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BACiiM

Generic Name: Bacitracin
Class: Bacitracins
VA Class: AM900
Molecular Formula: C66H103N17O16S
CAS Number: 1405-87-4

Warning(s)

  • May cause renal failure due to tubular and glomerular necrosis.104 137

  • Restrict use to infants with pneumonia and empyema caused by susceptible staphylococci.104 137 Use only if adequate laboratory facilities are available and constant supervision of the patient is possible.104 137

  • Determine renal function prior to and daily during therapy.104 137 Do not exceed recommended daily dosage.104 137 Maintain fluid intake and urinary output at proper levels to avoid kidney toxicity.104 137

  • Discontinue drug if renal toxicity occurs.104 137 Avoid concurrent use of other nephrotoxic drugs, particularly aminoglycosides (streptomycin, kanamycin, neomycin, viomycin [not commercially available in the US]), polymyxin B, and colistimethate/colistin.104 137

Introduction

Antibacterial; polypeptide antibiotic derived from Bacillus subtilis.104 137

Uses for BACiiM

Staphylococcal Pneumonia and Empyema in Infants

Has been used in infants for treatment of pneumonia and empyema caused by susceptible staphylococci.104 137

Not considered a drug of choice or alternative for staphylococcal infections.139 144 Penicillinase-resistant penicillins (nafcillin, oxacillin) are the usual drugs of choice for infections caused by penicillinase-producing staphylococci, and vancomycin (with or without gentamicin and rifampin) or linezolid usually is recommended for infections caused by methicillin-resistant staphylococci.105 138 139

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Clostridium difficile-associated Diarrhea and Colitis

Has been used orally for the treatment of Clostridium difficile-associated diarrhea and colitis (CDAD; antibiotic-associated diarrhea and colitis) or pseudomembranous colitis.100 101 102 103 105 117 140 143 Designated an orphan drug by FDA for use in this condition.114

Oral metronidazole or, alternatively, oral vancomycin usually is recommended for the treatment of CDAD.105 108 109 110 111 112 113 116 117 119 120 121 122 123 124 139 140 143 Some clinicians have suggested that oral bacitracin may be an alternative to metronidazole or vancomycin101 102 105 and may also be useful in patients who are allergic to vancomycin100 or whose diarrhea and/or colitis does not respond to vancomycin.100 101 102 However, oral preparations of bacitracin are not commercially available in the US.

BACiiM Dosage and Administration

Administration

Administer IM.104 137

IM Administration

Inject into the upper outer quadrant of the buttocks, alternating right and left.104 137 Avoid multiple injections in the same region because of transient pain following injection.104 137

Reconstitution

Dissolve powder for injection in 0.9% sodium chloride injection containing 2% procaine hydrochloride. 104 137 Add 9.8 mL of this diluent to a vial containing 50,000 units to provide a solution containing 5000 units/mL.104 137 Bacitracin solutions containing <5,000 units/mL or >10,000 units/mL should not be used.104 137

Do not use diluents containing parabens.104 137

Dosage

Pediatric Patients

Staphylococcal Pneumonia and Empyema in Infants
IM

Infants <2.5 kg: 900 units/kg daily given in 2 or 3 divided doses.104 137

Infants >2.5 kg: 1000 units/kg daily in 2 or 3 divided doses.104 137

Adults

Clostridium-difficile-associated Diarrhea and Colitis
Oral

20,000–25,000 units every 6 hours for 7–10 days has been used.100 101 102 103 Oral dosage form not commercially available in the US.

Prescribing Limits

Pediatric Patients

Staphylococcal Pneumonia and Empyema in Infants

Do not exceed recommended dosage;104 137 do not exceed 12 days of therapy.a

Special Populations

No special population dosage recommendations at this time.a

Cautions for BACiiM

Contraindications

  • History of hypersensitivity or toxic reactions to bacitracin.104 137

Warnings/Precautions

Warnings

Nephrotoxicity

IM bacitracin may cause renal failure due to tubular and glomerular necrosis.104 137 Albuminuria,104 137 hematuria,a cylindruria,104 137 and rising blood concentrations of the drug104 137 may occur initially followed eventually by oliguria,a azotemia,104 137 and renal failure.104 137

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.104 137 Discontinue drug if renal toxicity occurs.104 137

Keep patient well hydrated using oral or, if necessary, parenteral fluids.104 137 Maintain urine output at proper levels to avoid renal toxicity.104 137 Some suggest using sodium bicarbonate or another alkali to keep urine at pH 6 or greater to avoid renal irritation.a

Avoid concurrent use of other nephrotoxic drugs.104 137 (See Specific Drugs under Interactions.)

