nystatin
Regulatory sources consulted
Approved indications
- Treatment with topical powder of cutaneous or mucocutaneous fungal infections caused by Candida albicans and other susceptible Candida species; it is not for systemic, oral, intravaginal, or ophthalmic use.
Contraindications
Absolute
- History of hypersensitivity to any component of the topical powder.
Clinical warnings
- For topical use only; discontinue if sensitization or irritation occurs and reassess if there is no therapeutic response. — openFDA Nyamyc topical powder set ID 01b44f91-9b68-464a-9693-b5d3e793bf3c
- Adverse events reported with topical nystatin occur in fewer than 0.1% of patients and include allergic reaction, burning, itching, rash, eczema, and application pain. — openFDA Nyamyc topical powder set ID 01b44f91-9b68-464a-9693-b5d3e793bf3c
Pregnancy and lactation
During pregnancy, use the topical powder only if the potential benefit outweighs fetal risk. It is unknown whether nystatin is excreted in human milk; use cautiously while breastfeeding.
Recent literature (PubMed)
Candidiasis is a highly pervasive infection posing major health risks, especially for immunocompromised populations. Pathogenic Candida species have evolved intrinsic and acquired resistance to a variety of antifungal medications. The primary goal of this literature review is to summarize the molecular mechanisms associated with antifungal resistance in Candida species. Resistance can be conferred via gain-of-function mutations in target pathway genes or their transcriptional regulators. Therefore, an overview of the known gene mutations is presented for the following antifungals: azoles (fluconazole, voriconazole, posaconazole and itraconazole), echinocandins (caspofungin, anidulafungin and micafungin), polyenes (amphotericin B and nystatin) and 5-fluorocytosine (5-FC). The following mutation hot spots were identified: (1) ergosterol biosynthesis pathway mutations (ERG11 and UPC2), resulting in azole resistance; (2) overexpression of the efflux pumps, promoting azole resistance (transcription factor genes: tac1 and mrr1; transporter genes: CDR1, CDR2, MDR1, PDR16 and SNQ2); (3) cell wall biosynthesis mutations (FKS1, FKS2 and PDR1), conferring resistance to echinocandins; (4) mutations of nucleic acid synthesis/repair genes (FCY1, FCY2 and FUR1), resulting in 5-FC resistance; and (5) biofilm production, promoting general antifungal resistance. This review also provides a summary of standardized inhibitory breakpoints obtained from international guidelines for prominent Candida species. Notably, N. glabrata, P. kudriavzevii and C. auris demonstrate fluconazole resistance.
The use of antifungal drugs started in the 1950s with polyenes nystatin, natamycin and amphotericin B-deoxycholate (AmB). Until the present day, AmB has been considered to be a hallmark in the treatment of invasive systemic fungal infections. Nevertheless, the success and the use of AmB were associated with severe adverse effects which stimulated the development of new antifungal drugs such as azoles, pyrimidine antimetabolite, mitotic inhibitors, allylamines and echinochandins. However, all of these drugs presented one or more limitations associated with adverse reactions, administration route and more recently the development of resistance. To worsen this scenario, there has been an increase in fungal infections, especially in invasive systemic fungal infections that are particularly difficult to diagnose and treat. In 2022, the World Health Organization (WHO) published the first fungal priority pathogens list, alerting people to the increased incidence of invasive systemic fungal infections and to the associated risk of mortality/morbidity. The report also emphasized the need to rationally use existing drugs and develop new drugs. In this review, we performed an overview of the history of antifungals and their classification, mechanism of action, pharmacokinetic/pharmacodynamic (PK/PD) characteristics and clinical applications. In parallel, we also addressed the contribution of fungi biology and genetics to the development of resistance to antifungal drugs. Considering that drug effectiveness also depends on the mammalian host, we provide an overview on the roles of therapeutic drug monitoring and pharmacogenomics as means to improve the outcome, prevent/reduce antifungal toxicity and prevent the emergence of antifungal resistance. Finally, we present the new antifungals and their main characteristics.
Oral candidiasis is the most common opportunistic fungal infection caused by commensal Candida species. Since there are various local and systemic predisposing factors for the disease, the treatment also varies from topical to systemic antifungal agents. Nystatin is a common antifungal agent used topically. The aim of this systematic review was to evaluate and compare the efficacy of different antifungal agents and the safety of nystatin in the treatment of oral candidiasis. Three electronic databases were searched for randomized controlled trials comparing nystatin with other anti-fungal therapies or placebo. Clinical and/or mycological cure was the outcome evaluation. A meta-analysis and descriptive study on the efficacy, treatment protocols, and safety of nystatin was also conducted. The meta-analysis included five studies, which compared the efficacy of nystatin suspensions with photodynamic therapy. A significant difference in the colony-forming units per milliliters (CFU/mL) of Candida species was observed at 60 days intervals for both palatal mucosa and denture surfaces, with both groups favoring nystatin with low heterogeneity at a 95% confidence interval. Nystatin and photodynamic therapy were found to be equally effective for the clinical remission of denture stomatitis as well as a significant reduction of CFU/mL of Candida species from dentures and palatal surfaces of the patients.
Whether selective decontamination of the digestive tract (SDD) reduces mortality in critically ill patients remains uncertain. To determine whether SDD reduces in-hospital mortality in critically ill adults. A cluster, crossover, randomized clinical trial that recruited 5982 mechanically ventilated adults from 19 intensive care units (ICUs) in Australia between April 2018 and May 2021 (final follow-up, August 2021). A contemporaneous ecological assessment recruited 8599 patients from participating ICUs between May 2017 and August 2021. ICUs were randomly assigned to adopt or not adopt a SDD strategy for 2 alternating 12-month periods, separated by a 3-month interperiod gap. Patients in the SDD group (n = 2791) received a 6-hourly application of an oral paste and administration of a gastric suspension containing colistin, tobramycin, and nystatin for the duration of mechanical ventilation, plus a 4-day course of an intravenous antibiotic with a suitable antimicrobial spectrum. Patients in the control group (n = 3191) received standard care. The primary outcome was in-hospital mortality within 90 days. There were 8 secondary outcomes, including the proportion of patients with new positive blood cultures, antibiotic-resistant organisms (AROs), and Clostridioides difficile infections. For the ecological assessment, a noninferiority margin of 2% was prespecified for 3 outcomes including new cultures of AROs. Of 5982 patients (mean age, 58.3 years; 36.8% women) enrolled from 19 ICUs, all patients completed the trial. There were 753/2791 (27.0%) and 928/3191 (29.1%) in-hospital deaths in the SDD and standard care groups, respectively (mean difference, -1.7% [95% CI, -4.8% to 1.3%]; odds ratio, 0.91 [95% CI, 0.82-1.02]; P = .12). Of 8 prespecified secondary outcomes, 6 showed no significant differences. In the SDD vs standard care groups, 23.1% vs 34.6% had new ARO cultures (absolute difference, -11.0%; 95% CI, -14.7% to -7.3%), 5.6% vs 8.1% had new positive blood cultures