ETOMIDATE injection

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

HF Acquisition Co LLC, DBA HealthFirst

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Etomidate Injection, USP is indicated by intravenous injection for 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 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.

Resumen del producto:

ETOMIDATE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1485-1 ETOMIDATE INJECTION, USP 20mg/10mL (2mg/mL) 10mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms 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].

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

ETOMIDATE- ETOMIDATE INJECTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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ETOMIDATE INJECTION, USP 20MG/10ML (2MG/ML) 10ML VIAL
SPL UNCLASSIFIED
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: C14H16N2O2 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 (PaCO2). (See also ADVERSE REACTIONS).
Reduced cortisol plasma levels have been reported with induction doses
of 0.3 mg/kg eto