NYSTATIN AND TRIAMCINOLONE ACETONIDE cream

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E), TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)

Доступна з:

Alembic Pharmaceuticals Inc.

Адміністрація маршрут:

TOPICAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

These preparations are contraindicated in those patients with a history of hypersensitivity to any of their components.

Огляд продуктів:

Nystatin and triamcinolone acetonide cream, USP is light yellow to buff color cream supplied as follows: 15 g tube (NDC 62332-606-15) 30 g tube (NDC 62332-606-30) 60 g tube (NDC 62332-606-60). STORAGE Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Avoid freezing. Manufactured for:  Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by; Alembic Pharmaceuticals Limited (Derma Division), Karakhadi, Vadodara 391450, India. Mfg. License No.: G/28/1626 Revised: 12/2023

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

NYSTATIN AND TRIAMCINOLONE ACETONIDE- NYSTATIN AND TRIAMCINOLONE
ACETONIDE CREAM
ALEMBIC 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 is a polyene antimycotic obtained from _Streptomyces
noursei_. It is a yellow to
light tan powder with a cereal-like odor, practically insoluble or
insoluble in water and in
alcohol. Structural formula:
C
H
NO
MW = 926.23
Triamcinolone acetonide is designated chemically as
pregna-1,4-diene-3,20-dione, 9-
fluoro-11,21-dihydroxy-16,17- [(1-methylethylidene)bis(oxy)]-,
(11β,16α)-9-fluoro-
11b,16a,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
FO MW = 434.51
Nystatin and triamcinolone acetonide cream, USP is a soft, smooth
cream having a light
yellow to buff color. Each gram contains 100,000 USP nystatin units
and 1 mg
triamcinolone acetonide USP in a cream base of polysorbate-60,
aluminum hydroxide
gel, titanium dioxide, mono-and di-glycerides, polyoxyl 8 stearate,
simethicone emulsion,
sorbic acid, propylene glycol, white petrolatum, polyoxyl 20-
cetostearyl ether,
methylparaben, propylparaben, noncrystallizing sorbitol solution and
purified water.
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 f