Levofloxacin
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Levofloxacin: From Bacterial Infections to Punctate Epithelial Keratoconjunctivitis
One-Sentence Summary
Levofloxacin is a broad-spectrum fluoroquinolone antibiotic, originally used for bacterial infections such as pneumonia, sinusitis, pyelonephritis and conjunctivitis. The TxGNN model predicts it may be effective for punctate epithelial keratoconjunctivitis, but there are 0 clinical trials and only 1 publication, and that publication does not support efficacy.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Bacterial infections (pneumonia, sinusitis, pyelonephritis, conjunctivitis, anthrax and others) |
| Predicted New Indication | Punctate epithelial keratoconjunctivitis |
| TxGNN Prediction Score | 99.92% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 12 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Levofloxacin belongs to the fluoroquinolone class, which generally acts by inhibiting bacterial DNA gyrase and topoisomerase IV. It has an established role in bacterial infections, including bacterial conjunctivitis. That gives a plausible link to infections of the ocular surface.
The prediction is weaker than the score suggests. Punctate epithelial keratoconjunctivitis is not only a bacterial disease. It is often associated with viral or other non-bacterial causes, and an antibacterial would help only if a susceptible bacterial pathogen were involved. The single retrieved paper describes microsporidial keratoconjunctivitis. Microsporidia are not targeted by fluoroquinolones, so this paper gives no support for efficacy. The high TxGNN score is therefore not backed by clinical evidence.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 30055152 | 2018 | Outbreak report | American Journal of Ophthalmology | Outbreak of microsporidial keratoconjunctivitis linked to contaminated swimming pool water in Taiwan. It does not evaluate levofloxacin efficacy. |
Singapore Market Information
There are 12 valid single-ingredient registrations. The five below are representative. Approved indication text is not recorded for these registrations in the data compiled for this report.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| SIN15341P | AVATAC Film Coated Tablet 500 mg | Film-coated tablet | Meditop Pharmaceutical Ltd |
| SIN13953P | LOCIKLINE Tablets 500 mg | Film-coated tablet | Dr. Reddy's Laboratories Limited |
| SIN11632P | CRAVIT Tablet 500 mg | Film-coated tablet | PT Kalbe Farma Tbk |
| SIN16966P | LEVORES Solution for Infusion 5 mg/ml | Infusion solution | PT Novell Pharmaceutical Laboratories |
| SIN11883P | CRAVIT I.V. for Infusion 5 mg/ml | Injection | OLIC (Thailand) Limited |
Available routes are oral (film-coated tablets) and injectable (infusion solution and injection). No ophthalmic formulation appears among the registrations.
Safety Considerations
- Disease associations flagged in the knowledge graph (not package insert text): Levofloxacin is linked to caution or contraindication in these conditions:
- Cardiac: long QT syndrome (including familial), torsades de pointes, myocardial ischemia, coronary artery disease.
- Neurological and muscular: epilepsy, peripheral neuropathy and other peripheral nervous system disease, myasthenia gravis and neuromuscular junction disease, rhabdomyolysis.
- Tendon and joint: tendinitis, periarthritis.
- Liver and kidney: liver disease, drug-induced liver injury, impaired renal function, gallbladder disease.
- Blood: thrombocytopenia, leukopenia, anemia, pancytopenia.
- Metabolic: diabetes mellitus, diabetic ketoacidosis, potassium deficiency.
- Gastrointestinal: Clostridium difficile colitis.
- Drug Interactions: 100 interaction records were found. Major-level interactions include tramadol and hydrocortisone. Moderate-level interactions include abiraterone, acarbose, famotidine, formoterol, ketorolac, ibuprofen, metformin, pioglitazone and several others.
Please refer to the package insert for full warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on a model score alone (L5). No clinical trials exist, and the only publication concerns a non-bacterial (microsporidial) outbreak that fluoroquinolones do not target. The drug is widely marketed in Singapore, but no registered formulation is ophthalmic.
To proceed, the following is needed:
- Clinical or microbiological evidence that levofloxacin helps in punctate epithelial keratoconjunctivitis, including evidence on the causative pathogens.
- Detailed mechanism of action data (MOA).
- Package insert warnings and contraindications from the HSA, to complete safety screening.
- An assessment of route and formulation, since an ophthalmic preparation would be needed for ocular use.
Note on other candidates: Among the other predictions, septicemic plague has the strongest support (L3). It rests on animal-model evidence, including cure of experimental pneumonic plague in African green monkeys, and no human RCTs exist. It may be a better lead to evaluate, with guardrails such as confirming local susceptibility, monitoring for resistance and using expert infectious disease guidance.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.