Label: NYSTATIN- nystatin cream cream
- NDC Code(s): 0713-0678-15, 0713-0678-31
- Packager: Cosette Pharmaceuticals, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated November 2, 2020
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Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei.
C47H75NO17 Molecular Weight: 926.13
Nystatin Cream, USP is for dermatologic use.
Nystatin cream for topical use, contains 100,000 USP nystatin units per gram in a cream base containing aluminum hydroxide gel, ceteareth-15, glyceryl monostearate, polyethylene glycol 400 monostearate, propylene glycol, purified water, simethicone emulsion, sorbitol solution, titanium dioxide, white petrolatum, methylparaben, propylparaben, and sodium hydroxide.
- CLINICAL PHARMACOLOGY
Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a 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 a 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.
- INDICATIONS AND USAGE
Nystatin cream 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:
1. 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.
2. 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.
3. If symptoms of irritation develop, the patient should be advised to notify the physician promptly.
- Laboratory Tests
- Carcinogenesis, Mutagenesis, and Impairment of Fertility
Animal reproduction studies have not been conducted with any nystatin cream. It also is not known whether this cream can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin cream should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.
- Nursing Mothers
Safety and effectiveness have been established in the pediatric population from birth to 16 years.
(See DOSAGE AND ADMINISTRATION.)
Clinical studies with nystatin cream 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.
The frequency of adverse events reported in patients using nystatin cream 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.
- DOSAGE AND ADMINISTRATION
Nystatin Cream, USP is a smooth yellow cream.
Nystatin Cream, USP is supplied in 15 g (NDC 0713-0678-15) and 30 g (NDC 0713-0678-31) tubes providing 100,000 USP Nystatin units per gram.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing.
Cosette Pharmaceuticals, Inc.
111 Coolidge Street
South Plainfield, NJ 07080
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
nystatin cream cream
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0713-0678 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Nystatin (UNII: BDF1O1C72E) (Nystatin - UNII:BDF1O1C72E) Nystatin 100000 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength Algeldrate (UNII: 03J11K103C) Ceteareth-15 (UNII: 867H4YOZ8Z) Glyceryl Monostearate (UNII: 230OU9XXE4) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Dimethicone (UNII: 92RU3N3Y1O) Sorbitol (UNII: 506T60A25R) Titanium Dioxide (UNII: 15FIX9V2JP) Petrolatum (UNII: 4T6H12BN9U) Methylparaben (UNII: A2I8C7HI9T) Propylparaben (UNII: Z8IX2SC1OH) Sodium Hydroxide (UNII: 55X04QC32I) Polyethylene Glycol 400 (UNII: B697894SGQ) Product Characteristics Color YELLOW Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0713-0678-15 1 in 1 CARTON 04/01/2015 1 15 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0713-0678-31 1 in 1 CARTON 04/01/2015 2 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA061966 04/01/2015 Labeler - Cosette Pharmaceuticals, Inc. (116918230) Registrant - Cosette Pharmaceuticals, Inc. (116918230) Establishment Name Address ID/FEI Business Operations Cosette Pharmaceuticals, Inc. 116918230 analysis(0713-0678) , label(0713-0678) , manufacture(0713-0678) , pack(0713-0678)