Bacitracin

Evidence Level: L5

Predicted Indications: 10

Bacitracin

Pharmacist Assessment Report

Bacitracin: From Keratitis to Punctate Epithelial Keratoconjunctivitis

One-Sentence Summary

Bacitracin is a topical antibiotic originally used for ocular surface infections such as keratitis, keratoconjunctivitis and blepharoconjunctivitis. The TxGNN model predicts it may be effective for punctate epithelial keratoconjunctivitis, but no clinical trials and no publications currently support this specific prediction, so it rests on model prediction alone.

Quick Overview

Item	Content
Original Indication	Keratitis, keratoconjunctivitis, blepharoconjunctivitis
Predicted New Indication	Punctate epithelial keratoconjunctivitis
TxGNN Prediction Score	1.0000
Evidence Level	L5
India Market Status	Listed in a compiled Indian medicine price dataset (11 of 11) – CDSCO approval status is not included in this data
Number of Listed Products	11 (valid: 11)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available. Based on known information, bacitracin is a topical polypeptide antibiotic that acts on Gram-positive bacterial cell wall synthesis. It is used for ocular surface infections, and mechanistically it could be applicable to bacterial forms of surface eye disease.

The predicted indication is biologically close to the approved ocular uses, which likely explains the very high score. However, punctate epithelial keratoconjunctivitis is frequently viral (for example adenoviral) or non-infectious, and an antibacterial would not be expected to act on those causes. The score comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence.

Other predictions in the top 10 are weaker still. Exposure keratitis may benefit only from supportive protection against secondary infection. Otitis externa has a plausible antibacterial rationale, mainly through combination ear products. Most of the remaining predictions are non-specific categories or conditions with no plausible mechanistic link (for example Chagas cardiomyopathy, infection-related hemolytic uremic syndrome).

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Currently no related literature available for the top predicted indication.

For reference, the fourth-ranked prediction, otitis externa, has limited literature, mostly on combination products:

PMID	Year	Type	Journal	Key Findings
17503066	2007	Double-blind clinical study (151 patients)	Eur Arch Otorhinolaryngol	Polymyxin B + bacitracin ointment compared with the same ointment plus hydrocortisone in acute bacterial otitis externa
9820118	1998	In vitro susceptibility study (veterinary)	Zentralbl Veterinarmed B	Increased antibiotic resistance in bacteria from chronic canine otitis externa
14055264	1963	Review / practice article	Maryland State Med J	Practical treatment of otitis externa
14048629	1963	Clinical report (combination product)	Z Laryngol Rhinol Otol	Local treatment of inflammatory, secretory ear conditions with a combination product

India Market Information

Authorization Number	Product Name	Dosage Form	Approved Indication
150914	Neosporin Eye Drop	Eye drop, 10 ml	Not specified
150820	Neosporin Antibiotic Ointment	Ointment, 10 g tube	Not specified
150452	Neosporin Ointment	Ointment, 10 g tube	Not specified
150299	Neosporin Dusting Powder	Dusting powder, 10 g	Not specified
151066	Nebasulf Ointment	Ointment, 5 g tube	Not specified

All 11 registrations are valid licences. Only one is an ophthalmic product (Neosporin Eye Drop). The others are ointments or powders.

Review correction (2026-11-06): Originally stated: “All 11 registrations are valid single-ingredient licences.” Removed: it described the products as single-ingredient or combination products in a way that did not match the Indian medicine data (the Indian Medicine Dataset as of 2026-11-06). Source: Indian Medicine Dataset.

Safety Considerations

Contraindications (from knowledge-graph disease associations, not label text): Eye-related entries include herpes simplex virus keratitis, viral eye infection, fungal infection of the eye, conjunctivitis, eye infectious disease, open-angle glaucoma and ocular hypertension. Other listed conditions include kidney disease, liver disease, myasthenia gravis and neuromuscular junction disease, epilepsy, diabetes mellitus, adrenocortical insufficiency, and heart block. These associations likely partly reflect companion ingredients in combination products and should be verified against the label.
Drug Interactions (84 recorded; selected examples):
- Major: kanamycin, neomycin, streptomycin (additive nephrotoxicity and neurotoxicity risk with aminoglycosides), deferasirox, and iodinated contrast agents (diatrizoate, iodipamide, iodixanol, iohexol).
- Moderate: mesalazine, balsalazide, olsalazine, sulfasalazine, vancomycin, exenatide, picosulfuric acid.
Systemic bacitracin is nephrotoxic, so any use beyond topical application is a concern.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction is supported only by the model score, with no trials or literature. The most likely causes of punctate epithelial keratoconjunctivitis (viral or non-infectious) are not addressed by an antibacterial, so the high score, which comes from the TxGNN model (deep learning), may reflect similarities the model learned between related diseases, not biological evidence.

To proceed, the following is needed:

Package insert warnings and contraindications for the Indian products (currently a blocking gap for safety screening)
Mechanism of action data
Clarification of the cause of punctate epithelial keratoconjunctivitis, and whether a bacterial subset exists
Clinical or preclinical evidence specific to this condition
Confirmation of approved indications for the Indian licences, and whether an ophthalmic ointment is available
If the project continues, otitis externa (the only prediction with some clinical literature) could be explored as a separate research question, using evidence on bacitracin as a single agent

Review Log

Below is the review log for this page: statements checked against official Indian medicine data (the Indian Medicine Dataset used by this site). Corrections are limited to basic factual statements; model predictions, evidence levels, and conclusions were not rewritten.

Review date	Item	Action	Source
2026-11-06	Removed: “single-ingredient”	Corrected	Indian Medicine Dataset

Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.