Dosulepin
| Evidence Level: N/A | Predicted Indications: 0 |
Table of Contents
- Dosulepin
Dosulepin: Known uses and market status in Australia
Summary
The TxGNN deep-learning model (score ≥ 0.99) produced candidates for Dosulepin, but every candidate that can be traced to a source is already a known use. There is therefore currently no new predicted indication for this drug. The two known uses below are recorded as knowledge graph relations, and no approval was found for them in the data used here.
Quick overview
| Item | Content |
|---|---|
| New predicted indications | None (all traceable model candidates are known uses) |
| Known uses among model candidates | 2 |
| Evidence level | Not applicable |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
Known uses among the model’s candidates
Approved (supported by a licence or label)
| Indication | Source |
|---|---|
| none | none |
Related to an approved indication (same disease category)
| Indication | Approved category |
|---|---|
| none | none |
Relations recorded in the knowledge graph (no approval found)
| Indication |
|---|
| anxiety disorder |
| endogenous depression |
Australia Market Information
| Licence | Product | Dosage form | Status |
|---|---|---|---|
| 1357K | Dosulepin Viatris | Capsule containing dosulepin hydrochlori | Valid |
Safety Considerations
- Cardiac effects: Two ECG studies in patients treated with dosulepin reported changes in QT dispersion, suggesting cardiotoxicity.
- Anticholinergic and sedative effects: Dosulepin binds muscarinic M1–M5 and histamine H1 receptors, which accounts for anticholinergic and sedative effects. This is a particular concern in infants and for ocular surface disease.
- Overdose and seizure risk: The compiled assessments flag overdose toxicity and lowered seizure threshold as concerns, especially in paediatric and rare neurodevelopmental populations.
- Pharmacological targets: SERT, NET, M1–M5 and H1 receptors (an 8-target pharmacology profile, not a list of drug–drug interactions with specific agents).
Please refer to the TGA-approved Product Information (PI) for full warnings, contraindications and drug interaction information.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.