BACiiM

Name: BACiiM

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 drug100 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

Rash100 104 and pruritusa 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

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