Superficial Bacterial Skin Infections
Bacitracin,100, 101 bacitracin zinc,102 and bacitracin zinc in fixed combination with other anti-infectives (i.e., polymyxin B sulfate with or without neomycin sulfate)104, 105, 106, 107, 108, 109, 111, 112 are used topically for the prevention of superficial bacterial skin infections associated with minor cuts, scrapes, or burns.100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 111, 116, 141, 144 Bacitracin, bacitracin zinc, and bacitracin zinc in fixed combination with other anti-infectives also have been used for the topical treatment † of minor skin infections caused by susceptible bacteria.14, 116, 141, 144
Although minor skin infections and wounds usually heal without treatment, some minor skin wounds do not heal without treatment and it is impossible to determine at the time of injury which wounds will be self-healing. Some experts believe that, by reducing the number of superficial bacteria, topical anti-infectives are useful for preventing infection in minor skin injuries (e.g., cuts, scrapes, burns). The role, if any, of most topical anti-infectives for the treatment of superficial skin infections has not been fully elucidated, and systemic anti-infective therapy is usually required for the treatment of serious or extensive skin infections. Self-medication with topical anti-infectives for the prevention or treatment of superficial skin infections is not usually recommended.116
Infected Corticosteroid-responsive Dermatoses
Bacitracin zinc in fixed combination with other anti-infectives (i.e., polymyxin B sulfate and neomycin sulfate) and a corticosteroid (i.e., hydrocortisone) is used for the topical treatment of corticosteroid-responsive dermatoses with secondary infection.110
It has not been proven that fixed-combination topical preparations that include anti-infectives and a corticosteroid provide greater benefit than use of a topical corticosteroid alone after 7 days of treatment.110 The possible benefits of a fixed-combination topical preparation containing anti-infectives and a corticosteroid must be weighed against the risk that the corticosteroid may mask clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the anti-infective; or suppress hypersensitivity reactions to ingredients in the formulation.
Bacitracin100, 101 and bacitracin zinc102 are applied topically to the skin as ointments.100, 101
Bacitracin zinc in fixed combination with polymyxin B sulfate with or without neomycin sulfate is applied topically to the skin as an ointment.104, 105, 107, 109 Bacitracin zinc in fixed combination with polymyxin B also is commercially available as a powder for topical application to the skin.106
Bacitracin zinc in fixed combination with neomycin sulfate, polymyxin B sulfate, and hydrocortisone is commercially available as an ointment for topical application to the skin.110
Bacitracin zinc also is commercially available in fixed combination with a topical anesthetic (i.e., pramoxine hydrochloride) as an ointment103 or in fixed combination with neomycin sulfate, polymyxin B sulfate, and a topical anesthetic (i.e., lidocaine hydrochloride or pramoxine hydrochloride) as ointments108, 112 or creams111 for topical application to the skin.
Bacitracin and bacitracin zinc topical preparations and fixed-combination topical preparations containing bacitracin zinc are for external use only on skin and should not be used in the eyes.100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112
These topical preparations should not be applied to extensive areas of skin, deep or puncture wounds, animal bites, or serious burns.100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 111, 112
A small amount of topical ointment or cream (amount equal to the surface area of a fingertip) should be applied to cleansed, affected areas of skin.100, 101, 102, 103, 104, 105, 107, 108, 109, 110, 111, 112 If the powder is used, a light dusting of the powder should be applied to cleansed, affected areas of skin.106
The treated areas of skin may be covered with a sterile bandage.100, 101, 102, 104, 105, 106, 107, 108, 109, 111, 112
Prevention of Superficial Bacterial Skin Infections
For the prevention of superficial skin infections associated with minor cuts, scrapes, or burns, a small amount of ointment or cream containing bacitracin, bacitracin zinc, or a fixed combination containing bacitracin zinc should be applied to affected areas of skin 1-3 times daily.100, 101, 102, 103, 104, 105, 107, 108, 109, 111 If the fixed-combination powder containing bacitracin zinc is used, it should be applied to affected areas of skin 1-3 times daily.106
For self-medication , topical preparations containing bacitracin, bacitracin zinc, or a fixed combination containing bacitracin zinc may be used for up to 1 week.100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 111, 112 If the condition persists for longer than 1 week or worsens, a clinician should be contacted.100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 111, 112
Infected Corticosteroid-responsive Dermatoses
If the fixed-combination topical preparation containing bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and hydrocortisone is used for the topical treatment of corticosteroid-responsive dermatoses with secondary infection, a thin film of the ointment should be applied to affected areas of skin 2-4 times daily for up to 7 days.110
Bacitracin has a low order of toxicity when applied topically;141 however, minor skin irritation, rash, and allergic contact dermatitis or other hypersensitivity reactions have occurred in some patients.141, 144 More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely following topical application of the drug to skin.113, 114, 115, 141, 144 Hypersensitivity reactions have ranged from generalized itching, swelling of the lips and face, sweating, and tightness of the chest, to hypotension, unconsciousness, apnea, and cardiac arrest.
