ETOMIDATE- etomidate injection solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Gland Pharma Limited

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 whohave shown hypersensitivity to it.

Product summary:

Etomidate Injection, USP is supplied in single-dose containers as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ETOMIDATE - ETOMIDATE INJECTION SOLUTION
GLAND PHARMA LIMITED
----------
ETOMIDATE INJECTION, USP
2 MG/ML
(FOR INTRAVENOUS USE ONLY)
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).
2
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