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Pedi-Dri Powder

Generic Name: nystatin
Dosage Form: powder

PEDI-DRI® TOPICAL POWDER
Nystatin Topical Powder USP

Rx only
For topical use only.
Not for ophthalmic use.

Pedi-Dri Powder Description

PEDI-DRI®, Nystatin Topical Powder USP is for dermatologic use.

PEDI-DRI® provides, in each gram, 100,000 USP nystatin units dispersed in talc.

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Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei.

Pedi-Dri Powder - 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 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. stalltoides) 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 Pedi-Dri Powder

PEDI-DRI® 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

PEDI-DRI® 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 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 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.

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).

Adverse Reactions

The frequency of adverse events reported in patients using nystatin topical preparations is less that 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application (see PRECAUTIONS: General.)

Pedi-Dri 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 foot wear.

PEDI-DRI® does not stain skin or mucous membranes and provides a simple, convenient means of treatment.

How is Pedi-Dri Powder Supplied

PEDI-DRI®, Nystatin Topical Powder USP, supplied as 2 oz. of powder in a 6 oz. plastic squeeze bottle.

PEDI-DRI® TOPICAL POWDER
Nystatin Topical Powder USP 56.7g (2oz.)
NDC 0884-0396-02

Keep tightly closed.

Store at controlled room temperature 15° - 30°C (59° - 86°F); avoid excessive heat 40°C; 104°F).

Manufactured for:
PEDINOL PHARMACAL INC.
Farmingdale, NY 11735
(09-01)

Each gram contains 100,000 USP nystatin units dispersed in talc.

FOR TOPICAL USE ONLY.

Not for Ophthalmic Use.

Usual Dosage: Apply to affected area 2 or 3 times daily.

See insert – Keep tightly closed

Store at controlled room temperature 15°-30°C (59° - 86°F); avoid excessive heat (40°C; 104°F).

Manufactured for:
PEDINOL PHARMACAL INC.
Farmingdale, NY 11735

2122662 (09-01)

PRINCIPAL DISPLAY PANEL - 56.7 g Bottle Label

NDC 0884-0396-02

PEDI-DRI®
TOPICAL POWDER
Nystatin Topical Powder USP
100,000 USP units per gram

Rx only

Net Wt: 56.7g (2 oz.)

PEDiNOL

PHARMACAL INC

PEDI-DRI 
nystatin powder
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0884-0396
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 WHITE Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:0884-0396-02 56.7 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064118 08/16/1996
Labeler - Pedinol Pharmacal, Inc. (064737125)
Establishment
Name Address ID/FEI Operations
Paddock Laboratories, LLC. 967694121 MANUFACTURE
Revised: 02/2012
 
Pedinol Pharmacal, Inc.
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