TRIAMCINOLONE ACETONIDE cream

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)

Tillgänglig från:

Unit Dose Services

INN (International namn):

TRIAMCINOLONE ACETONIDE

Sammansättning:

TRIAMCINOLONE ACETONIDE 5 mg in 1 g

Administreringssätt:

TOPICAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Produktsammanfattning:

Product: 50436-0842 NDC: 50436-0842-1 15 g in a CARTON

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE CREAM
UNIT DOSE SERVICES
----------
TRIAMCINOLONE ACETONIDE CREAM USP, 0.025%, 0.1%, 0.5%
RX ONLY
DESCRIPTION:
Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide
[Pregna-1,4-diene-3,20-dione,
9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-,
(11β,16α)-], with the empirical
formula C
H FO and molecular weight 434.50. CAS 76-25-5.
Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of
Triamcinolone Acetonide per gram
in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl
Palmitate, Sorbitol Solution, Glycerin,
Lactic Acid, Benzyl Alcohol and Purified Water.
Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of
Triamcinolone Acetonide per gram in a
base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate,
Sorbitol Solution, Glycerin,
Lactic Acid, Benzyl Alcohol and Purified Water.
Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of
Triamcinolone Acetonide per gram in a
base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate,
Sorbitol Solution, Glycerin,
Lactic Acid, Benzyl Alcohol and Purified Water.
CLINICAL PHARMACOLOGY:
Topical corticosteroids share anti-inflammatory, anti-pruritic and
vasoconstrictive actions. The
mechanism of anti-inflammatory activity of the topical corticosteroids
is unclear. Various laboratory
methods, including vasoconstrictor assays, are used to compare and
predict potencies and/or clinical
efficacies of the topical corticosteroids. There is some evidence to
suggest that a recognizable
correlation exists between vasoconstrictor potency and therapeutic
efficacy in man.
PHARMACOKINETICS: The extent of percutaneous absorption of topical
corticosteroids is determined by
many factors including the vehicle, the integrity of the epidermal
barrier, and the use of occlusive
dressings. Topical corticosteroids can be absorbed from normal intact
skin. Inflammation and/or other
disease processes in the skin increase percutaneous absorption.
Occlusive dressings substantiall