Amlodipine
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
- Amlodipine
- Pharmacist Assessment Report
- Amlodipine: Dihydropyridine calcium channel blocker → brain stem infarction
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- India Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Amlodipine: Dihydropyridine calcium channel blocker → brain stem infarction
One-Sentence Summary
Amlodipine is a dihydropyridine calcium channel blocker used mainly for blood pressure control. The TxGNN model predicts it may be effective for brain stem infarction, but no clinical trials and no publications 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 |
| 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 is not available in the data compiled for this report. Based on known pharmacology, amlodipine is a dihydropyridine calcium channel blocker that relaxes vascular smooth muscle and lowers blood pressure.
Blood pressure control is a cornerstone of preventing stroke, so a link to a brain stem infarction is plausible. However, it is probably a secondary-prevention extension of blood pressure management in cerebrovascular disease rather than a genuinely new mechanism. No trials or publications were found for brain stem infarction itself, so this remains a model-based hypothesis.
Clinical Trial Evidence
Currently no related clinical trials registered for brain stem infarction.
Literature Evidence
Currently no related literature available for brain stem infarction.
India Market Information
The data compiled for this report list 20 valid single-ingredient licences, with no cancelled licences. The list may be partial. No approved indication text is recorded for these licences. Main authorizations:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 234726 | Vintol Plus 5mg/50mg Tablet | Strip of 10 tablets | Not recorded |
| 1017 | Amlopin 2.5 Tablet | Strip of 10 tablets | Not recorded |
| 193130 | Renace AM 5 mg/50 mg Tablet | Strip of 10 tablets | Not recorded |
| 73116 | Exforge 10 mg/160 mg Tablet | Strip of 14 tablets | Not recorded |
| 65587 | D P Lol 5mg Tablet | Strip of 10 tablets | Not recorded |
Safety Considerations
- Drug Interactions: 292 interactions are recorded. Examples at Moderate level include hydrocortisone, aprepitant, acetylsalicylic acid, betamethasone, budesonide, bupropion, clarithromycin, canagliflozin, dapagliflozin and dexamethasone, as well as several calcium salts.
Package insert warnings and contraindications were not available; please refer to the package insert for further safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is very high (0.9994), but there are no clinical trials or publications on brain stem infarction, so the evidence is at the model-prediction level (L5). The likely benefit overlaps with existing blood pressure control in cerebrovascular disease.
To proceed, the following is needed:
- Studies or trials that directly address brain stem infarction
- Mechanism of action data
- Package insert warnings and contraindications
- Assessment of whether any benefit goes beyond blood pressure lowering
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.