Overview
Nystatin is a polyene antifungal drug that has broad-spectrum fungicidal and fungistatic activity against a number of yeasts and fungi, most notably Candida species. It is one of the most effective antifungal agents synthesized by bacteria, in this case a strain of Streptomyces noursei, and is closely related to amphotericin B, differing only slightly in structure. Nystatin has a greater antifungal activity than amphotericin B - parenterally administered nystatin, however, is associated with significant toxicity and is not available in a formulation appropriate for systemic use. As it undergoes very little absorption following oral or topical administration, nystatin's efficacy is limited to the treatment/prevention of cutaneous, mucocutaneous, and gastrointestinal fungal infections.
Indication
Nystatin is available in oral formulations for the treatment and/or prevention of oral candidiasis (a.k.a. thrush), intestinal candidiasis, and anal candidiasis. It is indicated topically for the treatment of vulvovaginal candidiasis and other cutaneous candida infections. A combination product containing nystatin alongside neomycin, gramicidin D, and triamcinolone (Viaderm K.C.®) is indicated in the treatment of corticosteroid-responsive dermatoses caused by bacterial or candidal infections and for pruritus ani/vulvae. It is also available in combination with metronidazole for the treatment of mixed infections due to Trichomonas vaginalis and Candida albicans. Nystatin is also sometimes used off-label for the prevention of invasive candidiasis in low birth weight neonates, though it is generally reserved as a second-line option after fluconazole.
Associated Conditions
- Anal candidiasis
- Intestinal Candidiasis
- Invasive Candidiasis
- Mixed Vaginal Infections caused by Trichomonas Vaginalis, candida albicans
- Oral Candidiasis
- Pruritus Ani
- Pruritus Vulvae
- Skin candida
- Trichomonas Vaginitis
- Vaginal Candidiasis
- Vulvovaginal Candidiasis
- Corticosteroid-responsive dermatoses
- Cutaneous candidiasis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/04/08 | Phase 3 | UNKNOWN | |||
2020/09/16 | Phase 1 | Completed | |||
2020/08/31 | Phase 2 | Completed | São Paulo State University | ||
2019/03/05 | Phase 2 | Withdrawn | |||
2018/01/04 | Phase 4 | Completed | Dr Cipto Mangunkusumo General Hospital | ||
2017/06/06 | Phase 1 | Recruiting | |||
2016/01/25 | Phase 4 | UNKNOWN | Riyadh Colleges of Dentistry and Pharmacy | ||
2015/12/30 | Phase 4 | Completed | |||
2014/06/18 | N/A | UNKNOWN | Jagiellonian University | ||
2012/12/06 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Lohxa | 70166-331 | ORAL | 100000 [USP'U] in 1 mL | 1/3/2019 | |
| NuCare Pharmaceuticals,Inc. | 68071-2491 | TOPICAL | 100000 [USP'U] in 1 g | 8/4/2021 | |
| H.J. Harkins Company, Inc. | 76519-1007 | TOPICAL | 100000 [USP'U] in 1 g | 10/19/2012 | |
| Alembic Pharmaceuticals Inc. | 62332-606 | TOPICAL | 100000 [USP'U] in 1 g | 12/12/2023 | |
| Bryant Ranch Prepack | 63629-2495 | TOPICAL | 100000 [USP'U] in 1 g | 2/15/2022 | |
| VistaPharm, Inc. | 66689-008 | ORAL | 100000 [USP'U] in 1 mL | 6/30/2022 | |
| Bryant Ranch Prepack | 63629-2492 | ORAL | 100000 [USP'U] in 1 mL | 3/11/2022 | |
| Lupin Pharmaceuticals, Inc. | 68180-545 | TOPICAL | 100000 [USP'U] in 1 g | 1/3/2024 | |
| Central Texas Community Health Centers | 76413-167 | TOPICAL | 100000 [USP'U] in 1 g | 4/28/2017 | |
| RedPharm Drug, Inc | 67296-1519 | TOPICAL | 100000 U in 1 g | 2/15/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| NYSTATIN VAGINAL TABLET 100,000 units | SIN06750P | TABLET | 100000 units | 12/27/1991 | |
