Amlodipine
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
Amlodipine: Calcium channel blocker → Brain stem infarction
One-Sentence Summary
Amlodipine is a calcium channel blocker that is currently marketed in Canada as a single-ingredient product. The TxGNN model predicts it may be useful for brain stem infarction, with a score of 0.9994. There are currently 0 clinical trials and 0 publications that directly study this disease, so the prediction rests on the model alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Brain stem infarction |
| TxGNN Prediction Score | 0.9994 |
| 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?
Detailed mechanism-of-action data is not currently available in the data compiled for this report. Amlodipine is generally known as a dihydropyridine calcium channel blocker. It relaxes vascular smooth muscle, lowers peripheral vascular resistance and reduces blood pressure.
Brain stem infarction is an ischemic stroke affecting the brain stem. Blood pressure control is a central part of stroke prevention, so a link through vasodilation and blood pressure lowering is plausible. However, this link is a reasoning step, not direct evidence. No trial or publication in the compiled data examines amlodipine in brain stem infarction. Whether it would help, for example by preventing a first or recurrent event or by protecting brain tissue, has not been tested for this specific condition.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Canada Market Information
Amlodipine is marketed in Canada. Health Canada records show 20 valid single-ingredient licences, with none cancelled. The list may be partial. The five main authorizations are shown below.
| DIN | Product Name | Status |
|---|---|---|
| 02490781 | AMLODIPINE | Valid |
| 02490803 | AMLODIPINE | Valid |
| 02468018 | M-AMLODIPINE | Valid |
| 02371707 | MAR-AMLODIPINE | Valid |
| 02522527 | PRZ-AMLODIPINE | Valid |
Safety Considerations
Warnings and contraindications from the package insert are not available in the compiled data. Please refer to the package insert for these.
- Drug Interactions: The interaction screen returned 100 entries. The first 20 returned are all rated Moderate. They include:
- corticosteroids (hydrocortisone, betamethasone, budesonide, dexamethasone)
- calcium salts (acetate, carbonate, chloride, citrate, gluconate, lactate and others)
- aprepitant
- acetylsalicylic acid
- bupropion
- clarithromycin
- clotrimazole
- SGLT2 inhibitors (canagliflozin, dapagliflozin)
The full interaction list should be reviewed before any new use is considered.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is very high (0.9994), but no clinical trial or publication directly studies amlodipine in brain stem infarction, so the evidence level is L5. A plausible blood-pressure-related mechanism is not enough to justify moving forward.
To proceed, the following is needed:
- A literature and trial search focused on brain stem infarction and posterior circulation stroke
- Mechanism-of-action data and a clear rationale for any benefit beyond blood pressure lowering
- Package insert warnings and contraindications, including hypotension risk in acute ischemic stroke
- Preclinical or observational evidence specific to this condition before any clinical study is designed
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.