A Comparison of Triamcinolone Acetonide Econazole Cream and Nystatin Suspension in Treatment of Otomycosis.

OBJECTIVES/HYPOTHESIS: To compare the efficacy and adverse effects of triamcinolone acetonide econazole cream and nystatin suspension in the treatment of otomycosis, and to determine the clinical features, predisposing factors, and etiology of otomycosis. STUDY DESIGN: A prospective study. METHODS: A prospective clinical trial was conducted on 786 patients diagnosed with otomycosis. The study population was randomly divided into two treatment groups of triamcinolone acetonide econazole cream (TAEC) and nystatin suspension in a 1:1 ratio. After clearing all fungal deposits in the external auditory canal, the antimycotic drugs were locally applied for at least 2 weeks. The efficacy and adverse effects were compared between the two antifungal reagents by statistical analysis. Meanwhile, patient clinical data were collected to find out the clinical features, predisposing factors, and etiology. RESULTS: Pruritis was the most common symptom and Aspergillus niger was the leading fungal pathogen. There was high association (44.5%) of otomycosis with a history of unclean ear picking. The cure rate was 97.6% in the TAEC group and 73.5% in the nystatin group (P < .01). Treatment with TAEC resulted in 2.4% of patients complaining of discomforts (irritant dermatitis, otalgia, or headache) versus 59.8% of patients complaining discomforts treated with nystatin (P < .01). The residue rate of antifungals was 1.9% in the TAEC group and 89.9% in the nystatin group (P < .01) at the end of treatment. CONCLUSIONS: Thoroughly cleaning of the external auditory canal followed by local use of TAEC under endotoscope is an effective, convenient, and well-tolerated treatment for otomycosis. LEVEL OF EVIDENCE: 1 Laryngoscope, 131:E1640-E1646, 2021.

Effects of Streptococcus salivarius K12 with nystatin on oral candidiasis-RCT.

OBJECTIVE: To evaluate the efficacy and safety of Streptococcus salivarius K12 as an adjuvant in treating oral candidiasis. METHODS: A total of 56 patients were participated in the randomized, double-blinded, placebo-controlled clinical trial. The S. salivarius K12 or placebo lozenges plus nystatin tablets were given for up to 4 weeks at 1-week interval and then followed up for 1 week thereafter. We collected and analyzed the mycological and clinical data, treatment course, and safety data. RESULTS: At the end of the treatment, significant differences were found in the mycological cure rates between K12 group and control group (90.48% and 55.56%, respectively, p = 0.008). Survival analysis demonstrated no statistical difference in overall cure rates comprehensively considering mycological cure, clinical improvement, and recurrence (p = 0.078), while statistical difference was found in mycological cure (p = 0.013) between the two groups. The median treatment courses of K12 group and control group were 3 weeks and 4 weeks, respectively. No severe events were reported during the study. CONCLUSION: Streptococcus salivarius K12 exhibited potential efficacy and safety as an adjuvant in treating oral candidiasis by enhancing mycological cure and shortening the treatment course of conventional antifungal therapy in this randomized, double-blinded, placebo-controlled clinical trial. Further large-scale clinical studies are desired to accumulate more evidence for its clinical applications.

PRISM study: Comparison of a nystatin-neomycin-polymyxin B combination with miconazole for the empirical treatment of infectious vaginitis.

