imaginable [5000:<2.5 kg: Manufacturers recommend 900 units/kg daily given in 2 or 3 divided doses. 100 104 Infants >2.5 kg: Manufacturers recommend 1000 units/kg daily in 2 or 3 divided doses. 100 104 Prescribing Limits Pediatric Patients Staphylococcal Pneumonia and Empyema in Infants Do not exceed recommended dosage; 100 104 duration >12 days not recommended. a Special Populations No special population dosage recommendations. 100 104 Cautions for BACiiM Contraindications History of hypersensitivity or toxic reactions to bacitracin. 100 104 Warnings/Precautions Warnings Nephrotoxicity IM bacitracin may cause renal failure due to tubular and glomerular necrosis. 100 104 Albuminuria, 100 104 hematuria, a cylindruria, 100 104 and rising blood concentrations of the drug 100 104 may occur initially followed eventually by oliguria, a azotemia, 100 104 and renal failure. 100 104 Infants less prone to bacitracin nephrotoxicity than older children and adults. a Toxicity is related to total daily dosage and duration of therapy. a Assess renal function prior to and daily during therapy. 100 104 Discontinue drug if renal toxicity occurs. 100 104 Keep patient well hydrated using oral or, if necessary, parenteral fluids. 100 104 Maintain urine output at proper levels to avoid renal toxicity. 100 104 Some suggest using sodium bicarbonate or another alkali to keep urine at pH 6 or greater to avoid renal irritation. a Avoid concomitant use with other nephrotoxic drugs. 100 104 (See Specific Drugs under Interactions.) Because of the risk of nephrotoxicity, manufacturers state restrict use of IM bacitracin only to the treatment of staphylococcal pneumonia and empyema in infants when the causative organism has been shown to be susceptible to the drug. 100 104 In addition, use the drug only if adequate laboratory facilities are available and constant supervision of the patient is possible. 100 104 Sensitivity Reactions Hypersensitivity Anaphylaxis and/or allergic contact dermatitis reported when bacitracin used for non-FDA-labeled indications. 100 104 Rash 100 104 and pruritus a also reported. General Precautions Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD) Possible emergence and overgrowth of nonsusceptible bacteria or fungi may occur. 100 104 Institute appropriate therapy if superinfection occurs. 100 104 Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile . 100 104 110 111 112 C. difficile infection (CDI) and CDAD (also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives and may range in severity from mild diarrhea to fatal colitis. 100 104 110 111 112 C. difficile produces toxins A and B which contribute to development of CDAD; 100 104 110 hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required. 100 104 Consider CDAD if diarrhea develops during or after therapy and manage accordingly. 100 104 110 111 112 Obtain careful medical history since CDAD may occur as late as ≥2 months after anti-infective therapy is discontinued. 100 104 If CDAD suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible. 100 104 110 Initiate appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated. 100 104 110 111 112 Selection and Use of Anti-infectives To reduce development of drug-resistant bacteria and maintain effectiveness of bacitracin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria. 100 104 When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing. 100 104 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy. 100 104 Specific Populations Pregnancy Category C. 145 Not labeled for use in adults, including pregnant women. 100 104 Lactation Not known whether bacitracin is distributed into milk. 145 Not labeled for use in adults, including nursing women. 100 104 Common Adverse Effects Nephrotoxicity (albuminuria, cylindruria, azotemia, rising blood concentrations of the drug); 100 104 GI effects (nausea, vomiting); 100 104 pain at injection site; 100 104 hypersensitivity reactions (rash). 