FLUOCINOLONE ACETONIDE TOPICAL solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Actavis Pharma, Inc.

INN (nume internaţional):

FLUOCINOLONE ACETONIDE

Compoziție:

FLUOCINOLONE ACETONIDE 0.1 mg in 1 mL

Calea de administrare:

TOPICAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

Fluocinolone Acetonide) Topical Solution, 0.01% 60 mL Bottle with applicator tip – NDC 0591-2990-60  STORAGE Store at room temperature 15° to 25°C (59° to 77°F); avoid freezing and excessive heat above 40°C (104°F). Manufactured by: Actavis Laboratories UT, Inc. Salt Lake City, UT 84108 USA  Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 234192-00  Revised – August 2016

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

FLUOCINOLONE ACETONIDE TOPICAL- FLUOCINOLONE ACETONIDE TOPICAL
SOLUTION
ACTAVIS PHARMA, INC.
----------
FLUOCINOLONE ACETONIDE TOPICAL SOLUTION, USP 0.01%
RX ONLY
DESCRIPTION
Fluocinolone acetonide topical solution, USP 0.01% is intended for
topical administration. The active
component is the corticosteroid fluocinolone acetonide, USP, which has
the chemical name pregna-1,4-
diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis
(oxy)]-,(6α,11β,16α)-. It
has the following chemical structure:
Fluocinolone acetonide topical solution, USP contains fluocinolone
acetonide, USP (anhydrous) 0.1
mg/mL in a water-washable base of citric acid anhydrous and propylene
glycol.
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 adjunct for treatment of resistant dermatoses_ (see DOSAGE
AND ADMINISTRATION)._
Once absorbed through the skin, topical corticosteroids are handled
through pharmacokinetic pathways
similar to systemically administered corticosteroids. Corticosteroids
are bound to plasma proteins in
varying degrees. Corticosteroids are metab