FLUOCINOLONE ACETONIDE cream

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)

Tilgængelig fra:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

INN (International Name):

FLUOCINOLONE ACETONIDE

Sammensætning:

FLUOCINOLONE ACETONIDE 0.1 mg in 1 g

Indgivelsesvej:

TOPICAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Fluocinolone Acetonide cream is 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.

Produkt oversigt:

15 gram tube NDC 0168-0058-15 15 gram tube NDC 0168-0060-15 60 gram tube NDC 0168-0058-60 60 gram tube NDC 0168-0060-60 Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat. Protect from freezing. E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I25815F R11/12 #43

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE CREAM
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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FLUOCINOLONE ACETONIDE CREAM, USP
0.01%, 0.025%
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.
RX ONLY
DESCRIPTION:
Fluocinolone Acetonide Cream contains Fluocinolone Acetonide USP
(Pregna-1,4-diene-3,20-dione,
6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)-bis(oxy)]-,
(6α,11β,16α)-); it has an
empirical formula of C
H F O and a molecular weight of 452.49 (CAS Registry Number 67-73-2).
Each gram of the 0.01% cream contains 0.1 mg of Fluocinolone Acetonide
in a base containing Stearic
Acid, Propylene Glycol, Sorbitan Monostearate, Sorbitan Monooleate,
Polysorbate 60, Citric Acid,
Methylparaben, Propylparaben and Purified Water.
Each gram of the 0.025% cream contains 0.25 mg of Fluocinolone
Acetonide in a base containing
Stearic Acid, Propylene Glycol, Sorbitan Monostearate, Sorbitan
Monooleate, Polysorbate 60, Citric
Acid, Methylparaben, Propylparaben 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 substantially
increase the percutaneous absorption of topical corticosteroids. Thus,
occlusive dressings may be a
valuable therapeutic adj