100 104 Interactions for BACiiM Specific Drugs Drug Interaction Comments Aminoglycosides (kanamycin, neomycin, streptomycin) Possible additive nephrotoxic effects 14 Avoid concomitant use 14 100 104 Colistimethate/colistin Possible additive nephrotoxic effects 14 Avoid concomitant use 14 100 104 Polymyxin b sulfate Possible additive nephrotoxic effects 14 100 104 Avoid concomitant use 14 100 104 Neuromuscular blocking agents and general anesthetics Possible enhanced neuromuscular blockade if bacitracin used concomitantly during surgery or postoperatively 14 Vancomycin Possible additive nephrotoxic effects 14 Avoid concomitant use 14 100 BACiiM Pharmacokinetics Absorption Bioavailability Not appreciably absorbed from GI tract. 14 Completely and rapidly absorbed following IM injection. 100 104 Following IM dosage of 200 300 units/kg every 6 hours in individuals with normal renal function, serum concentrations are 0.2 2 mcg/mL. 100 104 Following single IM dose of 10,000 20,000 units in adults with normal renal function, peak serum concentrations occur after 1 2 hours and the drug is detectable in serum for 6 8 hours after the dose. a Distribution Extent Widely distributed into all body organs; 100 104 readily diffuses into ascitic and pleural fluids following IM injection. 100 104 Only low concentrations distributed into CSF. 14 Plasma Protein Binding Only slightly protein bound. a Elimination Elimination Route IM: 10 40% of a dose excreted slowly by glomerular filtration and appears in urine within 24 hours. 14 Oral: Excreted in feces. a Stability Storage Parenteral Powder for Injection 2 8°C. 100 104 Following reconstitution with 0.9% sodium chloride injection containing 2% procaine hydrochloride as directed by manufacturer, stable at 2 8°C for 1 week. 100 104 Actions and Spectrum Polypeptide antibiotic produced by B. subtilis or B. licheniformis ; 7 14 100 104 bacitracin commercially available in US is derived from cultures of B. subtilis (Tracey). 100 104 Mixture of polypeptides (bacitracin A, B1, B2, B3); 7 100 104 major component is bacitracin A. 100 104 Commercially available bacitracin for injection has a potency of not less than 50 units of bacitracin activity per mg. 7 100 104 May be bactericidal or bacteriostatic, depending on drug concentration at site of infection. a Inhibits bacterial cell wall synthesis. a Active in vitro against some gram-positive bacteria, including staphylococci (e.g., Staphylococcus aureus ) and Streptococcus pyogenes (group A β-hemolytic streptococci, GAS). 144 Also active in vitro against some gram-negative bacteria, including Haemophilus influenzae and Neisseria , but not active against most gram-negative bacilli. 14 144 Although some strains of Clostridium difficile are susceptible to bacitracin in vitro, 142 strains with high-level resistance to the drug reported. 113 141 142 144 S. aureus resistant to bacitracin have been reported. 14 144 Does not exhibit cross-resistance with other antibiotics. a Advice to Patients Advise patients that antibacterials (including bacitracin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold). 100 104 Advise patients that it is common to begin feeling better after a few days, but that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with bacitracin or other antibacterials in the future. 100 104 Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. 100 104 Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose. 100 104 Importance of informing clinicians of existing concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses. 100 104 Importance of informing patients of other important precautionary information. 100 104 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. * available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name Bacitracin Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral For injection, for IM use 50,000 units* BACiiM X-Gen Bacitracin for Injection AHFS DI Essentials. Copyright 2017, Selected Revisions May 4, 2016. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. † Use is not currently included in the labeling approved by the US Food and Drug Administration. References 7. Bacitracin. In: U.S. pharmacopeia, 38th rev, and The national formulary, 33rd ed. Rockville, MD: The United States Pharmacopeial Convention. From UPS-NF online. Accessed 2015 Nov 12. 