Bacitracin is a polypeptide antibiotic.7
Bacterial Ophthalmic Infections
Bacitracin is used for the topical treatment of superficial infections of the eye involving the conjunctiva and/or cornea caused by susceptible bacteria.101
Bacitracin zinc in fixed combination with polymyxin B sulfate with or without neomycin sulfate is used for the topical treatment of superficial infections of the eye involving the conjunctiva and/or cornea (e.g., conjunctivitis, keratitis, keratoconjunctivitis, blepharitis, blepharoconjunctivitis) caused by susceptible bacteria.102, 103, 105, 106
Fixed-combination topical ophthalmic preparations containing bacitracin zinc and polymyxin B sulfate with or without neomycin sulfate are considered active against Staphylococcus aureus , streptococci (including Streptococcus pneumoniae ), Escherichia coli , Haemophilus influenzae , Enterobacter , Klebsiella , Neisseria , and Pseudomonas aeruginosa , but do not provide adequate coverage against Serratia marcescens .103, 105, 106
Although mild, acute bacterial conjunctivitis often resolves spontaneously without anti-infective treatment,135, 136, 137, 141 topical ophthalmic anti-infectives may shorten the time to resolution and reduce severity and risk of complications.135, 136, 137, 141 Treatment of acute bacterial conjunctivitis generally is empiric and use of a broad-spectrum topical ophthalmic antibacterial usually is recommended;135, 136, 141 however, indiscriminate use of topical anti-infectives should be avoided.135, 141 In vitro staining and/or cultures of conjunctival material may be indicated in the management of recurrent, severe, or chronic purulent conjunctivitis or when acute conjunctivitis does not respond to initial empiric topical treatment.135, 136, 141
Because many forms of bacterial keratitis are associated with subsequent loss of vision as the result of corneal scarring or topographic irregularities and because untreated or severe bacterial keratitis may result in perforation of the cornea with the potential for endophthalmitis and possible loss of the eye, optimal management involves rapid evaluation and diagnosis, timely initiation of treatment, and appropriate follow-up.138 Treatment of community-acquired bacterial keratitis generally is empiric and use of a broad-spectrum topical ophthalmic antibacterial usually is recommended.138 Subconjunctival therapy with an appropriate anti-infective may be necessary if scleral spread or perforation is imminent.138 In vitro staining and/or cultures are indicated in the management of keratitis involving corneal infiltrates that are central, large, and extending to the middle to deep stroma; when keratitis is chronic or unresponsive to broad-spectrum topical anti-infective treatment; or when atypical features are present suggesting fungal, amebic or mycobacterial infection.138
Topical ophthalmic preparations containing bacitracin zinc in fixed combination with neomycin sulfate, polymyxin B sulfate, and a corticosteroid (i.e., hydrocortisone or hydrocortisone acetate) are used for the treatment of corticosteroid-responsive ocular conditions when a corticosteroid is indicated and superficial bacterial ocular infection or risk of such infection exists.107, 108
Ophthalmic corticosteroids may be indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain diminution in edema and inflammation.107, 108 Ophthalmic corticosteroids also may be indicated in the treatment of chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns or penetration of foreign bodies.107, 108
Although the manufacturers state that use of fixed-combination ophthalmic preparations containing anti-infectives and a corticosteroid may be indicated in ocular inflammatory conditions when the risk of superficial ocular infection is high or when there is an expectation that potentially dangerous numbers of bacteria will be present in the eye,107, 108 experts state that such preparations should be avoided in patients with bacterial conjunctivitis because of the risk of potentiating the infection.136
Clinicians should consider that use of fixed-combination ophthalmic preparations containing anti-infectives and a corticosteroid may mask the clinical signs of bacterial, fungal, or viral infections; prevent recognition of ineffectiveness of the anti-infectives; and/or increase intraocular pressure.107, 108 (See Precautions Related to Use of Fixed Combinations Containing Corticosteroids under Cautions: Precautions and Contraindications.)
