FLURANDRENOLIDE lotion

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Cintex Services, LLC

INN (Միջազգային անվանումը):

FLURANDRENOLIDE

Կազմը:

FLURANDRENOLIDE 0.5 mg in 1 mL

Կառավարման երթուղին:

TOPICAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

Flurandrenolide Lotion is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of components of the preparation.

Ապրանքի ամփոփագիր:

Flurandrenolide Lotion USP, 0.05% is supplied in plastic squeeze bottles as follows: 15 mL (NDC 24470-921-15) 60 mL (NDC 24470-921-60) 120 mL (NDC 24470-921-12) 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] Manufactured by: Medical Products Laboratories Philadelphia, PA 19115 827620 v1 Rev. 10/17 Manufactured for: Cintex Services, LLC. 9330 LBJ Freeway, Suite 900 Dallas, TX 75243

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

FLURANDRENOLIDE- FLURANDRENOLIDE LOTION
CINTEX SERVICES, LLC
----------
FLURANDRENOLIDE LOTION USP, 0.05%
RX ONLY
DESCRIPTION
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 Flurandrenolide Lotion, USP 0.05% 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
FLURANDRENOLIDE 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
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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
antiinflammatory 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. 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
f