Boxed Warning
Nephrotoxicity:
Bacitracin in parenteral (IM) 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.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution Reconstituted, Intramuscular:
BACiiM: 50,000 units (1 ea)
Generic: 50,000 units (1 ea [DSC])
Solution Reconstituted, Intramuscular [preservative free]:
BACiiM: 50,000 units (1 ea [DSC])
Generic: 50,000 units (1 ea)
Pharmacology
Mechanism of Action
Inhibits bacterial cell wall synthesis by preventing transfer of mucopeptides into the growing cell wall
Pharmacokinetics/Pharmacodynamics
Absorption
Rapidly following IM administration
Distribution
Widely distributed in all body organs and is demonstrable in ascitic and pleural fluids after IM injection
Excretion
Urine
Use: Labeled Indications
Pneumonia and empyema: Treatment of pneumonia and empyema in infants caused by susceptible staphylococci; due to toxicity risks, systemic uses of bacitracin should be limited to situations where less toxic alternatives would not be effective
Contraindications
Hypersensitivity to bacitracin or any component of the formulation
Dosage and Administration
Dosing: Pediatric
Note: In February 2020, the FDA requested that all current manufacturers of bacitracin for injection voluntarily withdraw their product from the market because other effective FDA-approved treatments are available that do not have the same serious risks as bacitracin, including nephrotoxicity, anaphylactic reactions, and the need for repeated IM injections. This requested voluntary withdrawal does not impact approved topical or ophthalmic drugs that contain bacitracin. Further information may be found at https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-bacitracin-injection-market.
Pneumonia and empyema; staphylococcal: Note: Due to toxicity risks, systemic use of bacitracin should be limited to situations where less toxic alternatives would not be effective; systemic use in pediatric patients is rare. Do not administer IV:
Infants: IM:
≤2.5 kg: 900 units/kg/day in 2 to 3 divided doses.
>2.5 kg: 1,000 units/kg/day in 2 to 3 divided doses.
Storage
Solution for injection (IM use only): Store unreconstituted vials in the refrigerator at 2°C to 8°C (36°F to 46°F). Once reconstituted, bacitracin is stable for 1 week under refrigeration at 2°C to 8°C (36°F to 46°F).
Drug Interactions
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Avoid combination
Colistimethate: May enhance the nephrotoxic effect of Bacitracin (Systemic). Avoid combination
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy
Neomycin: May enhance the nephrotoxic effect of Bacitracin (Systemic). Avoid combination
Neuromuscular-Blocking Agents: Bacitracin (Systemic) may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy
Polymyxin B: May enhance the nephrotoxic effect of Bacitracin (Systemic). Avoid combination
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification
Streptomycin: May enhance the nephrotoxic effect of Bacitracin (Systemic). Avoid combination
Adverse Reactions
Frequency not defined.
Dermatologic: Skin rash
Endocrine & metabolic: Albuminuria
Gastrointestinal: Nausea, vomiting
Genitourinary: Azotemia, casts in urine, nephrotoxicity
Local: Pain at injection site
Renal: Renal failure
Postmarketing and/or case reports: Anaphylaxis (intraoperative exposure [Damm, 2011])
Warnings/Precautions
Concerns related to adverse effects:
- Anaphylaxis: Use with caution in patients who have been previously exposed to bacitracin; anaphylactic reactions have occurred on repeat exposure especially with irrigation use (Damm 2011; Elsner 1990; Farley 1995).
- Renal failure: [US Boxed Warning]: IM use may cause renal failure due to tubular and glomerular necrosis; monitor renal function daily. Avoid concurrent use with other nephrotoxic drugs; discontinue use if toxicity occurs; maintain adequate fluid intake and urine output throughout therapy. Do not exceed recommended doses.
- Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Other warnings/precautions:
- Appropriate use: Do not administer intravenously because severe thrombophlebitis occurs.
- Monitoring: Should only be used when adequate laboratory facilities are available and constant patient supervision is available.
Monitoring Parameters
IM: Urinalysis, renal function tests, urine output
Pregnancy
Pregnancy Considerations
This product is not indicated for use in women of reproductive age.
Patient Education
What is this drug used for?
- It is used to treat infections.
Frequently reported side effects of this drug
- Injection site pain
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Kidney problems like unable to pass urine, blood in the urine, change in amount of urine passed, or weight gain
- Clostridium difficile (C. diff)-associated diarrhea like abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools
- Severe nausea
- Vomiting
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
