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Bacitracin (United States: Withdrawn from market) (systemic): Drug information

Bacitracin (United States: Withdrawn from market) (systemic): Drug information
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For additional information see "Bacitracin (United States: Withdrawn from market) (systemic): Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: Canada
  • Baciject
Pharmacologic Category
  • Antibiotic, Miscellaneous
Dosing: Pediatric

(For additional information see "Bacitracin (United States: Withdrawn from market) (systemic): Pediatric drug information")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of other effective antibiotics, the FDA determined that risks outweigh benefits; systemic bacitracin has been withdrawn from the US market (Ref). Although it is still approved for use in Canada, use has been replaced by other agents due to the risk of toxicity (Ref).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

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.

Dosing: Kidney Impairment: Pediatric

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.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

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

Contraindications

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.

Warnings/Precautions

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.

Warnings: Additional Pediatric Considerations

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."

Product Availability

Not approved in the United States.

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Bacitracin Intramuscular)

50000 unit (per each): $6.20

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intramuscular:

Baciject: 50,000 units (1 ea)

Administration: Pediatric

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.

Use: Labeled Indications

Note: Not approved in the United States.

Pneumonia and empyema: Treatment of pneumonia and empyema in infants caused by susceptible staphylococci.

Medication Safety Issues
Sound-alike/look-alike issues:

Bacitracin may be confused with Bactrim, Bactroban

Other safety concerns:

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.

Metabolism/Transport Effects

None known.

Drug Interactions

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

Reproductive Considerations

Animal reproduction studies have not been conducted. This product is not indicated for use in patients who could become pregnant.

Pregnancy Considerations

Animal reproduction studies have not been conducted.

Breastfeeding Considerations

It is not known if bacitracin is present in breast milk.

Monitoring Parameters

Urinalysis, renal function tests (prior to initiation of therapy and daily during therapy), urine output.

Mechanism of Action

Inhibits bacterial cell wall synthesis by preventing transfer of mucopeptides into the growing cell wall.

Pharmacokinetics (Adult Data Unless Noted)

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

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (PR) Puerto Rico: Baciim
  1. BaciJect (bacitracin) [product monograph]. Oakville, Ontario, Canada: SteriMax Inc; January 2023.
  2. Damm S. Intraoperative anaphylaxis associated with bacitracin irrigation. Am J Health Syst Pharm. 2011;68(4):323-327. doi:10.2146/ajhp090238 [PubMed 21289327]
  3. Elsner P, Pevny I, Burg G. Anaphylaxis induced by topically applied bacitracin. Am J Contact Dermat. 1990;1:162-164.
  4. Farley M, Pak H, Carregal V, Engler R, James W. Anaphylaxis to topically applied bacitracin. Am J Contact Dermat. 1995:6:28-31.
  5. Health Canada. Health professional risk communication. Bacitracin for injection (50,000 IU per vial) and the risk of nephrotoxicity and anaphylactic reactions. https://recalls-rappels.canada.ca/en/alert-recall/bacitracin-injection-50000-iu-vial-and-risk-nephrotoxicity-and-anaphylactic-reactions. Updated December 21, 2020. Accessed December 3, 2024.
  6. US Food and Drug Administration (FDA). FDA requests withdrawal of bacitracin for injection from market. https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-bacitracin-injection-market. Updated January 31, 2020. Accessed December 3, 2024.
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