Etomidate

Indications

INDICATIONS AND USAGE 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 ) . Intravenous etomidate injection is also indicated for the supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION 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 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.

Contraindications

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

Warnings and precautions

WARNINGS 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.

Pregnancy

Pregnancy Risk Summary There are no adequate and well-controlled studies in pregnant women. In animal reproduction studies, fetal deaths and reduced pup survival were noted after intravenous administration of etomidate to pregnant rats at doses 0.17 times the human induction dose of 0.3 mg/kg.

Storage and supply

HOW SUPPLIED Etomidate Injection, USP is supplied in single dose vials in packages of 10 vials as follows. 20 mg/10 mL single-dose vial NDC 67457-902-10 40 mg/20 mL single-dose vial NDC 67457-903-20 Store at 20° to 25°C (68° to 77° F).

Source: Etomidate (Etomidate) — US FDA prescribing information, 2023-05-15, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.