Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
ETOMIDATE (UNII: Z22628B598) (ETOMIDATE - UNII:Z22628B598)
HF Acquisition Co LLC, DBA HealthFirst
INTRAVENOUS
PRESCRIPTION DRUG
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.
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.
Abbreviated New Drug Application
ETOMIDATE- ETOMIDATE INJECTION, SOLUTION HF ACQUISITION CO LLC, DBA HEALTHFIRST ---------- 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 Citiți documentul complet