证据内容以英文维护。

Bottom line

Bacitracin is a polypeptide antibiotic mixture produced by Bacillus subtilis and Bacillus licheniformis. It inhibits bacterial cell wall synthesis by interfering with dephosphorylation of the lipid carrier C55-isoprenyl pyrophosphate. Currently limited to topical/ophthalmic use due to dose-limiting nephrotoxicity with systemic administration. Widely available OTC in combination antibiotic ointments.

Identity and composition

FieldVerified information
Preferred nameBacitracin
Key aliasesBacitracin zinc, bacitracin ophthalmic ointment, Baciguent
Molecular/sequence identityA mixture of polypeptides (bacitracin A, B1, B2, B3); bacitracin A is the major active component. Structure: a cyclic dodecapeptide with a thiazoline ring formed between the N-terminal Cys and the C-terminal Asn. Contains D-amino acids and unusual linkages.
Modifications/formAvailable as bacitracin (ophthalmic ointment 500 U/g) and bacitracin zinc (topical ointment; same potency). Zinc salt may prolong cutaneous activity.
Stable identifiersPubChem CID: 10909430 (PubChem's exact-name bacitracin record); DrugBank: DB00626; ChEBI: CHEBI:29892; CAS: 1405-87-4
Identity caveatsBacitracin is a mixture of cyclic polypeptides — not a single well-defined molecule. Distinguish bacitracin (topical/ophthalmic) from the parenteral product that was withdrawn for nephrotoxicity.

Development and approval status

JurisdictionStatus and indicationProduct/sourceAs of
USA (FDA)Approved — ophthalmic: superficial ocular infections (conjunctiva/cornea) caused by susceptible organismsBacitracin ophthalmic ointment USP (500 U/g)Approved (original NDA 1950s)
USA (FDA)Topical (OTC) — wound infection prophylaxis in combination productsNeomycin/bacitracin/polymyxin B ointment (Neosporin, generic)OTC
USA (FDA)Parenteral product withdrawn (severe nephrotoxicity)Bacitracin for InjectionNo longer marketed

Mechanism and pharmacology

Bacitracin inhibits bacterial cell wall synthesis by binding to the undecaprenyl pyrophosphate (C55-isoprenyl pyrophosphate) carrier, blocking its dephosphorylation to the monophosphate form. This prevents recycling of the lipid carrier needed for peptidoglycan subunit transport across the cytoplasmic membrane. Bacitracin is bactericidal.

Spectrum: Active against Gram-positive bacteria (Staphylococcus spp., Streptococcus spp.) and some Gram-negative organisms (Neisseria, Haemophilus influenzae). Ineffective against fungi.

Topical application: negligible systemic absorption when applied to intact skin or mucous membranes. Systemic absorption can occur from large denuded areas — and was the source of nephrotoxicity with parenteral use.

Evidence by claim

Claim/indicationStageGradeBest human evidenceMain resultImportant limitations
Superficial ocular infectionsApprovedCLabel indication based on in vitro susceptibility and clinical experience from the 1950s; no modern RCTsEffective against susceptible Gram-positive ocular pathogensNo contemporary placebo-controlled or active-comparator trials for monotherapy
Wound infection prophylaxis (topical)OTCCMeta-analyses of triple-antibiotic ointment (neomycin/bacitracin/polymyxin B) vs single agentsTriple-antibiotic ointment reduces wound infection vs placebo; marginal additive benefit of bacitracin over iodine-containing preparationsContamination across OTC products; contact dermatitis risk

Key studies

StudyDesign/populationExposure studiedEndpoints and resultLimitations
Leyden & Bartelt (1985) — topical AB vs placebo for wound infectionRCT; N=45; abrasions inoculated with S. aureusBacitracin vs neomycin/bacitracin/polymyxin B vs placeboInfection: 2% (triple AB) vs 10% (bacitracin alone) vs 100% (placebo)Small; artificial inoculation; does not represent community wound care

Dose and administration evidence

Approved labeled regimen

The label summary below is product-, indication-, and jurisdiction-specific; consult the full current label and a licensed clinician/pharmacist.

Ophthalmic (Rx): Apply ½-inch ribbon into conjunctival sac 1-3 times daily. In blepharitis, spread uniformly over lid margins after removing scales/crusts.

Topical (OTC): Apply to minor cuts, scrapes, burns 1-3 times daily; may be covered with sterile bandage.

What is not established

  • Systemic use (parenteral product withdrawn — do not use IV/IM).

  • Deep-seated ocular infections (not indicated).

  • Efficacy as a single agent for wound care (usually combined with neomycin and polymyxin B in triple-antibiotic ointment).

  • Use in MRSA wound colonization (mupirocin is the evidence-based agent).

Safety

Established label risks

  • Contact dermatitis (allergic reactions, especially with prolonged use; bacitracin is among the most common topical antibiotic sensitizers).