Sensitivity Reactions

Hypersensitivity

Rash,104 137 urticaria,a and anaphylactoid reactionsa have occurred.

General Precautions

Neurotoxicity

Respiratory paralysis may occur as a result of neuromuscular blockade, especially in patients with a neuromuscular disease such as myasthenia gravis.a Severe neuromuscular blockade resulting in respiratory depression unresponsive to calcium or neostigmine has occurred in several patients treated with bacitracin and neomycin sulfate instilled intrapleurally or into a pancreatic pseudocyst.a

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.104 137

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.104 137 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.104 137

Superinfection

Overgrowth of nonsusceptible organisms, including fungi, may occur.104 137 Institute appropriate therapy if superinfection occurs.104 137

Specific Populations

Pregnancy

Category C.145

Not labeled for use in adults, including pregnant women.104 137

Lactation

Not known whether bacitracin is distributed into milk.145 Not labeled in adults, including nursing women.104 137

Common Adverse Effects

Nephrotoxicity (albuminuria, cylindruria, azotemia, rising blood concentrations of the drug);104 137 GI effects (nausea, vomiting);104 137 pain at injection site;104 137 hypersensitivity reactions (rash).104 137

Interactions for BACiiM

Specific Drugs

Drug

Interaction

Comments

Aminoglycosides (streptomycin, neomycin, kanamycin)

Possible potentiation of nephrotoxic effects104 137

Avoid concomitant use 104 137

Colistimethate/colistin

Possible potentiation of nephrotoxic effects104 137

Avoid concomitant use 104 137

Polymyxin b sulfate

Possible potentiation of nephrotoxic effects104 137

Avoid concomitant use 104 137

Neuromuscular blocking agents and general anesthetics

Possible prolongation of skeletal muscle relaxation and potentiation of neuromuscular blockadea

BACiiM Pharmacokinetics

Absorption

Bioavailability

Not absorbed from GI tract, pleura, or synovia.a

Completely and rapidly absorbed following IM injection.104 137

Following a single IM dose of 10,000–20,000 units in adults with normal renal function, peak serum concentrations occur after 1–2 hours and are detectable in serum for 6–8 hours after the dose.a

Distribution

Extent

Widely distributed in all body organs and is present in ascitic and pleural fluids following IM injection.104 137

Only trace amounts cross the blood-brain barrier into the CSF, unless the meninges are inflamed.a

Elimination

Elimination Route

IM: 10–40% of the dose is excreted slowly by glomerular filtration and appears in urine within 24 hours.a

Oral: Excreted in the feces.a

Stability

Storage

Parenteral

Powder for Injection

2–8°C.104 137 Protect from direct sunlight.a

Following reconstitution, stable at 2–8°C for up to one week.104

Actions and Spectrum

  • Polypeptide antibiotic.104 137

  • Has a potency of not less than 50 units of bacitracin activity per mg.104 137

  • 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 some staphylococci and streptococci.144 Also active in vitro against some gram-negative bacteria, including Neisseria, but not against most gram-negative bacilli.a

  • Some strains of Clostridium difficile are susceptible to bacitracin in vitro,142 but other strains are resistant to the drug.141 144

  • Staphylococci, including penicillin G-resistant staphylococci, resistant to bacitracin have been reported.a Does not exhibit cross-resistance with any other antibiotic.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).104 137

  • 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.104 137

  • Importance of informing clinicians of existing concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.a

  • Importance of informing patients of other important precautionary information.a (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

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, 2004-2014, Selected Revisions September 1, 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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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. [IDIS 113759] [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. [IDIS 207130] [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. [IDIS 217153] [PubMed 3521518]

104. Pharmacia & Upjohn. Bacitracin for injection, USP prescribing information. Kalamazoo, MI. 2003 Sept.

105. American Academy of Pediatrics. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006.

108. Centers for Disease Control and Prevention. Recommendations for preventing the spread of vancomycin resistance: recommendations of the Hospital Infection Control Practices Advisory Committee (HICPAC). MMWR Morb Mortal Wkly Rep. 1995; 44(No. RR 12):1-13. [PubMed 7799912]

