TEMOVATE- clobetasol propionate gel

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

clobetasol propionate (UNII: 779619577M) (clobetasol - UNII:ADN79D536H)

Tillgänglig från:

PharmaDerm, A division of Fougera Pharmaceuticals Inc.

Administreringssätt:

TOPICAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

TEMOVATE® Gel is a super-high potency cor-ticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. TEMOVATE® Gel is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Produktsammanfattning:

TEMOVATE® (clobetasol propionate gel) Gel 0.05% is supplied in: 60-g tubes (NDC 0462-0293-60). Store between 2° and 30°C (36° and 86°F). PharamDerm ® A division of Nycomed US Inc. Melville, NY 11747 USA www.pharmaderm.com I8293A R3/08 #164

Bemyndigande status:

New Drug Application

Produktens egenskaper

TEMOVATE- CLOBETASOL PROPIONATE GEL
PHARMADERM, A DIVISION OF FOUGERA PHARMACEUTICALS INC.
----------
TEMOVATE
(CLOBETASOL PROPIONATE GEL) GEL, 0.05%
RX ONLY
FOR TOPICAL DERMATOLOGIC USE ONLY—
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE
DESCRIPTION
TEMOVATE (clobetasol propionate gel) Gel, 0.05% contains the active
compound clobetasol
propionate, a synthetic corticosteroid, for topical dermatologic use.
Clobetasol, an analog of pred-
nisolone, has a high degree of glucocorticoid activity and a slight
degree of mineralocorticoid activity.
Chemically, clobetasol propionate is (11β,16
β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-
oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following
structural formula:
Clobetasol propionate has the molecular formula C
H CIFO and a molecular weight of 467. It is a
white to cream-colored crystalline powder insoluble in water.
TEMOVATE Gel contains clobetasol propi-onate 0.5 mg/g in a base of
propylene glycol, carbomer
934P, sodium hydroxide, and purified water.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, clobetasol propionate has
anti-inflammatory, antipruritic, and
vasoconstrictive properties. The mechanism of the anti-inflammatory
activity of the topical steroids, in
general, is unclear. However, corti-costeroids are thought to act by
the induction of phospholipase A
inhibitory proteins, collectively called lipocortins. It is postulated
that these proteins control the
biosynthesis of potent mediators of inflammation such as
prosta-glandins and leukotrienes by inhibiting
the release of their common precursor, arachidonic acid. Arachidonic
acid is released from membrane
phospholipids by phospholipase A .
PHARMACOKINETICS: The extent of percutaneous absorption of topical
corticosteroids is determined by
many factors, including the vehicle and the integrity of the epidermal
barrier. Occlusive dressing with
hydrocortisone for up to 24 hours has not been demonstrated to
increase penetration; however,
occlusion of hydrocortisone for 96 hours markedly enh