NYAMYC SUMMARY
Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei.
Nyamyc™ (Nystatin Topical Powder, USP) is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.
This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.
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NEWS HIGHLIGHTS
Clinical Trials Related to Nyamyc (Nystatin Cutaneous)
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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