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FDA Drug information

Nystatin

Read time: 1 mins
Marketing start date: 23 Nov 2024
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Summary of product characteristics


Adverse Reactions

ADVERSE REACTIONS Nystatin is virtually nontoxic and nonsensitizing and is well tolerated by all age groups including debilitated infants, even on prolonged administration. If irritation on topical application should occur, discontinue medication.

Contraindications

CONTRAINDICATIONS Nystatin ointment, USP is contraindicated in patients with a history of hypersensitivity to any of its components.

Description

DESCRIPTION Each gram of nystatin ointment, USP contains 100,000 units of nystatin in a white petrolatum base.

Dosage And Administration

DOSAGE AND ADMINISTRATION Nystatin ointment, USP should be applied liberally to the affected areas twice a day or as indicated until healing is complete. The ointment does not stain the skin or mucous membranes and it provides a simple, convenient means of treatment.

Indications And Usage

INDICATIONS AND USAGE Nystatin ointment, USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida (Monilia) albicans and other Candida species.

Clinical Pharmacology

CLINICAL PHARMACOLOGY Nystatin is an antifungal antibiotic which is both fungistatic and fungicidal in vitro, against a wide variety of yeasts and yeast-like fungi. It probably acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin is a polyene antibiotic of undetermined structural formula that is obtained from Streptomyces noursei , and is the first well tolerated antifungal antibiotic of dependable efficacy for the treatment of cutaneous, oral and intestinal infections caused by Candida (Monilia) albicans and other Candida species. It exhibits no appreciable activity against bacteria. Nystatin provides specific therapy for all localized forms of candidiasis. Symptomatic relief is rapid, often occurring within 24 to 72 hours after the initiation of treatment. Cure is effected both clinically and mycologically in most cases of localized candidiasis.

Effective Time

20230623

Version

6

Spl Product Data Elements

Nystatin Nystatin NYSTATIN NYSTATIN PETROLATUM

Application Number

ANDA062840

Brand Name

Nystatin

Generic Name

Nystatin

Product Ndc

0472-0166

Product Type

HUMAN PRESCRIPTION DRUG

Route

TOPICAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0472-0166-15 Nystatin Ointment, USP 100,000 units per gram Rx only For External Use Only - Not for Ophthalmic Use 15 g (0.53 oz) 15 g (0.53 oz)

Spl Unclassified Section

Rx only

How Supplied

HOW SUPPLIED Nystatin ointment, USP 100,000 units/g is available as follows: 15 g tube (0 . 53 oz) NDC 0472-0166-15 30 g tube (1 . 1 oz) NDC 0472-0166-30 Store at controlled room temperature 15° to 30°C (59° to 86°F). Do not freeze. Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. B 6/2023

Precautions

PRECAUTIONS Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.

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The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).

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Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.