well-deserved Bacitracin (Systemic) Pronunciation (bas i TRAY sin) 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) Solution Reconstituted, Intramuscular [preservative free]: Generic: 50,000 units (1 ea [DSC]) Brand Names: U.S. BACiiM Pharmacologic Category Antibiotic, Miscellaneous Pharmacology 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 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 Dosing: Pediatric Do not administer IV Treatment of pneumonia and empyema: Infants: IM: 2.5 kg: 900 units/kg/day in 2 to 3 divided doses >2.5 kg: 1000 units/kg/day in 2 to 3 divided doses Reconstitution Solution for injection (IM use only): Bacitracin sterile powder should be dissolved in NS; although the manufacturer recommends using NS 0.9% sodium chloride injection containing 2% procaine hydrochloride, this product is no longer available in the US market. Concentration after reconstitution should be between 5,000 to 10,000 units/mL. Do not use diluents containing parabens; cloudy solutions and precipitation have occurred. Administration For IM administration only, do not administer IV . Confirm any orders for parenteral use. Administer to upper outer quadrant of the buttocks; rotate administration site. 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. Avoid combination Colistimethate: May enhance the nephrotoxic effect of Bacitracin (Systemic). Avoid combination Kanamycin: 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 (Limited to important or life-threatening): Anaphylaxis (intraoperative exposure [Damm, 2011]) ALERT: U.S. 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. 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 Considerations This product is not indicated for use in women of reproductive age. Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience injection site pain. Have patient report immediately to prescriber signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of Clostridium difficile ( C. diff )-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools), severe nausea, or vomiting (HCAHPS). Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. 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