ETOMIDATE injection solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ETOMIDATE (UNII: Z22628B598) (ETOMIDATE - UNII:Z22628B598)

Available from:

American Regent, Inc.

INN (International Name):

ETOMIDATE

Composition:

ETOMIDATE 2 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ETOMIDATE- ETOMIDATE INJECTION, SOLUTION
AMERICAN REGENT, INC.
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ETOMIDATE INJECTION
RX ONLY
DESCRIPTION
Etomidate Injection is a sterile, nonpyrogenic solution. Each
milliliter contains etomidate, 2 mg,
propylene glycol 35% v/v. The pH is 6.0 (4.0 to 7.0).
It is intended for the induction of general anesthesia by intravenous
injection.
The drug etomidate is chemically identified as (R)-(+)-ethyl-1-(1
-phenylethyl)-1H-imidazole-5-
carboxylate and has the following structural formula:
CLINICAL PHARMACOLOGY
Etomidate is a hypnotic drug without analgesic activity. Intravenous
injection of etomidate produces
hypnosis characterized by a rapid onset of action, usually within one
minute. Duration of hypnosis is
dose dependent but relatively brief, usually three to five minutes
when an average dose of 0.3 mg/kg is
employed. Immediate recovery from anesthesia (as assessed by awakening
time, time needed to follow
simple commands and time to perform simple tests after anesthesia as
well as they were performed
before anesthesia), based upon data derived from short operative
procedures where intravenous
etomidate was used for both induction and maintenance of anesthesia,
is about as rapid as, or slightly
faster than, immediate recovery after similar use of thiopental. These
same data revealed that the
immediate recovery period will usually be shortened in adult patients
by the intravenous administration
of approximately 0.1 mg of intravenous fentanyl, one or two minutes
before induction of anesthesia,
probably because less etomidate is generally required under these
circumstances (consult the package
insert for fentanyl before using).
The most characteristic effect of intravenous etomidate on the
respiratory system is a slight elevation in
arterial carbon dioxide tension (PaCO ). See also ADVERSE REACTIONS.
Reduced cortisol plasma levels have been reported with induction doses
of 0.3 mg/kg etomidate. These
persist for approximately 6 to 8 hours and appear to be unresponsive
to ACTH administration.
The intravenous adm