Precautions and Contraindications
Topical preparations containing bacitracin or bacitracin zinc should not be used by patients allergic to any ingredient in the formulation.100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112
The fixed-combination topical preparation containing bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and hydrocortisone is contraindicated in patients hypersensitive to any ingredient in the formulation.110 This fixed combination also is contraindicated in patients with tuberculous, fungal, or viral (e.g., herpes simplex, varicella zoster) skin lesions and is contraindicated for use in the eyes or in the external ear canal if the eardrum is perforated.110
Patients should be informed that topical preparations containing bacitracin or bacitracin zinc are intended for external use only and should not be used in the eyes or applied over large areas of the body.100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 111, 112
Patients using topical preparations containing bacitracin or bacitracin zinc for self-medication for the prevention of infection in minor skin injuries (e.g., cuts, scrapes, burns) should be advised that these topical preparations should not be used for longer than 1 week unless directed by a clinician and to discontinue use of the topical anti-infective preparation and consult a clinician if the condition persists or worsens.100, 101, 102, 103, 104, 105, 107, 108, 109, 111, 112
Chronic use of topical anti-infectives may promote bacterial resistance and should be avoided.141 Overgrowth of nonsusceptible organisms, including fungi, may occur.110
Patients should be advised to first consult a clinician if considering self-medication with a topical anti-infective for deep or puncture wounds, animal bites, or serious burns.100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 111, 112
Precautions Related to Sensitivity Reactions
Patients should be advised to discontinue topical preparations containing bacitracin or bacitracin zinc and contact a clinician if itching, burning, rash, or any other signs of sensitivity or allergic reaction occur.100, 101, 102, 103, 104, 105, 107, 108, 109, 110, 111, 112
Topical anti-infectives, including bacitracin and neomycin, are known contact sensitizers.
Clinicians should consider that patients allergic to bacitracin may have delayed cell-mediated contact dermatitis reactions or immediate IgE-mediated (e.g., anaphylactic) reactions to the drug.113, 114, 141, 144
Patients allergic to one of the fixed-combination topical preparations containing bacitracin or bacitracin zinc should avoid preparations containing any of the component drugs. Patients sensitive to bacitracin may also have cross-sensitivity to polymyxin B.141 In addition, patients allergic to fixed combinations containing neomycin may also be allergic to other aminoglycosides.110
Precautions Related to Use of Fixed Combinations
When bacitracin zinc is used topically in fixed combination with other topical anti-infectives (i.e., polymyxin B sulfate with or without neomycin sulfate), topical corticosteroids (i.e., hydrocortisone), or topical anesthetics (i.e., lidocaine hydrochloride, pramoxine hydrochloride), the cautions, precautions, and contraindications associated with each drug in the fixed combination should be considered.
