Nyamyc - Nystatin powder prescribing information
INDICATIONS AND USAGE
Nyamyc® (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® (Nystatin Topical Powder, USP) 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
Nyamyc® (Nystatin Topical Powder, USP) is contraindicated in patients with a history of hypersensitivity to any of its components.
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 ].
DESCRIPTION
Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei.
Nyamyc® (Nystatin Topical Powder, USP) is for dermatologic use.
Nyamyc® (Nystatin Topical Powder, USP) contains 100,000 USP nystatin units per gram dispersed in talc.
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 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.
HOW SUPPLIED
Nyamyc® (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® (Nystatin Topical Powder, USP)
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid excessive heat (40°C/104°F). Keep tightly closed. Keep out of reach of children.
Nyamyc is a registered trademark of Upsher-Smith Laboratories, LLC.
