DIFLORASONE DIACETATE ointment

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

VersaPharm Incorporated

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 the 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.

Produkt oppsummering:

Diflorasone Diacetate Ointment USP, 0.05% is available in 15 gram (NDC 61748-350-15), 30 gram (NDC 61748-350-30) and 60 gram (NDC 61748-350-60) tubes. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

DIFLORASONE DIACETATE- DIFLORASONE DIACETATE OINTMENT
VERSAPHARM INCORPORATED
----------
DIFLORASONE DIACETATE OINTMENT USP, 0.05%
RX ONLY
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Each gram of diflorasone diacetate ointment contains 0.5 mg
diflorasone diacetate in an ointment base.
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 and a molecular weight of
494.54. The structural formula is represented below:
Each gram of diflorasone diacetate ointment contains 0.5 mg
diflorasone diacetate in an ointment base of
propylene glycol, glyceryl monostearate and white petrolatum.
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
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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 systemically administered corticosteroids. Corticosteroids
are bound to plasma proteins in
varying degrees.