Imipenem
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
Imipenem: Diffuse scleroderma
One-Sentence Summary
Imipenem is a carbapenem antibacterial that inhibits bacterial cell wall synthesis and is marketed in Canada as an injectable product. The TxGNN model predicts it may be effective for diffuse scleroderma, with a score of 0.9999. No clinical trials and no publications currently support this direction, so the prediction rests on the model alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Diffuse scleroderma |
| TxGNN Prediction Score | 0.9999 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs: 2 of 2) |
| Number of DINs | 2 (marketed: 2) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data are not available in the data compiled for this report. Based on general pharmacology, imipenem is a carbapenem that kills bacteria by blocking cell wall synthesis.
Diffuse scleroderma is an autoimmune, fibrotic disease. It is not driven by a bacterial infection, and no mechanistic link between an antibacterial’s mode of action and the disease process is supported. The very high TxGNN score is a computational prediction only. Without trials or literature, it should not be read as evidence of benefit.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02351706 | TARO-IMIPENEM-CILASTATIN | Not recorded | Not recorded |
| 02358344 | IMIPENEM AND CILASTATIN FOR INJECTION USP | Not recorded | Not recorded |
Both licences are currently valid.
Safety Considerations
- Drug Interactions: 15 interactions were identified.
- Major: bupropion, iohexol, iopamidol.
- Moderate: polyethylene glycol (3350 with electrolytes), dicoumarol, warfarin, lindane, aminophylline, dyphylline, oxtriphylline, theophylline, cyclosporine, ethinylestradiol, mycophenolic acid, pemetrexed.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The score for diffuse scleroderma is high, but there are no clinical trials or publications, and no plausible mechanism links a bacterial cell wall inhibitor to an autoimmune fibrotic disease. The evidence level is L5.
To proceed, the following is needed:
- Preclinical or mechanistic data showing a biological rationale for imipenem in diffuse scleroderma
- Review of the Health Canada package insert for warnings and contraindications
- Any clinical or observational studies directly addressing diffuse scleroderma, which could justify re-evaluation
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.