HOW SUPPLIED SECTION.

HOW SUPPLIED. Nystatin Ointment, USP (100,000 USP Nystatin Units per gram) is light yellow to yellow ointment available as follows:NDC 0713-0686-15 15 gram tubeNDC 0713-0686-31 30 gram tubeStore at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature].Distributed by:Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0686CPLNC2 Rev: 03/2021 VC7553.

INDICATIONS & USAGE SECTION.

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.

ADVERSE REACTIONS SECTION.

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.

CLINICAL PHARMACOLOGY SECTION.

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 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 change in membrane permeability and the subsequent leakage of intracellular components. On repeated subculturing with increasing concentrations 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.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION Nystatin OintmentAdults and Pediatric Patients (Neonates and Older):Apply liberally to affected areas twice daily or as indicated until healing is complete.

GENERAL PRECAUTIONS SECTION.

General. Nystatin Ointment 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.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS Nystatin Ointment is contraindicated in patients with history of hypersensitivity to any of their components.

DESCRIPTION SECTION.

DESCRIPTION Nystatin Ointment, USP is for dermatologic use. Nystatin Ointment, USP for topical use only, contains 100,000 USP nystatin units per gram, in white petrolatum base.Nystatin is polyene antifungal antibiotic drug obtained from Streptomyces nursei. The structural formula is as follows:Molecular Weight 926.13Molecular Formula 47H 75NO 17 image description.

MICROBIOLOGY SECTION.

Microbiology. Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against 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 change in membrane permeability and the subsequent leakage of intracellular components. On repeated subculturing with increasing concentrations 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL. NDC 0713-0686-15Nystatin Ointment, USP100,000 USP Nystatin Units Per Gram15 gRx onlyFOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.Cosette Pharmaceuticals, Inc.NDC 0713-0686-15Nystatin Ointment, USP100,000 USP Nystatin Units Per Gram15 gRx onlyFOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.Cosette Pharmaceuticals, Inc.NDC 0713-0686-31Nystatin Ointment, USP100,000 USP Nystatin Units Per Gram30 gRx onlyFOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.Cosette Pharmaceuticals, Inc.NDC 0713-0686-31Nystatin Ointment, USP100,000 USP Nystatin Units Per Gram30 gRx onlyFOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.Cosette Pharmaceuticals, Inc.. 15gm-carton. 15gm-tube. 30gm-carton. 30gm-tube.

PHARMACOKINETICS SECTION.

Pharmacokinetics. Nystatin is not absorbed from intact skin or mucous membrane.

PRECAUTIONS SECTION.

PRECAUTIONS . General. Nystatin Ointment 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 these medications should receive the following information and instructions: The patient should be instructed to use these medications as directed (including the replacement of missed doses). These medications are not for any disorder other than that for which they are prescribed.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.If symptoms of irritation develop, the patient should be advised to notify the physician promptly.. The patient should be instructed to use these medications as directed (including the replacement of missed doses). These medications are not for any disorder other than that for which they are prescribed.. 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.. If symptoms of irritation develop, the patient should be advised to notify the physician promptly.. Laboratory Tests. If there is 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 pregnant woman or can affect reproductive capacity. Nystatin topical preparations should be prescribed for 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 nursing woman.. Pediatric Use. Safety and effectiveness have been established in the pediatric population from birth to 16 years.See DOSAGE AND ADMINISTRATION.

SPL UNCLASSIFIED SECTION.

INFORMATION FOR THE PATIENT. Patients using these medications should receive the following information and instructions: The patient should be instructed to use these medications as directed (including the replacement of missed doses). These medications are not for any disorder other than that for which they are prescribed.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.If symptoms of irritation develop, the patient should be advised to notify the physician promptly.. The patient should be instructed to use these medications as directed (including the replacement of missed doses). These medications are not for any disorder other than that for which they are prescribed.. 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.. If symptoms of irritation develop, the patient should be advised to notify the physician promptly.