When fixed combinations containing bacitracin zinc and neomycin sulfate are used, clinicians should consider that topical neomycin sulfate may cause cutaneous sensitization.110, 141 A precise incidence of hypersensitivity reactions (primarily rash) due to topical neomycin is not known.110
When the fixed combination containing bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and hydrocortisone is used, clinicians should consider that topical corticosteroids used in fixed combination with topical anti-infectives may mask the clinical signs of bacterial, fungal, or viral infections, or may suppress hypersensitivity reactions to the anti-infectives or other ingredients in the formulation.144 Clinicians also should consider that use of topical corticosteroids can result in signs and symptoms of exogenous hyperadrenocorticism, including adrenal suppression, and that systemic absorption of topically applied corticosteroids is increased if extensive body surface areas are treated or if occlusive dressings are used.110 Patients using the fixed-combination preparation containing hydrocortisone should be advised that the preparation should not be used for longer than 7 days and to discontinue use and contact a clinician if redness, irritation, swelling, or pain persists or increases.110
Some manufacturers state that topical preparations containing bacitracin zinc should not be used in children younger than 2 years of age unless directed by a clinician.103, 108, 111
Safety and efficacy of the topical preparation containing bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and hydrocortisone have not been established in pediatric patients.110
At least one manufacturer of a topical preparation containing neomycin sulfate, polymyxin B sulfate, bacitracin zinc, and a topical anesthetic (i.e., lidocaine hydrochloride) states that the preparation should not be used in children younger than 12 years of age unless directed by a clinician.112
Although clinical studies evaluating the topical preparation containing bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and hydrocortisone did not include sufficient numbers of patients 65 years of age or older to determine whether geriatric individuals respond differently than younger patients, other reported clinical experience has not identified differences in responses between geriatric and younger patients.110
Bacitracin and bacitracin zinc should be used during pregnancy only if potential benefits justify potential risks to the fetus.144
Some manufacturers state that patients who are pregnant should consult a clinician before using topical preparations containing bacitracin or bacitracin zinc.101, 103
The topical preparation containing bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and hydrocortisone should be used during pregnancy only if potential benefits justify potential risks to the fetus.110 Corticosteroids have been teratogenic in mice and rabbits when applied topically.110
It is not known whether topical bacitracin is distributed into milk.140
Some experts consider topical bacitracin compatible with nursing.140
Some manufacturers state that patients who are breast-feeding should consult a clinician before using topical preparations containing bacitracin or bacitracin zinc.101, 103
The topical preparation containing bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and hydrocortisone should be used with caution in nursing women.110 Hydrocortisone is distributed into human milk following oral administration, and systemic absorption may occur when hydrocortisone is applied topically.110
Bacitracin may be bactericidal or bacteriostatic in action, depending on the concentration of the drug attained at the site of infection and the susceptibility of the infecting organism. Bacitracin inhibits bacterial cell wall synthesis by preventing the incorporation of amino acids and nucleotides into the cell wall. The drug probably interferes with the final dephosphorylation step in the phospholipid carrier cycle and, in this manner, bacitracin prevents the transfer of the mucopeptide to the growing cell wall. Bacitracin also damages the bacterial plasma membrane and is active against protoplasts.
Bacitracin is active in vitro against some gram-positive aerobic bacteria, including staphylococci (e.g., Staphylococcus aureus ), streptococci (e.g., Streptococcus pyogenes ), and Corynebacterium .14, 141, 144 In vitro, susceptible S. aureus generally are inhibited by bacitracin concentrations of 0.05-5 mcg/mL. The drug also is active in vitro against some gram-negative aerobic bacteria, including Haemophilus influenzae and Neisseria , but is not active against most gram-negative bacilli.144
The activity of bacitracin is not impaired by blood, pus, necrotic tissue, or large inocula.
Staphylococci (e.g., Staphylococcus aureus ) and streptococci resistant to bacitracin have been reported.14, 141, 144
Bacitracin does not exhibit cross-resistance with other anti-infectives.
Bacitracin is not appreciably absorbed from intact or denuded skin, wounds, or mucous membranes.14, 144
Bacitracin is a polypeptide antibiotic produced by Bacillus subtilis or B. licheniformis .7, 14, 117, 141, 144 The antibiotic is a mixture of polypeptides (bacitracin A, B1, B2, and B3);7, 14, 117 the major component is bacitracin A.141, 144, 117
Bacitracin occurs as a white to pale buff, hygroscopic powder that is odorless or has a slight odor, and has a bitter taste. The drug is freely soluble in water and soluble in alcohol. Bacitracin zinc occurs as a white to pale tan, hygroscopic powder that is odorless or has a slight odor. Bacitracin zinc is sparingly soluble in water.
