NYSTATIN AND TRIAMCINOLONE ACETONIDE- nystatin and triamcinolone acetonide ointment

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:

Teligent Pharma, 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 Ointment 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 Ointment is supplied in 15 g, 30 g, and 60 g tubes. 15 g tube – NDC 52565-042-15 30 g tube – NDC 52565-042-30 60 g tube – NDC 52565-042-60 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid freezing. Manufactured by: Teligent Phama, Inc. Buena, NJ 08310 Rev 08/2016

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NYSTATIN AND TRIAMCINOLONE ACETONIDE - NYSTATIN AND TRIAMCINOLONE
ACETONIDE OINTMENT
TELIGENT PHARMA, INC.
----------
NYSTATIN AND TRIAMCINOLONE ACETONIDE OINTMENT, USP
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION
Nystatin and Triamcinolone Acetonide Ointment 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 cereallike odor, very slightly soluble in water, and slightly
to sparingly soluble in alcohol.
Structural formula:
C
H NO MW = 926.13
Triamcinolone acetonide 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
Each gram of Nystatin and Triamcinolone Acetonide Ointment provides
100,000 USP Nystatin units and
1 mg Triamcinolone Acetonide in an ointment base of mineral oil and
white petrolatum.
CLINICAL PHARMACOLOGY
47
75
17
24
31
6
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 pharmacologic
effects of the topical corticosteroids are well known; however, the
mechanisms of their dermatologic
actions are unclear. Various laboratory