NYSTATIN AND TRIAMCINOLONE ACETONIDE ointment

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Lifestar Pharma LLC

INN (Internationale Bezeichnung):

NYSTATIN

Zusammensetzung:

NYSTATIN 100000 [USP'U] in 1 g

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Nystatin and Triamcinolone Acetonide Ointment, USP 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.

Produktbesonderheiten:

Nystatin and Triamcinolone Acetonide Ointment, USP is supplied in 15 g (NDC 70756-811-15), 30 g (NDC 70756-811-35) and 60 g (NDC 70756-811-65) tubes.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

NYSTATIN AND TRIAMCINOLONE ACETONIDE- NYSTATIN AND TRIAMCINOLONE
ACETONIDE OINTMENT
LIFESTAR PHARMA LLC
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NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT, USP
Rx only
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE
DESCRIPTION
Nystatin and Triamcinolone Acetonide Ointment, 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, slightly soluble in methanol, and
freely soluble in dimethylformamide,
dimethyl sulfoxide, and practically insoluble in n-propyl alcohol,
n-butyl alcohol, water, alcohol,
chloroform, ether. Structural formula:
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 sparingly soluble in
dehydrated alcohol, chloroform, and slightly soluble in methanol.
Structural formula:
Each gram of Nystatin and Triamcinolone Acetonide Ointment, USP
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 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 effective because of its
anti-inflammatory, antipruritic and
vasoconstrictive actions, characteristic of the topical corticosteroid
class of drugs. The pharmacologi