CORDRAN- flurandrenolide tape

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Flurandrenolide (UNII: 8EUL29XUQT) (Flurandrenolide - UNII:8EUL29XUQT)

Disponível em:

Almirall, LLC

Via de administração:

TOPICAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

For relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, particularly dry, scaling localized lesions. Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of these preparations. Use of Cordran Tape is not recommended for lesions exuding serum or in intertriginous areas.

Resumo do produto:

Tape: 4 mcg/sq cm—small roll, 24 in x 3 in (60 cm x 7.5 cm), in a flip-top vial NDC 16110-587-24 4 mcg/sq cm—large roll, 80 in x 3 in (200 cm x 7.5 cm), in a flip-top vial NDC 16110-587-80 Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Keep out of reach of children. Rx only

Status de autorização:

New Drug Application

Características técnicas

CORDRAN- FLURANDRENOLIDE TAPE
ALMIRALL, LLC
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CORDRAN TAPE
_FLURANDRENOLIDE TAPE, USP_
RX ONLY
DESCRIPTION
Cordran Tape (Flurandrenolide Tape, USP) is a transparent,
inconspicuous, plastic
surgical tape. It contains Cordran (Flurandrenolide, USP), a potent
corticosteroid 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
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, 11ß, 16α)-;
its empirical formula is
C
H
FO . The structural formula is as follows:
Each square centimeter contains 4 mcg (0.00916 μmol) flurandrenolide
uniformly
distributed in the adhesive layer. The tape is made of a thin,
matte-finish polyethylene
film that is slightly elastic and highly flexible.
The adhesive is a synthetic copolymer of acrylate ester and acrylic
acid that is free from
substances of plant origin. The pressure-sensitive adhesive surface is
covered with a
protective paper liner to permit handling and trimming before
application.
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
®
24
33
6
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