BACITRACIN injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BACITRACIN A (UNII: DDA3RRX0P7) (BACITRACIN A - UNII:DDA3RRX0P7)

Available from:

Pharmacia and Upjohn Company

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 0009-0233-01) and as a pack of ten vials (10's) each containing 50,000 units (NDC 0009-0233-03). Store the unreconstituted product in a refrigerator 2° to 8°C (36° to 46°F).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BACITRACIN- BACITRACIN INJECTION, POWDER, FOR SOLUTION
PHARMACIA AND UPJOHN COMPANY
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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 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
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_