ETOMIDATE injection, solution

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

HF Acquisition Co LLC, DBA HealthFirst

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Etomidate Injection is indicated by intravenous injection for the induction of general anesthesia. When considering use of Etomidate Injection, 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 Injection 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.

Resumen del producto:

Etomidate Injection, USP is a sterile, non-pyrogenic, clear, colorless solution, free from visible particles and is supplied as follows: Etomidate Injection, USP is supplied in the following dosage forms. NDC 51662-1542-1 ETOMIDATE INJECTION, USP 40mg PER 20mL (2mg/mL) 20mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Etomidate Injection, USP is a sterile, non-pyrogenic, clear, colorless solution, free from visible particles and is supplied as follows: 20 mg per 10 mL (2 mg / mL) 10 mL Single-Dose Vials in a Carton of 10 NDC 55150-221-10 40 mg per 20 mL (2 mg / mL) 20 mL Single-Dose Vials in a Carton of 10 NDC 55150-222-20 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The vial stoppers are not made with natural rubber latex.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

ETOMIDATE- ETOMIDATE INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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ETOMIDATE INJECTION, USP 40MG PER 20ML (2MG/ML)
RX ONLY
DESCRIPTION
Etomidate Injection, USP is a sterile, non-pyrogenic, clear, colorless
solution, free from
visible particles. Each milliliter contains etomidate USP 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:
Etomidate USP is a white or almost white powder.
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 ind