HYPNOMIDATE

Imidazole derivative anesthetic and hypnotic with little effect on blood gases, ventilation, or the cardiovascular system.

It has been proposed as an induction anesthetic.

Used in the induction of general anesthesia.

Etomidate is a non-barbiturate hypnotic that acts at the level of the reticular-activating system to produce anesthesia.

Etomidate is an imidazole compound that appears to depress CNS function via GABA.

Duration of action is intermediate between thiopental and methohexital, and recovery from a single dose is rapid with little residual depression.

Like the barbiturates and propofol, etomidate is does not induce analgesia.

Etomidate induces unconsciousness within one circulation time.

Recovery is rapid as a result of extensive redistribution and rapid metabolism.

Gamma-aminobutyric acid receptor subunit alpha-1 Agonist Alpha-2B adrenergic receptor Agonist GABA(A) Receptor Positive allosteric modulator.

Metabolized rapidly by ester hydrolysis to inactive metabolites.

Approximately 75% of the administered dose is excreted in the urine during the first day after injection.

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Undesirable side effects of etomidate that may limit its use include pain on injection, myoclonus and adrenocortical suppression lasting 4-6 hours following an induction dose.

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.

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.

Anesthetic and sedation drugs are a necessary part of the care of children needing surgery, other procedures, or tests that cannot be delayed, and no specific medications have been shown to be safer than any other.

Decisions regarding the timing of any elective procedures requiring anesthesia should take into consideration the benefits of the procedure weighed against the potential risks.

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

Do not administer unless solution is clear and container is undamaged.

Discard unused portion See DOSAGE AND ADMINISTRATION.

Injection is intended for administration only by the intravenous route.

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 to 60 seconds.

There are inadequate data to make dosage recommendations for induction of anesthesia in patients below the age of ten 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.

Etomidate Injection is compatible with commonly administered pre-anesthetic medications, which may be employed as indicated.

See also CLINICAL

PHARMACOLOGY, ADVERSE REACTIONS, and dosage recommendations for maintenance of anesthesia.

Injection anesthesia does not significantly alter the usual dosage requirements of neuromuscular blocking agents employed for endotracheal intubation or other purposes shortly after induction of anesthesia.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

To prevent needle-stick injuries, needles should not be recapped, purposely bent, or broken by hand.

Injection, USP is a sterile, non-pyrogenic, clear, colorless solution, free from visible particles and is supplied as follows: 20 mg per 10 mL (2 mg / mL) 10 mL Single-Dose Vials in a Carton of 10 NDC 51662-1634-1 Store at 20° to 25°C (68° to 77°F) .

The vial stoppers are not made with natural rubber latex.