MYCOSTATIN- nystatin cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E)

Available from:

Direct_Rx

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nystatin Cream USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin Cream USP is not indicated for systemic, oral, intravaginal or ophthalmic use. Nystatin Cream USP is contraindicated in patients with a history of hypersensitivity to any of its components.

Product summary:

Nystatin Cream USP (100,000 USP Nystatin Units per gram) is a yellow cream available as follows: 15 g tube (NDC 45802-059-35) 30 g tube (NDC 45802-059-11)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MYCOSTATIN- NYSTATIN CREAM
DIRECT_RX
----------
NYSTATIN
For Dermatologic Use Only
Not For Ophthalmic Use
Rx Only
Nystatin is a polyene antifungal antibiotic obtained from Streptomyces
noursei. The
molecular formula is C47H75NO17, and the molecular weight is 926.13.
Structural formula:
[structural formula]
Nystatin Cream USP is for dermatologic use.
Nystatin Cream USP for topical use, contains 100,000 USP nystatin
units per gram.
Inactive ingredients: emulsifying wax, glycerin, isopropyl myristate,
lactic acid, purified
water, sodium hydroxide, and sorbic acid.
Pharmacokinetics
Nystatin Cream USP 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.
Nystatin Cream USP is indicated in the treatment of cutaneous or
mucocutaneous
mycotic infections caused by Candida albicans and other susceptible
Candida species.
Nystatin Cream USP is not indicated for systemic, oral, intravaginal
or ophthalmic use.
Nystatin Cream USP is contraindicated in patients with a history of
hypersensitivity to
any of its co