APEXICON diflorasone diacetate ointment

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

diflorasone diacetate (UNII: 7W2J09SCWX) (diflorasone diacetate - UNII:7W2J09SCWX)

זמין מ:

Pharmaderm, A division of Nycomed US Inc.

INN (שם בינלאומי):

diflorasone diacetate

הרכב:

diflorasone diacetate 0.5 mg in 1 g

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

APEXICON- DIFLORASONE DIACETATE OINTMENT OINTMENT
PHARMADERM, A DIVISION OF NYCOMED US INC.
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APEXICON OINTMENT
(DIFLORASONE DIACETATE OINTMENT, USP, 0.05%)
RX ONLY
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
ApexiCon Ointment (diflorasone diacetate ointment USP 0.05%) 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 ApexiCon Ointment (diflorasone diacetate ointment USP
0.05%), for topical
administration, contains 0.5 mg diflorasone diacetate in an ointment
base consisting of propylene glycol,
glyceryl monostearate and white petrolatum.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, anti-pruritic 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.
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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 pa