Bacitracin topical ointment should be stored at 20-25°C.100, 101
Bacitracin zinc topical ointment should be stored at 15-30°C;102 exposure to excessive heat and humidity should be avoided.102
Fixed-combination topical ointments containing bacitracin zinc and polymyxin B sulfate with or without neomycin sulfate should be stored at104 20-25105, 107 or 15-30°C,109 depending on the manufacturer.
The fixed-combination topical powder containing bacitracin zinc and polymyxin B sulfate should be stored at 20-25°C and should not be refrigerated.106
The fixed-combination topical ointment containing bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and hydrocortisone should be stored at 15-25°C.110
Fixed-combination topical preparations containing bacitracin zinc and a local anesthetic (i.e., lidocaine hydrochloride, pramoxine hydrochloride) with or without neomycin sulfate and polymyxin B sulfate should be stored at 15-30°C, depending on the manufacturer;103, 108, 111, 112 these preparations should be protected from excessive heat111, 112 and freezing.111
Bacitracin is stable in petrolatum, paraffins, white wax, and lanolin, but not in water-miscible bases.
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
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.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Topical | Ointment | 500 units per g* | Bacitracin Ointment | |
Bacitraycin Plus® Original | First Aid |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Topical | Ointment | 500 units (of bacitracin) per g* | Bacitracin Zinc Ointment |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Topical | Ointment | Bacitracin Zinc 500 units (of bacitracin) per g and Polymyxin B Sulfate 10,000 units (of polymyxin B) per g* | Bacitracin Zinc and Polymyxin B Sulfate Ointment | |
Fougera | ||||
Polysporin® Ointment | Johnson & Johnson | |||
Powder | Bacitracin Zinc 500 units (of bacitracin) per g and Polymyxin B Sulfate 10,000 units (of polymyxin B) per g | Polysporin® Powder | Johnson & Johnson |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Topical | Ointment | Neomycin Sulfate 3.5 mg (of neomycin) per g, Polymyxin B Sulfate 5000 units (of polymyxin B) per g, and Bacitracin Zinc 400 units (of bacitracin) per g* | Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ointment | |
Neosporin® Original | Johnson & Johnson | |||
Triple Antibiotic Ointment |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Topical | Ointment | Neomycin Sulfate 3.5 mg (of neomycin) per g, Polymyxin B Sulfate 5000 units (of polymyxin B) per g, Bacitracin Zinc 400 units (of bacitracin) per g, and Hydrocortisone 1% | Cortisporin® Ointment |
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Topical | Cream | Bacitracin Zinc 400 units (of bacitracin) per g, Neomycin Sulfate 3.5 mg (of neomycin) per g, Polymyxin B Sulfate 5000 units (of polymyxin B) per g, and Lidocaine Hydrochloride 20 mg per g* | Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Lidocaine Hydrochloride Cream | |
Ointment | Bacitracin Zinc 400 units per g, Neomycin Sulfate 3.5 mg (of neomycin) per g, Polymyxin B Sulfate 5000 units per g, and Lidocaine 40 mg per g* | Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Lidocaine Ointment | ||
Bacitracin Zinc 500 units (of bacitracin) per g, Neomycin Sulfate 3.5 mg (of neomycin) per g, Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, and Pramoxine Hydrochloride 10 mg per g* | Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride Ointment | |||
Neosporin® Plus | Johnson & Johnson | |||
Triple Antibiotic Plus | ||||
Bacitracin Zinc 500 units (of bacitracin) per g and Pramoxine Hydrochloride 10 mg per g* | Bacitracin Zinc and Pramoxine Hydrochloride Ointment | |||
Bacitraycin Plus® | First Aid |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Only references cited for selected revisions after 1984 are available electronically.
7. Bacitracin. In: U.S. pharmacopeia, 40th rev, and The national formulary, 35th ed. Rockville, MD: The United States Pharmacopeial Convention. From UPS-NF online. Accessed 2018 Jan 19.
