DIFLORASONE DIACETATE cream

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Diflorasone Diacetate (UNII: 7W2J09SCWX) (Diflorasone - UNII:T2DHJ9645W)

Tilgjengelig fra:

Emerald Therapeutics, LLC

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Diflorasone diacetate cream USP is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Produkt oppsummering:

Diflorasone diacetate cream USP, 0.05% is available in a 60 g tube, NDC 72919-549-60. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep tightly closed.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

DIFLORASONE DIACETATE- DIFLORASONE DIACETATE CREAM
EMERALD THERAPEUTICS, LLC
----------
DIFLORASONE DIACETATE
CREAM USP, 0.05%
RX ONLY
FOR EXTERNAL USE ONLY - NOT FOR OPHTHALMIC USE.
DESCRIPTION
Diflorasone diacetate cream USP, 0.05% contains the active compound
diflorasone
diacetate, a synthetic corticosteroid for topical dermatological use.
Chemically, diflorasone diacetate is 6α,
9α-difluoro-11β,17,21-trihydroxy-16-
methylpregna-1,4-diene-3,20-dione 17,21 diacetate, with the empirical
formula
C
H
F O , a molecular weight of 494.5, and the following structural
formula:
Each gram of diflorasone diacetate cream USP, 0.05% contains 0.5 mg
diflorasone
diacetate in a cream base consisting of butylated hydroxytoluene,
cetyl alcohol, citric
acid, glyceryl stearate/PEG 100 stearate, isopropyl myristate, lanolin
alcohol, mineral oil,
monobasic sodium phosphate, polyoxyl 40 stearate, polysorbate 60,
propylene glycol,
purified water, sorbitan monostearate and vegetable oil.
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
26
32 2
7
2
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, occlusion of hydrocortisone for 96
hours markedly
enhances penetration. Topical co