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

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: C₆₆H₁₀₃N₁₇O₁₆S. 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.

Bacitracin 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.

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.

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.

Prescribing Bacitracin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Nephrotoxic reactions. Albuminuria, cylindruria, azotemia. Rising blood levels without any increase in dosage.
Other reactions. Nausea and vomiting. Pain at site of injection. Skin rashes.

To report SUSPECTED ADVERSE DRUG EVENTS, contact Xellia Pharmaceuticals at safety@xellia.com or 1-855-642-2594, or FDA at 1-800-FDA-1088 or www.fda.gov.

TO BE ADMINISTERED INTRAMUSCULARLY ONLY

Infant dose: For infants under 2500 grams-900 units/kg/24 hours in 2 or 3 divided doses. For infants over 2500 grams-1,000 units/kg/24 hours, in 2 or 3 divided doses. Intramuscular injections of the solution should be given in the upper outer quadrant of the buttocks, alternating right and left and avoiding multiple injections in the same region because of the transient pain following injection.

Sterile Bacitracin, USP is available in a vial containing 50,000 units (NDC 39822-0278-1) sold in boxes of ten vials (NDC 39822-0278-5).

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

Manufactured for:
Xellia Pharmaceuticals, Inc.,
Grayslake, IL 60030 
 

Distributed by:
 X-GEN Pharmaceuticals, Inc.,
Big Flats, NY 14814

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

Manufactured in India
LEA-019648-00
BACI-XE-PI-01
Revised: February 2015

NDC 39822-0278-1  

Bacitracin for Injection, USP

50,000 units per vial

For Intramuscular Use

Rx Only

X-GEN Pharmaceuticals, Inc.