| PMS-NYSTATIN SUSPENSION 500,000 u/5 ml | SIN05499P | SUSPENSION | 500000 u/5 ml | 2/22/1991 | |
| POLYGYNAX VAGINAL CAPSULE | SIN07745P | CAPSULE | 100000 iu | 6/15/1994 | |
| FLAGYSTATIN VAGINAL OVULE | SIN03798P | SUPPOSITORY | 100000 iu | 2/1/1990 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| FORTIN CREAM | N/A | N/A | N/A | 2/23/2000 | |
| POLYSTATIN CREAM | N/A | N/A | N/A | 5/30/2001 | |
| WEPPERS CREAM | N/A | N/A | N/A | 12/10/2005 | |
| DIPRODERM CREAM | N/A | N/A | N/A | 1/30/2003 | |
| TRI-MOVATE CREAM | N/A | N/A | N/A | 1/11/2002 | |
| SANLER CREAM | N/A | N/A | N/A | 12/5/2001 | |
| SEAKA CREAM | N/A | N/A | N/A | 12/5/2001 | |
| ROMACOMB CREAM | N/A | N/A | N/A | 5/22/1992 | |
| QUESITAN CREAM | N/A | N/A | N/A | 10/10/1995 | |
| WINSLET CREAM | N/A | N/A | N/A | 12/5/2001 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PHARMACY HEALTH NYSTATIN ORAL DROPS nystatin 100,000IU/mL suspension bottle | 389908 | Medicine | A | 6/9/2022 | |
| Kenacomb Otic Ointment tube | 19201 | Medicine | A | 9/30/1991 | |
| GUARDIAN NYSTATIN ORAL DROPS nystatin 100,000IU/mL suspension bottle | 219878 | Medicine | A | 2/5/2014 | |
| OTOCOMB Otic ear drops bottle | 56477 | Medicine | A | 8/7/1996 | |
| OMEGAPHARM NYSTATIN ORAL DROPS nystatin 100,000IU/mL suspension bottle | 164020 | Medicine | A | 8/4/2009 | |
| Nilstat Cream Pessaries | 15102 | Medicine | A | 9/9/1991 | |
| NILSTAT ORAL CAPSULES nystatin 500,000I.U. bottle | 15228 | Medicine | A | 9/9/1991 | |
| NILSTAT ORAL TABLETS nystatin 500,000I.U. bottle | 15227 | Medicine | A | 9/9/1991 | |
| NILSTAT VAGINAL CREAM nystatin 20000 U/g tube | 15103 | Medicine | A | 9/9/1991 | |
| NILSTAT ORAL DROPS nystatin 100000 IU/mL suspension bottle | 48569 | Medicine | A | 4/18/1994 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| MYCOSTATIN TOPICAL PWR 100,000UNITS/GM | convatec, division of bristol-myers squibb canada co. | 02004674 | Powder - Topical | 100000 UNIT / G | 12/31/1994 |
| NYADERM | taropharma, a division of taro pharmaceuticals inc. | 00716901 | Cream - Vaginal | 25000 UNIT / G | 12/31/1979 |
| NADOSTINE TAB 500000UNIT | lab nadeau ltée, division of technilab inc. | 00270113 | Tablet - Oral | 500000 UNIT / TAB | 12/31/1973 |
| TEVA-NYSTATIN | teva canada limited | 02194201 | Suspension - Oral | 100000 UNIT / ML | 9/12/1996 |
| JAMP-NYSTATIN ORAL SUSPENSION USP | 02433443 | Suspension - Oral | 100000 UNIT / ML | 1/9/2015 | |
| MYCOSTATIN VAGINAL CRM 25000UNIT | squibb canada inc., division of bristol-myers squibb canada inc. | 00295973 | Cream - Vaginal | 25000 UNIT / G | 12/31/1973 |
| NILSTAT VAG TAB 100000UNIT | lederle cyanamid canada inc. | 00015067 | Tablet - Vaginal | 100000 UNIT / TAB | 12/31/1970 |
| TEVA-TRIACOMB | teva canada limited | 00550507 | Cream - Topical | 100000 UNIT / G | 12/31/1992 |
| NILSTAT SUCROSE-FREE | technilab pharma inc. | 02229852 | Suspension - Oral | 100000 UNIT / ML | 3/12/1997 |
| NADOSTINE SUS 100000IU/ML | lab nadeau ltée, division of technilab inc. | 00282219 | Suspension - Oral | 100000 UNIT / ML | 12/31/1974 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| POSITON 2,5 MG/G + 1 MG/G + 100.000 UI/G CREMA | 48825 | CREMA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| POSITON 2,5 MG/G + 1 MG/G + 100000 UI/G POMADA | 34215 | POMADA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| MYCOSTATIN 100.000 UI/ml SUSPENSION ORAL | 28262 | SUSPENSIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| INTERDERM CREMA 30 GRAMOS | Interpharma S.A. | 52411 | CREMA | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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