Nyata kit

Rx only

FOR TOPICAL USE ONLY.

NOT FOR OPHTHALMIC USE.

Description

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei. The molecularformula for Nystatin is C 47H 75N0 17. The molecular weight of Nystatin is 926.1.

Structural formula:

nystatinstructure

Nystatin topical powder is for dermatologic use.

Nystatin topical powder contains 100,000 USP nystatin units per gram dispersed in talc.

Clinical pharmacology

Pharmacokinetics

Nystatin is not absorbed from intact skin or mucous membrane.

Microbiology

Nystatin is an antibiotic which is both fungistatic and fungicidal in vitroagainst a wide varietyof 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 achange in membrane permeability and the subsequent leakage of intracellular components.On repeated subculturing with increasing levels of nystatin, Candida albicansdoes not developresistance 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 resistantto amphotericin as well. This resistance is lost when the antibiotic is removed.

Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

Indications and usage

Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycoticinfections caused by Candida albicans and other susceptible Candida species.

Nystatin topical powder is not indicated for systemic, oral, intravaginal orophthalmic use.

Contraindications

Nystatin topical powder is contraindicated in patients with a history of hypersensitivity to anyof its components.

Precautions

General

Nystatin topical powder should not be used for the treatment of systemic, oral, intravaginal orophthalmic infections.

If irritation or sensitization develops, treatment should be discontinued and appropriatemeasures taken as indicated. It is recommended that KOH smears, cultures, or other diagnosticmethods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.

Information for the patient

Patients using this medication should receive the following information and instructions:

1. The patient should be instructed to use this medication as directed (including thereplacement of missed doses). This medication is not for any disorder other than that forwhich it is prescribed.

2. Even if symptomatic relief occurs within the first few days of treatment, the patientshould be advised not to interrupt or discontinue therapy until the prescribed course oftreatment is completed.

3. If symptoms of irritation develop, the patient should be advised to notify the physicianpromptly.

Laboratory tests

If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methodsshould be repeated.

Carcinogenesis, mutagenesis, impairment of fertility

No long-term animal studies have been performed to evaluate the carcinogenic potential ofnystatin. No studies have been performed to determine the mutagenicity of nystatin or itseffects on male or female fertility.

Pregnancy

Teratogenic Effects

Category C

Animal reproduction studies have not been conducted with any nystatin topical preparation. Italso is not known whether these preparations can cause fetal harm when used by a pregnantwoman or can affect reproductive capacity. Nystatin topical powder should be prescribed for apregnant woman only if the potential benefit to the mother outweighs the potential risk to thefetus.

Nursing mothers

It is not known whether nystatin is excreted in human milk. Caution should be exercised whennystatin is prescribed for a nursing woman.

Pediatric use

Safety and effectiveness have been established in the pediatric population from birth to 16years. (See DOSAGE AND ADMINISTRATION.)

Geriatric use

Clinical studies with nystatin topical powder did not include sufficient numbers of subjectsaged 65 years and older to determine whether they respond differently than younger subjects.Other reported clinical experience has not identified differences in responses between elderlyand younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Adverse reactions

The frequency of adverse events reported in patients using nystatin topical powder is less than0.1 %. The more common events that were reported include allergic reactions, burning,itching, rash, eczema, and pain on application. (See PRECAUTIONS, General.)

Dosage and administration

Very moist lesions are best treated with the topical dusting powder.

Adults and Pediatric Patients (Neonates and Older)

Apply to candidal lesions two or three times daily until healing is complete. For fungalinfection of the feet caused by Candida species, the powder should be dusted on the feet, aswell as, in all foot wear.

How supplied

Nystatin topical powder, USP is supplied as 100, 000 units nystatin per gram inplastic squeeze bottles:
15 g (NDC 0316-0187-15)

Storage

Store at 20C to 25C (68F to 77F) [See USP Controlled Room Temperature]; avoidexcessive heat (40C/104F).

Keep tightly closed.

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873 USA

Distributed by:

Crown Laboratories, Inc.

Johnson City, TN 37604 USA

Revised: 07/2015

Rx Only

Ingredients and appearance - Product information

Nyata kit- Nystatin topical powder and exfoliating serum

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0316-1010
Route of Administration Topical

Product Characteristics

Color yellow (greenish yellow)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA065138 USA 2015/12/17

Labeler - Crown Laboratories( 079035945)

Nystatin topical powder- 15 gram label

Nystatin Topical Powder

Curatin exfoliating serum

Curatin Exfoliating Serum - 114 grams

Nyata carton

Nyata Carton