Nystatin
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Nystatin: From Candidiasis to Vulvovaginitis
One-Sentence Summary
Nystatin is a polyene antifungal originally used to treat candidiasis, including cutaneous, oral and vulvovaginal forms. The TxGNN model predicts it may be effective for vulvovaginitis, but this is essentially an on-label use (vulvovaginal candidiasis) rather than true repurposing. Support comes from 0 clinical trials and 20 publications (mostly reviews and clinical overviews).
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Cutaneous candidiasis, oral candidiasis, candidiasis, vulvovaginal candidiasis (licence indication text is not available) |
| Predicted New Indication | Vulvovaginitis |
| TxGNN Prediction Score | 99.92% |
| Evidence Level | L4 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 4 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data are not currently available in the data compiled for this report. From known pharmacology, nystatin binds ergosterol in the fungal cell membrane, forming pores that cause leakage of cell contents and fungal cell death.
Vulvovaginitis is frequently caused by Candida species, and vulvovaginal candidiasis is already among nystatin's original indications. The prediction is therefore mostly a broader label for a use that already exists. The evidence applies to candidal or mixed infections. Nystatin is not expected to work for bacterial or trichomonal vulvovaginitis, or for non-infectious causes.
Clinical Trial Evidence
Currently no related clinical trials registered for vulvovaginitis.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 39771534 | 2024 | Review | Pharmaceutics | Management of fluconazole-resistant vulvovaginal candidiasis; nystatin is discussed among alternatives such as boric acid, oteseconazole and ibrexafungerp |
| 25775428 | 2015 | Review | BMJ Clinical Evidence | Vulvovaginal candidiasis is the second most common cause of vaginitis; C. albicans accounts for 85–90% of cases |
| 21774671 | 2011 | Review | J Women's Health | Boric acid for recurrent vulvovaginal candidiasis; non-albicans species are more resistant to azoles |
| 21718579 | 2010 | Review | BMJ Clinical Evidence | Evidence summary on vulvovaginal candidiasis treatment |
| 19454049 | 2007 | Review | BMJ Clinical Evidence | Evidence summary on vulvovaginal candidiasis treatment |
| 1436934 | 1992 | Review | Obstet Gynecol Clin North Am | Nystatin was introduced in the 1950s for vulvovaginal candidiasis but has been surpassed by imidazoles and triazoles as first choice |
| 2212172 | 1990 | Review | J Am Acad Dermatol | Many effective antimycotics exist; little evidence that formulation affects outcome |
| 16047929 | 2005 | Clinical study | Ceska Gynekologie | Combined vaginal nystatin and nifuratel products for mixed and miscellaneous vulvovaginal infections |
| 20406393 | 2011 | Clinical study | Mycoses | Fluconazole and nystatin susceptibility correlated with clinical outcome in 287 Candida isolates from complicated vulvovaginal candidosis |
| 4919155 | 1970 | Review | Med Clin North Am | General review of nystatin |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN05499P | PMS-NYSTATIN SUSPENSION 500,000 u/5 ml | Suspension | Not specified in the available data |
| SIN06750P | NYSTATIN VAGINAL TABLET 100,000 units | Tablet | Not specified in the available data |
| SIN03798P | FLAGYSTATIN VAGINAL OVULE | Suppository | Not specified in the available data |
| SIN07745P | POLYGYNAX VAGINAL CAPSULE | Capsule | Not specified in the available data |
Safety Considerations
- Disease associations flagged in the knowledge graph (not label text): adrenocortical insufficiency, Addison disease, skin atrophy, telangiectasis, capillary disease, hereditary hemorrhagic telangiectasia. These should be verified against the official package insert.
- Drug Interactions: 100 potential interactions were identified, none with a severity grade. Examples include cyclosporine, fluconazole, erythromycin, azithromycin, bortezomib, tramadol and lorazepam. Clinical significance has not been classified.
Please refer to the package insert for full warnings and contraindications.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Vulvovaginitis of candidal origin is already within nystatin's established use, and four products are registered in Singapore, including three vaginal products. The supporting evidence consists of reviews and small studies, with no registered trials, and nystatin is no longer the first-line choice over azoles. Evidence is indirect for non-Candida or mixed etiologies.
To proceed, the following is needed:
- HSA package insert warnings, contraindications and approved indications (a blocking gap for safety screening)
- Detailed mechanism of action data from DrugBank
- A clear restriction to confirmed or suspected candidal vulvovaginitis, with exclusion of bacterial and trichomonal causes
- Comparative efficacy data against azoles, particularly for azole-resistant or non-albicans Candida
- Review of the knowledge-graph disease flags and the interaction list against the label
Other predictions (disease of orbital region, cystic teratoma, spinal cord dermoid cyst, biotin metabolic disease, and others) rest on model scores alone with no plausible antifungal rationale and should be held. Vulvitis has similar candidal-only support to vulvovaginitis.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.