CORDRAN- flurandrenolide cream CORDRAN- flurandrenolide ointment

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

FLURANDRENOLIDE (UNII: 8EUL29XUQT) (FLURANDRENOLIDE - UNII:8EUL29XUQT)

זמין מ:

Almirall, LLC

INN (שם בינלאומי):

FLURANDRENOLIDE

הרכב:

FLURANDRENOLIDE 0.5 mg in 1 g

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Cordran® (flurandrenolide, USP) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of these preparations.

leaflet_short:

Cordran® Cream is supplied in aluminum tubes as follows: Cordran® Cream, 0.025%:     120 g  (NDC 16110-034-12) Cordran® Cream, 0.05%:     120 g  (NDC 16110-035-12) Cordran® Ointment is supplied in aluminum tube as follows: Cordran® Ointment, 0.05%:     60 g  (NDC 16110-026-60)     120 g  (NDC 16110-026-12) Keep out of reach of children. Storage Keep tightly closed. Protect from light. Store at 20° to 25°C (68° to 77°F) with excursions permitted to 15° to 30°C (59° to 86°F) [See USP controlled room temperature.].

מצב אישור:

New Drug Application

מאפייני מוצר

CORDRAN- FLURANDRENOLIDE CREAM
CORDRAN- FLURANDRENOLIDE OINTMENT
ALMIRALL, LLC
----------
CORDRAN CREAM
AND
CORDRAN OINTMENT
FLURANDRENOLIDE, USP
DESCRIPTION
Cordran (flurandrenolide, USP) is a potent corticosteroid intended for
topical use.
Flurandrenolide occurs as white to off-white, fluffy, crystalline
powder and is odorless.
Flurandrenolide is practically insoluble in water and in ether. One
gram of flurandrenolide
dissolves in 72 mL of alcohol and in 10 mL of chloroform. The
molecular weight of
flurandrenolide is 436.52.
The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione,
6-fluoro-11,21-
dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-, (6α, 11β, 16α)-;
its empirical formula
is C
H
FO . The structure is as follows:
Each gram of Cordran Cream (flurandrenolide Cream, USP) contains 0.5
mg (1.145
µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in an
emulsified base
composed of cetyl alcohol, citric acid, mineral oil, polyoxyl 40
stearate, propylene glycol,
sodium citrate, stearic acid, and purified water.
Each gram of Cordran Ointment (flurandrenolide Ointment, USP) contains
0.5 mg
(1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide
in a base
composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white
petrolatum.
CLINICAL PHARMACOLOGY
Cordran is primarily effective because of its anti-inflammatory,
antipruritic, and
vasoconstrictive actions.
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The mechanism of the anti-inflammatory effect of topical
corticosteroids is not
completely understood. Corticosteroids with anti-inflammatory activity
may stabilize
cellular and lysosomal membranes. There is also the suggestion that
the effect on the
membranes of lysosomes prevents the release of proteolytic enzymes
and, thus, plays
a part in reducing inflammation.
_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 corticost