FLUOCINOLONE ACETONIDE cream

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

fluocinolone acetonide (UNII: 0CD5FD6S2M) (fluocinolone acetonide - UNII:0CD5FD6S2M)

Verfügbar ab:

STAT RX USA LLC

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat. Protect from freezing. E. FOUGERA and CO. a division of Nycomed US Inc. MELVILLE, NEW YORK 11747 I25815D R12/07 #43

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

FLUOCINOLONE ACETONIDE - FLUOCINOLONE ACETONIDE CREAM
STAT RX USA LLC
----------
FOR DERMATOLOGIC 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 a 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 Gycol, Sorbitan Monostearate and 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 Gycol, Sorbitan Monostearate and 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
24
30
2
6
increase the percutaneous absorption of topical corticosteroids. Thus,
occlusive dressings may be a
valuable therapeutic adjunct for treatment of resistant dermatoses.
(SeeDOSAGE AND
ADMINISTRATION ). Once absorbed t