INFORMATION FOR PATIENTS SECTION.

INFORMATION FOR THE PATIENT. Patients using this medication should receive the following information and instructions: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.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 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.. 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.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. The frequency of adverse events reported in patients using nystatin topical 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 ].

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

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.

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 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. 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.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Nyamyc(R) (Nystatin Topical Powder, USP) is contraindicated in patients with history of hypersensitivity to any of its components.

DESCRIPTION SECTION.

DESCRIPTION. Nystatin is polyene antifungal antibiotic obtained from Streptomyces nursei. Nyamyc(R) (Nystatin Topical Powder, USP) is for dermatologic use.Nyamyc(R) (Nystatin Topical Powder, USP) contains 100,000 USP nystatin units per gram dispersed in talc.. Chemical Structure.

DOSAGE & ADMINISTRATION SECTION.

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.

GENERAL PRECAUTIONS SECTION.

General. Nyamyc(R) (Nystatin Topical Powder, USP) 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.

GERIATRIC USE SECTION.

Geriatric Use. Clinical studies with nystatin topical powder did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Nyamyc(R) (Nystatin Topical Powder, USP) 100,000 units nystatin per gram is available as follow: Bottles of 15 g(NDC 0832-0465-15) Bottles of 30 g(NDC 0832-0465-30) Bottles of 60 g(NDC 0832-0465-60). STORAGE. Nyamyc(R) (Nystatin Topical Powder, USP). Store at 20 to 25C (68 to 77F); excursions permitted to 15 to 30C (59 to 86F) [See USP Controlled Room Temperature]. Avoid excessive heat (40C/104F). Keep tightly closed. Keep out of reach of children.Nyamyc is registered trademark of Upsher-Smith Laboratories, LLC.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Nyamyc(R) (Nystatin Topical Powder, USP) is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.Nyamyc(R) (Nystatin Topical Powder, USP) is not indicated for systemic, oral, intravaginal or ophthalmic use.

LABORATORY TESTS SECTION.

Laboratory Tests. If there is lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated.

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 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. 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.

NURSING MOTHERS SECTION.

Nursing Mothers. It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for nursing woman.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 15 gram Bottle Carton. NDC 0832-0465-15Nyamyc(R) Nystatin Topical Powder, USP100,000 USPunits per gramFOR TOPICAL USE ONLY.NOT FOR OPHTHALMIC USE.NET WT. 15 grams Rx only UPSHER-SMITH. PRINCIPAL DISPLAY PANEL 15 gram Bottle Carton.

PEDIATRIC USE SECTION.

Pediatric Use. Safety and effectiveness have been established in the pediatric population from birth to 16 years. [see DOSAGE AND ADMINISTRATION ].

PHARMACOKINETICS SECTION.

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

PRECAUTIONS SECTION.

PRECAUTIONS. General. Nyamyc(R) (Nystatin Topical Powder, USP) 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: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.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 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.. 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. Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether theses preparations can cause fetal harm when used by pregnant woman or can affect reproductive capacity. Nyamyc(R) (Nystatin Topical Powder, USP) 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 ]. Geriatric Use. Clinical studies with nystatin topical powder did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

PREGNANCY SECTION.

Pregnancy. Teratogenic Effects. Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether theses preparations can cause fetal harm when used by pregnant woman or can affect reproductive capacity. Nyamyc(R) (Nystatin Topical Powder, USP) should be prescribed for pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

SPL UNCLASSIFIED SECTION.

100,000 units per gramRx onlyFOR TOPICAL USE ONLY NOT FOR OPHTHALMIC USE.

STORAGE AND HANDLING SECTION.

STORAGE. Nyamyc(R) (Nystatin Topical Powder, USP). Store at 20 to 25C (68 to 77F); excursions permitted to 15 to 30C (59 to 86F) [See USP Controlled Room Temperature]. Avoid excessive heat (40C/104F). Keep tightly closed. Keep out of reach of children.Nyamyc is registered trademark of Upsher-Smith Laboratories, LLC.

TERATOGENIC EFFECTS SECTION.

Teratogenic Effects. Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether theses preparations can cause fetal harm when used by pregnant woman or can affect reproductive capacity. Nyamyc(R) (Nystatin Topical Powder, USP) should be prescribed for pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.