OBJECTIVE: An empirical treatment of infectious vaginitis is justified because of its multiple etiologies, the frequent uncertainty of clinical diagnosis and limits of microbiological analysis. Our aim was to comparatively investigate nystatin-neomycin-polymyxin B combination (NNP, Polygynax®) and miconazole. PATIENTS AND METHODS: In this European multicenter, double-blind PRISM trial, participating women presenting with infectious vaginitis were randomized to receive one vaginal capsule containing either NNP for 12 days or miconazole for 3 days followed by 9 days of placebo. RESULTS: The clinical success rate was higher in the NNP group (n=302) than the miconazole group (n=309), with a difference between groups close to statistical significance (91.1% vs. 86.7%, P=0.0906). The risk of treatment failure was 36% lower in the NNP group (odds ratio, 0.64; 95% confidence interval, 0.38-1.07). Vaginal burning on Day 2 and vaginal discharge on Day 4 were significantly less intense in the NNP group than in the miconazole group (39.1 vs. 42.3, P=0.031 and 34.6 vs. 37.6, P=0.031, respectively). Adverse drug reactions were reported by 1.2% and 2.1% of patients in the NNP and miconazole group respectively, with the ratio of adverse drug reactions relative to total adverse events significantly higher in the miconazole group (20.3% vs. 6.9%, P=0.022). CONCLUSION: The widespread use of NNP for several decades and its good efficacy and safety profile, as well as the frequent diagnostic uncertainties due to the various pathogens sustain the initiation of this broad-spectrum empirical treatment in infectious vaginitis.

Avaliação in vitro do potencial erosivo e cariogênico de antifúngicos tópicos / In vitro evaluation of erosive and cariogenic potential of topical antifungal agents

Introdução: a candidíase é uma infecção fúngica oportunista, causada pela proliferação e disseminação de espécies de Candida, que pode acometer a cavidade oral. Dentre os antifúngicos mais utilizados e de uso tópico, a nistatina é considerada o medicamento de primeira escolha. Objetivo: avaliar as propriedades físico-químicas de diferentes marcas de nistatina disponíveis no mercado, incluindo o pH, a acidez total titulável (ATT) e a determinação de sólidos solúveis totais (SST). Metodologia: trata-se de um estudo experimental in vitro, constituído por uma amostra de oito diferentes marcas de nistatina em suspensão oral de uso tópico. Foi analisado o potencial erosivo e cariogênico dessas soluções mediante a determinação de pH, ATT e SST (°Brix). Resultados: no tocante ao pH, verificou-se que a média obtida foi de 6,05 (± 0,66). Dois dos medicamentos analisados (marcas A e H) apresentaram pH abaixo do crítico para a dissolução do esmalte dental. Quanto à ATT das soluções, os valores variaram de 1,9 a 14,53 mL para atingir o pH neutro, indicando que as marcas B, C e E podem levar mais tempo para ser neutralizadas em razão da quantidade de solução necessária. A análise do °Brix revelou que a marca H apresentou o maior teor de açúcares em sua composição (44,9%). Conclusão: a formulação de nistatina da marca H apresentou pH endógeno mais crítico e percentual de sólidos solúveis totais elevado, sendo, portanto, a medicação com maior fator de risco para o desenvolvimento de cárie e erosão dentária, devendo ser consideradas as doses e frequências de uso, bem como os hábitos de higiene oral do paciente

Introduction: candidiasis is an opportunistic fungal infection caused by the proliferation and spread of Candida species that can affect the oral cavity. Among the most commonly used topical antifungal agents, nystatin is considered the first choice drug. Methodology: to evaluate the physical and chemical properties of different brands of nystatin available in the market, including pH, titratable acidity and determination of total soluble solids. Results: Regarding pH, it was verified that the mean obtained was 6.05 (± 0.66). Two of the analyzed drugs (A and H) presented pH below that considered critical for the dissolution of dental enamel. As for the titratable total acidity of the solutions, values ranged from 1.9 to 14.53 mL to reach neutral pH, indicating that the B, C and E marks may take longer to neutralize because of the amount of solution required. The analysis of ° Brix revealed that the H mark had the highest sugar content in its composition (44.9%). Conclusion: Nystatin brand H presented the worst indices in terms of endogenous pH and total sugar percentage, being therefore the medication with the highest risk factor for the development of caries and dental erosion.

A Drug-drug Interaction Between Cyclosporine and Nystatin.

We present a case of increased cyclosporine concentration and liver function right after the combinational use of cyclosporine and nystatin, which indicated a drug-drug interaction between them. Both the concentration and liver function were decreased after discontinuation of nystatin and remained normal after taking on cyclosporine again. To our knowledge, this is the first case report of the interactions between nystatin and cyclosporine. Enteric P-glycoprotein could play an important role in the pharmacokinetic profile of cyclosporine, which needs further identification by physicians and pharmacists.

