Ofloxacin
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Ofloxacin: From Bacterial Infections to Hyperamylasemia
One-Sentence Summary
Ofloxacin is a fluoroquinolone antibiotic, originally used for bacterial infections such as urinary tract infection, bronchitis, bacterial pneumonia, typhoid fever and dysentery. The TxGNN model predicts it may be effective for hyperamylasemia, but there are no clinical trials and no publications supporting this prediction, so it rests on model output alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Bacterial infections (e.g. typhoid fever, urinary tract infection, bronchitis, bacterial pneumonia). No approved indication text is available from the Singapore licences. |
| Predicted New Indication | Hyperamylasemia |
| TxGNN Prediction Score | 99.91% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 6 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Based on general knowledge, ofloxacin is a fluoroquinolone that inhibits bacterial DNA gyrase and topoisomerase IV, and its efficacy in bacterial infections is well established.
That mechanism does not clearly connect to hyperamylasemia. Hyperamylasemia is a laboratory finding, often linked to pancreatic or salivary gland disorders, and it has no clear antibacterial target. The high TxGNN score is a graph-based prediction only. No trials or literature support it, so the prediction should be treated as a hypothesis with no demonstrated mechanistic basis.
Other predictions worth noting: Among the other top-ranked predictions, septicemic plague is the only biologically plausible one. Ofloxacin is active in vitro against Yersinia pestis (PMIDs 8540736, 8913481), and mouse and other animal studies report efficacy in prophylaxis and treatment (e.g. PMIDs 9517950, 8203841, 16127904). The evidence there is limited to in vitro and animal data (L4), with no human trials. This is an extension within infectious disease rather than a distant repurposing. If the team wants a lead worth pursuing, this is a better candidate than hyperamylasemia.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Singapore Market Information
Six valid single-ingredient licences, all oral film-coated tablets. Approved indication text was not available for any of them.
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| SIN11433P | OFLOX TABLET 200 mg | Tablet, film coated | Brown & Burk Pharmaceutical Ltd |
| SIN08409P | FUGACIN TABLET 200 mg | Tablet, film coated | Shin Poong Pharmaceutical Co Ltd |
| SIN11377P | AKILEN TABLET 200 mg | Tablet, film coated | PT Sanbe Farma |
| SIN10118P | OFCIN FILM COATED TABLET 400 mg | Tablet, film coated | Y.S.P. Industries (M) Sdn Bhd |
| SIN10119P | OFCIN FILM COATED TABLET 200 mg | Tablet, film coated | Yung Shin Pharmaceutical Ind Co Ltd / YSP Industries (M) Sdn Bhd |
A sixth licence, SIN13219P (FLOVID 200, HOVID Bhd., film-coated tablet), is also valid.
Safety Considerations
Package insert warnings and contraindications were not available in the data compiled for this report. Please refer to the package insert for safety information.
The following items come from a knowledge graph, not from label text:
- Disease-level contraindication signals: QT-related conditions (long QT syndrome, torsades de pointes), liver failure and liver disease, kidney disease and impaired renal function, epilepsy, myasthenia gravis and other neuromuscular junction disease, tendon disorders (tendinitis, periarthritis), peripheral neuropathy, diabetes and diabetic ketoacidosis, rhabdomyolysis, Clostridium difficile colitis, and blood disorders (thrombocytopenia, anaemia, leukopenia).
- Drug interactions: 100 interactions were found. Examples rated Major are the corticosteroids hydrocortisone, triamcinolone, dexamethasone and betamethasone, plus bupropion and chlorpropamide. Examples rated Moderate include antidiabetic drugs (metformin, pioglitazone, acarbose, alogliptin, canagliflozin, albiglutide), famotidine, loperamide, aspirin, and calcium and potassium salts.
The interaction list shown here is partial. The diabetes-related contraindications and the antidiabetic interactions together suggest a need for glucose monitoring. For hyperamylasemia, which is often a pancreatic issue, these safety signals add concern rather than support.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction for hyperamylasemia has no trials, no literature, and no plausible mechanistic link. The score is purely model-based (L5). Other fluoroquinolone safety signals (QT prolongation, tendon, neuropathy, liver and kidney concerns) would further complicate any new use.
To proceed, the following is needed:
- A mechanistic rationale for ofloxacin in hyperamylasemia, plus detailed mechanism of action data
- Any clinical or preclinical evidence for this indication
- Package insert warnings and contraindications from the HSA, since the safety screening cannot proceed without them
- Approved indication text for the Singapore licences
- If an infectious disease direction is of interest, a separate evaluation of septicemic plague (currently L4, animal and in vitro data only)
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.