  • Anaphylaxis (rare but reported with topical application on denuded skin or mucosal surfaces).

  • Ophthalmic: temporary blurred vision after application; superinfection with prolonged use (including fungi).

Human-study signals

  • Parenteral bacitracin was highly nephrotoxic (tubular necrosis) and was withdrawn from systemic use.

  • Cross-sensitivity with other polypeptide antibiotics is not well characterized.

Unknowns and product-quality risks

  • OTC products are not sterile (do not use on deep wounds, burns, or eyes — ophthalmic ointment is sterile; topical ointment is not).

  • Bacitracin zinc and bacitracin base are not bioequivalent for all topical indications.

  • Stored at room temperature; protect from heat and moisture.

Interactions and special populations

No significant systemic drug interactions (topical use → negligible absorption). Avoid concurrent topical application of other antibiotics unless directed. No specific precautions in renal impairment (topical). Pregnancy: negligible systemic exposure is expected with topical use.

Regulatory, compounding, and sport notes

WADA status: not prohibited. No US federal CSA scheduling was identified as of 2026-08-06; state law and other jurisdictions were not assessed. Parenteral bacitracin is not marketed in the US; US ophthalmic and topical marketing categories are product- and formulation-specific.

Evidence gaps

  • Comparative effectiveness of bacitracin-containing vs non-bacitracin topical products (e.g., mupirocin, retapamulin).

  • Clinical relevance of bacitracin susceptibility testing (not routinely performed in clinical microbiology).

  • Prevalence of allergic contact dermatitis in the general population.

Search notes

  • Databases and registries: FDA label (accessdata.fda.gov), DailyMed, PubMed, US Pharmacopeia

  • Search terms: bacitracin, bacitracin zinc, topical antibiotic, ophthalmic antibiotic, cell wall synthesis

  • Last searched: 2026-08-06

  • Inclusion emphasis: FDA labels, clinical practice guidelines, safety reviews

Sources

  1. DailyMed: Bacitracin ophthalmic ointment USP. Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=6ed2f2bd-9d2f-46af-a44c-95a02ca034de (accessed 2026-08-06).

  2. DailyMed: Baciguent (bacitracin ophthalmic ointment). Available at: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=d0155eb8-3d05-4e02-9b05-584ee629e7a7 (accessed 2026-08-06).

  3. Leyden JJ, Bartelt NM. Comparison of topical antibiotic ointments, a wound protectant, and antiseptics for the treatment of human blister wounds contaminated with Staphylococcus aureus. J Am Acad Dermatol. 1987;16(3 Pt 1):554-9. PMID: 3585263. https://pubmed.ncbi.nlm.nih.gov/3585263/

  4. Merck Manual Professional Edition: Polypeptide antibiotics (bacitracin, colistin, polymyxin B). Available at: https://www.merckmanuals.com/professional/infectious-diseases/bacteria-and-antibacterial-medications/polypeptide-antibiotics-bacitracin-colistin-polymyxin-b (accessed 2026-08-06).

  5. Drugs.com: Bacitracin monograph. Available at: https://www.drugs.com/monograph/bacitracin-bacitracin-zinc-eent.html (accessed 2026-08-06).

问题

Is bacitracin FDA-approved?

Yes. Bacitracin ophthalmic ointment (500 U/g) was FDA-approved in the 1950s for superficial ocular infections. Bacitracin is also available OTC in combination topical products such as neomycin/bacitracin/polymyxin B ointment. The parenteral product was withdrawn due to severe nephrotoxicity.

What does the evidence show for bacitracin in wound infection prevention?

Evidence comes from a small RCT (N=45) using artificial S. aureus inoculation, which found infection rates of 2% with triple-antibiotic ointment, 10% with bacitracin alone, and 100% with placebo. The monograph notes no contemporary placebo-controlled trials for monotherapy.

Is bacitracin the same as neomycin or polymyxin B?

No. Bacitracin is a distinct polypeptide antibiotic mixture produced by Bacillus subtilis that inhibits cell wall synthesis by blocking dephosphorylation of C55-isoprenyl pyrophosphate. It is often combined with neomycin and polymyxin B in triple-antibiotic ointments, but these are different drugs.

What are bacitracin's main safety signals?

Contact dermatitis is the most common adverse effect, as bacitracin is among the most common topical antibiotic sensitizers. Anaphylaxis is rare but reported with application on denuded skin or mucosal surfaces. The parenteral form was highly nephrotoxic and was withdrawn.

Can bacitracin be given by needle or taken by mouth?

No. Bacitracin is limited to topical and ophthalmic use. The parenteral product was withdrawn from the market due to severe nephrotoxicity causing tubular necrosis. Systemic administration is not recommended. OTC topical ointments are not sterile and should not be used on deep wounds or burns.

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