DIFLORASONE DIACETATE cream

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

diflorasone diacetate (UNII: 7W2J09SCWX) (diflorasone - UNII:T2DHJ9645W)

Tilgjengelig fra:

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

INN (International Name):

diflorasone diacetate

Sammensetning:

diflorasone diacetate 0.5 mg in 1 g

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Topical corticosteroids are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Topical steroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. Use of topical corticosteroids, including diflorasone diacetate emollient cream may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts have been reported in postmarketing experience with the use of topical diflorasone diacetate products. Glaucoma, with possible damage to the optic nerve, and increased intraocular pressure have been reported in postmarketing experience with the use of topical dermal corticosteroids. Avoid contact of diflorasone diacetate emollient cream with eyes. Advise patients to report any visual symptoms.

Produkt oppsummering:

Diflorasone Diacetate Cream USP, 0.05% (Emollient) is available in the following size tubes: NDC 0168-0353-30 30 gram tube NDC 0168-0353-60 60 gram tube Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 46228066A R05/18 #46

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

DIFLORASONE DIACETATE- DIFLORASONE DIACETATE CREAM
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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DIFLORASONE DIACETATE
CREAM USP, 0.05% (EMOLLIENT)
FOR TOPICAL USE
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
Each gram of diflorasone diacetate cream USP, 0.05% (emollient)
contains 0.5 mg diflorasone diacetate
in a cream base for topical dermatological use.
Chemically, diflorasone diacetate is:
6α,9-difluoro-11β,17,21-trihydroxy-16β-methylpregna-1,
4-diene-3,20-dione17,21-diacetate.The structural formula is
represented below:
Each gram of diflorasone diacetate cream USP, 0.05% (emollient)
contains: 0.5 mg diflorasone
diacetate in a hydrophilic vanishing cream base of propylene glycol,
stearyl alcohol, cetyl alcohol,
sorbitan monostearate, polysorbate 60, mineral oil and purified water.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, antipruritic 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 systemical