NYSTATIN AND TRIAMCINOLONE ACETONIDE- 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:

NuCare Pharmaceuticals,Inc.

INN (International Name):

NYSTATIN

Composition:

NYSTATIN 100000 [USP'U] 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 as follows: NDC 68071-3363-3 Box of 30g 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
NUCARE PHARMACEUTICALS,INC.
----------
NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION
Nystatin and triamcinolone acetonide cream USP for dermatologic use
contains the antifungal agent
nystatin USP and the synthetic corticosteroid triamcinolone acetonide
USP.
Nystatin USP is a polyene antimycotic obtained from _Streptomyces
noursei_. It is a yellow or slightly
brownish, hygroscopic powder, having a bitter taste and an odor
suggestive of cereals. It is practically
insoluble in water, freely soluble in dimethyl formamide, freely
soluble in dimethyl sulfoxide, slightly
soluble in methanol, practically insoluble in ethanol 96%, practically
insoluble in acetone h, practically
insoluble in n-butanol, practically insoluble n-propanol and
practically insoluble 2-propanol.
Structural formula:
1. C
H
NO
MW = 926.09
Triamcinolone acetonide USP 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-11β,16α,17,21-
tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16, 17-acetal with
acetone. The white to cream-
colored, crystalline powder, having not more than a slight odor, is
practically insoluble in water,
sparingly soluble in dehydrated alcohol, in chloroform and in
methanol.
Structural formula:
47
75
17
1. C
H
FO
MW = 434.50
Nystatin and Triamcinolone Acetonide Cream USP is a soft, smooth
yellow color cream. Each gram
provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide
USP in a cream base with
dried aluminum hydroxide gel, glyceryl monostearate, methylparaben,
polyethylene glycol 400
monostearate, polyoxyl 20 cetostearyl ether, polysorbate-60, propylene
glycol, propylparaben, purified
water, 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 nonpath