Nystatin Ointment
Generic Name: nystatin ointment
Brand Names:
Nystatin
DESCRIPTION Nystatin Ointment, USP is for dermatologic use. Nystatin Ointment, USP for topical use only, contains 100,000 USP nystatin units per gram, in a white petrolatum base. Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei . The structural formula is as follows: Molecular Weight 926.13 Molecular Formula C 47 H 75 NO 17 image description
Overview
DESCRIPTION Nystatin Ointment, USP is for dermatologic use. Nystatin Ointment, USP for topical use only, contains 100,000 USP nystatin units per gram, in a white petrolatum base. Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei . The structural formula is as follows: Molecular Weight 926.13 Molecular Formula C 47 H 75 NO 17 image description
Uses
INDICATIONS AND USAGE Nystatin Ointment, USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candidaspecies. Nystatin Ointment, USP is not indicated for systemic, oral, intravaginal or ophthalmic use.
Dosage
DOSAGE AND ADMINISTRATION Nystatin Ointment Adults and Pediatric Patients (Neonates and Older): Apply liberally to affected areas twice daily or as indicated until healing is complete.
Side Effects
ADVERSE REACTIONS The frequency of adverse events reported in patients using Nystatin Ointment 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. ) To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Warnings
CONTRAINDICATIONS Nystatin Ointment is contraindicated in patients with a history of hypersensitivity to any of their components.
Storage
HOW SUPPLIED Nystatin Ointment, USP (100,000 USP Nystatin Units per gram) is a light yellow to yellow ointment available as follows: NDC 0713-0686-15 15 gram tube NDC 0713-0686-31 30 gram tube Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0686CPLNC3 Rev.03/2022 VC7623
Frequently Asked Questions
What is Nystatin Ointment used for?▼
INDICATIONS AND USAGE Nystatin Ointment, USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candidaspecies. Nystatin Ointment, USP is not indicated for systemic, oral, intravaginal or ophthalmic use.
What are the side effects of Nystatin Ointment?▼
ADVERSE REACTIONS The frequency of adverse events reported in patients using Nystatin Ointment 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. ) To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
What are the important warnings for Nystatin Ointment?▼
CONTRAINDICATIONS Nystatin Ointment is contraindicated in patients with a history of hypersensitivity to any of their components.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.