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 - UNII:1ZK20VI6TY)

Disponível em:

H.J. Harkins Company, 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 and Ointment are 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 is supplied in 15 g, 30 g, and 60 g tubes. Nystatin and Triamcinolone Acetonide Ointment is supplied in 15 g, 30 g, and 60 g tubes. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid freezing.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

NYSTATIN AND TRIAMCINOLONE ACETONIDE - NYSTATIN AND TRIAMCINOLONE
ACETONIDE CREAM
H.J. HARKINS COMPANY, INC.
----------
NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM, USP
RX ONLY
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION
Nystatin and Triamcinolone Acetonide Cream and Ointment for
dermatologic use contain the antifungal
agent nystatin and the synthetic corticosteroid triamcinolone
acetonide.
Nystatin is a polyene antimycotic obtained from Streptomyces noursei.
It is a yellow to light tan powder
with a cereallike odor, very slightly soluble in water, and slightly
to sparingly soluble in alcohol.
Structural formula:
C
H NO MW = 926.13
Triamcinolone acetonide 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 very soluble in
alcohol. Structural formula:
C
H FO MW = 434.50
Nystatin and Triamcinolone Acetonide Cream is a soft, smooth cream
having a light yellow to buff
color. Each gram provides 100,000 USP Nystatin units and 1 mg
Triamcinolone Acetonide in an
47
75
17
24
31
6
aqueous perfumed vanishing cream base with polysorbate-60, aluminum
hydroxide, titanium dioxide,
glyceryl monostearate, polyethylene glycol monostearate, simethicone
emulsion, sorbic acid, propylene
glycol, white petrolatum, polyoxyethylene fatty alcohol ether,
methylparaben, propylparaben and
sorbitol.
Each gram of Nystatin and Triamcinolone Acetonide Ointment provides
100,000 USP Nystatin units and
1 mg Triamcinolone Acetonide in an ointment base of mineral oil 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 Candida sp