BACITRACIN injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Xellia Pharmaceuticals ApS

INN (International Name):

BACITRACIN

Composition:

BACITRACIN 50000 [iU]

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

In accordance 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.

Product summary:

Sterile Bacitracin USP is available in a vial (1’s) containing 50,000 units (NDC 45932-0026-1) and as pack of ten (10’s) each containing 50,000 units (NDC 45932-0026-2). Store the unreconstituted product in a refrigerator 2˚ to 8˚C (36˚ to 46˚F). Rx only Manufactured for: Xellia Pharmaceuticals ApS Dalslandsgade 11 2300 Copenhagen S Denmark Manufactured by: Gland Pharma Limited Survey No.: 143 – 148, 150 & 151 Near Gandimaisamma Cross Roads D.P. Pally, Quthubullapur Mandal Ranga Reddy District Hyderabad – 500 043 INDIA Revised December, 2015

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BACITRACIN- BACITRACIN INJECTION
XELLIA PHARMACEUTICALS APS
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BACITRACIN FOR INJECTION, USP
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 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
Sterile Bacitracin USP is an 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 antibacterial action _in vitro_ against a
variety of gram-positive