Effect of Incorporation of Antifungal Agents on the Ultimate Tensile Strength of Temporary Soft Denture Liners.

PURPOSE: To investigate the ultimate tensile strength of temporary soft denture liners modified by minimum inhibitory concentrations (MICs) of antifungal agents for Candida albicans biofilm (SC5314) determined in previous microbiological research. MATERIALS AND METHODS: Dumbbell-shaped specimens (n = 7) with a central cross-sectional area of 6 × 3 × 33 mm were produced by Softone and Trusoft, without (control) or with incorporation of drugs in powder form at MICs for C. albicans biofilm (per g of material powder): nystatin (0.032 g), chlorhexidine diacetate (0.064 g), ketoconazole (0.128 g), miconazole (0.256 g), and itraconazole (0.256 g). After plasticization, specimens were immersed in distilled water at 37°C for 24 hours, 7 or 14 days, and then tested in tension in a universal testing machine at 40 mm/min. Data of tensile strength (MPa) and elongation percentage (%) were submitted to 3-way ANOVA and Tukey's test (α = 0.05). RESULTS: At the end of 14 days, the tensile strength for both materials was significantly lower in the groups modified by miconazole and itraconazole compared to the other groups (p < 0.0001), which showed no significant difference between them (p > 0.05). After 7 and 14 days in water, miconazole and itraconazole added into both materials resulted in significantly lower elongation percentages compared to the other antifungal agents and control (p < 0.0001), which were similar to each other (p > 0.05). CONCLUSIONS: The addition of the nystatin, chlorhexidine, and ketoconazole at MICs for C. albicans biofilm resulted in no harmful effects on the tensile strength and elongation percentage of the temporary soft denture liner materials up to 14 days.

Congenital Cutaneous Candidiasis: Prompt Systemic Treatment Is Associated With Improved Outcomes in Neonates.

BACKGROUND: Congenital cutaneous candidiasis (CCC) is a challenging diagnosis due to various rash presentations. Inadequate early treatment is associated with high rates of dissemination and death. The effects of early diagnosis, dermatologic presentation, and antifungal treatment on outcomes are lacking. METHODS: CCC cases were reviewed from 2 academic neonatal intensive care units (NICUs) from 2004 to 2015. We defined CCC as a diffuse rash involving the body, extremities, face or scalp, and/or funisitis, presenting in the first week (≤7 days), with identification of Candida species from skin or mucous membrane cultures, and/or by culture or staining of the placenta or umbilical cord. RESULTS: CCC occurred in 0.1% of all NICU admissions (21 of 19 303) and 0.6% of infants <1000 grams birth weight. Median gestational age of CCC infants was 26 3/7 (range, 23 0/7-40 4/7) weeks. Skin findings were commonly present on the day of birth [median (range): 0 (0-6) days], appearing most frequently as a desquamating, maculopapular, papulopustular, and/or erythematous diffuse rash. When systemic antifungal therapy was started empirically at the time of rash presentation and continued for a median (interquartile range) of 14 (14-15) days, all patients survived and none developed dissemination. Delaying systemic treatment, exclusive use of nystatin, and treating for <10 days was associated with Candida bloodstream dissemination. CONCLUSIONS: CCC is an invasive infection that presents as a diffuse rash in preterm and term infants. Prompt systemic antifungal treatment at the time of skin presentation for ≥14 days prevents dissemination and Candida-related mortality.

Topical Antimycotics for Oral Candidiasis in Warfarin Users.