14. Bacitracin. In: Martindale: The complete drug reference. London: Pharmaceutical Press; 2015. From MedicinesComplete website. Accessed 2015 Nov 11. 100. X-gen Pharmaceuticals, Inc. BACiiM (bacitracin) lyophilized powder for injection for IM use prescribing information. Big Flatts, NY. 2012 Jun. 101. Chang TW, Gorbach SL, Bartlett JG et al. Bacitracin treatment of antibiotic-associated colitis and diarrhea caused by Clostridium difficile toxin. Gastroenterology . 1980; 78:1584-6. [PubMed 7372074] 102. Young GP, Ward PB, Bayley N et al. Antibiotic-associated colitis due to Clostridium difficile : double-blind comparison of vancomycin with bacitracin. Gastroenterology . 1985; 89:1038-45. [PubMed 4043661] 103. Dudley MN, McLaughlin JC, Carrington G et al. Oral bacitracin vs vancomycin therapy for Clostridium difficile -induced diarrhea: a randomized double-blind trial. Arch Intern Med . 1986; 146:1101-4. [PubMed 3521518] 104. Pharmacia & Upjohn Company division of Pfizer. Bacitracin lyophilized powder for injection, USP, for IM use prescribing information. New York, NY. 2013 Oct. 106. Bond GC, Himelick RE, Macdonald LH. The stability of bacitracin. J Am Pharm Assoc . 1949; 38:30-4. 110. Cohen SH, Gerding DN, Johnson S et al. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol . 2010; 31:431-55. [PubMed 20307191] 111. Fekety R for the American College of Gastroenterology Practice Parameters Committee. Guidelines for the diagnosis and management of Clostridium difficile - associated diarrhea and colitis. Am J Gastroenterol . 1997; 92:739-50. [PubMed 9149180] 112. American Society of Health-System Pharmacists Commission on Therapeutics. ASHP therapeutic position statement on the preferential use of metronidazole for the treatment of Clostridium difficile -associated disease. Am J Health-Syst Pharm . 1998; 55:1407-11. [PubMed 9659970] 113. Venugopal AA, Johnson S. Current state of Clostridium difficile treatment options. Clin Infect Dis . 2012; 55 Suppl 2:S71-6. 114. Food and Drug Administration. List of orphan designations and approvals. From FDA website. Accessed 2015 Nov 2. 115. Souney PF, Braun L, Steele L et al. Stability of bacitracin solution frozen in glass vials or plastic syringes. Am J Hosp Pharm . 1987; 44:1125-6. [PubMed 3605124] 117. Kelly CP, Pothoulakis C, LaMont JT. Clostridium difficile colitis. N Engl J Med . 1994; 330:257-62. [PubMed 8043060] 137. Bradley JS, Byington CL, Shah SS et al. The management of community-acquired pneumonia in infants and children older than 3 months of age: clinical practice guidelines by the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America. Clin Infect Dis . 2011; 53:e25-76. 138. Mandell LA, Wunderink RG, Anzueto A et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis . 2007; 44 Suppl 2:S27-72. [PubMed 17278083] 139. Anon. Choice of antibacterial drugs. Med Lett Treat Guid . 2007; 5:33-50. 140. Nelson R. Antibiotic treatment for Clostridium difficile-associated diarrhea in adults. Cochrane Database Syst Rev . 2007; :CD004610. 141. Bourgault AM, Lamothe F, Loo VG et al. In vitro susceptibility of Clostridium difficile clinical isolates from a multi-institutional outbreak in Southern Québec, Canada. Antimicrob Agents Chemother . 2006; 50:3473-5. [PubMed 17005836] 142. Bacon AE, McGrath S, Fekety R et al. In vitro synergy studies with Clostridium difficile. Antimicrob Agents Chemother . 1991; 35:582-3. [PubMed 2039211] 143. McMaster-Baxter NL, Musher DM. Clostridium difficile: recent epidemiologic findings and advances in therapy. Pharmacotherapy . 2007; 27:1029-39. [PubMed 17594209] 144. Kucers A, Crowe S, Grayson ML et al, eds. The use of antibiotics. A clinical review of antibacterial, antifungal, and antiviral drugs. 5th ed. Jordan Hill, Oxford: Butterworth-Heinemann; 1997: 542-3. 145. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 8th ed. Baltimore, MD: Williams & Wilkins; 2008:162-3. a. AHFS drug information 2016. McEvoy GK, ed. Bacitracin. Bethesda, MD: American Society of Health-System Pharmacists; 2016. 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