NYSTATIN- nystatin cream cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

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. This cream is not indicated for systemic, oral, intravaginal or ophthalmic use. Nystatin cream is contraindicated in patients with a history of hypersensitivity to any of its components. 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.

Product summary:

Nystatin Cream, USP is a smooth yellow cream. Nystatin Cream, USP is supplied 30 g (NDC 68071-2483-3) 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. Manufactured by: Cosette Pharmaceuticals, Inc. 111 Coolidge Street South Plainfield, NJ 07080 Iss. 08/2019 8-0678CP1

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NYSTATIN- NYSTATIN CREAM CREAM
NUCARE PHARMACEUTICALS,INC.
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DESCRIPTION
Nystatin is a polyene antifungal antibiotic obtained from
_Streptomyces nursei_.
Structural formula:
C
H NO 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
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
47
75
17
appreciable activity against bacteria, protozoa, or viruses.
INDICATIONS AND USAGE
Nystatin Cream, USP is indicated in the treatment of cutaneous or
mucocutaneous
mycotic infections caused by _Candida albicans _and other susceptible
_Candida _species.
THIS CREAM IS NOT INDICATED FOR SYSTEMIC, ORAL, INTRAVAGINAL OR
OPHTH