Treatment for oral candidiasis in warfarin users may be complicated by drug-drug interactions (DDIs) between warfarin and topically applied antimycotics. However, current knowledge of these putative DDIs is merely based on case series. We therefore performed a cohort cross-over study with the objective to evaluate the potential DDIs between warfarin and miconazole oral gel or nystatin oral solution. The cohort consisted of individuals using warfarin in the period of 1998-2012 (n ≈ 7400). We collected data on cohort members' measurements of the international normalized ratio (INR) from a clinical database, and obtained information on their use of topically applied miconazole and nystatin from a regional prescription register. Potential DDIs were assessed by comparing INR values before and after initiation of an antimycotic drug. Among 17 warfarin users exposed to miconazole oral gel, the mean INR increased from 2.5 (95% CI: 2.1-2.8) to 3.8 (95% CI: 2.8-4.8) after exposure, corresponding to a mean INR increase of 1.4 (95% CI: 0.3-2.4). Among 30 warfarin users exposed to nystatin oral solution, the mean INR was 2.7 (95% CI: 2.3-3.1) before and 2.5 (95% CI: 2.2-2.9) after exposure. In conclusion, we found evidence supporting a clinically relevant drug-drug interaction between warfarin and miconazole oral gel. In contrast, we did not find any indication of an interaction between warfarin and nystatin oral solution. Nystatin rather than miconazole should be preferred when treating warfarin users for oral candidiasis.

Topical gentian violet compared with nystatin oral suspension for the treatment of oropharyngeal candidiasis in HIV-1-infected participants.

OBJECTIVE: Compare the safety and efficacy of topical gentian violet with that of nystatin oral suspension (NYS) for the treatment of oropharyngeal candidiasis in HIV-1-infected adults in resource-limited settings. DESIGN: Multicenter, open-label, evaluator-blinded, randomized clinical trial at eight international sites, within the AIDS Clinical Trials Group. STUDY PARTICIPANTS AND INTERVENTION: Adult HIV-infected participants with oropharyngeal candidiasis, stratified by CD4 cell counts and antiretroviral therapy status at study entry, were randomized to receive either gentian violet (0.00165%, BID) or NYS (500 000 units, QID) for 14 days. MAIN OUTCOME MEASURE(S): Cure or improvement after 14 days of treatment. Signs and symptoms of oropharyngeal candidiasis were evaluated in an evaluator-blinded manner. RESULTS: The study was closed early per Data Safety Monitoring Board after enrolling 221 participants (target = 494). Among the 182 participants eligible for efficacy analysis, 63 (68.5%) in the gentian violet arm had cure or improvement of oropharyngeal candidiasis versus 61 (67.8%) in the NYS arm, resulting in a nonsizable difference of 0.007 (95% confidence interval: -0.129, 0.143). There was no sizable difference in cure rates between the two arms (-0.0007; 95% confidence interval: -0.146, 0.131). No gentian violet-related adverse events were noted. No sizable differences were identified in tolerance, adherence, quality of life, or acceptability of study drugs. In gentian violet arm, 61 and 39% of participants reported 'no' and 'mild-to-moderate' staining, respectively. Cost for medication procurement was significantly lower for gentian violet versus NYS (median $2.51 and 19.42, respectively, P = 0.01). CONCLUSION: Efficacy of gentian violet was not statistically different than NYS, was well tolerated, and its procurement cost was substantially less than NYS.

Efficacy of nystatin for the treatment of oral candidiasis: a systematic review and meta-analysis.

OBJECTIVE: To systematically review and assess the efficacy, different treatment protocols (formulation, dosage, and duration), and safety of nystatin for treating oral candidiasis. METHODS: Four electronic databases were searched for trials published in English till July 1, 2015. Randomized controlled trials comparing nystatin with other antifungal therapies or a placebo were included. Clinical and/or mycological cure was the outcome evaluation. A meta-analysis or descriptive study on the efficacy, treatment protocols, and safety of nystatin was conducted. RESULTS: The meta-analysis showed that nystatin pastille was significantly superior to placebo in treating denture stomatitis. Nystatin suspension was not superior to fluconazole in treating oral candidiasis in infants, children, or HIV/AIDS patients. The descriptive investigations showed that administration of nystatin suspension and pastilles in combination for 2 weeks might achieve a higher clinical and mycological cure rate, and using the nystatin pastilles alone might have a higher mycological cure rate, when compared with using nystatin suspensions alone. Nystatin pastilles at a dose of 400,000 IU resulted in a significantly higher mycological cure rate than that administrated at a dose of 200,000 IU. Furthermore, treatment with nystatin pastilles for 4 weeks seemed to have better clinical efficacy than treatment for 2 weeks. Descriptive safety assessment showed that poor taste and gastrointestinal adverse reaction are the most common adverse effects of nystatin. CONCLUSION: Nystatin pastille was significantly superior to placebo in treating denture stomatitis, while nystatin suspension was not superior to fluconazole in treating oral candidiasis in infants, children, or HIV/AIDS patients. Indirect evidence from a descriptive study demonstrated that administration of nystatin pastille alone or pastille and suspension in combination is more effective than that of suspension alone; prolonged treatment duration for up to 4 weeks can increase the efficacy of nystatin. More well designed and high quality randomized control studies are needed to confirm these findings.

