Brand name: BACiiM
Drug class: Bacitracins
VA class: AM900
Molecular formula: C₆₆H₁₀₃N₁₇O₁₆S
CAS number: 1405-87-4

Introduction

Antibacterial; polypeptide antibiotic.

Uses for Bacitracin

Staphylococcal Pneumonia and Empyema in Infants

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

Not considered a preferred or alternative agent for treatment of staphylococcal infections; other anti-infectives are used for treatment of staphylococcal respiratory tract infections.

Manufacturers state use bacitracin only when adequate laboratory facilities are available and constant supervision of the patient is possible.

Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Has been used orally† for treatment of CDAD† (also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis). Designated an orphan drug by FDA for use in this condition.

Oral bacitracin not recommended as a preferred or alternative agent for treatment of C. difficile infection (CDI) or CDAD. Bacitracin-resistant C. difficile reported, and the drug generally has been less effective that other anti-infectives used in management of CDAD. In addition, bacitracin oral preparations not commercially available in US.

Bacitracin Dosage and Administration

Administration

Administer IM.

Has been administered orally†, but oral preparations not commercially available in US.

IM Injection

Inject into upper outer quadrant of the buttocks. Alternate injection sites between right and left side. Avoid making multiple injections in same region because of transient pain following injection.

Reconstitution

Reconstitute lyophilized powder for injection by dissolving in 0.9% sodium chloride injection containing 2% procaine hydrochloride. If 9.8 mL of this diluent is used to reconstitute a vial containing 50,000 units of bacitracin, resultant solution contains 5000 units/mL.

Do not use bacitracin solutions containing <5000 units/mL or >10,000 units/mL.

Do not use diluents containing parabens; cloudy solutions and precipitate formation may occur.

Dosage

Pediatric Patients

Staphylococcal Pneumonia and Empyema in Infants

IM

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

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

Prescribing Limits

Pediatric Patients

Staphylococcal Pneumonia and Empyema in Infants

Do not exceed recommended dosage; duration >12 days not recommended.

Special Populations

No special population dosage recommendations.

Cautions for Bacitracin

Contraindications

• History of hypersensitivity or toxic reactions to bacitracin.

Warnings/Precautions

Warnings

Nephrotoxicity

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

Infants less prone to bacitracin nephrotoxicity than older children and adults. Toxicity is related to total daily dosage and duration of therapy.

Assess renal function prior to and daily during therapy. Discontinue drug if renal toxicity occurs.

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

Avoid concomitant use with other nephrotoxic drugs. (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. In addition, use the drug only if adequate laboratory facilities are available and constant supervision of the patient is possible.

Sensitivity Reactions

Hypersensitivity

Anaphylaxis and/or allergic contact dermatitis reported when bacitracin used for non-FDA-labeled indications.

Rash and pruritus also reported.

General Precautions

Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)

Possible emergence and overgrowth of nonsusceptible bacteria or fungi may occur. Institute appropriate therapy if superinfection occurs.

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile. 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. C. difficile produces toxins A and B which contribute to development of CDAD; 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.

Consider CDAD if diarrhea develops during or after therapy and manage accordingly. Obtain careful medical history since CDAD may occur as late as ≥2 months after anti-infective therapy is discontinued.

If CDAD suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible. 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.

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.

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

Specific Populations

Pregnancy

Category C.

Not labeled for use in adults, including pregnant women.

Lactation

Not known whether bacitracin is distributed into milk.

Not labeled for use in adults, including nursing women.

Common Adverse Effects

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

Interactions for Bacitracin

Specific Drugs

Bacitracin Pharmacokinetics

Absorption

Bioavailability

Not appreciably absorbed from GI tract.

Completely and rapidly absorbed following IM injection.

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.

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.

Distribution

Extent

Widely distributed into all body organs; readily diffuses into ascitic and pleural fluids following IM injection.

Only low concentrations distributed into CSF.

Plasma Protein Binding

Only slightly protein bound.

Elimination

Elimination Route

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

Oral: Excreted in feces.

Stability

Storage

Parenteral

Powder for Injection

2–8°C.

Following reconstitution with 0.9% sodium chloride injection containing 2% procaine hydrochloride as directed by manufacturer, stable at 2–8°C for 1 week.

Actions and Spectrum

• Polypeptide antibiotic produced by B. subtilis or B. licheniformis; bacitracin commercially available in US is derived from cultures of B. subtilis (Tracey).

• Mixture of polypeptides (bacitracin A, B1, B2, B3); major component is bacitracin A.

• Commercially available bacitracin for injection has a potency of not less than 50 units of bacitracin activity per mg.

• May be bactericidal or bacteriostatic, depending on drug concentration at site of infection.

• Inhibits bacterial cell wall synthesis.

• Active in vitro against some gram-positive bacteria, including staphylococci (e.g., Staphylococcus aureus) and Streptococcus pyogenes (group A β-hemolytic streptococci, GAS). Also active in vitro against some gram-negative bacteria, including Haemophilus influenzae and Neisseria, but not active against most gram-negative bacilli.

• Although some strains of Clostridium difficile are susceptible to bacitracin in vitro, strains with high-level resistance to the drug reported.

• S. aureus resistant to bacitracin have been reported.

• Does not exhibit cross-resistance with other antibiotics.

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).

• 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.

• Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. 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.

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

• Importance of informing patients of other important precautionary information. (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

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