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Bacitracin (United States: Withdrawn from market) (systemic): Pediatric drug information

Bacitracin (United States: Withdrawn from market) (systemic): Pediatric drug information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For additional information see "Bacitracin (United States: Withdrawn from market) (systemic): Drug information"

For abbreviations, symbols, and age group definitions show table
ALERT: US 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.

Brand Names: Canada
  • Baciject
Therapeutic Category
  • Antibiotic, Miscellaneous
Dosing: Neonatal

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

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 neonatal patients is rare. Do not administer IV:

Neonates: 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.

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

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.

Dosing: Kidney Impairment: Pediatric

Discontinue if any renal dysfunction occurs. Bacitracin may cause renal failure due to tubular and glomerular necrosis; monitor renal function and urine output closely.

Dosing: Hepatic 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

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.

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."

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. [DSC] = Discontinued product

Solution Reconstituted, Intramuscular:

Baciject: 50,000 units (1 ea)

Generic: 50,000 units ([DSC])

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.

Storage/Stability

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).

Use

Treatment of pneumonia and empyema in infants caused by susceptible staphylococci (FDA approved in infants); Note: Due to toxicity risks, systemic use of bacitracin is rare and should be limited to situations where less toxic alternatives would not be effective.

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

Bacitracin may be confused with Bactrim, Bactroban

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.

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

Aminoglycosides: Bacitracin (Systemic) may enhance the nephrotoxic effect of Aminoglycosides. Bacitracin (Systemic) may enhance the neurotoxic effect of Aminoglycosides. Risk X: Avoid combination

Bacillus clausii: Antibiotics may diminish the therapeutic effect 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 diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: 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. Risk X: Avoid combination

Colistimethate: May enhance the nephrotoxic effect of Bacitracin (Systemic). Risk X: Avoid combination

Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination

Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy

Mycophenolate: Antibiotics may decrease serum concentrations of the active metabolite(s) of Mycophenolate. Specifically, concentrations of mycophenolic acid (MPA) may be reduced. Risk C: Monitor therapy

Neomycin (Systemic): May enhance the nephrotoxic effect of Bacitracin (Systemic). Risk X: Avoid combination

Neuromuscular-Blocking Agents: Bacitracin (Systemic) may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy

Polymyxin B: May enhance the nephrotoxic effect of Bacitracin (Systemic). Risk X: 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. Risk D: Consider therapy modification

Streptomycin: May enhance the nephrotoxic effect of Bacitracin (Systemic). Risk X: Avoid combination

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect 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

This product is not indicated for use in women of reproductive age.

Pregnancy Considerations

This product is not indicated for use in women of reproductive age.

Monitoring Parameters

Renal function assessment (eg, SCr, BUN), fluid intake, and urine output: Baseline, daily.

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. BACiiM (bacitracin) [prescribing information], Horseheads, NY: X-Gen Pharmaceuticals Inc; June 2008.
  2. BaciJect (bacitracin) [product monograph]. Oakville, Ontario, Canada: SteriMax Inc; July 2018.
  3. BaciJect (bacitracin) [product monograph]. Oakville, Ontario, Canada: SteriMax Inc; January 2023.
  4. Bacitracin (prescribing information). New York, NY: Pharmacia & Upjohn; September 2015.
  5. Bacitracin for injection (bacitracin) [prescribing information]. Schaumberg, IL: APP Pharmaceuticals, LLC; October 2010.
  6. Bacitracin for injection (bacitracin) [prescribing information]. New York, NY: Pharmacia & Upjohn Co; April 2018.
  7. Damm S. Intraoperative anaphylaxis associated with bacitracin irrigation. Am J Health-Syst Pharm. 2011;68(4):323-327. [PubMed 21289327]
  8. Elsner P, Pevny I, Burg G. Anaphylaxis induced by topically applied bacitracin. Am J Contact Dermat. 1990;1:162-164.
  9. Farley M, Pak H, Carregal V, Engler R, James W. Anaphylaxis to topically applied bacitracin. Am J Contact Dermat. 1995:6(1):28-31.
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