Dantrolene
| Evidence Level: L5 | Predicted Indications: 7 |
Table of Contents
- Dantrolene
- Pharmacist Assessment Report
- Dantrolene: Ryanodine receptor–targeting skeletal muscle relaxant → moderate multiminicore disease with hand involvement
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- Canada Market Information
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Dantrolene: Ryanodine receptor–targeting skeletal muscle relaxant → moderate multiminicore disease with hand involvement
One-Sentence Summary
Dantrolene is a skeletal muscle relaxant. The approved indication is not recorded in the local licence data. The TxGNN model predicts it may be useful for moderate multiminicore disease with hand involvement, but no clinical trials and no publications currently support this direction. This is a model prediction only.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | moderate multiminicore disease with hand involvement |
| TxGNN Prediction Score | 0.9990 |
| Evidence Level | L5 |
| Canada Market Status | Marketed (marketed DINs: 3 of 3) |
| Number of DINs | 3 (marketed: 3) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data for dantrolene is not available in the data compiled for this report. Dantrolene is generally understood to act on calcium release in skeletal muscle through the ryanodine receptor.
Multiminicore disease is commonly linked to variants in SELENON or RYR1. A RYR1-related subtype could plausibly share the calcium-handling mechanism that dantrolene targets. This is the only rationale for the prediction. The score is high, but no trial or publication tests the idea, so any benefit remains speculative. The mechanism would also be relevant only to RYR1-related cases, not to SELENON-related disease.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
Canada Market Information
Dantrolene is marketed in Canada, with 3 valid single-ingredient licences and none cancelled. The approved indication text is not recorded in the local data.
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 01997572 | DANTRIUM INTRAVENOUS | Not recorded | Not recorded |
| 02529998 | DANTROLENE SODIUM FOR INJECTION, USP | Not recorded | Not recorded |
| 01997602 | DANTRIUM CAPSULES | Not recorded | Not recorded |
Safety Considerations
- Drug Interactions: 72 interactions were found in the interaction database. The main ones are:
- Major: morphine and liposomal morphine.
- Moderate: dronabinol, metoclopramide, nabilone, naltrexone, opium, sibutramine, ethanol and promethazine.
Label 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 score is high, but there are no clinical trials and no publications for this disease. The evidence level is therefore L5, and the mechanistic link is a plausible inference only.
To proceed, the following is needed:
- Genetic subtyping, to identify whether any patients have RYR1-related disease.
- Preclinical or case-level evidence that dantrolene affects the myopathy itself.
- Detailed mechanism-of-action data.
- Label warnings and contraindications from the Health Canada package insert.
- A safety plan for the interactions listed above, particularly with opioids.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.