Azithromycin
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Azithromycin
- Pharmacist Assessment Report
- Azithromycin: macrolide antibiotic (50S ribosomal inhibitor) → hyperamylasemia
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- Australia Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Azithromycin: macrolide antibiotic (50S ribosomal inhibitor) → hyperamylasemia
One-Sentence Summary
Azithromycin is a macrolide antibiotic that is marketed in Australia as an oral tablet. The TxGNN model predicts it may be associated with hyperamylasemia, but no clinical trials and no publications were found for this prediction, so the prediction rests on the model alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | hyperamylasemia |
| TxGNN Prediction Score | 0.9981 |
| Evidence Level | L5 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Azithromycin is a macrolide antibiotic, a class that generally acts by inhibiting the bacterial 50S ribosomal subunit.
Hyperamylasemia is a laboratory finding with many possible causes (pancreatic, salivary and renal), not a disease with a defined drug target. No identifiable mechanistic link between a macrolide antibiotic and this finding was found. The high TxGNN score should be treated as a model-generated signal only, with no supporting trials or literature.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 4115N | Zithromax | Tablet 500 mg (as dihydrate) | Not recorded in the local data |
Safety Considerations
- Drug Interactions: 100 interactions were recorded in total. Examples from the listed entries:
- Major: cisapride, dolasetron
- Moderate: famotidine, loperamide, clarithromycin, levofloxacin, granisetron, aluminium hydroxide, magnesium hydroxide, several laxatives
- Minor: amoxicillin, metronidazole
Further safety information should be taken from the TGA-approved Product Information (PI).
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has no supporting clinical trials or publications and no plausible mechanistic link. Hyperamylasemia is a laboratory finding rather than a treatable disease, so the evidence level is L5.
To proceed, the following is needed:
- A clear clinical definition of the target condition (the cause of the raised amylase) and a biologically plausible mechanism
- Mechanism of action data for azithromycin
- Studies that directly examine azithromycin in this condition
- Warnings and contraindications from the TGA-approved PI, with a review of the major interactions (cisapride, dolasetron)
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.