109. Johnson S, Gerding DN. Clostridium difficile-associated diarrhea. Clin Infect Dis. 1998; 26:1027-36. [IDIS 407733] [PubMed 9597221]

110. Gerding DN, Johnson S, Peterson LR et al for the Society for Healthcare Epidemiology of America. Position paper on Clostridium difficile-associated diarrhea and colitis. Infect Control Hosp Epidemiol. 1995; 16:459-77. [PubMed 7594392]

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. [IDIS 386628] [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. [IDIS 407213] [PubMed 9659970]

113. Wilcox MH. Treatment of Clostridium difficile infection. J Antimicrob Chemother. 1998; 41(Suppl C):41-6. [IDIS 407246] [PubMed 9630373]

114. Food and Drug Administration. List of orphan designations and approvals. From FDA website. Accessed 2009 Mar 3.

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]

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119. Fekety R, Shah AB. Diagnosis and treatment of Clostridium difficile colitis. JAMA. 1993; 269:71-5. [IDIS 307078] [PubMed 8416409]

120. Barlett JG. Antibiotic-associated diarrhea. Clin Infect Dis. 1992; 269:2088.

121. Caputo GM, Weitekamp MR. The treatment of Clostridium difficile colitis. JAMA. 1993; 269:2088. [IDIS 313397] [PubMed 8468761]

122. Spera RV, Farber BF. Multiply-resistant Enterococcus faecium: the nosocomial pathogen of the 1990s. JAMA. 1992; 268:2563-4. [PubMed 1308665]

123. Spera RV, Farber BF. The treatment of Clostridium difficile colitis. JAMA. 1993; 269:2088.

124. Oh T, Mostes de Oca G, Osorno RJ. Antibiotic-associated pseudomembranous colitis. Am J Dis Child. 1990; 144:526. [IDIS 266029] [PubMed 2330918]

126. Wilcox MH, Spencer RC. Clostridium difficile infection: responses, relapses, and reinfections. J Hosp Infect. 1992; 22:85-92. [PubMed 1358964]

127. Courvalin P. Resistance of enterococci to glycopeptides. Antimicrob Agents Chemother. 1990; 34:2291-6. [IDIS 281901] [PubMed 2088183]

128. Handwerger S, Perlman DC, Altarac D et al. Concomitant high-level vancomycin and penicillin resistance in clinical isolates of enterococci. Clin Infect Dis. 1992; 14:655-61. [IDIS 292447] [PubMed 1562656]

129. Livornese LL, Dias S, Samel C et al. Hospital-acquired infection with vancomycin-resistant Enterococcus faecium. transmitted by electronic thermometers. Ann Intern Med. 1992; 117:112-6. [PubMed 1605425]

130. Landman D, Mobarakai NK, Quale JM. Novel antibiotic regimens against Enterococcus faecium resistant to ampicillin, vancomycin, and gentamicin. Antimicrob Agents Chemother. 1993; 37:1904-8. [PubMed 8239604]

131. Centers for Disease Control and Prevention. Nosocomial enterococci resistant to vancomycin–United States, 1989-1993. MMWR Morb Mortal Wkly Rep. 1993; 42:597-9. [IDIS 318269] [PubMed 8336690]

132. Rubin LG, Tucci V, Cercenado E et al. Vancomycin-resistant Enterococcus faecium in hospitalized children. Infect Control Hosp Epidemiol. 1992; 13:700-5. [PubMed 1289397]

133. Goldmann DA. Vancomycin-resistant Enterococcus faecium: headline news. Infect Control Hosp Epidemiol. 1992; 13:695-9. [PubMed 1289396]

134. Schaberg D. Major trends in the microbial etiology of nosocomial infection. Am J Med. 1991; 91:72-5.

135. Vemuri RK, Zervos MJ. Enterococcal infections: the increasing threat of nosocomial spread and drug resistance. Postgrad Med. 1993; 93:121-4,127-8. [PubMed 8446521]

136. Centers for Disease Control and Prevention. Preventing the spread of vancomycin resistance—report from the hospital infection control practices advisory committee; comment period and public meeting; notice. Fed Regist. 1994; 59:25758-63. [PubMed 10136017]

137. X-gen. BACiiM (bacitracin for injection USP) prescribing information. Northport, NY. 2003 Dec.

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 2007. McEvoy GK, ed. Bacitracin. Bethesda, MD: American Society of Health-System Pharmacists; 2007:[page 453-454].

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