DIFLORASONE DIACETATE cream

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Taro Pharmaceuticals U.S.A., Inc.

Via di somministrazione:

TOPICAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

Diflorasone diacetate cream USP, 0.05% is available in 15 g (NDC 51672-1296-1), 30 g (NDC 51672-1296-2) and 60 g (NDC 51672-1296-3) tubes. Store at 20 ° to 25 °C (68 ° to 77 °F) [see USP Controlled Room Temperature]. Keep tightly closed.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

DIFLORASONE DIACETATE- DIFLORASONE DIACETATE CREAM
TARO PHARMACEUTICALS U.S.A., 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 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 mediators of inflammation such as
prostaglandins and leukotrienes by inhibiting
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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. Top