BACIIM- bacitracin injection, powder, lyophilized, for solution

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I)

זמין מ:

X-GEN Pharmaceuticals, Inc.

INN (שם בינלאומי):

BACITRACIN

הרכב:

BACITRACIN 50000 [USP'U]

מסלול נתינה (של תרופות):

INTRAMUSCULAR

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

In accord with the statements in the “Warning Box” the use of intramuscular bacitracin is limited to the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug. To reduce the development of drug-resistant bacteria and maintain the effectiveness of bacitracin and other antibacterial drugs, bacitracin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. This drug is contraindicated in those individuals with a history of previous hypersensitivity or toxic reaction to it.

leaflet_short:

Bacitracin for Injection, USP is available in vials containing 50,000 units. NDC 39822-0277-5. Boxes of ten vials use NDC 39822-0277-2. Store the unreconstituted product in a refrigerator 2° to 8°C (36° to 46°F). Solutions are stable for one week when stored in a refrigerator 2° to 8°C (36° to 46°F). Manufactured for: X-Gen Pharmaceuticals, Inc. Big Flats, 14814 Revised June 2012 BIM-P04

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

BACIIM- BACITRACIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
X-GEN PHARMACEUTICALS, INC.
----------
BACIIM™
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF BACITRACIN
AND OTHER ANTIBACTERIAL DRUGS, BACITRACIN SHOULD BE USED ONLY TO TREAT
OR PREVENT INFECTIONS THAT
ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY BACTERIA.FOR
INTRAMUSCULAR USE
WARNING
Nephrotoxicity: Bacitracin in parenteral (intramuscular) therapy may
cause renal failure due to
tubular and glomerular necrosis. Its use should be restricted to
infants with staphylococcal
pneumonia and empyema when due to organisms shown to be susceptible to
bacitracin. It should
be used only where adequate laboratory facilities are available and
when constant supervision of
the patient is possible.
Renal function should be carefully determined prior to and daily
during therapy. The
recommended daily dose should not be exceeded and fluid intake and
urinary output should be
maintained at proper levels to avoid kidney toxicity. If renal
toxicity occurs the drug should be
discontinued. The concurrent use of other nephrotoxic drugs,
particularly streptomycin,
kanamycin, polymyxin B, polymyxin E (colistin), neomycin, and
vancomycin, should be avoided.
DESCRIPTION
Bacitracin for Injection, USP is a sterile antibiotic for
intramuscular administration. Bacitracin is
derived from cultures of Bacillus subtilis (Tracey). It is a white to
pale buff, hygroscopic powder,
odorless or having a slight odor. It is freely soluble in water;
insoluble in acetone, chloroform, and
ether. While soluble in alcohol, methanol, and glacial acetic acid,
there is some insoluble residue. It is
precipitated from its solutions and inactivated by many of the heavy
metals.
Each vial contains 50,000 units of bacitracin.
The structural formula is:
BACI- MOLECULAR
The molecular formula is: C
H
N O S
Bacitracin is comprised of a polypeptide complex and Bacitracin A is
the major component in this
complex. The molecular weight of Bacitracin A is 1422.71.
CLINICAL