Amiloride

Evidence Level: L5

Predicted Indications: 5

Amiloride

Pharmacist Assessment Report

Amiloride: Potassium-sparing diuretic → malignant hypertensive renal disease

One-Sentence Summary

Amiloride is an oral potassium-sparing diuretic that is currently marketed in India. The TxGNN model predicts it may be useful for malignant hypertensive renal disease. The prediction is supported by 0 clinical trials and 0 publications, so it rests on the model score alone.

Quick Overview

Item	Content
Original Indication	Not recorded in the local data
Predicted New Indication	malignant hypertensive renal disease
TxGNN Prediction Score	0.9982
Evidence Level	L5
India Market Status	Listed in a compiled Indian medicine price dataset (4 of 4) – CDSCO approval status is not included in this data
Number of Listed Products	4 (valid: 4)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Detailed mechanism-of-action data is not available in the data compiled for this report. Amiloride belongs to the potassium-sparing diuretic class, which reduces sodium reabsorption in the kidney while retaining potassium.

The link to malignant hypertensive renal disease is plausible only by extension, through amiloride’s sodium-handling and blood-pressure-lowering effects. No trial or publication was found that tests amiloride in this kidney condition. The high score therefore reflects a computational prediction, not independent clinical or experimental evidence.

Safety is a particular concern in this setting. Amiloride can cause hyperkalaemia, and the risk rises when kidney function is impaired. Patients with malignant hypertensive renal disease would be expected to have impaired kidney function.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Currently no related literature available.

India Market Information

Four valid licences are recorded. The approved indication text is not recorded in the local data.

Review correction (2026-11-06): Originally stated: “Four valid single-ingredient licences are recorded.” Removed: it described the products as single-ingredient or combination products in a way that did not match the Indian medicine data (the Indian Medicine Dataset as of 2026-11-06). Source: Indian Medicine Dataset.

Authorization Number	Product Name	Dosage Form	Manufacturer
11714	Amiur H Forte 5mg/50mg Tablet	Strip of 10 tablets	East West Pharma
26232	Biduret -L Tablet	Strip of 10 tablets	Oaknet Healthcare Pvt Ltd
3897	Amiur 5mg Tablet	Strip of 10 tablets	East West Pharma
4158	Amiur H 2.5mg/25mg Tablet	Strip of 10 tablets	East West Pharma

Safety Considerations

Hyperkalaemia risk: Amiloride retains potassium, so there is a safety concern in patients with impaired kidney function.
Drug Interactions: 136 interactions are recorded. Examples at Moderate level include:
- Corticosteroids: hydrocortisone, betamethasone, budesonide and dexamethasone.
- Glucose-lowering drugs: metformin, the SGLT2 inhibitors canagliflozin, dapagliflozin, empagliflozin and ertugliflozin, and exenatide.
- Laxatives: bisacodyl, castor oil, glycerin, lactitol and lactulose.
- Others: bupropion and dronabinol.
Minor-level examples are doxycycline, amoxicillin and cimetidine.

Package insert warnings and contraindications were not available in the data compiled for this report. Please refer to the package insert for them.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction has a high model score but no supporting clinical trials or publications (Evidence Level L5). Amiloride’s hyperkalaemia risk in kidney impairment adds a safety concern for this population.

To proceed, the following is needed:

Studies that directly examine amiloride in malignant hypertensive renal disease, whether preclinical, observational or clinical.
Detailed mechanism-of-action data.
Package insert warnings and contraindications from the India licences.
A potassium and kidney-function monitoring plan, and a review of the interaction burden in this population.

Review Log

Below is the review log for this page: statements checked against official Indian medicine data (the Indian Medicine Dataset used by this site). Corrections are limited to basic factual statements; model predictions, evidence levels, and conclusions were not rewritten.

Review date	Item	Action	Source
2026-11-06	Removed: “single-ingredient”	Corrected	Indian Medicine Dataset

Disclaimer

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