Concomitant sensitization to inhaled budesonide and oral nystatin presenting as allergic contact stomatitis and systemic allergic contact dermatitis.

Concomitant allergic reactions to multiple drugs are uncommon. We report the case of a 66-year-old woman who presented with concomitant sensitization to inhaled budesonide and oral nystatin presenting as allergic contact stomatitis and systemic allergic contact dermatitis. It is notable that one of the reactions was caused by oral nystatin, which generally is not considered to be allergenic due to its poor intestinal absorption. Diagnoses were confirmed on patch testing with histologic examination along with oral challenge testing. We also used challenge testing to rule out cross-reactivity among nystatin and other macrolide drugs, both antifungals and antibiotics.

Vaginal nystatin versus oral fluconazole for the treatment for recurrent vulvovaginal candidiasis.

Recurrent vulvovaginal candidiasis (RVVC) is a common condition that can physically and psychologically impact patients. We compared the efficacy and safety of vaginal nystatin suppositories for 14 days each month versus standard oral fluconazole regimens for the treatment for RVVC. Patients (n = 293) were enrolled in the study from April 2010 to September 2013. After the initial therapy, the mycological cure rates were 78.3% (119/152) and 73.8% (104/141) in the nystatin group and fluconazole group, respectively (95% CI, 0.749-2.197, p > 0.05). The mycological cure rates at the end of maintenance therapy were 80.7% (96/119) and 72.7% (72/99) in the two groups, respectively (95% CI, 0.954-3.293, p > 0.05).The mycological cure rates at the end without treatment for 6 months were 81.25% (78/96) and 82.19% (60/73) in the two groups, respectively (95% CI, 0.427-2.066, p > 0.05). The mycological cure rates of RVVC caused by C. albicans were 84.0% (89/106) and 81.8% (99/121) in the two groups, respectively. The mycological cure rates of RVVC caused by C. glabrata were 64.3% (27/42) and 12.5% (2/16) in the two groups, respectively. The initial and 6-month maintenance therapy were successful in five of the nine patients in the nystatin group with RVVC caused by fluconazole-resistant Candida, whereas in the fluconazole group, initial therapy failed in all patients with RVVC caused by fluconazole-resistant Candida (n = 7). We conclude that both fluconazole and nystatin therapies are effective in treating RVVC. Nystatin may also be effective for the treatment for RVVC caused by C. glabrata or fluconazole-resistant Candida.

Pustulosis exantemática aguda generalizada inducida por nistatina / Nystatin-Induced Acute Generalized Exanthematous Pustulosis

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Chemoprophylaxis of neonatal fungal infections in very low birthweight infants: efficacy and safety of fluconazole and nystatin.

