Rx Item-Amidate 2Mg/ml Amp 5X20ml By Hospira Worldwide

AMIDATE etomidate injection, solution
General Injectables Vaccines, Inc
Description
Amidate (Etomidate Injection, USP) is sterile, nonpyrogenic solution. Each milliliter contains etomidate, 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
Clinical Pharmacology
Etomidate is hypnotic drug without analgesic activity. Intravenous injection of etomidate produces hypnosis characterized by rapid onset of action, usually within one minute. Duration of hypnosis 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)
Amidate Indications and USAge
Etomidate is indicated by intravenous injection for the induction of general anesthesia. When considering use of etomidate, the usefulness of its hemodynamic properties should be weighed against the high frequency of transient skeletal muscle movements Intravenous etomidate 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.
Contraindications
Etomidate is contraindicated in patients who have shown hypersensitivity to it.
Warnings
INTRAVENOUS ETOMIDATE SHOULD BE ADMINISTERED ONLY BY PERSONS TRAINED IN THE ADMINISTRATION OF GENERAL ANESTHETICS AND IN THE MANAGEMENT OF COMPLICATIONS ENCOUNTERED DURING THE CONDUCT OF GENERAL ANESTHESIA.
BECAUSE OF THE HAZARDS OF PROLONGED SUPPRESSION OF ENDOGENOUS CORTISOL AND ALDOSTERONE PRODUCTION, THIS FORMULATION IS NOT INTENDED FOR ADMINISTRATION BY PROLONGED INFUSION.
Precautions
Do not administer unless solution is clear and container is undamaged. Discard unused portion (see DOSAGE AND ADMINISTRATION).
Carcinogenesis, Mutagenesis, Impairment of Fertility: No carcinogenesis or mutagenesis studies have been carried out on etomidate. The results of reproduction studies showed no impairment of fertility in male and female rats when etomidate was given prior to pregnancy at 0.31, 1.25 and mg/kg (approximately 1X, 4X and 16X human dosage).
Pregnancy Category C


Dosage and Administration
Etomidate Injection, USP is intended for administration only by the intravenous route.
The dose for induction of anesthesia in adult patients and in pediatric patients above the age of ten (10) years will vary between 0.2 and 0.6 mg/kg of body weight, and it must be individualized in each case. The usual dose for induction in these patients is 0.3 mg/kg, injected over period of 30 to 60 seconds. There are inadequate data to make dosage recommendations for induction of anesthesia in patients below the age of ten (10) years; therefore, such use is not recommended. Geriatric patients may require reduced doses of etomidate.
How Supplied
Amidate? (Etomidate Injection, USP) is supplied in single-dose containers as follows:
Conc.
NDC No.
Container
Container Size
2 mg/mL
0409-6695-01
Fliptop vial
10 mL
2 mg/mL
0409-6695-02
Fliptop Vial
20 mL
2 mg/mL
0409-8061-01
Ampul
20 mL
2 mg/mL
0409-8062-01
Ampul
10 mL
2 mg/mL
0409-8060-29
Abboject Syringe with male luer lock adapter
20 mL

Rx Item-Amidate 2Mg/ml Amp 5X20ml By Hos
NDC No.00409-8061-01 UPC/GTIN No.3-04098-06101-2 MPN No. 806101 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA

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Hospira Worldwide Inc.

ETOMIDATE INTRAVEN AMPUL
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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