DIFLORASONE DIACETATE ointment

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

RICONPHARMA LLC

INN (International Adı):

DIFLORASONE DIACETATE

Kompozisyon:

DIFLORASONE DIACETATE 0.5 mg in 1 g

Reçete türü:

PRESCRIPTION DRUG

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

DIFLORASONE DIACETATE- DIFLORASONE DIACETATE OINTMENT
RICONPHARMA LLC
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DIFLORASONE DIACETATE OINTMENT USP, 0.05%
RX ONLY
FOR TOPICAL 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. 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
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. They are metabolized primarily in the liver and are
then excreted by the kidneys. Some
of