NYSTATIN AND TRIAMCINOLONE ACETONIDE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

IPG PHARMACEUTICALS, INC.

INN (International Name):

Nystatin

Composition:

Nystatin 100000 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nystatin and Triamcinolone Acetonide Cream 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.

Product summary:

Nystatin and Triamcinolone Acetonide Cream, USP is supplied in 30 g (NDC 71085-009-30) tubes. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NYSTATIN AND TRIAMCINOLONE ACETONIDE- NYSTATIN AND TRIAMCINOLONE
ACETONIDE CREAM
IPG PHARMACEUTICALS, INC.
----------
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, very slightly soluble in water, and
slightly to sparingly soluble in
alcohol. Structural formula:
C
H NO MW = 926.13
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 very soluble in alcohol.
Structural formula:
C
H FO MW = 434.50
Nystatin and Triamcinolone Acetonide Cream, USP 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
aqueous perfumed vanishing cream base with aluminum hydroxide,
glyceryl monostearate,
methylparaben, polyethylene glycol monostearate, polyoxyethylene fatty
alcohol ether, propylene
glycol, polysorbate 60, propylparaben, simethicone emulsion, sorbic
acid, sorbitol, titanium dioxide,
and white petrolatum.
47
75
17
24
31
6
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 species, but is not active against
bacteria, protozoa, trichomonads, or
viruses.
Nystatin is not absorbed from intact skin or mucous membranes.
TRIAMCINOLONE ACETONIDE
Triamcinolon