Version May 2024
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.
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 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.
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.
Discontinue if any renal dysfunction occurs. Bacitracin may cause renal failure due to tubular and glomerular necrosis; monitor renal function and urine output closely.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
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])
Hypersensitivity to bacitracin or any component of the formulation
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.
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."
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. [DSC] = Discontinued product
Solution Reconstituted, Intramuscular:
Baciject: 50,000 units (1 ea)
Generic: 50,000 units ([DSC])
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.
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).
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.
Bacitracin may be confused with Bactrim, Bactroban
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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
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
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
This product is not indicated for use in women of reproductive age.
This product is not indicated for use in women of reproductive age.
Renal function assessment (eg, SCr, BUN), fluid intake, and urine output: Baseline, daily.
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
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