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Nystatin

Generic Name
Nystatin
Brand Names
Flagystatin, Mycostatin, Nyaderm, Nyamyc, Nystop, Viaderm Kc
Drug Type
Small Molecule
Chemical Formula
C47H75NO17
CAS Number
1400-61-9
Unique Ingredient Identifier
W1LX4T91WI
Background

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

Comparison of Lactobacillus Reuteri and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants

Phase 4
Completed
Conditions
Very Low Birth Weight Infants
Interventions
Dietary Supplement: Lactobacillus reuteri
First Posted Date
2012-02-10
Last Posted Date
2013-07-16
Lead Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
Target Recruit Count
300
Registration Number
NCT01531192
Locations
🇹🇷

Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology, Ankara, Turkey

Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients

Phase 4
Completed
Conditions
Critical Illness
Fungal Prophylaxis
Candida Infection
Surgery
Interventions
First Posted Date
2011-12-19
Last Posted Date
2017-04-05
Lead Sponsor
Policlinico Hospital
Target Recruit Count
99
Registration Number
NCT01495039
Locations
🇮🇹

Intensive care Unit, Policlinico Hospital Bari, Bari, Italy

Gentian Violet Vs. Nystatin Oral Suspension for Treatment of Oropharyngeal Candidiasis

Phase 3
Completed
Conditions
HIV-1 Infection
Interventions
First Posted Date
2011-09-02
Last Posted Date
2015-02-16
Lead Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Target Recruit Count
221
Registration Number
NCT01427738
Locations
🇧🇼

Molepolole Prevention/Treatment Trials CRS (12702), Molepolole, Botswana

🇿🇦

Durban Adult HIV CRS (11201), Durban, South Africa

🇮🇳

National AIDS Research Institute Pune CRS (11601), Pune, Maharashtra, India

and more 7 locations

Oral Anti-Infective Agent for Esophageal Anastomotic Leakage

Phase 2
Conditions
Anastomotic Leakage
Interventions
First Posted Date
2009-07-21
Last Posted Date
2009-07-21
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
120
Registration Number
NCT00942526
Locations
🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

Pharmacokinetics of Sublingual Versus Oral Tacrolimus in Patients Awaiting Kidney Transplantation

First Posted Date
2008-03-05
Last Posted Date
2019-06-12
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
5
Registration Number
NCT00629122
Locations
🇺🇸

NewYork-Presbyterian Hospital, New York, New York, United States

A Comparison of Gentian Violet (GV) Mouth Washes, Nystatin, and Ketoconazole Tabs in Treating Oropharyngeal Candidiasis

Phase 3
Completed
Conditions
Candidiasis, Oral
First Posted Date
2005-08-09
Last Posted Date
2008-02-11
Lead Sponsor
Kamuzu University of Health Sciences
Target Recruit Count
558
Registration Number
NCT00128323
Locations
🇲🇼

Queen Elizabeth Central Hospital, Paediatric Dept, Box 360, Blantyre, Malawi

Antifungal Therapy for Fever and Neutropenia in Patients Receiving Treatment for Hematologic Cancer

Phase 3
Completed
Conditions
Chronic Myeloproliferative Disorders
Infection
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
First Posted Date
2004-08-24
Last Posted Date
2013-03-26
Lead Sponsor
Aronex Pharmaceuticals
Registration Number
NCT00002742
Locations
🇺🇸

Scott and White Clinic, Temple, Texas, United States

🇺🇸

Infections Limited, P.S., Tacoma, Washington, United States

🇺🇸

Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, United States

and more 56 locations

Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults

First Posted Date
2004-03-02
Last Posted Date
2018-06-29
Lead Sponsor
University of Wisconsin, Madison
Target Recruit Count
10
Registration Number
NCT00078559
Locations
🇺🇸

University of Wisconsin - Department of Medicine, Madison, Wisconsin, United States

A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Impact of Nystatin on the Development of Oral Irritation in Patients Receiving High Dose Intravenous Interleukin-2

Phase 3
Completed
Conditions
Candidiasis, Oral
Gastrointestinal Diseases
Stomatitis
First Posted Date
2002-12-10
Last Posted Date
2008-03-04
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
84
Registration Number
NCT00001812
Locations
🇺🇸

National Cancer Institute (NCI), Bethesda, Maryland, United States

Pharmacokinetics of Nystatin LF I.V. in Patients With Acquired Immune Deficiency Syndrome-Related Complex (ARC)

Not Applicable
Completed
Conditions
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
Argus Pharmaceuticals
Registration Number
NCT00001998
Locations
🇺🇸

Twelve Oaks Hosp, Houston, Texas, United States

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