ETOMIDATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

etomidate (UNII: Z22628B598) (etomidate - UNII:Z22628B598)

Available from:

Sagent Pharmaceuticals

INN (International Name):

etomidate

Composition:

etomidate 2 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Etomidate Injection, USP is indicated by intravenous injection for the induction of general anesthesia. When considering use of etomidate, 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 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. Etomidate is contraindicated in patients who have shown hypersensitivity to it.

Product summary:

Etomidate Injection, USP is a clear colorless solution supplied as follows: Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ETOMIDATE- ETOMIDATE INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
----------
ETOMIDATE INJECTION, USP
(FOR INTRAVENOUS USE)
SAGENT
Rx only
DESCRIPTION
Etomidate Injection, USP is a sterile, nonpyrogenic solution. Each
milliliter contains
etomidate USP, 2 mg, propylene glycol USP, 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 general anesthetic without analgesic activity.
Intravenous injection of
etomidate produces anesthesia characterized by a rapid onset of
action, usually within
one minute. Duration of anesthesia 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
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