Bacitracin is applied topically into the conjunctival sac of the eye as an ophthalmic ointment.101
Bacitracin zinc in fixed combination with polymyxin B sulfate with or without neomycin sulfate is applied topically to the eye as ophthalmic ointments.102, 103, 105, 106
Bacitracin zinc also is commercially available in fixed combination with neomycin sulfate, polymyxin B sulfate, and a corticosteroid (i.e., hydrocortisone or hydrocortisone acetate) for topical application to the eye as ophthalmic ointments.107, 108
Bacitracin ophthalmic ointment and fixed-combination ophthalmic ointments containing bacitracin zinc and other anti-infectives with or without a corticosteroid are for topical ophthalmic use only ;101, 102, 103, 105, 106, 107, 108 these preparations are not for subconjunctival injection and should not be introduced directly into the anterior chamber of the eye.103, 105, 106, 107, 108
Care should be taken to avoid contaminating the container tip with material from the eye, eyelids, fingers, or other source.101, 103, 105, 106, 107, 108
Dosage of bacitracin101 or bacitracin zinc102, 103, 105, 106, 107, 108 is expressed in terms of the base.101, 102, 103, 105, 106, 107, 108
Bacterial Ophthalmic Infections
For the topical treatment of superficial bacterial infections of the eye, bacitracin ophthalmic ointment should be applied directly into the conjunctival sac of the affected eye(s) 1-3 times daily.101 In patients with blepharitis, all scales and crusts should be carefully removed and the ointment then spread uniformly over the lid margins.101
When a fixed-combination ophthalmic ointment containing bacitracin zinc and polymyxin B sulfate with or without neomycin sulfate is used for the topical treatment of superficial bacterial infections of the eye in adults, the ophthalmic ointment should be applied to the affected eye(s) every 3 or 4 hours for 7-10 days, depending on the severity of the infection.102, 103, 105, 106
The usual duration of topical anti-infective treatment for bacterial conjunctivitis is 5-10 days;135, 136, 141 some experts state that 5-7 days of such treatment usually is adequate for mild bacterial conjunctivitis.135
When a fixed-combination ophthalmic ointment containing bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and a corticosteroid (i.e., hydrocortisone or hydrocortisone acetate) is used in adults, the ointment should be applied to the affected eye(s) every 3 or 4 hours, depending on the severity of the condition.107, 108
If there is no improvement after 48 hours of treatment with a fixed-combination preparation containing anti-infectives and a corticosteroid, the patient should be reevaluated.107, 108 (See Precautions Related to Use of Fixed Combinations Containing Corticosteroids under Cautions: Precautions and Contraindications.)
Bacitracin has a low order of toxicity when applied topically;101, 144 however, local irritation and allergic reactions may occur when topical ophthalmic preparations containing bacitracin or bacitracin zinc are used.103, 105, 106, 107, 108 More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.103, 105, 106, 107, 108
Topical anti-infectives, particularly neomycin sulfate, may cause cutaneous sensitization.103, 105, 106, 107, 108 A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical anti-infectives is not known.105, 106, 107, 108
Local irritation and allergic reactions reported in patients receiving topical ophthalmic preparations containing bacitracin zinc and other anti-infectives include pruritus, edema of the conjunctiva and eyelid, and conjunctival erythema.103, 105, 106, 107, 108 In some patients, sensitization reactions may manifest as failure to heal.103, 105, 106, 107, 108
There have been reports of bacterial keratitis developing in patients using topical ophthalmic preparations.103, 105, 106, 107, 108 These infections occurred because the patients inadvertently contaminated the multiple-dose container of the ophthalmic preparation; in most reported cases, the patient had concurrent corneal disease or disruption of the ocular epithelial surface.103, 105, 106, 107, 108
Precautions and Contraindications
Bacitracin ophthalmic ointment is contraindicated in patients hypersensitive to the drug.101
Fixed-combination ophthalmic ointments containing bacitracin zinc and polymyxin B sulfate with or with neomycin sulfate are contraindicated in patients hypersensitive to any ingredient in the formulation.102, 103, 105, 106
