NYSTATIN AND TRIAMCINOLONE ACETONIDE cream

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Nystatin (UNII: BDF1O1C72E) (Nystatin - UNII:BDF1O1C72E), Triamcinolone Acetonide (UNII: F446C597KA) (Triamcinolone Acetonide - UNII:F446C597KA)

Disponível em:

Dr. Reddy's Laboratories, Inc.

DCI (Denominação Comum Internacional):

Nystatin

Composição:

Nystatin 100000 [USP'U] in 1 g

Via de administração:

TOPICAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Nystatin and Triamcinolone Acetonide Cream, USP is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment. These preparations are contraindicated in those patients with a history of hypersensitivity to any of their components.

Resumo do produto:

Nystatin and Triamcinolone Acetonide Cream, USP is supplied in 15 g (NDC 43598-431-44), 30 g (NDC 43598-431-30) and 60 g (NDC 43598-431-60) tubes.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

NYSTATIN AND TRIAMCINOLONE ACETONIDE- NYSTATIN AND TRIAMCINOLONE
ACETONIDE CREAM
DR. REDDY'S LABORATORIES, INC.
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NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM, USP
Rx only
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION
Nystatin and Triamcinolone Acetonide Cream, USP for dermatologic use
contain the antifungal agent
nystatin and the synthetic corticosteroid triamcinolone acetonide.
Nystatin, USP is a polyene antimycotic obtained from Streptomyces
noursei. It is a yellow to light tan
powder with a cereallike odor, slightly soluble in methanol, and
freely soluble in dimethylformamide,
dimethyl sulfoxide, and practically insoluble in _n_-propyl alcohol,
_n_-butyl alcohol, water, alcohol,
chloroform, ether. Structural formula:
Triamcinolone acetonide, USP is designated chemically as
9-fluoro-11β, 16α, 17, 21-
tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with
acetone. The white to cream
crystalline powder has a slight odor, is practically insoluble in
water, and sparingly soluble in
dehydrated alcohol, chloroform, and slightly soluble in methanol.
Structural formula:
Nystatin and Triamcinolone Acetonide Cream, USP is a yellow color
soft, smooth cream. Each gram
provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide
in an aqueous vanishing cream
base with aluminum hydroxide, methylparaben, mono & diglycerides,
polyethylene glycol monostearate,
base with aluminum hydroxide, methylparaben, mono & diglycerides,
polyethylene glycol monostearate,
polyoxyl 20 cetostearyl ether, propylparaben, polysorbate 60,
propylene glycol, simethicone emulsion,
sorbic acid, sorbitol, titanium dioxide and white petrolatum.
CLINICAL PHARMACOLOGY
NYS TATIN
Nystatin exerts its antifungal activity against a variety of
pathogenic and nonpathogenic yeasts and fungi
by binding to sterols in the cell membrane. The binding process
renders the cell membrane incapable of
functioning as a selective barrier. Nystatin provides specific
anticandidal activity to _Candida_ (Monilia)
_albicans_ and other C