14. Bacitracin. In: Martindale: The complete drug reference. London: Pharmaceutical Press; 2015. From MedicinesComplete website. Accessed 2015 Nov 11. [Web]
100. Perrigo. Bacitracin ointment patient information. New York, NY; Undated. From Dailymed website. Accessed 2020 Jan 17.
101. First Aid Research. Bacitraycin Plus® Original (bacitracin) ointment patient information. Jupiter, FL; Undated. From Dailymed website. Accessed 2020 Jan 15.
102. McKesson. Bacitracin zinc ointment patient information. Richmond, VA; Undated. From Dailymed website. Accessed 2020 Jan 15.
103. First Aid Research. Bacitraycin Plus® (bacitracin zinc and pramoxine hydrochloride) ointment patient information. Jupiter, FL; Undated. From Dailymed website. Accessed 2020 Jan 15.
104. E Fougera. Double antibiotic (bacitracin zinc and polymyxin B sulfate) ointment patient information. Melville, NY; Undated. From Dailymed website. Accessed 2020 Jan 15.
105. Johnson & Johnson. Polysporin® (bacitracin zinc and polymyxin B sulfate) ointment patient information. Skillman, NJ; Undated. From Dailymed website. Accessed 2020 Jan 15.
106. Johnson & Johnson. Polysporin® (bacitracin zinc and polymyxin B sulfate) powder patient information. Skillman, NJ; Undated. From Dailymed website. Accessed 2020 Jan 15.
107. Johnson & Johnson. Neosporin® Original (bacitracin zinc, neomycin sulfate, and polymyxin B sulfate) ointment patient information. Skillman, NJ; Undated. From Dailymed website. Accessed 2020 Jan 15.
108. Johnson & Johnson. Neosporin® Plus (bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and pramoxine hydrochloride) ointment patient information. Skillman, NJ; Undated. From Dailymed website. Accessed 2020 Jan 15.
109. Actavis Pharma. Triple Antibiotic (bacitracin zinc, neomycin sulfate, and polymyxin B sulfate) ointment patient information. Parsippany, NJ; Undated. From Dailymed website. Accessed 2020 Jan 15.
110. Pfizer Laboratories. Cortisporin® (neomycin and polymyxin B sulfates, bacitracin zinc, and hydrocortisone) ointment prescribing information. New York, NY; 2016 Aug.
111. CellNovation Technology. Bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and lidocaine hydrochloride cream patient information. Undated. From Dailymed website. Accessed 2020 Jan 15.
112. Hart Health. Bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and lidocaine ointment patient information. Seattle, WA; Undated. From Dailymed website. Accessed 2020 Jan 15.
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114. Saryan JA, Dammin TC, Bouras AE. Anaphylaxis to topical bacitracin zinc ointment. Am J Emerg Med . 1998; 16:512-3. [PubMed 9725969]
115. Schechter JF, Wilkinson RD, Del Carpio J. Anaphylaxis following the use of bacitracin ointment. Report of a case and review of the literature. Arch Dermatol . 1984; 120:909-11. [PubMed 6732261]
116. Williamson DA, Carter GP, Howden BP. Current and Emerging Topical Antibacterials and Antiseptics: Agents, Action, and Resistance Patterns. Clin Microbiol Rev . 2017; 30:827-860. [PubMed 28592405]
117. Pavli V, Kmetec V. Pathways of chemical degradation of polypeptide antibiotic bacitracin. Biol Pharm Bull . 2006; 29:2160-7. [PubMed 17077508]
140. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 6th ed. Philadelphia: Lippincott Williams & Wilkins; 2002: 120/b.
141. O'Donnell JA, Gelone SP, and Safdar M. Topical antibacterials. In: Bennett JE, Dolin R, and Blaser MJ, eds. Mandell, Douglas, and Bennett's principles and practices of infectious diseases. 8th ed. Philadelphia, PA: Elsevier Saunders; 2015:1844-80.
144. Murk JL and Kluytmans J. Bacitracin and gramicidin. In: Grayson ML, ed. Kucers' the use of antibiotics: a clinical review of antibacterial, antifungal, antiparasitic, and antiviral drugs. 7th ed. Boca Raton, FL: CRC Press; 2018: 1454-9.