Nystatin (Nystatin) - Summary

NYSTATIN SUMMARY

Nystatin Oral Suspension, USP

Nystatin USP is an antifungal antibiotic obtained from Streptomyces noursei. It is known to be a mixture, but the composition has not been completely elucidated. Nystatin A is closely related to amphotericin B. Each is a macrocyclic lactone containing a ketal ring, an all- trans polyene system, and a mycosamine (3-amino-3-deoxy-rhamnose) moiety.

Nystatin is indicated for the following:

For the treatment of intestinal and oral cavity infections caused by Candida (Monilia) albicans.

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NEWS HIGHLIGHTS

Published Studies Related to Nystatin

Effects of nystatin, fluconazole and propolis on poly(methyl methacrylate) resin surface. [2008]
The prevalence of candidosis in denture wearers is as well established as its treatment with antifungal agents (AAs). However, little research has been done regarding the effects of AAs on denture base surfaces... In conclusion, PRO was able to induce changes in PMMA surface properties, such as roughness, which could be related to microbial adhesion.

Prevention of fungal peritonitis with nystatin prophylaxis in patients receiving CAPD. [2007.09]
OBJECTIVE: Fungal peritonitis (FP) is a serious complication of continuous ambulatory peritoneal dialysis (CAPD), being associated with significant morbidity and mortality. The role of nystatin prophylaxis during antibiotic therapy in the prevention of FP remains controversial, especially in programs with a modest or low baseline FP rate. The aim of the present study was to evaluate the effect of nystatin prophylaxis on the occurrence of FP in programs with a relatively modest baseline FP rate... CONCLUSION: Oral nystatin prophylaxis might prevent the occurrence of AR-FP in CAPD patients, resulting in a trend toward reduction in the incidence of FP even in programs with a modest baseline FP rate. A large scale, prospective, randomized controlled trial is needed to further examine this issue.

Oral nystatin prophylaxis to prevent invasive candidiasis in Neonatal Intensive Care Unit. [2006.11]
The use of oral nystatin to prevent fungal colonisation and infection in neonates in the Neonatal Intensive Care Unit (NICU) is still an open question and not yet recommended as a standard of care. To determine whether prophylactic oral nystatin results in a decreased incidence of invasive candidiasis in the newborn infants, a total of 3991 infants were divided randomly into two groups...

Oral nystatin prophylaxis of Candida spp. colonization in ventilated critically ill patients. [2005.11]
OBJECTIVE: Colonization of multiple body sites is a leading risk factor for Candida spp. infection in intensive care unit (ICU) patients. We evaluated whether oral nystatin prophylaxis reduces Candida spp. colonization in ventilated ICU patients... CONCLUSIONS: Oral nystatin prophylaxis efficiently prevented Candida spp. colonization in ICU patients at low risk of developing invasive candidiasis. Further studies are needed to determine whether this strategy remains efficient in reducing Candida spp. infections in higher risk ICU patients.

Effect of a buccal bioadhesive nystatin tablet on the lifetime of a Provox silicone tracheoesophageal voice prosthesis. [2005.03]
CONCLUSION: Daily application of a buccal bioadhesive slow-release nystatin tablet (100,000 IU per tablet) significantly increased the voice prosthesis lifetime in laryngectomized patients compared to conventional local cleaning of the prosthesis with an antimicrobial agent on a brush. OBJECTIVE: To investigate the effect of a buccal bioadhesive nystatin tablet on the lifetime of a Provox tracheoesophageal voice prosthesis in post-laryngectomy patients. MATERIAL AND METHODS: A buccal bioadhesive tablet, based on a spray-dried Amioca/Carbopol 974P mixture containing 10% (w/w) Carbopol 974P, was loaded with 100,000 IU of nystatin. Patients were included in the study when replacement of their voice prosthesis was required and were divided into three groups. Conventional daily local cleaning of the voice prosthesis by means of an oral nystatin suspension on a brush (Group 1; n = 7) was compared with application of one nystatin buccal bioadhesive tablet per day, after breakfast, on the gingiva above the upper canine (Group 2; n = 7). The control group (n = 5) used no antimicrobial agents. The lifetime of the prosthesis was followed and expressed in days. RESULTS: The lifetime of the voice prosthesis was significantly increased in Group 2 compared to Group 1 (p < 0.05; paired t-test), indicating that sustained release of nystatin in the oral cavity, by means of erosion of the tablet over a period of approximately = 8 h, is more effective at preventing microbial colonization of the prosthesis than local cleaning.

