Clarithromycin
| Evidence Level: L5 | Predicted Indications: 5 |
Table of Contents
- Clarithromycin
- Pharmacist Assessment Report
- Clarithromycin: From Respiratory and Ear/Sinus Bacterial Infections to Hyperamylasemia
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- Canada Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Clarithromycin: From Respiratory and Ear/Sinus Bacterial Infections to Hyperamylasemia
One-Sentence Summary
Clarithromycin is a macrolide antibiotic originally used for bacterial infections such as otitis media, streptococcal and staphylococcal infections, pneumonia, and maxillary sinusitis. The TxGNN model predicts it may be effective for hyperamylasemia, but there are 0 clinical trials and only 1 publication (a case report), and that report does not show a therapeutic effect.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Bacterial infections, including infectious otitis media, streptococcal infection, bacterial pneumonia, staphylococcal infection, maxillary sinusitis, Mycoplasma pneumoniae pneumonia (Canadian license indication text not available) |
| Predicted New Indication | Hyperamylasemia |
| TxGNN Prediction Score | 0.9935 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs on record: at least 20) |
| Number of DINs | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on known information, clarithromycin is a macrolide antibiotic, its efficacy in bacterial respiratory, ear and sinus infections is established, but no mechanism is known that would make it applicable to hyperamylasemia.
The only retrieved publication describes a patient with Mycobacterium abscessus lung infection who also had primary macroamylasemia. Clarithromycin was most likely used to treat the infection, not the raised amylase. Macrolides have also occasionally been associated with pancreatic enzyme changes or pancreatitis, so a therapeutic role is not supported. The high score (0.9935) is a computational prediction only and should not be read as clinical support.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 15228140 | 2004 | Case report | Nihon Kokyuki Gakkai Zasshi (J Jpn Respir Soc) | A 76-year-old man with M. abscessus lung infection (after earlier pulmonary tuberculosis) who also had primary macroamylasemia. It describes co-occurrence of the two conditions, not treatment of hyperamylasemia. |
Canada Market Information
Twenty valid single-ingredient licenses are listed. Dosage form and approved-indication text are not available for these products. The main ones are:
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02146908 | BIAXIN | Not available | Not available |
| 02244641 | BIAXIN | Not available | Not available |
| 02126710 | BIAXIN BID | Not available | Not available |
| 02413345 | APO-CLARITHROMYCIN XL | Not available | Not available |
| 02361434 | TARO-CLARITHROMYCIN | Not available | Not available |
Safety Considerations
- Disease contraindications from the knowledge graph (not label text): long QT syndrome, torsades de pointes, ventricular tachycardia, liver failure, liver disease, cholestasis, kidney disease, porphyria, myasthenia gravis, Clostridium difficile colitis, osteoporosis, bone fracture, gallbladder disease, and infectious mononucleosis, among others.
- Drug Interactions: 100 interactions were found. Major-level ones among those listed include abemaciclib, fentanyl, and acalabrutinib. Moderate-level ones include paclitaxel, tramadol, nifedipine, famotidine, formoterol, adenosine, afatinib, ethinylestradiol, hydrocortisone, abiraterone, acarbose, flunisolide, trastuzumab emtansine, and abametapir (topical). Minor-level ones include dolutegravir, zidovudine, and loratadine.
Package insert warnings and contraindications were not available, so please refer to the Health Canada package insert for official safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction rests on a model score alone. There are no registered trials, and the single publication is a case report of co-occurring conditions with no evidence that clarithromycin treats hyperamylasemia. A possible link to pancreatic enzyme elevation is a safety concern rather than a benefit.
To proceed, the following is needed:
- Mechanism of action data and a plausible biological link to hyperamylasemia
- Health Canada package insert warnings and contraindications (a blocking gap for safety screening)
- Controlled or observational studies of clarithromycin’s effect on amylase levels
- Review of the other predicted indications. Punctate epithelial keratoconjunctivitis (score 0.9911, one 2024 observational study, Research Question) has a more plausible link through the anti-inflammatory effects of macrolides, but it still needs confirmation that clarithromycin itself was evaluated.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.