Fixed-combination ophthalmic ointments containing bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and a corticosteroid (i.e., hydrocortisone or hydrocortisone acetate) are contraindicated in patients with known or suspected hypersensitivity to any ingredient in the formulation.107, 108 In addition, these fixed-combination preparations are contraindicated in patients with viral diseases of the cornea and conjunctiva (e.g., epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella) and in patients with mycobacterial infections of the eye or fungal diseases of ocular structures.107, 108
Prolonged use of ophthalmic preparations containing bacitracin or bacitracin zinc with other anti-infectives may result in overgrowth of nonsusceptible organisms, including fungi.101, 102, 103, 105, 106 Appropriate therapy should be initiated if superinfection occurs.101, 102, 103, 105, 106 Resistance to bacitracin or other anti-infectives in fixed-combination preparations may develop.103, 105, 106
Patients should be informed that ophthalmic preparations, if handled improperly, can become contaminated by common bacteria known to cause ocular infections and that serious damage to the eye and subsequent loss of vision may occur if contaminated ophthalmic preparations are used.103, 105, 106, 107 Patients should be advised to avoid allowing the tip of the container to contact the eye, eyelid, fingers, or any other surface101, 103, 105, 106, 107, 108 and to not share ophthalmic preparations with others.103, 105, 106, 107, 108
The manufacturers caution that ophthalmic ointments may delay corneal healing.102, 103, 105, 106, 107, 108
Precautions Related to Sensitivity Reactions
During long-term use of topical ophthalmic anti-infectives, patients should be examined periodically for signs of sensitization (e.g., rash, pruritus, edema of the conjunctiva and eyelid, conjunctival erythema);103, 105, 106, 107, 108 sensitization may manifest as failure to heal in some patients.103, 105, 106, 107, 108
Patients should be advised to discontinue ophthalmic preparations if any signs of sensitivity or allergic reactions occur.101, 103, 105, 106, 107 Symptoms usually subside quickly after the preparation is discontinued.103, 105, 106, 107, 108
Patients allergic to one of the fixed-combination ophthalmic preparations should avoid preparations containing any of the component drugs.103, 105, 106, 107, 108 In addition, patients allergic to fixed combinations containing neomycin may also be allergic to other aminoglycosides (e.g., gentamicin, paromomycin, streptomycin).103, 105, 106, 107, 108
Precautions Related to Use of Fixed Combinations Containing Corticosteroids
When ophthalmic preparations containing bacitracin zinc in fixed combination with other anti-infectives and a corticosteroid (i.e., hydrocortisone or hydrocortisone acetate) are used, the usual cautions, precautions, and contraindications associated with the corticosteroid also must be considered.107, 108
Initial prescriptions for fixed-combination ophthalmic preparations containing a corticosteroid or renewal prescriptions (beyond 8 g of ophthalmic ointment) should be made only after examining the patient with slit lamp microscopy and, when appropriate, fluorescein staining.107, 108
Patients should be advised to discontinue the fixed-combination ophthalmic preparation and contact a clinician if inflammation or pain persists for more than 48 hours or becomes aggravated.108
Prolonged use of fixed-combination ophthalmic preparations containing a corticosteroid may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.107, 108 If an ophthalmic preparation containing a corticosteroid is used for 10 days or longer, intraocular pressure should be routinely monitored, even though this may be difficult in children and uncooperative patients.107, 108 Such preparations should be used with caution in patients with glaucoma and intraocular pressure should be checked frequently in such patients.107, 108
Use of fixed-combination ophthalmic preparations containing a corticosteroid after cataract surgery may delay healing and increase the incidence of bleb formation.107, 108
Various ocular diseases and long-term use of topical ophthalmic corticosteroids have caused corneal and scleral thinning.108 Use of topical ophthalmic corticosteroids in patients with thin corneal and scleral tissue may result in perforation.107, 108
Prolonged use of fixed-combination ophthalmic preparations containing a corticosteroid may suppress host responses and increase the risk of secondary ocular infections.107, 108 Use of such preparations in patients with acute purulent conditions of the eye may mask infection or enhance existing infection.107, 108