AIM: To review the use of antifungal chemoprophylaxis to prevent neonatal invasive fungal infections (IFI) in very low birthweight infants (VLBW <1500 g). METHOD: Systematic review of randomised controlled trials. RESULTS: Nine trials were identified (2029 infants), with six comparing fluconazole with placebo/no treatment (840 infants), three comparing nystatin with placebo/no treatment (1200 infants) and two comparing fluconazole and nystatin (257 infants). Prophylactic fluconazole reduced the incidence of IFI in VLBW infants <1500 g to 5.1% compared with 16.0% in infants receiving placebo, relative risk (RR) = 0.36 (95% confidence interval 0.15-0.89). The mortality was 10.9% and 16.7%, respectively (RR 0.76, 0.54-1.08). Oral nystatin reduced the incidence of IFI in VLBW infants to 5.3% compared with 28.0% in infants receiving placebo (RR 0.16, 0.11-0.23). Mortality was 7.5% with nystatin and 10.9% with placebo (RR 0.86, 0.59-1.26). The incidence of IFI in studies comparing fluconazole and nystatin was 3.6% and 8.0%, respectively (RR 0.54, 0.19-1.56), and mortality was not significantly different: 4.6% versus 9.8% (RR 0.43, 0-4.31) CONCLUSIONS: Prophylactic fluconazole and oral nystatin are both highly effective in preventing IFI in VLBW infants. Both agents are safe without significant toxicities. Antifungal prophylaxis should therefore be used in all VLBW infants. Given the paucity of data comparing fluconazole with nystatin, the choice of antifungal agent should be influenced by the incidence of IFI, local epidemiology and relative cost.

Pharmacokinetics, tissue distribution and immunomodulatory effect of intralipid formulation of nystatin in mice.

OBJECTIVES: We developed a novel lipid formulation of nystatin suitable for parenteral administration, nystatin-intralipid (NYT-IL), with antifungal activity and reduced toxicity in mice. We investigated the pharmacokinetics, tissue distribution and immunomodulatory effect of NYT-IL in mice. METHODS: Nystatin levels in serum and organs were determined using HPLC after NYT-IL or nystatin administration in mice. The levels of the pro-inflammatory cytokines tumour necrosis factor-α (TNF-α) and interferon-γ (IFN-γ) and the anti-inflammatory cytokine interleukin 10 (IL-10) produced by splenocytes from mice injected with NYT-IL or nystatin were evaluated by an ELISA assay. RESULTS: Injection of NYT-IL resulted in similar levels and similar kinetics of nystatin in serum, higher concentrations in the liver and lower concentrations in the kidneys, in comparison with nystatin injection. Injection of mice with NYT-IL yielded higher levels of IL-10 than that of nystatin, whereas the levels of TNF-α and IFN-γ induced by NYT-IL were lower than those elicited by nystatin. CONCLUSIONS: Since polyene treatment is associated with nephrotoxicity, lower levels of nystatin in the kidneys following NYT-IL injection suggest the possibility of reduced toxicity. As the acute infusion-related adverse effects associated with polyene treatment are considered to be induced by pro-inflammatory cytokines, a higher level of anti-inflammatory and lower levels of pro-inflammatory cytokines elicited by NYT-IL administration suggest the possibility of amelioration of such effects. In summary, the altered pharmacokinetics, tissue distribution and immune response due to the use of this intralipid formulation of nystatin merit further research towards the development of a therapeutic agent against invasive mycoses.

Comparison of therapeutic effect of aqueous extract of garlic and nystatin mouthwash in denture stomatitis.

INTRODUCTION: Denture stomatitis (DS) is the most common form of chronic oral candidiasis. The standard treatment for DS is nystatin, which is accompanied with complications such as a bitter taste. The aim of this study was to compare the effect of garlic with nystatin in DS. MATERIAL AND METHODS: This randomised clinical trial study was performed on 40 patients with DS. After obtaining written consent, patients were divided into two groups while members of each group were given either nystatin or garlic extract for 4 weeks. The length and width of erythema area was measured at the end of the first, second, third, and the fourth weeks using a calliper. Data were analysed by SPSS and statistical tests including variance analysis with anova repeated measures, chi-square, and least square differences. RESULTS: The changes in the length and width of erythema at different times according to the type of treatment were found to be significant while an accelerated recovery was demonstrated for nystatin (p < 0.001). Both regimens resulted in significant recovery (p < 0.0001). Greater satisfaction with the use of garlic rather than nystatin was mentioned (p < 0.0001). CONCLUSION: Considering the efficacy of garlic and lack of side effects for this compound and also regarding the nystatin-associated complications, garlic extract can be introduced as a substitution for standard treatment in DS.