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Nystatin (Nystatin) - Summary



Nystatin is 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 macro-cyclic lactone containing a ketal ring, an all-trans polyene system, and a mycosamine (3-amino-3-deoxyrhamose) moiety.

Nystatin oral suspension, USP is indicated for the treatment of infections of the oral cavity caused by Candida albicans.

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Published Studies Related to Nystatin

Comparison of therapeutic effect of aqueous extract of garlic and nystatin mouthwash in denture stomatitis. [2012]
CONCLUSION: Considering the efficacy of garlic and lack of side effects for this

Randomised controlled trial of prophylactic fluconazole versus nystatin for the prevention of fungal colonisation and invasive fungal infection in very low birth weight infants. [2011.05]
BACKGROUND: Invasive fungal infections are a major cause of morbidity and mortality in preterm infants. The authors conducted the first prospective, randomised controlled trial of nystatin compared with fluconazole for the prevention of fungal colonisation and invasive fungal infection in very low birth weight (VLBW) neonates... CONCLUSIONS: Prophylactic nystatin and fluconazole reduce the incidence of colonisation and invasive fungal infection in VLBW neonates. The authors believe that nystatin is an alternative to fluconazole, because nystatin is safe, inexpensive, well tolerated and effective.

Oral sustained release nystatin tablets for the treatment of oral candidiasis: formulation development and validation of UV spectrophotometric analytical methodology for content determination. [2010.05]
OBJECTIVE: In this study, oral sustained release mucoadhesive nystatin tablets were developed to increase nystatin contact time with the oral cavity and mask its unpleasant taste... CONCLUSION: The oral nystatin tablets developed showed to present faster therapeutic response than the oral aqueous solution through the preliminary clinical assays. The UV absorption spectrophotometry method showed to be an attractive test for the usual routine in the pharmaceutical industry.

Comparison of fluconazole and nystatin oral suspensions for prophylaxis of systemic fungal infection in very low birthweight infants. [2010.01]
We compared the efficacy and safety of fluconazole and nystatin oral suspensions for the prevention of systemic fungal infection (SFI) in very low birthweight infants. A prospective, randomized clinical trial was conducted over a 15-month period, from May 1997 through September 1998, in 80 preterm infants with birthweights <1500 g...

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.

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Clinical Trials Related to Nystatin

Gentian Violet Vs. Nystatin Oral Suspension for Treatment of Oropharyngeal Candidiasis [Recruiting]
The purpose of this study is to see which one of two medicines (topical gentian violet [GV] or nystatin oral suspension) is better than the other in treating Oral Candidiasis (OC). This will be measured by whether the study participant still has OC or sores in his/her mouth after 14 days of treatment. Also, safety and tolerability of GV and nystatin in the treatment of OC will be assessed.

Comparing the Safety and Efficacy of Topical Gentian Violet Versus Nystatin Oral Suspension for the Treatment of Oropharyngeal Candidiasis in HIV-Infected People in Countries Outside of the United States [Recruiting]
Oropharyngeal candidiasis (OC) is a common health issue for HIV-infected people. This study will compare the safety and effectiveness of nystatin oral suspension versus gentian violet (GV) for the treatment of OC.

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.

more trials >>

Reports of Suspected Nystatin Side Effects

Hypersensitivity (7)Erythema (5)Pruritus (4)Drug Ineffective (4)Developmental Delay (4)DRY Mouth (4)Duane's Syndrome (4)Cleft LIP and Palate (4)Torticollis (4)Craniosynostosis (4)more >>


Based on a total of 2 ratings/reviews, Nystatin has an overall score of 6. The effectiveness score is 6 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.

Nystatin review by care giver of 2 year old female patient

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

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.

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Page last updated: 2013-02-10

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