(For additional information see "Bacitracin (United States: Withdrawn from market) (systemic): Pediatric drug information")
Dosage guidance:
Safety: Due to serious safety risks (eg, nephrotoxicity, anaphylactic reactions), the need for repeated IM injections, and the availability of other effective antibiotics, the FDA determined that risks outweigh benefits; systemic bacitracin has been withdrawn from the US market (Ref). Although it is still approved for use in Canada, use has been replaced by other agents due to the risk of toxicity (Ref).
Dosage form information: Bacitracin for injection is not available in the United States.
Pneumonia or 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:
Canadian labeling: Infants:
≤2.5 kg: IM: 900 units/kg/day in 2 to 3 divided doses.
>2.5 kg: IM: 1,000 units/kg/day in 2 to 3 divided doses.
Infants: Discontinue if any kidney toxicity occurs. Bacitracin may cause kidney failure due to tubular and glomerular necrosis; monitor kidney function and urine output closely.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions are derived from product labeling unless otherwise specified.
Frequency not defined:
Dermatologic: Skin rash
Endocrine & metabolic: Albuminuria
Gastrointestinal: Nausea, vomiting
Genitourinary: Azotemia
Local: Pain at injection site
Renal: Casts in urine
Postmarketing:
Dermatologic: Allergic contact dermatitis
Hypersensitivity: Hypersensitivity reaction (including anaphylaxis [intraoperative exposure], severe hypersensitivity reaction) (Damm 2011)
Renal: Kidney failure, nephrotoxicity
Hypersensitivity to bacitracin or any component of the formulation; history or previous hypersensitivity or toxic reaction to bacitracin; impaired renal function, including patients taking nephrotoxic drugs.
Concerns related to adverse effects:
• Anaphylaxis/Hypersensitivity: [Canadian Boxed Warning]: Serious hypersensitivity and/or anaphylactic reactions have been reported in patients exposed to bacitracin. Allergic contact dermatitis has also been reported with IM administration. Reactions may occur following the first dose.
• Renal failure: [Canadian Boxed Warning]: There have been reports of nephrotoxicity, including renal failure in patients exposed to bacitracin; has been reported with IM and local exposure. 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.
Anaphylactic reactions may occur on repeat exposure; anaphylaxis and other hypersensitivity reactions have been reported with application of bacitracin ointment and with intraprocedure irrigation use; use with caution in patients who have been previously exposed to bacitracin (Damm 2011; Elsner 1990; Farley 1995).
Bacitracin is seldom used systemically; consider confirmation of use and route with prescriber prior to administration. Bacitracin is a mixture of antimicrobial polypeptides and should be dosed in "units."
Not approved in the United States.
No
Solution (reconstituted) (Bacitracin Intramuscular)
50000 unit (per each): $6.20
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intramuscular:
Baciject: 50,000 units (1 ea)
Parenteral: Bacitracin is seldom used systemically; consider confirmation of use and route with prescriber prior to administration. For IM administration only; administer to upper outer quadrant of the buttocks; rotate administration site. Do not administer IV.
Note: Not approved in the United States.
Pneumonia and empyema: Treatment of pneumonia and empyema in infants caused by susceptible staphylococci.
Bacitracin may be confused with Bactrim, Bactroban
ALERT: Canadian Boxed Warning: Health Canada-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Aminoglycosides: Bacitracin (Systemic) may increase nephrotoxic effects of Aminoglycosides. Bacitracin (Systemic) may increase neurotoxic effects of Aminoglycosides. Risk X: Avoid
Bacillus clausii: Antibiotics may decrease therapeutic effects of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider Therapy Modification
BCG (Intravesical): Antibiotics may decrease therapeutic effects of BCG (Intravesical). Risk X: Avoid
BCG Vaccine (Immunization): Antibiotics may decrease therapeutic effects of BCG Vaccine (Immunization). Risk C: Monitor
Cholera Vaccine: Antibiotics may decrease therapeutic effects of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid
Colistimethate: May increase nephrotoxic effects of Bacitracin (Systemic). Risk X: Avoid
Fecal Microbiota (Live) (Oral): May decrease therapeutic effects of Antibiotics. Risk X: Avoid
Fecal Microbiota (Live) (Rectal): Antibiotics may decrease therapeutic effects of Fecal Microbiota (Live) (Rectal). Risk X: Avoid
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor
Lactobacillus and Estriol: Antibiotics may decrease therapeutic effects of Lactobacillus and Estriol. Risk C: Monitor
Mycophenolate: Antibiotics may decrease active metabolite exposure of Mycophenolate. Specifically, concentrations of mycophenolic acid (MPA) may be reduced. Risk C: Monitor
Neomycin (Systemic): May increase nephrotoxic effects of Bacitracin (Systemic). Risk X: Avoid
Neuromuscular-Blocking Agents: Bacitracin (Systemic) may increase neuromuscular-blocking effects of Neuromuscular-Blocking Agents. Risk C: Monitor
Polymyxin B: May increase nephrotoxic effects of Bacitracin (Systemic). Risk X: Avoid
Sodium Picosulfate: Antibiotics may decrease therapeutic effects 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. Risk D: Consider Therapy Modification
Streptomycin: May increase nephrotoxic effects of Bacitracin (Systemic). Risk X: Avoid
Typhoid Vaccine: Antibiotics may decrease therapeutic effects of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider Therapy Modification
Animal reproduction studies have not been conducted. This product is not indicated for use in patients who could become pregnant.
Animal reproduction studies have not been conducted.
It is not known if bacitracin is present in breast milk.
Urinalysis, renal function tests (prior to initiation of therapy and daily during therapy), urine output.
Inhibits bacterial cell wall synthesis by preventing transfer of mucopeptides into the growing cell wall.
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