pharmacopeia
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/api/v1/drug/etomidate

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Adrenergic alpha2-Agonists; GABA A Modulators.

GABA A

Indications

Sourced from openFDA
  • Etomidate Injection is indicated by intravenous injection for the induction of general anesthesia. When considering use of Etomidate Injection, the usefulness of its hemodynamic properties (see CLINICAL PHARMACOLOGY ) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS ).

Contraindications

Sourced from openFDA
  • Etomidate is contraindicated in patients who have shown hypersensitivity to it.contraindicated

Dosage & administration

Sourced from openFDA

Do not administer unless solution is clear and container is undamaged. Discard unused portion (see DOSAGE AND ADMINISTRATION ). Etomidate Injection is intended for administration only by the intravenous route (see CLINICAL PHARMACOLOGY ). The dose for induction of anesthesia in adult patients and in pediatric patients above the age of ten (10) years will vary between 0.2 mg/kg and 0.6 mg/kg of body weight, and it must be individualized in each case. The usual dose for induction in these patients is 0.3 mg/kg, injected over a period of 30 to 60 seconds. There are inadequate data to make dosage recommendations for induction of anesthesia in patients below the age of ten (10) years; therefore, such use is not recommended. Geriatric patients may require reduced doses of etomidate. Smaller increments of intravenous etomidate may be administered to adult patients during short operative procedures to supplement subpotent anesthetic agents, such as nitrous oxide. The dosage employed under these circumstances, although usually smaller than the original induction dose, must be individualized. There are insufficient data to support this use of etomidate for longer adult procedures or for any procedures in pediatric patients; therefore, such use is not recommended. The use of intravenous fentanyl and other neuroactive drugs employed during the conduct of anesthesia may alter the etomidate dosage requirements. Consult the prescribing information for all other such drugs before using.

Warnings & precautions

Sourced from openFDA

INTRAVENOUS ETOMIDATE SHOULD BE ADMINISTERED ONLY BY PERSONS TRAINED IN THE ADMINISTRATION OF GENERAL ANESTHETICS AND IN THE MANAGEMENT OF COMPLICATIONS ENCOUNTERED DURING THE CONDUCT OF GENERAL ANESTHESIA. BECAUSE OF THE HAZARDS OF PROLONGED SUPPRESSION OF ENDOGENOUS CORTISOL AND ALDOSTERONE PRODUCTION, THIS FORMULATION IS NOT INTENDED FOR ADMINISTRATION BY PROLONGED INFUSION. Pediatric Neurotoxicity: Published animal studies demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity increase neuronal apoptosis in the developing brain and result in long-term cognitive deficits when used for longer than 3 hours. The clinical significance of these findings is not clear. However, based on the available data, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester of gestation through the first several months of life, but may extend out to approximately three years of age in humans (see PRECAUTIONS/Pregnancy, Pediatric Use, ANIMAL TOXICOLOGY AND/OR PHARMACOLOGY ). Some published studies in children suggest that similar deficits may occur after repeated or prolonged exposures to anesthetic agents early in life and may result in adverse cognitive or behavioral effects. These studies have substantial limitations, and it is not clear if the observed effects are due to the anesthetic/sedation drug administration or other factors such as the surgery or underlying illness.

Adverse reactions

Sourced from openFDA

The most frequent adverse reactions associated with use of intravenous etomidate are transient venous pain on injection and transient skeletal muscle movements, including myoclonus: 1. Transient venous pain was observed immediately following intravenous injection of etomidate in about 20% of the patients, with considerable difference in the reported incidence (1.2% to 42%). This pain is usually described as mild to moderate in severity but it is occasionally judged disturbing. The observation of venous pain is not associated with a more than usual incidence of thrombosis or thrombophlebitis at the injection site. Pain also appears to be less frequently noted when larger, more proximal arm veins are employed and it appears to be more frequently noted when smaller, more distal, hand or wrist veins are employed. 2. Transient skeletal muscle movements were noted following use of intravenous etomidate in about 32% of the patients, with considerable difference in the reported incidence (22.7% to 63%). Most of these observations were judged mild to moderate in severity but some were judged disturbing. The incidence of disturbing movements was less when 0.1 mg of fentanyl was given immediately before induction. These movements have been classified as myoclonic in the majority of cases (74%), but averting movements (7%), tonic movements (10%), and eye movements (9%) have also been reported. No exact classification is available, but these movements may also be placed into three groups by location: a. Most movements are bilateral.

Overdosage

Sourced from openFDA

Overdosage may occur from too rapid or repeated injections. Too rapid injection may be followed by a fall in blood pressure. No adverse cardiovascular or respiratory effects attributable to etomidate overdose have been reported. In the event of suspected or apparent overdosage, the drug should be discontinued, a patent airway established (intubate, if necessary) or maintained and oxygen administered with assisted ventilation, if necessary.

