Rx Item-Bacitraci Amn 50000 Vial by Pfizer Pharma USA Injec

BACITRACIN- bacitracin injection, powder, for solution
APP Pharmaceuticals, LLC


Rx only

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 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.

DESCRIPTION

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
(click image for full-size original)
C66 H103 N17 O16 SM.W. 1422.71

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

CLINICAL PHARMACOLOGY

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.

Susceptibility plate testing
If the Kirby-Bauer method of disk susceptibility is used, a 10 unit bacitracin disk should give a zone of over 13 mm when tested against a bacitracin-susceptible strain of Staphylococcus aureus. Absorption of bacitracin following intramuscular injection is rapid and complete. A dose of 200 or 300 units/kg every 6 hours gives serum levels of 0.2 to 2 mcg/mL in individuals with normal renal function. The drug is excreted slowly by glomerular filtration. It is widely distributed in all body organs and is demonstrable in ascitic and pleural fluids after intramuscular injection.

INDICATIONS AND USAGE

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.

Rx Item-Bacitraci Amn 50000 Vial by Pfiz
Item No. RX259010, 259010, NDC No.: 00009-0233-44, 00009-233-44, 0000923344, 00009023344, 0233-44, 023344 UPC No. 3-00090-23344-0, 300090-233440, 300090233440

Rx Item-Bacitraci Amn 50000 Vial by Pfiz
Item No. RX259010, 259010, NDC No.: 00009-0233-44, 00009-233-44, 0000923344, 00009023344, 0233-44, 023344 UPC No. 3-00090-23344-0, 300090-233440, 300090233440

Rx Item-Bacitraci Amn 50000 Vial by Pfiz
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