Nystatin

Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei
Nystatin Ointment USP, for topical use only, contains 100,000 USP Nystatin Units per gram, in an ointment base of light mineral oil and white petrolatum. The structural formula is as follows:

Molecular Weight 926.13

Molecular Formula C₄₇H₇₅NO₁₇

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 concentrations of nystatin, Candida albicans does not develop resistance to nystatin.Generally, resistance to nystatin does not develop during therapy. However, other species of 47 75 17 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.

Nystatin Ointment, is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.
Nystatin Ointment is not indicated for systemic, oral, intravaginal or ophthalmic use.

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

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.

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 Macleods Pharma USA, Inc., at 1-888-943-3210 or 1-855-926-338 or FDA at 1-800-FDA-1088 ( www.fda.gov/medwatch ).

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

Nystatin Ointment (100,000 USP Nystatin Units per gram) is a yellowish ointment available as follows:

NDC 33342-481-15 15 gram tube
NDC 33342-481-30 30 gram tube

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Manufactured for:
Macleods Pharma USA, Inc.

Princeton, NJ 08540

Manufacturer:
Macleods Pharmaceuticals Limited
At Oxalis Labs
Baddi, Himachal Pradesh, INDIA

Rev. 01/2021

Nystatin Ointment (100,000 USP Nystatin Units per gram)
Pack Count: 15 g Tube
NDC 33342-481-15
nystatin-tube-15-gm
Nystatin Ointment (100,000 USP Nystatin Units per gram)
Pack Count: 15 g Carton
NDC 33342-481-15
nystatin-carton-15-gm
Nystatin Ointment (100,000 USP Nystatin Units per gram)
Pack Count: 30 g Tube
NDC 33342-481-30
nystatin-tube-30-gm
Nystatin Ointment (100,000 USP Nystatin Units per gram)
Pack Count: 30 g Carton
NDC 33342-481-30

nystatin-carton-30-gm