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Clinical Trials Related to Nystatin

A Comparison of Gentian Violet (GV) Mouth Washes, Nystatin, and Ketoconazole Tabs in Treating Oropharyngeal Candidiasis [Completed]
In resource constrained societies and where HIV is a problem, oral thrush causes significant morbidity. In adults, ketoconazole is used and sometimes oral nystatin. Both drugs are relatively expensive compared to GV solution and ketoconazole has significant side effects especially in association with some of the treatments for HIV related problems.

In children, either GV solutions or nystatin are used, GV is a fraction of the cost of nystatin.

GV at 1% solution discolours the mouth (blue) and in the older child and adult would mark them out as having HIV infections. A much more dilute solution of GV has proved equally effective in vitro and would not carry the same cosmetic problem.

In this study of children, the investigators have compared the 3 solutions, 1% GV, 0. 00165%

GV and nystatin oral drops - all masked so that they look the same - to see if GV is more

effective than nystatin, and to see if the weaker solution of GV is as effective as the stronger solution.

A Phase I/II Clinical Study of Nystatin I.V. (Intravenous) in Patients With HIV Infection. [Completed]
To evaluate the clinical toxicity, safety, and maximum tolerated dose (MTD) of intravenous nystatin in patients with HIV infection. To evaluate the potential anti-HIV activity and clinical pharmacology of intravenous nystatin.

A Study of Nystatin in HIV-Infected Patients [Completed]
To evaluate the clinical toxicity, safety, and potential anti-HIV activity of intravenous nystatin in patients with HIV infection who have completed protocol FDA 103C. To evaluate the safety and potential antiviral activity of intravenous nystatin and oral didanosine (ddI) administered in an alternating regimen in this patient population.

Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC [Completed]
To determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the prevention of oral candidiasis in patients with AIDS or AIDS related complex (ARC) (group III or IV, CDC classification).

A Study of Nystatin in the Prevention of Fungal Infections of the Mouth in Patients With AIDS or AIDS-Related Syndromes [Completed]
To determine a safe, effective, and convenient dosing schedule for nystatin pastilles in the prophylaxis of oral candidiasis in patients with AIDS or AIDS related syndromes (group III or IV, CDC classification)

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PATIENT REVIEWS / RATINGS / COMMENTS

Nystatin review by care giver of 2 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		yeast diaper rash
Dosage & duration:		pea sized (dosage frequency: with each diaper change) for the period of 3 days, 12 or more times
Other conditions:		none
Other drugs taken:		had to administer otc hydrocortisone due to medication induced eczema
		Reported Results
Benefits:		Daily application, cured the fungal infection despite side effects. Over the counter use of lotrimin AG did no work, and prescription alternaitve medication using miconizole nitrate (same as in monistay) cost upwards of $200 / tube, as my insurance did not cover much of it.
Side effects:		caused localized eczema that had to be treated with hydrocortisone cream, which is risky as that can cause damage to the skin under the diaper area.
Comments:		had to apply with each diaper change, along with a otc diaper cream or applied with aquaphor, and twice a day had to add the otc hydrocortisone cream.

Nystatin review by 45 year old female patient
		Rating
Overall rating:
Effectiveness:		Marginally Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		Candida rashes
Dosage & duration:		Thin film of cream applied to area (dosage frequency: twice daily) for the period of 4 weeks
Other conditions:		None
Other drugs taken:		None
		Reported Results
Benefits:		Candida rashes did not disappear. I was doing an anti-candida diet at the same time. i.e cutting out sugars, refined carbs etc. and taking oregano oil, probiotics, pau d'arco tea, caprylic acid. Cream did not work any better than ti tree oil.
Side effects:		None.
Comments:		I have found other creams to be more effective. Most notably Clotrimazole and Hydrocortizone.