Nystatin Powder

Dosage Form: powder
Nystatin Topical Powder, USP

FOR TOPICAL USE ONLY

NOT FOR OPTHALMIC USE

Rx Only

P5196 04/06

Nystatin Powder Description

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei.

Structural formula:

Nystatin topical powder is for dermatologic use.

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

Nystatin Powder - Clinical Pharmacology

Phamacokinetics

Nystatin is not absorbed from intact skin or mucous membrane.

Microbiology

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.

Indications and Usage for Nystatin Powder

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

This preparation is not indicated for systemic, oral, intravaginal, or ophthalmic use.

Contraindications

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

Precautions

General

Nystatin topical powder 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.

Information for Patients

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

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


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


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

Laboratory Tests

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

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 its effects on male or female fertility.

Pregnancy

Teratogenic Effects - Category C

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

Nursing Mothers

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

Pediatric Use

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

Geriatric Use

Clinical studies with nystatin topical powder 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.

Adverse Reactions

The frequency of adverse events reported in patients using nystatin topical preparations 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).

Nystatin Powder 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 fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as in all footwear.

How is Nystatin Powder Supplied

Nystatin topical powder, USP, is supplied as 100,000 units nystatin per gram, packaged as follows:

NDC 58177-839-45 15 gram bottle

NDC 58177-839-46 30 gram bottle

NDC 58177-839-61 60 gram bottle

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Avoid excessive heat 40°C (104°F). Keep tightly closed.

Manufactured by

KV Pharmaceutical Co. for

ETHEX Corporation

St. Louis, MO 63044

P5196 4/06

Principal Displacy Panel 15 g Bottle Label

NDC 58177-839-45

Nystatin Topical

Powder,USP

100,000 USP

units per gram

15 grams Rx Only

P5194-1 01/06

ETHEX ETHEX

Principal Displacy Panel 30 g Bottle Label

NDC 58177-839-46

Nystatin Topical

Powder,USP

100,000 USP

units per gram

30 grams Rx Only

ETHEX ETHEX

Principal Displacy Panel 60 g Bottle Label

NDC 58177-839-61

Nystatin Topical

Powder,USP

100,000 USP

units per gram

60 grams Rx Only

ETHEX ETHEX

NYSTATIN  nystatin  powder

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 58177-839 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Nystatin (Nystatin) Nystatin 100000 [USP'U]  in 1 g

Inactive Ingredients Ingredient Name Strength Talc

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 58177-839-45 15 g In 1 BOTTLE None 2 58177-839-46 30 g In 1 BOTTLE None 3 58177-839-61 60 g In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA065321	10/13/2009

Labeler - Ethex Corporation (615424686)

Registrant - KV Pharmaceutical Co. (006291405)

Establishment
Name	Address	ID/FEI	Operations
KV Pharmaceutical Co. (Westport)		152053658	manufacture

Establishment
Name	Address	ID/FEI	Operations
KV Pharmaceutical Co. (ECI)		034060843	analysis

Revised: 10/2010Ethex Corporation

More Nystatin Powder resources

• Nystatin Powder Use in Pregnancy & Breastfeeding
• Nystatin Powder Support Group
• 6 Reviews for Nystatin - Add your own review/rating

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