Use of ophthalmic preparations containing a corticosteroid may prolong the course and exacerbate severity of many viral infections of the eye (including herpes simplex).107, 108 Such preparations should be used with great caution in patients with herpes simplex107, 108 and frequent slit lamp microscopy is recommended.108
The possibility of fungal infections of the cornea should be considered after prolonged use of ophthalmic preparations containing a corticosteroid.107, 108 Fungal cultures should be taken when appropriate.107, 108
Safety and efficacy of fixed-combination ophthalmic preparations containing bacitracin zinc and other anti-infectives (i.e., neomycin sulfate, polymyxin B sulfate) with or without a corticosteroid have not been established in pediatric patients.103, 105, 106, 107, 108
No overall differences in safety or efficacy of the fixed-combination ophthalmic preparations containing bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and hydrocortisone acetate have been observed between geriatric and younger adults.108
Animal reproduction studies have not been performed with bacitracin.103, 105, 106 It is not known whether ophthalmic preparations containing bacitracin or bacitracin zinc can cause fetal harm when administered to pregnant women.103, 105, 106
Fixed-combination ophthalmic preparations containing bacitracin zinc and polymyxin B sulfate with or without neomycin sulfate should be used during pregnancy only if clearly needed.103, 105, 106
Fixed-combination ophthalmic preparations containing bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and a corticosteroid (i.e., hydrocortisone, hydrocortisone acetate) should be used during pregnancy only if potential benefits justify potential risks to the fetus.107, 108
It is not know whether bacitracin is distributed into milk.103, 105, 106
Bacitracin and fixed-combination ophthalmic preparations containing bacitracin zinc and polymyxin B sulfate with or without neomycin sulfate should be used with caution in nursing women.103, 105, 106
The manufacturers of fixed-combination ophthalmic preparations containing bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and a corticosteroid (i.e., hydrocortisone, hydrocortisone acetate) state that a decision should be made whether to discontinue nursing or the ophthalmic preparation, taking into account the importance of the drug to the woman.107, 108
Some experts consider topical bacitracin compatible with nursing.140
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.144
The activity of bacitracin is not impaired by blood, pus, necrotic tissue, or large inocula.
Bacitracin is active in vitro against some gram-positive bacteria, including staphylococci (e.g., Staphylococcus aureus ) and Streptococci pyogenes (group A β-hemolytic streptococci).14, 144 In vitro, susceptible S. aureus generally are inhibited by bacitracin concentrations of 0.05-5 mcg/mL. The drug is active in vitro against some gram-negative bacteria, including Haemophilus influenzae and Neisseria .14, 144 Bacitracin is inactive against fungi.101
Bacitracin in fixed combination with polymyxin B sulfate with or without neomycin sulfate is considered active against S. aureus , streptococci (including S. pneumoniae ), Escherichia coli , H. influenzae , Enterobacter , Klebsiella , Neisseria , and Pseudomonas aeruginosa , but does not provide adequate coverage against Serratia marcescens .103, 105, 106, 107, 108
Staphylococcus aureus resistant to bacitracin have been reported.14, 144
Bacteria resistant to bacitracin may emerge in patients receiving topical ophthalmic preparations containing the drug.103, 105, 106
Bacitracin is not appreciably absorbed from intact or denuded skin, wounds, or mucous membranes.14
Bacitracin is a polypeptide antibiotic produced by Bacillus subtilis or B. licheniformis .7, 14, 102, 103, 105, 106, 107, 108 Bacitracin commercially available in the US is derived from cultures of B. subtilis (Tracey).102, 103, 105, 106, 107, 108 The antibiotic is a mixture of polypeptides (bacitracin A, B1, B2, and B3);7, 14 the major component is bacitracin A.102, 103, 105, 106, 107, 108
Bacitracin occurs as a white to pale buff, hygroscopic powder that is odorless or has a slight odor.14 The drug is freely soluble in water and soluble in alcohol.14 Bacitracin zinc occurs as a white to pale tan, hygroscopic powder which is odorless or has a slight odor.14 The zinc salt is sparingly soluble in water.14