Approval history

Sourced from openFDA
  • Sep 7, 1982NDANDA018227Hospira
  • Feb 25, 2016ANDAANDA202354Hikma
  • Feb 7, 2017ANDAANDA201044Mylan Labs Ltd
  • Feb 24, 2017ANDAANDA206126Eugia Pharma
  • Apr 18, 2017ANDAANDA209058Gland
  • Dec 18, 2020ANDAANDA215028Caplin

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.

  • Amidate, Injection, 2 mg/1 mL (NDC 0409-6695-01)Active
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Amidate, Injection, 2 mg/mL (NDC 0409-6695-02)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Other
    Updated
  • Etomidate, Injection, 2 mg/1 mL (NDC 0143-9310-10)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc.
    Updated
  • Etomidate, Injection, 2 mg/1 mL (NDC 0143-9311-10)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc.
    Updated
  • Etomidate, Injection, 2 mg/1 mL (NDC 0143-9506-10)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc.
    Updated
  • Etomidate, Injection, 2 mg/1 mL (NDC 0143-9507-10)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc. · Reason: Demand increase for the drug
    Updated
  • Etomidate, Injection, 2 mg/1 mL (NDC 65219-445-10)Active
    Sponsor: Caplin Steriles, Ltd.
    Updated
  • Etomidate, Injection, 2 mg/1 mL (NDC 67457-902-10)Active
    Sponsor: Mylan Institutional, a Viatris Company
    Updated
  • Etomidate, Injection, 2 mg/1 mL (NDC 67457-903-20)Active
    Sponsor: Mylan Institutional, a Viatris Company
    Updated
  • Etomidate, Injection, 2 mg/1 mL (NDC 72266-146-10)Active
    Sponsor: Gland Pharma Limited
    Updated
  • Etomidate, Injection, 2 mg/1 mL (NDC 72266-147-10)Active
    Sponsor: Gland Pharma Limited
    Updated
  • Etomidate, Injection, 2 mg/1 mL (NDC 72572-160-10)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc.
    Updated
  • Etomidate, Injection, 2 mg/1 mL (NDC 72572-161-10)Active
    Sponsor: Hikma Pharmaceuticals USA, Inc.
    Updated
  • Etomidate, Injection, 2 mg/mL (NDC 65219-447-20)Active
    Sponsor: Caplin Steriles, Ltd.
    Updated
  • Etomidate, Injection, 2 mg/mL (NDC 72485-508-10)Active
    Sponsor: Caplin Steriles, Ltd.
    Updated
  • Etomidate, Injection, 2 mg/mL (NDC 72485-509-10)Active
    Sponsor: Caplin Steriles, Ltd.
    Updated
  • Etomidate, Injection, 20 mg/10 mL (NDC 55150-221-10)Active
    Sponsor: Eugia US LLC · Reason: Demand increase for the drug
    Updated
  • Etomidate, Injection, 40 mg/20 mL (NDC 55150-222-20)Active
    Sponsor: Eugia US LLC · Reason: Demand increase for the drug
    Updated
  • Etomidate, Injection, 40 mg/20 mL (NDC 65219-445-20)Active
    Sponsor: Caplin Steriles, Ltd.
    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.
2,164 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. 1Renal Failure23811%
  2. 2Pain2059.5%
  3. 3Injury1868.6%
  4. 4Anxiety1808.3%
  5. 5Unevaluable Event1687.8%
  6. 6Drug Ineffective1647.6%
  7. 7Fear1547.1%
  8. 8Hypotension1527.0%
  9. 9Cardiac Arrest1446.7%
  10. 10Emotional Distress1446.7%
  11. 11Renal Injury1346.2%
  12. 12Renal Impairment1255.8%
  13. 13Death1235.7%
  14. 14Stress1165.4%
  15. 15Anhedonia1125.2%

Literature

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Recent PubMed references pinned to Etomidate 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 143 ClinicalTrials.gov registrations naming Etomidate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Etomidate work?
Mechanism-of-action classes: Adrenergic alpha2-Agonists; GABA A Modulators.
What is Etomidate used for?
According to FDA labeling, Etomidate carries indications including: Etomidate Injection is indicated by intravenous injection for the induction of general anesthesia. When considering use of Etomidate Injection, the usefulness of its hemodynamic properties (see CLINICAL PHARMACOLOGY ) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Etomidate?
Etomidate is classified as Other general anesthetics, General Anesthetic, Adrenergic alpha2-Agonists, GABA A Modulators, Decreased Central Nervous System Organized Electrical Activity, General Anesthesia.
What are the brand names for Etomidate?
Etomidate is marketed under brand names including Amidate.
What are the contraindications for Etomidate?
Etomidate labeling lists contraindications including: Etomidate is contraindicated in patients who have shown hypersensitivity to it.. Always consult the full prescribing information and a clinician.
Note. Data for etomidate 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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