Etomidate

Etomidate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

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Overview

Etomidate is a general anesthetic that is FDA approved for the {{{indicationType}}} of induction of general anesthesia, maintenance of general anesthesia; adjunct.. Common adverse reactions include * Dermatologic: Injection site pain (20%)

• Gastrointestinal: Nausea, Vomiting.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Induction of general anesthesia: induction, usual dose 0.3 mg/kg IV (range 0.2 to 0.6 mg/kg) over 30 to 60 sec.
• Maintenance of general anesthesia; adjunct: maintenance, 0.01 to 0.02 mg/kg/min IV infusion; dosage must be individualized.
• Procedural sedation: 0.1 to 0.2 mg/kg IV over 30 to 60 seconds, followed by 0.05 mg/kg every 3 to 5 minutes as needed for sedation.

Rapid sequence intubation, Induction: 0.15 to 0.3 mg/kg IV.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Etomidate in adult patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Etomidate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

not recommended in children under 10 y of age Induction of general anesthesia: (children 10 y and older) induction, usual dose 0.3 mg/kg IV (range 0.2 to 0.6 mg/kg) over 30 to 60 sec Rapid sequence intubation, Induction: 0.2 to 0.3 mg/kg IV

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Etomidate in pediatric patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Etomidate in pediatric patients.

Contraindications

Etomidate is contraindicated in patients who have shown hypersensitivity to it.

Warnings

NTRAVENOUS 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.

Adverse Reactions

Clinical Trials Experience

The most frequent adverse reactions associated with use of intravenous etomidate are transient venous pain on injection and transient skeletal muscle movements, including myoclonus:

   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.

   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. The arms, legs, shoulders, neck, chest wall, trunk and all four extremities have been described in some cases, with one or more of these muscle groups predominating in each individual case. Results of electroencephalographic studies suggest that these muscle movements are a manifestation of disinhibition of cortical activity; cortical electroencephalograms, taken during periods when these muscle movements were observed, have failed to reveal seizure activity.

   b. Other movements are described as either unilateral or having a predominance of activity of one side over the other. These movements sometimes resemble a localized response to some stimuli, such as venous pain on injection, in the lightly anesthetized patient (averting movements). Any muscle group or groups may be involved, but a predominance of movement of the arm in which the intravenous infusion is started is frequently noted.

   c. Still other movements probably represent a mixture of the first two types.

Skeletal muscle movements appear to be more frequent in patients who also manifest venous pain on injection.

OTHER ADVERSE OBSERVATIONS

Respiratory System: Hyperventilation, hypoventilation, apnea of short duration (5 to 90 seconds with spontaneous recovery); laryngospasm, hiccup and snoring suggestive of partial upper airway obstruction have been observed in some patients. These conditions were managed by conventional countermeasures.

Circulatory System: Hypertension, hypotension, tachycardia, bradycardia and other arrhythmias have occasionally been observed during induction and maintenance of anesthesia. One case of severe hypotension and tachycardia, judged to be anaphylactoid in character, has been reported.

(Reference: M. Sold and A. Rothhammer, Anaesthetist 34:208-210, 1985. Submitted to NDA 18-228 on 16 May 1985).

Geriatric patients, particularly those with hypertension, may be at increased risk for the development of cardiac depression following etomidate administration (see CLINICAL PHARMACOLOGY).

Gastrointestinal System: Postoperative nausea and/or vomiting following induction of anesthesia with etomidate is probably no more frequent than the general incidence. When etomidate was used for both induction and maintenance of anesthesia in short procedures such as dilation and curettage, or when insufficient analgesia was provided, the incidence of postoperative nausea and/or vomiting was higher than that noted in control patients who received thiopental.

Postmarketing Experience

There is limited information regarding Etomidate Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Etomidate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Etomidate in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Etomidate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Etomidate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Etomidate in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Etomidate in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Etomidate in geriatric settings.

Gender

There is no FDA guidance on the use of Etomidate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Etomidate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Etomidate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Etomidate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Etomidate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Etomidate in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Etomidate Administration in the drug label.

Monitoring

There is limited information regarding Etomidate Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Etomidate and IV administrations.

Overdosage

There is limited information regarding Etomidate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Etomidate Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Etomidate Mechanism of Action in the drug label.

Structure

There is limited information regarding Etomidate Structure in the drug label.

Pharmacodynamics

There is limited information regarding Etomidate Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Etomidate Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Etomidate Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Etomidate Clinical Studies in the drug label.

How Supplied

There is limited information regarding Etomidate How Supplied in the drug label.

Storage

There is limited information regarding Etomidate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Etomidate Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Etomidate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Etomidate Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Etomidate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.