Bacitracin is commercially available for topical ophthalmic use as an ophthalmic ointment containing 500 units of bacitracin per g in a white petrolatum and mineral oil base.101
Bacitracin zinc is commercially available for topical ophthalmic use as fixed-combination ophthalmic ointments containing polymyxin B sulfate with or without neomycin sulfate in a white petrolatum or white petrolatum and mineral oil base.102, 103, 105, 106 Bacitracin zinc also is commercially available for ophthalmic use as fixed-combination ophthalmic ointments containing neomycin sulfate, polymyxin B sulfate, and a corticosteroid (i.e., hydrocortisone or hydrocortisone acetate) in a white petrolatum and mineral oil base.107, 108
Bacitracin ophthalmic ointment should be stored at 20-25°C.101
Fixed-combination ophthalmic ointments containing bacitracin zinc and polymyxin B sulfate with or without neomycin sulfate should be stored at 15-25°C.102, 103, 105, 106
Fixed-combination ophthalmic ointments containing bacitracin zinc, neomycin sulfate, polymyxin B sulfate, and a corticosteroid (i.e., hydrocortisone or hydrocortisone acetate) should be stored at 15-25°C.107, 108
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 |
|---|---|---|---|---|
Ophthalmic | Ointment | 500 units per g* | Bacitracin Ophthalmic Ointment |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | 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 Ophthalmic Ointment |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Ointment | Neomycin Sulfate 3.5 mg (of neomycin) per g, Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, and Bacitracin Zinc 400 units (of bacitracin) per g* | Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment | |
Neosporin® Ophthalmic Ointment |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Ointment | Neomycin Sulfate 3.5 mg (of neomycin) per g, Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, and Bacitracin Zinc 400 units (of bacitracin) per g, and Hydrocortisone 1%* | Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Ointment | Neomycin Sulfate 3.5 mg (of neomycin) per g, Polymyxin B Sulfate 10,000 units (of polymyxin B) per g, Bacitracin Zinc 400 units (of bacitracin) per g, and Hydrocortisone Acetate 1%* | Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Acetate Ophthalmic Ointment |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
AHFS® Drug Information. © Copyright, 1959-2025, Selected Revisions October 10, 2024. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
Only references cited for selected revisions after 1984 are available electronically.
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101. Perrigo. Bacitracin ophthalmic ointment USP prescribing information. Minneapolis, MN; 2013 Aug.
102. Bausch & Lomb. Bacitracin zinc and polymyxin B sulfate ophthalmic ointment USP prescribing information. Tampa, FL; 2013 Mar.
103. E. Fougera & Co. Bacitracin zinc and polymyxin B sulfate ophthalmic ointment USP prescribing information. Melville, NY; 2007 Oct.
105. MWI. Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment USP prescribing information. Boise, ID; 2016 Oct.
106. Burroughs Wellcome. Neosporin® (neomycin and polymyxin B sulfates and bacitracin zinc) ophthalmic ointment USP prescribing information. Research Triangle Park, NC; undated.
107. Bausch & Lomb. Neomycin and polymyxin B sulfates, bacitracin zinc and hydrocortisone ophthalmic ointment USP prescribing information. Bridgewater, NJ; 2016 Nov.
108. E. Fougera & Co. Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone acetate ophthalmic ointment prescribing information. Melville, NY. 2004 Aug.
135. American Academy of Ophthalmology. Preferred practice pattern (PPP) guidelines: conjunctivitis PPP - 2013. From American Academy of Ophthalmology website. Accessed 20 Dec 2017. [Web]
136. Azari AA, Barney NP. Conjunctivitis: a systematic review of diagnosis and treatment. JAMA . 2013; 310:1721-9. [PubMed 24150468]
137. Sheikh A, Hurwitz B, van Schayck CP et al. Antibiotics versus placebo for acute bacterial conjunctivitis. Cochrane Database Syst Rev . 2012; :CD001211. [PubMed 22972049]
138. American Academy of Ophthalmology. Preferred Practice Pattern (PPP) guidelines: bacterial keratitis - 2013. From the American Academy of Ophthalmology website. Accessed 5 Dec 2016. [Web]
140. Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and lactation, 7th ed. Lippincott Williams & Wilkins: Philadelphia, PA; 2005:144-5.
141. Barnes SD, Kumar NM, Pavin-Langston D et al. Microbial Conjunctivitis. 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; 2015:1392-1401.
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.