NYSTATIN AND TRIAMCINOLONE ACETONIDE- nystatin, 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:

REMEDYREPACK INC.

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. This preparation is contraindicated in those patients with a history of hypersensitivity to any of its components.

Product summary:

Nystatin and Triamcinolone Acetonide Cream is supplied in 30 g tubes. NDC: 70518-2777-00 PACKAGING: 1 in 1 CARTON, 30 g in 1 TUBE, TYPE 0 STORAGE: Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid freezing. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NYSTATIN AND TRIAMCINOLONE ACETONIDE- NYSTATIN, TRIAMCINOLONE
ACETONIDE CREAM
REMEDYREPACK INC.
----------
NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM, USP
RX ONLY
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
DESCRIPTION:
Nystatin and Triamcinolone Acetonide Cream for dermatologic use
contains 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 cereal-like odor, very slightly soluble in
water, and slightly to
sparingly soluble in alcohol. Structural formula:
C
H
N0
MW = 926.13
Triamcinolone acetonide is designated chemically as 9-fluoro-11ß,
16ɑ, 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:
47
75
17
C
H
F0
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 a cream base with aluminum hydroxide,
cetearyl alcohol and
ceteareth 20, glyceryl monostearate, methylparaben, polyethylene
glycol monostearate,
polysorbate 60, propylene glycol, propylparaben, purified water,
simethicone emulsion,
sodium hydroxide, sorbic acid, sorbitol, titanium dioxide, and white
petrolatum.
CLINICAL PHARMACOLOGY:
NYSTATIN: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: Triamcinolone acetonide is primarily
effectiv