Advertisement
Advertise here Publish your press releases here Sponsor BioPortfolio
Follow us on Twitter Sign up for daily news and research emails Contributors wanted

Nystatin Cream USP, 100,000 units per gram | Nystatin

03:50 EDT 1st August 2014 | BioPortfolio
Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

Rx only

FOR TOPICAL USE ONLY • NOT FOR OPHTHALMIC USE

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei.

Structural formula:

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.

IMAGE nystatin-01.jpg

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

PK-1161-4 107

NDC 51672-1289-2

30 g

Nystatin Cream USP, 100,000 units per gram

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

Rx only

Keep this and all medications out of the reach of children.

TARO

IMAGE nystatin-02.jpg

Manufacturer

Taro Pharmaceuticals U.S.A., Inc.

Active Ingredients

Source

Clinical Trials [9 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...

Antifungal Therapy for Fever and Neutropenia in Patients Receiving Treatment for Hematologic Cancer

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...

PubMed Articles [11 Associated PubMed Articles listed on BioPortfolio]

Nystatin and killer toxin sensitivity of free and immobilizedSaccharomyces cerevisiae.

The inhibitory effect of nystatin and killer toxin on the growth of free and covalently-immobilizedSaccharomyces cerevisiae cells was studied. The resistance of immobilized cells to both agents was ac...

Use of topical lidocaine, diphenhydramine hydrochloride, nystatin, and gabapentin swish in treatment for post-radiation neuropathy and oral mucositis.

Etiology of vaginal infections in Ouagadougou (Burkina Faso).

to determine the specific antimicrobial activity of the drugs proposed in the national algorithm for treatment of vaginal infections. Over a three-month period, the bacteriological laboratory of the Y...

Candiduria in children and susceptibility patterns of recovered Candida species to antifungal drugs in Ahvaz.

Background: Candiduria presents as an increasingly common nosocomial infection, which may involves urinary tract. Spectrum of disease is varying from asymptomatic candiduria to clinical sepsis. Diseas...

Antibiotics sensitivity of Candida clinical and food-borne isolates.

Candida is a yeast species recognized as the most frequent etiological agent of systemic and invasive thrush in humans. Invasions can affect all tissues, organs and systems of human in various stages...

Search BioPortfolio:
Advertisement

Relevant Topic

Dermatology
Latest News Clinical Trials Research Drugs Reports Corporate
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 a range of diseases including skin allergies, alopecia, Behcet'...

Advertisement

Drugs and Medication Quicklinks


Searches Linking to this Drug Record