DIFLORASONE DIACETATE- diflorasone diacetate cream

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

DIFLORASONE DIACETATE (UNII: 7W2J09SCWX) (DIFLORASONE - UNII:T2DHJ9645W)

Disponibil de la:

E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.

INN (nume internaţional):

DIFLORASONE DIACETATE

Compoziție:

DIFLORASONE DIACETATE 0.5 mg in 1 g

Calea de administrare:

TOPICAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Diflorasone diacetate cream USP, 0.05% is a high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Diflorasone diacetate cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Rezumat produs:

Diflorasone Diacetate Cream USP, 0.05% is available as follows: NDC 0168-0242-15  15 gram tube NDC 0168-0242-30  30 gram tube NDC 0168-0242-60  60 gram tube Store at or below 25°C (77°F). Keep tightly closed. E. FOUGERA & CO. a division of Fougera Pharmaceuticals Inc. Melville, New York 11747 I242B R03/12 #171

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

DIFLORASONE DIACETATE- DIFLORASONE DIACETATE CREAM
E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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DIFLORASONE DIACETATE CREAM
USP, 0.05%
RX ONLY
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Diflorasone diacetate cream, 0.05% contains the active compound
diflorasone diacetate, a synthetic
corticosteroid for topical dermatological use.
Chemically, diflorasone diacetate is
6α,9-difluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-
3,20-dione 17,21-diacetate, with the molecular formula C
H F O , a molecular weight of 494.54,
and the following structural formula:
Each gram of diflorasone diacetate cream, 0.05% contains: 0.5 mg
diflorasone diacetate in a cream base
consisting of cetyl alcohol, glyceryl stearate SE (nonionic),
isopropyl myristate, mineral oil (and)
lanolin alcohol, monobasic sodium phosphate, monoglyceride citrate,
polyoxyl 40 stearate, polysorbate
60, propylene glycol, purified water, sorbitan monostearate, vegetable
oil, butylated hydroxytoluene
and citric acid.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, diflorasone diacetate has
anti-inflammatory, anti-pruritic, and
vasoconstrictive actions. The mechanism of the anti-inflammatory
activity of the topical corticosteroids,
in general, is unclear. However, corticosteroids are thought to act by
the induction of phospholipase
A inhibitory proteins collectively called lipocortins. It is
postulated that these proteins control the
biosynthesis of potent mediators of inflammation such as
prostaglandins and leukotrienes by inhibiting
the release of their common precursor, arachidonic acid. Arachidonic
acid is released from membrane
phospholipids by phospholipase A .
PHARMACOKINETICS: The extent of percutaneous absorption of topical
corticosteroids is determined by
many factors including the vehicle and the integrity of the epidermal
barrier. Occlusive dressings with
hydrocortisone for up to 24 hours have not been demonstrated to
increase penetration; however,
26
32
2
7
2
2
occlusion of hydrocortisone fo