Label: BACITRACIN injection, powder, for solution

  • NDC Code(s): 72572-025-01, 72572-025-10
  • Packager: Civica, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 4, 2019

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  • SPL UNCLASSIFIED SECTION

    Rx Only

    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

  • BOXED WARNING (What is this?)

    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:

    Chemical Structure

    bacitracin A

    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.

  • CLINICAL PHARMACOLOGY

    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.

    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.

    Susceptibility Testing

    For specific information regarding susceptibility test criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: www.fda.gov/STIC.

  • INDICATIONS AND USAGE

    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.

  • CONTRAINDICATIONS

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

  • PRECAUTIONS

    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.

    Information for patients

    Patients should be counseled that antibacterial drugs including Bacitracin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Bacitracin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Bacitracin or other antibacterial drugs in the future.

  • ADVERSE REACTIONS

    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 REACTIONS, contact Xellia Pharmaceuticals USA, LLC at safety@xellia.com or 1-855-642-2594, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  • DOSAGE AND ADMINISTRATION

    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.

    Preparation of Solutions

    Should be dissolved in sodium chloride injection containing 2 percent procaine hydrochloride. The concentration of the antibiotic in the solution should not be less than 5,000 units per mL nor more than 10,000 units per mL.

    Diluents containing parabens should not be used to reconstitute bacitracin; cloudy solutions and precipitate formation have occurred.

    Reconstitution of the 50,000 unit vial with 9.8 mL of diluent will result in a concentration of 5,000 units per mL.

    Solutions are stable for one week when stored in a refrigerator 2˚ to 8˚C (36˚ to 46˚F).

  • HOW SUPPLIED

    Sterile Bacitracin, USP is available as a pack of ten (10's) with each vial containing 50,000 units (NDC 72572-025-10).

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

  • SPL UNCLASSIFIED SECTION

    Rx Only

    Distd by: Civica, Inc., Lehi, Utah 84043

    Mfd for: Xellia Pharmaceuticals USA, LLC
    Made in Hyderabad, Telangana India

    LEA-020307-00

    Revised: October 2019

  • PRINCIPAL DISPLAY PANEL - 10 Vial Carton

    NDC - 72572-025-10
    Rx Only

    Bacitracin for Injection, USP

    50,000 units per vial

    CIVICA™

    For Intramuscular Use

    10 vials

    PRINCIPAL DISPLAY PANEL - 10 Vial Carton
  • INGREDIENTS AND APPEARANCE
    BACITRACIN 
    bacitracin injection, powder, for solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72572-025
    Route of AdministrationINTRAMUSCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacitracin (UNII: 58H6RWO52I) (Bacitracin - UNII:58H6RWO52I) Bacitracin50000 [USP'U]
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72572-025-1010 in 1 CARTON12/01/2019
    1NDC:72572-025-011 in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20317712/01/2019
    Labeler - Civica, Inc. (081373942)
    Registrant - Xellia Pharmaceuticals ApS (305814345)