Duloxetine
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Duloxetine
- Pharmacist Assessment Report
- Duloxetine: serotonin-norepinephrine reuptake inhibitor (SNRI) → benign paroxysmal torticollis of infancy
- 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
Duloxetine: serotonin-norepinephrine reuptake inhibitor (SNRI) → benign paroxysmal torticollis of infancy
One-Sentence Summary
Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant that is currently marketed in India. The TxGNN model predicts it may be effective for benign paroxysmal torticollis of infancy, but no clinical trials and no publications currently support this prediction, so it rests on model output alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | benign paroxysmal torticollis of infancy |
| TxGNN Prediction Score | 0.9985 |
| 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?
Currently, detailed mechanism of action data is not available in the data compiled for this report. Duloxetine belongs to the SNRI class, which blocks reuptake of serotonin and norepinephrine.
Benign paroxysmal torticollis of infancy is a self-limiting paediatric disorder that is associated with CACNA1A channelopathy. No plausible link between serotonin-norepinephrine reuptake inhibition and this condition is evident. The high TxGNN score is a model-based prediction only, and it is not backed by any clinical or literature evidence. The prediction should therefore be treated as a hypothesis with no mechanistic support at present.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
India Market Information
At least 20 valid single-ingredient licences are recorded, and the list may be partial. Main examples:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 59906 | Dulox 30mg Tablet | Strip of 10 tablets | Not recorded |
| 64661 | Diligo 20 Tablet | Strip of 10 tablets | Not recorded |
| 59350 | Dt 20mg Tablet | Strip of 10 tablets | Not recorded |
| 58877 | Duvanta NP 20 Tablet | Strip of 10 tablets | Not recorded |
| 64218 | Dulotix 20mg Tablet | Strip of 10 tablets | Not recorded |
Safety Considerations
- Drug Interactions: 329 interactions were found in the interaction screening. Examples rated Major include bupropion, lorcaserin, diethylpropion, dolasetron and dexfenfluramine. Examples rated Moderate include epinephrine, morphine, acetylsalicylic acid and cimetidine.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has a very high model score, but there are no clinical trials or publications for this condition, and no plausible mechanism links duloxetine to it. The evidence level is L5.
To proceed, the following is needed:
- Mechanistic data showing how duloxetine could act on this condition
- Any preclinical or clinical studies in benign paroxysmal torticollis of infancy
- Package insert warnings and contraindications, plus a paediatric safety assessment, since the condition occurs in infants
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.