CORDRAN- flurandrenolide lotion

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Almirall, LLC

INN (Mezinárodní Name):

FLURANDRENOLIDE

Složení:

FLURANDRENOLIDE 0.5 mg in 1 mL

Podání:

TOPICAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Cordran Lotion is indicated for the relief of the inflammatory and pruritic manifestations of cortico-steroid-responsive dermatoses. Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of these preparations.

Přehled produktů:

Cordran® Lotion, 0.05% is supplied in plastic squeeze bottles as follows: 15 mL (NDC 16110-052-15) 60 mL (NDC 16110-052-60) 120 mL (NDC 16110-052-12) Keep out of reach of children. Storage: Avoid freezing. 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] Rx Only Revised: July 2016 ALMIRALL, LLC Manufactured by DPT Laboratories, San Antonio, TX 78215 For Almirall LLC, 101 Lindenwood Drive, Suite 400, Malvern, PA 19355

Stav Autorizace:

New Drug Application

Charakteristika produktu

CORDRAN- FLURANDRENOLIDE LOTION
ALMIRALL, LLC
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CORDRAN® LOTION, 0.05%
FLURANDRENOLIDE LOTION, 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 g
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 mL of Cordran Lotion contains 0.5 mg (1.145 µmol) (0.05%)
flurandrenolide in an
oil-in-water emulsion base composed of glycerin, cetyl alcohol,
stearic acid, glyceryl
monostearate, mineral oil, polyoxyl 40 stearate, menthol, benzyl
alcohol, and purified
water.
CLINICAL PHARMACOLOGY
Cordran is primarily effective because of its anti-inflammatory,
antipruritic, and
vasoconstrictive actions.
The mechanism of the anti-inflammatory effect of topical
corticosteroids is not
completely understood.
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. 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.
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Evaporation of water from the lotion vehicle produces a cooling
effect, which is often
desirable in the treatment of acutely inflamed or weeping lesions.
_Pharmacokinetics_—The extent of percutaneous absorption of topical
corticosteroids is
determined by many factors, including t