Track topics on Twitter Track topics that are important to you
FOR TOPICAL USE ONLY • NOT FOR OPHTHALMIC USE
Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei.
Nystatin cream is for dermatologic use.
Nystatin cream for topical use, contains 100,000 USP nystatin units per gram in an aqueous, perfumed cream base containing aluminum hydroxide gel, ceteareth-15, glyceryl monostearate, polyethylene glycol 400 monostearate, propylene glycol, purified water, simethicone emulsion, sorbitol solution, titanium dioxide, white petrolatum, with methylparaben and propylparaben as preservatives and, if necessary, sodium hydroxide for pH adjustment.
Nystatin is not absorbed from intact skin or mucous membrane.
Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsis glabrata, Tricophyton rubrum, T. mentagrophytes. Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components. On repeated subculturing with increasing levels of nystatin, Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of Candida (C. tropicalis, C. guilliermondi, C. krusei, and C. stellatoides) become quite resistant on treatment with nystatin and simultaneously become cross resistant to amphotericin as well. This resistance is lost when the antibiotic is removed. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.
Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.
This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.
Nystatin cream is contraindicated in patients with a history of hypersensitivity to any of its components.
Nystatin cream should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections.
If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.
Patients using this medication should receive the following information and instructions:
If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated.
No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or the effects on male or female fertility.
Animal reproduction studies have not been conducted with any nystatin cream. It also is not known whether this cream can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin cream should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.
It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.
Safety and effectiveness have been established in the pediatric population from birth to 16 years.
(See DOSAGE AND ADMINISTRATION .)
Clinical studies with nystatin cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
The frequency of adverse events reported in patients using nystatin cream is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application.
(See PRECAUTIONS: General .)
Apply liberally to affected areas twice daily or as indicated until healing is complete.
Nystatin Cream USP is a smooth yellow to light green cream with a characteristic perfume odor.
Nystatin Cream USP is supplied in 15 g (NDC 51672-1289-1) and 30 g (NDC 51672-1289-2) tubes providing 100,000 USP Nystatin Units per gram.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing.
Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532
Revised: August, 2010
Nystatin Cream USP, 100,000 units per gram
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
Keep this and all medications out of the reach of children.
Taro Pharmaceuticals U.S.A., Inc.
NYSTATIN OINTMENT USP
NYSTATIN OINTMENT USP (100,000 units/g)
Nystatin Cream USP, 100,000 units per gram
NYSTATIN CREAM USP (100,000 units/g)
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...
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...
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...
Nystatin is a polyene antimycotic obtained from Streptomyces noursei used in the treatment of topical and transdermal fungal infection. Nystatin is nearly insoluble in water (
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...
Acne Dermatology Eczema Psoriasis Wound Care Dermatology is the medical specialty concerned with the diagnosis and treatment of skin disorders (Oxford Medical Dictionary). As well as studying how the skin works, dermatology covers...
NYSTATIN CREAM USP 100000usp units pergramnystatin 100000nystatin uspnystatin cream 100000 units per gramnystatin cream usp 100000 usp units per framnystatin cream usp 100000 usp units per framnystatin cream usp 100000 usp units per framcream usp 100000nystatinnystatin 100000Nystatin 100000 nystatin cream usp 100.000 units IN GRAMnystatin cream appearencenystatin cream 100000 usp units per gramNYSTATIN10000 cream