Nystop
Nystatin · Powder · Topical
Uses
Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.
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.
Contraindications
Nystatin Topical Powder is contraindicated in patients with a history of hypersensitivity to any of its components.
Precautions
General Nystatin Topical Powder 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 If there is a 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 a pregnant woman or can affect reproductive capacity. Nystatin topical preparations should be prescribed for a 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 a nursing woman. Pediatric Use Safety and effectiveness have been established in the pediatric population from birth to 16 years. (See DOSAGE AND ADMINISTRATION ).
Side effects
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 .)
Pregnancy
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 a pregnant woman or can affect reproductive capacity. Nystatin topical preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.
Pediatric use
Pediatric Use Safety and effectiveness have been established in the pediatric population from birth to 16 years. (See DOSAGE AND ADMINISTRATION ).
Description
Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. The molecular formula for Nystatin is C 47 H 75 NO 17 . The molecular weight of Nystatin is 926.1. Structural formula: Nystatin Topical Powder USP is for dermatologic use. Nystatin Topical Powder USP contains 100,000 USP nystatin units per gram dispersed in talc. Structural Formula
How supplied
Nystop ® Nystatin Topical Powder USP is supplied as 100,000 units nystatin per gram in 15 g, 30 g and 60 g plastic squeeze bottles. (NDC 0574-2008-15) (NDC 0574-2008-30) (NDC 0574-2008-02) STORAGE Store at controlled room temperature 15°-30°C (59°-86°F); avoid excessive heat (40°C; 104°F). Manufactured by Padagis ® Minneapolis, MN 55427 www.padagis.com Rev 10-24 2204966 3W614 RC F4
Storage
Store at controlled room temperature 15°-30°C (59°-86°F); avoid excessive heat (40°C; 104°F). Manufactured by Padagis ® Minneapolis, MN 55427 www.padagis.com Rev 10-24 2204966 3W614 RC F4
Patient information
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.
Label text from the FDA structured product label by Padagis US LLC (revised Oct 31, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Nystatin in 7 products
Nystop NDC products (7)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 63629-8696 | Nystatin 100000 [USP'U]/g Powder | Bryant Ranch Prepack | ANDA |
| 63629-8697 | Nystatin 100000 [USP'U]/g Powder | Bryant Ranch Prepack | ANDA |
| 63629-8698 | Nystatin 100000 [USP'U]/g Powder | Bryant Ranch Prepack | ANDA |
| 71335-2845 | Nystatin 100000 [USP'U]/g Powder | Bryant Ranch Prepack | ANDA |
| 71335-2869 | Nystatin 100000 [USP'U]/g Powder | Bryant Ranch Prepack | ANDA |
| 72162-1124 | Nystatin 100000 [USP'U]/g Powder | Bryant Ranch Prepack | ANDA |
| 0574-2008 | Nystatin 100000 [USP'U]/g Powder | Padagis US LLC | ANDA |
Frequently asked questions
What is Nystop used for?
Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.
What are the side effects of Nystop?
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 .) See the full label for the complete list.
Who makes Nystop?
Nystop is listed by 2 labelers in the FDA NDC directory, including Bryant Ranch Prepack, Padagis US LLC.