SYNALAR- fluocinolone acetonide cream SYNALAR- fluocinolone acetonide kit

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:

Medimetriks Pharmaceuticals, Inc.

INN (nume internaţional):

fluocinolone acetonide

Compoziție:

fluocinolone acetonide 0.25 mg in 1 g

Calea de administrare:

TOPICAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

SYNALAR® Cream 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:

SYNALAR® (fluocinolone acetonide) Cream 0.025% is supplied in Store at room temperature 15-25°C (59-77°F); avoid freezing and excessive heat above 40°C (104°F). To report SUSPECTED ADVERSE REACTIONS, contact Medimetriks Pharmaceuticals, Inc. at 1-973-882-7512 or FDA at 1-800-FDA-1088 or www.fda/gov/medwatch.

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

SYNALAR- FLUOCINOLONE ACETONIDE CREAM
SYNALAR - FLUOCINOLONE ACETONIDE
MEDIMETRIKS PHARMACEUTICALS, INC.
----------
SYNALAR
(FLUOCINOLONE ACETONIDE)
CREAM, 0.025%
FOR INITIATION OF THERAPY IN INFLAMMATORY DERMATOSES.
RX ONLY
DESCRIPTION
SYNALAR (fluocinolone acetonide) Cream 0.025% is intended for topical
administration.
The active component is the corticosteroid fluocinolone acetonide,
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:
SYNALAR Cream contains fluocinolone acetonide 0.25 mg/g in a
water-washable
aqueous base of butylated hydroxytoluene, cetyl alcohol, citric acid,
edetate disodium,
methylparaben and propylparaben (preservatives), mineral oil, polyoxyl
20 cetostearyl
ether, propylene glycol, simethicone, stearyl alcohol, water
(purified) and white beeswax.
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 throu