Bacitracin for Injection, USP

Rx only

For Intramuscular Use

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 when 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.

Bacitracin for Injection, USP is an antibiotic for intramuscular administration.  Bacitracin is derived from cultures of Bacillus licheniformis.  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:

  structure 

C ₆₆H ₁₀₃N ₁₇O ₁₆S                                 M.W. 1422.71

Bacitracin is comprised of a polypeptide complex and Bacitracin A is the major component in this complex.

Bacitracin, an antibiotic substance derived from cultures of Bacillus licheniformis exerts pronounced antibacterial action in vitro against a variety of gram-positive and a few gram-negative organisms.  However, among systemic diseases, only staphylococcal infections qualify for consideration of bacitracin therapy.  Bacitracin is assayed against a standard and its activity is expressed in units, 1 mg having a potency of not less than 50 units.

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.

This drug is contraindicated in those individuals with a history of previous hypersensitivity or toxic reaction to it.

See “ Warning Box” for precautions in regard to kidney toxicity associated with intramuscular use of bacitracin.

Adequate fluid intake should be maintained orally, or if necessary, by parenteral method. 

As with other antibiotics, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi.  If superinfection occurs, appropriate therapy should be instituted.

TO BE ADMINISTERED INTRAMUSCULARLY ONLY

The container closure is not made with natural rubber latex.

Store the unreconstituted product in a refrigerator 2° to 8°C (36° to 46°F).

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45960E/Revised: December 2016

PACKAGE LABEL - PRINCIPAL DISPLAY -  Bacitracin 50,000 Units Vial Label

Bacitracin for Injection, USP

50,000 Units

For Intramuscular Use

Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY -  Bacitracin 50,000 Units Vial Carton Panel

Bacitracin for Injection, USP

50,000 Units

For Intramuscular Use

Rx only