BACITRACIN injection, powder, for solution

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

Bacitracin A (UNII: DDA3RRX0P7) (Bacitracin A - UNII:DDA3RRX0P7)

থেকে পাওয়া:

Akorn, Inc.

প্রশাসন রুট:

INTRAMUSCULAR

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

In accordance with the statements in the "Warning Box", the use of intramuscular Bacitracin for Injection, USP 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 for Injection, USP and other antibacterial drugs, Bacitracin for Injection, USP 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.

পণ্য সারাংশ:

Bacitracin for Injection, USP is available in a vial containing 50,000 units bacitracin. NDC 17478-608-30         Carton of 1 vial Store the unreconstituted product in a refrigerator 2° to 8°C (36° to 46°F). Rx Only AKORN Manufactured By: Akorn, Inc. Lake Forest, IL 60045 BC00N Rev. 10/17

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

BACITRACIN- BACITRACIN INJECTION, POWDER, FOR SOLUTION
AKORN, INC.
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BACITRACIN FOR INJECTION, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of bacitracin for
injection and other antibacterial drugs, bacitracin for injection
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), AND
NEOMYCIN 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.
The structural formula is:
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 PHARMACOLOGY
Bacitracin exerts pronounced antiba