of infusion of 15.9 hours (range: 0.2 to 157.2).

Use in specific populations

Sourced from openFDA

• Geriatric Patients: Dose reduction should be considered. (2.2, 2.3, 5.2, 8.5) • Hepatic Impairment: Dose reduction should be considered. (2.2, 2.3, 5.9, 8.6) 8.1 Pregnancy Risk Summary Available data from published randomized controlled trials and case reports over several decades of use with intravenously administered dexmedetomidine during pregnancy have not identified a drug-associated risk of major birth defects and miscarriage; however, the reported exposures occurred after the first trimester. Most of the available data are based on studies with exposures that occurred at the time of caesarean section delivery, and these studies have not identified an adverse effect on maternal outcomes or infant Apgar scores. Available data indicate that dexmedetomidine crosses the placenta. In animal reproduction studies, fetal toxicity that lower fetal viability and reduced live fetuses occurred with subcutaneous administration of dexmedetomidine to pregnant rats during organogenesis at doses 1.8 times the maximum recommended human dose (MRHD) of 17.8 mcg/kg/day.

Pharmacokinetics

Sourced from openFDA
Metabolism
Following intravenous administration to adults, dexmedetomidine exhibits the following pharmacokinetic parameters: a rapid distribution phase with a distribution half-life (t 1/2 ) of approximately 6 minutes; a terminal elimination half-life (t 1/2 ) of approximately 2 hours; and steady-state volume of distribution (V ss ) of approximately 118 liters. Clearance is estimated to be approximately 39 L/hour.

Overdosage

Sourced from openFDA

The tolerability of dexmedetomidine was studied in one study in which healthy adult subjects were administered doses at and above the recommended dose of 0.2 to 0.7 mcg/kg/hr. The maximum blood concentration achieved in this study was approximately 13 times the upper boundary of the therapeutic range. The most notable effects observed in two subjects who achieved the highest doses were first degree atrioventricular block and second-degree heart block. No hemodynamic compromise was noted with the atrioventricular block and the heart block resolved spontaneously within one minute. Five adult patients received an overdose of dexmedetomidine in the intensive care unit sedation studies. Two of these patients had no symptoms reported; one patient received a 2 mcg/kg loading dose over 10 minutes (twice the recommended loading dose) and one patient received a maintenance infusion of 0.8 mcg/kg/hr. Two other patients who received a 2 mcg/kg loading dose over 10 minutes, experienced bradycardia and/or hypotension. One patient who received a loading bolus dose of undiluted dexmedetomidine (19.4 mcg/kg), had cardiac arrest from which he was successfully resuscitated.

Approval history

Sourced from openFDA
  • Dec 17, 1999NDANDA021038Hospira
  • Aug 18, 2014ANDAANDA203972Ph Health
  • Aug 18, 2014ANDAANDA202881Mylan Institutional
  • Aug 20, 2015ANDAANDA202126Gland
  • Sep 18, 2015ANDAANDA201072Fresenius Kabi Usa
  • Oct 21, 2015NDANDA206628Hq Spclt Pharma
  • Feb 9, 2016ANDAANDA204023Accord Hlthcare
  • Mar 17, 2016ANDAANDA205867Eugia Pharma

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93)Active
    Sponsor: Accord Healthcare Inc. · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93)To be discontinued
    Sponsor: Accord Healthcare Inc.
    Updated
  • Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-600-04)Active
    Sponsor: HQ Specialty Pharma
    Updated
  • Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 44567-601-04)Active
    Sponsor: HQ Specialty Pharma
    Updated
  • Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 55150-209-02)Active
    Sponsor: Eugia US LLC
    Updated
  • Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 67457-251-02)Active
    Sponsor: Mylan Institutional, a Viatris Company
    Updated
  • Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 71288-505-03)Active
    Sponsor: Meitheal Pharmaceuticals, Inc.
    Updated
  • Dexmedetomidine Hydrochloride, Injection, 200 mcg/2 mL (NDC 83634-600-02)Active
    Sponsor: Jiangsu Hengrui Pharmaceuticals Co., Ltd.
    Updated
  • Dexmedetomidine Hydrochloride, Injection, 200 ug/2 mL (NDC 66794-230-42)Active
    Sponsor: Gland Pharma Limited
    Updated
  • Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 44567-602-24)Active
    Sponsor: HQ Specialty Pharma
    Updated
  • Dexmedetomidine Hydrochloride, Injection, 4 ug/1 mL (NDC 44567-603-24)Active
    Sponsor: HQ Specialty Pharma
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
6,178 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use65611%
  2. 2Bradycardia4667.5%
  3. 3Drug Ineffective4577.4%
  4. 4Hypotension3605.8%
  5. 5Cardiac Arrest3095.0%
  6. 6Drug Interaction2564.1%
  7. 7Agitation2243.6%
  8. 8Respiratory Failure2093.4%
  9. 9Pyrexia1812.9%
  10. 10Delirium1672.7%
  11. 11Product Use In Unapproved Indication1652.7%
  12. 12Tachycardia1632.6%
  13. 13Acute Kidney Injury1572.5%
  14. 14Pneumonia1552.5%
  15. 15Toxicity To Various Agents1382.2%

Literature

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Recent PubMed references pinned to Dexmedetomidine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 2,095 ClinicalTrials.gov registrations naming Dexmedetomidine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Dexmedetomidine work?
Dexmedetomidine is a relatively selective centrally acting alpha 2 -adrenergic agonist with sedative properties. Alpha 2 selectivity was observed in animals following slow intravenous infusion of low and medium doses (10 mcg/kg to 300 mcg/kg).
What is Dexmedetomidine used for?
According to FDA labeling, Dexmedetomidine carries indications including: Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection is a alpha 2 adrenergic receptor agonist indicated for: • Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer Dexmedetomidine Injection and Dexmedetomidine in 5% Dextrose Injection by continuous infusion not to exceed 24 hours.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Dexmedetomidine?
Dexmedetomidine is classified as Other hypnotics and sedatives, Central alpha-2 Adrenergic Agonist, Adrenergic alpha1-Agonists, Adrenergic alpha2-Agonists, Decreased Organized Electrical Activity, General Anesthesia, Increased Norepinephrine Activity.
What are the brand names for Dexmedetomidine?
Dexmedetomidine is marketed under brand names including Dexased, Dexdomitor, Dexmedesed, Dexmedvet, Igalmi, Precedex, Sedexodine, Sileo.
What are the contraindications for Dexmedetomidine?
Dexmedetomidine labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.
Note. Data for dexmedetomidine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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