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| NDC | 0009-0233-44, 0009-0233-45 |
| Set ID | 2dc33e75-dc52-4a36-86b9-474faa9e0a9f |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Pharmacia & Upjohn Company LLC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | ANDA060733 |
- SPL UNCLASSIFIED SECTION
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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 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.
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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: 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.
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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.
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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
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WARNINGS and PRECAUTIONS
See "Warning Box" for precautions in regard to kidney toxicity associated with intramuscular use of bacitracin.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
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.
There have been reports of anaphylaxis and/or allergic contact dermatitis in patients exposed to Bacitracin in non-approved indications.
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.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
- ADVERSE REACTIONS
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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 or 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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50,000 Unit Vial Label
- PRINCIPAL DISPLAY PANEL - 50,000 Unit 10 Vial Carton
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INGREDIENTS AND APPEARANCE
BACITRACIN
bacitracin injection, powder, for solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0009-0233 Route of Administration INTRAMUSCULAR Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN A (UNII: DDA3RRX0P7) (BACITRACIN A - UNII:DDA3RRX0P7) BACITRACIN A 5000 [USP'U] in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0009-0233-44 1 in 1 CARTON 07/29/1948 01/31/2022 1 10 mL in 1 VIAL; Type 0: Not a Combination Product 2 NDC:0009-0233-45 10 in 1 CARTON 07/29/1948 01/31/2022 2 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA060733 07/29/1948 01/31/2022 Labeler - Pharmacia & Upjohn Company LLC (618054084) Registrant - Pfizer Inc (113480771) Establishment Name Address ID/FEI Business Operations Pharmacia & Upjohn Company LLC 618054084 ANALYSIS(0009-0233) , MANUFACTURE(0009-0233) , PACK(0009-0233) , LABEL(0009-0233)
