Nystatin
- Nystatin NYSTATIN 100000 [USP'U]/g RPK Pharmaceuticals, Inc.
- Nystatin NYSTATIN 100000 [USP'U]/g Actavis Pharma, Inc.
- Nystatin and Triamcinolone Acetonide NYSTATIN 100000 [USP'U]/g Bryant Ranch Prepack
- Nystatin NYSTATIN 100000 [USP'U]/g Proficient Rx LP
- Nystatin NYSTATIN 100000 [USP'U]/g Cosette Pharmaceuticals, Inc.
- Nystatin and triamcinolone acetonide NYSTATIN 100000 [USP'U]/g Bryant Ranch Prepack
- Nystatin and Triamcinolone Acetonide NYSTATIN 100000 [USP'U]/g Bryant Ranch Prepack
- Nystatin NYSTATIN 100000 [USP'U]/g Padagis Israel Pharmaceuticals Ltd
- Nystatin and Triamcinolone Acetonide NYSTATIN 100000 [USP'U]/g Encube Ethicals Private Limited
- Nystatin and triamcinolone acetonide NYSTATIN 100000 [USP'U]/g Bryant Ranch Prepack
- Nystatin and Triamcinolone Acetonide NYSTATIN 100000 [USP'U]/g Bryant Ranch Prepack
- Nystatin NYSTATIN 100000 [USP'U]/g Proficient Rx LP
- Nystatin and Triamcinolone Acetonide NYSTATIN 100000 [USP'U]/g Strides Pharma Science Limited
- Nystatin and Triamcinolone Acetonide NYSTATIN 100000 [USP'U]/g E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
- Nystatin and triamcinolone acetonide NYSTATIN 100000 [USP'U]/g Bryant Ranch Prepack
- Nystatin and Triamcinolone Acetonide NYSTATIN 100000 [USP'U]/g Bryant Ranch Prepack
- Nystatin and Triamcinolone Acetonide NYSTATIN 100000 [USP'U]/g Zydus Lifesciences Limited
- Nystatin and Triamcinolone Acetonide NYSTATIN 100000 [USP'U]/g Alembic Pharmaceuticals, Inc.
- Nystatin and Triamcinolone Acetonide NYSTATIN 100000 [USP'U]/g Bryant Ranch Prepack
- Nystatin and Triamcinolone Acetonide NYSTATIN 100000 [USP'U]/g Bryant Ranch Prepack
- Nystatin NYSTATIN 100000 [USP'U]/g E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
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
20221001
Version
5
Spl Product Data Elements
Nystatin Nystatin NYSTATIN NYSTATIN PETROLATUM
Application Number
ANDA062840
Brand Name
Nystatin
Generic Name
Nystatin
Product Ndc
63187-464
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Package Label Principal Display Panel
Package/Label Display Panel 63187-464-15
Spl Unclassified Section
Rx Only
How Supplied
HOW SUPPLIED Nystatin Ointment USP 100,000 units/g 15 g tube (0 . 53 oz) Store at controlled room temperature 15°-30°C (59°-86°F). Do not freeze. Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA FORM NO. 0166 Rev. 10/19 VC2752 Relabeled By: Proficient Rx LP Thousand Oaks, CA 91320
Precautions
PRECAUTIONS Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
Disclaimer
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).
Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.
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.