ETOMIDATE injection

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Nopērc to tagad

Produkta apraksts Produkta apraksts (SPC)
20-11-2023

Aktīvā sastāvdaļa:

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

Pieejams no:

Hikma Pharmaceuticals USA Inc.

SNN (starptautisko nepatentēto nosaukumu):

ETOMIDATE

Kompozīcija:

ETOMIDATE 2 mg in 1 mL

Ievadīšanas:

INTRAVENOUS

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Etomidate Injection, USP is indicated by intravenous injection for induction of general anesthesia. When considering use of etomidate, the usefulness of its hemodynamic properties (seeCLINICAL PHARMACOLOGY ) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS ). Intravenous etomidate is also indicated for 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.

Produktu pārskats:

Etomidate Injection, USP 2 mg/mL is supplied in single dose containers as follows: Store at 20º to 25ºC (68º to 77ºF) [See USP controlled Room Temperature].

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

                                ETOMIDATE- ETOMIDATE INJECTION
HIKMA PHARMACEUTICALS USA INC.
----------
ETOMIDATE INJECTION, USP
RX ONLY
DESCRIPTION
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-phenyethyl)-1H-
imidazole-5-carboxylate and has the following structural formula:
Molecular Formula: C
H
N O Molecular Weight:
244.3
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 also
ADVERSE
14
16
2
2
2
REACTIONS).
Reduced cortisol plasma levels have been reported with induction doses
of 0.3 mg/kg
etomidate. These persist for approximately 6 to 
                                
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