Clarithromycin

Evidence Level: L5

Predicted Indications: 5

Clarithromycin

Pharmacist Assessment Report

Clarithromycin: Macrolide antibiotic (bacterial protein synthesis inhibitor) → hyperamylasemia

One-Sentence Summary

Clarithromycin is a macrolide antibiotic marketed in India in many tablet and oral liquid products. The TxGNN model predicts it may be effective for hyperamylasemia, with a score of 0.9935. No clinical trials are registered and only 1 publication (a 2004 case report) was found, so the prediction rests almost entirely on the model.

Quick Overview

Item	Content
Original Indication	Not recorded in the local data
Predicted New Indication	hyperamylasemia
TxGNN Prediction Score	0.9935
Evidence Level	L5
India Market Status	Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data
Number of Listed Products	at least 20
Recommended Decision	Hold

Why is This Prediction Reasonable?

Detailed mechanism-of-action data are not available in the data compiled for this report. Clarithromycin belongs to the macrolide class of antibiotics, which are generally known to inhibit bacterial protein synthesis and to have some anti-inflammatory and immunomodulatory activity.

No direct mechanistic link to hyperamylasemia has been established. The only retrieved publication (PMID 15228140, 2004) is a case report of Mycobacterium abscessus lung infection that coincided with primary macroamylasemia. Clarithromycin was most likely used there as an antimycobacterial agent, and the raised amylase is probably incidental or related to the underlying condition, not a treatment effect. The high score is a computational prediction without clinical corroboration, so this prediction should be treated as a hypothesis only.

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	Lung infection with M. abscessus in a 76-year-old man, complicated by primary macroamylasemia; no evidence that clarithromycin treats hyperamylasemia

India Market Information

At least 20 valid single-ingredient registrations were found, and the list may be partial. Approved indication text is not recorded for these records. Main examples:

Authorization Number	Product Name	Dosage Form	Approved Indication
54444	Clarinic Kid 125mg Tablet	Strip of 10 tablets	Not recorded
48478	Claricin 250mg Tablet	Strip of 10 tablets	Not recorded
53414	Claripax 250mg Tablet	Strip of 10 tablets	Not recorded
45283	Clarigal 500mg Tablet	Strip of 4 tablets	Not recorded
117637	Klear Dry Syrup	Bottle of 30 ml dry syrup	Not recorded

Safety Considerations

Drug Interactions: 822 interactions are recorded. Examples include:
- Major: abemaciclib, fentanyl, acalabrutinib
- Moderate: paclitaxel, tramadol, nifedipine, ethinylestradiol, hydrocortisone, afatinib
- Minor: dolutegravir, zidovudine, loratadine
Interactions with calcineurin inhibitors would be a particular concern in any transplant-related use.

Please refer to the package insert for warnings and contraindications.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction is supported only by the model score. No trials exist, and the single case report does not show a treatment effect. No cited study directly tests clarithromycin for hyperamylasemia, so the evidence level is L5.

To proceed, the following is needed:

Mechanism-of-action data and a plausible biological link to amylase regulation
Controlled or observational studies directly addressing hyperamylasemia
Package insert warnings and contraindications from the India label
A review of the interaction burden for the intended patient population
Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.