Dicyclomine
| Evidence Level: L5 | Predicted Indications: 2 |
Table of Contents
Dicyclomine: Antimuscarinic antispasmodic → cauda equina syndrome
One-Sentence Summary
Dicyclomine is an antimuscarinic antispasmodic that relaxes smooth muscle. The TxGNN model predicts it may be useful for cauda equina syndrome, with a score of 0.9966. There are currently no clinical trials and no publications supporting this direction, so it rests on model prediction alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | cauda equina syndrome |
| TxGNN Prediction Score | 0.9966 |
| 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 its known drug class, dicyclomine is an antimuscarinic/antispasmodic agent that relaxes smooth muscle.
A plausible but unverified link is symptomatic relief of the neurogenic bladder and bowel dysfunction (detrusor overactivity, spasm) that can accompany cauda equina syndrome. It would not treat the underlying nerve root compression, which requires urgent surgical decompression.
The prediction is a model output only. No studies were found that examine dicyclomine in this disease. Anticholinergics can also worsen urinary retention, which is common in cauda equina syndrome with an areflexic bladder, so safety is a specific concern.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
India Market Information
Dicyclomine is marketed in India. All 20 licences in the data compiled for this report are valid, and none are cancelled. The list may be partial. The licence records carry no approved-indication text. Main authorizations:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 44825 | Cefospas Tablet | Strip of 10 tablets | Not recorded |
| 114514 | Jonyspas Plus 20mg/250mg Tablet | Strip of 10 tablets | Not recorded |
| 198905 | Renalpane 10mg/250mg Tablet | Strip of 10 tablets | Not recorded |
| 35066 | Colispas Paed Oral Drops | Packet of 10 ml oral drops | Not recorded |
| 221552 | Topspas Injection | Vial of 2 ml injection | Not recorded |
Safety Considerations
- Drug Interactions: 344 interactions are recorded. Examples of moderate-level interactions include botulinum toxin type A, fentanyl, chlorpheniramine, codeine, tramadol, amitriptyline, hyoscyamine, loperamide, and ethanol. Additive anticholinergic and sedative effects are the main concern.
- Disease-related cautions (from drug-disease contraindication records, not label text): glaucoma (angle-closure), benign prostatic hyperplasia, liver and kidney disease, hepatic encephalopathy, porphyria, coronary artery disease, hypertension, and blood disorders such as neutropenia, agranulocytosis, thrombocytopenia, and anemia.
- Anticholinergic action may worsen urinary retention, which is relevant in cauda equina syndrome.
Please also refer to the package insert for label warnings and contraindications, which are not available in the data compiled for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction has a high model score (0.9966) but no supporting trials or literature, and the proposed use would only address symptoms, not the underlying cause. The anticholinergic effect on urinary retention is a specific safety concern.
To proceed, the following is needed:
- Published or registered studies of dicyclomine in cauda equina syndrome or closely related neurogenic bladder/bowel dysfunction
- Mechanism of action data
- Package insert warnings and contraindications for the India-marketed products
- A safety assessment of urinary retention risk in this population
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.