Nystatin Cream USP, 100,000 units per gram | Nystatin [Rebel Distributors Corp] | BioPortfolio

11:54 EST 27th January 2019 | BioPortfolio

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Rx only

Nystatin Cream is for dermatologic use.

Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very soluble in water, and slightly to sparingly soluble in alcohol. Structural formula:

Nystatin Cream contains the antifungal antibiotic nystatin at a concentration of 100,000 USP Nystatin Units per gram in an aqueous, perfumed cream base containing purified water, propylene glycol, methylparaben, propylparaben, white petrolatum, glyceryl monostearate, polyethylene glycol 400 monostearate, ceteareth-15, medical antifoam AF emulsion, aluminum hydroxide gel, titanium dioxide, sorbitol solution, and, if necessary, sodium hydroxide for pH adjustment.

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 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 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 Cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida (Monilia) albicans and other Candida species.

Nystatin Cream 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Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.

Nystatin Cream is not for ophthalmic use.

Nystatin is virtually nontoxic 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 Cream should be applied liberally to affected areas twice daily 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.

Nystatin Cream is a smooth yellow cream with a characteristic perfume odor.

Nystatin Cream is supplied in 15g (NDC 21695-761-15) and 30g (NDC 21695-761-30) tubes providing 100,000 USP Nystatin Units per gram.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Mfd. by: Taro Pharmaceuticals Inc.Brampton, Ontario, Canada L6T 1C1

Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320


Rebel Distributors Corp

Active Ingredients


Clinical Trials [15 Associated Clinical Trials listed on BioPortfolio]

A Study of Nystatin in HIV-Infected Patients

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...

A Comparison of Gentian Violet (GV) Mouth Washes, Nystatin, and Ketoconazole Tabs in Treating Oropharyngeal Candidiasis

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...

Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC

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...

Oral Nystatin Prophylaxis to Prevent Systemic Fungal Infection in Very Low Birth Weight Preterm Infants

This study determines the effectiveness of oral nystatin as prophylaxis in order to prevent systemic fungal infection in very low birth weight preterm neonates. 47 participants received or...

Photodynamic Therapy Against Candida Spp. in Complete Denture Wearers

Candida albicans is the most prevalent species in denture-related stomatitis (DS). There are several treatment options for this condition, including the use of antifungal agents such as ny...

PubMed Articles [13 Associated PubMed Articles listed on BioPortfolio]

Comparison of the efficacy of indocyanine green-mediated photodynamic therapy and nystatin therapy in treatment of denture stomatitis.

Candida species have an influence in the pathogenesis of denture stomatitis. The current study aimed to investigate the efficacy of indocyanine green (ICG)-mediated photodynamic therapy (PDT) in combi...

Efficacy of extract against species in patients with denture stomatitis.

Denture stomatitis is a chronic inflammation disease of the oral mucosa, which is specified by erythematous lesions mainly in the upper palate. Nystatin as a polyene, a class of antifungal agents, is ...

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

To evaluate the efficacy and safety of Streptococcus salivarius K12 as an adjuvant in treating oral candidiasis.

Pseudonocardia strain improvement for stimulation of the di-sugar heptaene Nystatin-like Pseudonocardia polyene B1 biosynthesis.

Pseudonocardia autotrophica was previously identified to produce a toxicity-reduced and solubility-improved disaccharide-containing anti-fungal compound belonging to the tetraene-family, Nystatin-like...

Erythrocyte ion content and dehydration modulate maximal Gardos channel activity in KCNN4 V282M/+ Hereditary Xerocytosis (HX) red cells.

Hereditary Xerocytosis (HX) is caused by missense mutations in either themechanosensitive cation channel, PIEZO1 or the Ca2-activated K channel, KCNN4. All HX-associated KCNN4 mutants studied to date ...

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