NYSTATIN OINTMENT USP | Nystatin
For Dermatologic Use Only
Not For Ophthalmic Use
Nystatin Ointment USP for topical use only, contains 100,000 USP Nystatin units per gram, in an ointment base of light mineral oil and white petrolatum. The structural formula is as follows:
Molecular Weight 926.13
Molecular Formula CHNO
Nystatin is an antifungal antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. It probably acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin is a polyene antibiotic that is obtained from Streptomyces noursei, and is the first well tolerated antifungal antibiotic of dependable efficacy for the treatment of cutaneous, oral and intestinal infections caused by Candida [Monilia]albicans and other Candida species. It exhibits no appreciable activity against bacteria.
Nystatin Ointment USP provides specific therapy for all localized forms of candidiasis. Symptomatic relief is rapid, often occurring within 24 to 72 hours after the initiation of treatment. Cure is effected both clinically and mycologically in most cases of localized candidiasis.
Nystatin Ointment USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia]albicans and other Candida species.
Nystatin Ointment USP is contraindicated in patients with a history of hypersensitivity to any of its components.
Should a reaction of hypersensitivity occur, the drug should be immediately withdrawn and appropriate measures taken.
This preparation is not for ophthalmic use.
Nystatin Ointment USP is virtually non-toxic and nonsensitizing and is well tolerated by all age groups including debilitated infants, even on prolonged administration. If irritation on topical application should occur, discontinue medication.
Nystatin Ointment USP should be applied liberally to affected areas twice a day or as indicated until healing is complete. Nystatin cream is usually preferred to nystatin ointment in candidiasis involving intertriginous areas; very moist lesions, however, are best treated with nystatin topical powder.
This preparation does not stain skin or mucous membranes and provides a simple, convenient means of treatment.
Nystatin Ointment USP (100,000 USP Nystatin Units per gram) is a yellow ointment available as follows:
15 g tube (NDC 45802-048-35)
30 g tube (NDC 45802-048-11)
Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
BRONX, NY 10457
ALLEGAN, MI 49010
Nystatin Ointment USP
(100,000 USP Nystatin Units)
Nystatin Ointment USP
(100,000 USP Nystatin Units)
Perrigo New York Inc
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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 safe...
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 relative...
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 o...
RATIONALE: Antifungal therapy with liposomal nystatin may reduce fever and neutropenia in patients undergoing treatment for hematologic cancer. It is not yet known whether liposomal nystat...
Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome
To compare the efficacy, safety, and toleration of fluconazole as a single daily oral suspension for 14 days versus nystatin oral suspension 4 times daily for 14 days in the treatment of o...
The aim of this study was to determine and compare the efficacy of treatment with fluconazole and nystatin in Brazilian women with vaginal Candida. In a population of 932 women, vaginal cultures were...
Nystatin is a topical antifungal agent. Its wide spectrum of action and low cost make it a treatment of choice. Though it is safe for external ear use, no study has proven its safety in cases of tympa...
Nystatin is commonly employed to treat fungal infections in the mouth. It is not absorbed via the stomach and it will therefore not treat fungal infections in any part of the body other than the mouth...
Gerodontology 2011; doi: 10.1111/j.1741-2358.2011.00544.x Comparison of therapeutic effect of aqueous extract of garlic and nystatin mouthwash in denture stomatitis Introduction: Denture stomatitis...
To develop more effective antifungal microparticulate therapeutic systems for the treatment of Candida vaginitis, microparticles containing nystatin were elaborated by emulsification/internal gelation...