Pfizer - Bacitracin for Injection, USP
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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.
Product Details
The structural formula is:
The molecular formula is: C6$H;o:-Ni-OjeS. 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 harms 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 tenal 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 interpretive criteria and associated test methods and quality control standards recognized by FDA for mis drug, please see: https://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 mat are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, the}' 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.
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 mat 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 water}' 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.
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