AMIDATE- etomidate injection, solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

Etomidate (UNII: Z22628B598) (Etomidate - UNII:Z22628B598)

Dostupno od:

Henry Schein, Inc.

Administracija rute:

INTRAVENOUS

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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

Proizvod sažetak:

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

Status autorizacije:

New Drug Application

Svojstava lijeka

AMIDATE- ETOMIDATE INJECTION, SOLUTION
HENRY SCHEIN, INC.
----------
AMIDATE™
(ETOMIDATE) INJECTION, USP
2 MG/ML
FOR INTRAVENOUS USE
EN-5867
DESCRIPTION
AMIDATE (Etomidate Injection, USP) 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 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 (PaCO2) (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