CLOBETASOL PROPIONATE solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)

Disponible desde:

Novel Laboratories, Inc.

Designación común internacional (DCI):

CLOBETASOL PROPIONATE

Composición:

CLOBETASOL PROPIONATE 0.5 mg in 1 mL

Vía de administración:

TOPICAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Clobetasol propionate topical solution, USP is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 mL/week because of the potential for the drug to suppress the HPA axis. This product is not recommended for use in pediatric patients under 12 years of age. Clobetasol propionate topical solution is contraindicated in patients with primary infections of the scalp, or in patients who are hypersensitive to clobetasol propionate, other corticosteroids, or any ingredient in this preparation.

Resumen del producto:

Clobetasol propionate topical solution USP, 0.05 % is supplied in plastic squeeze bottles, 50 mL (NDC 40032-028-60). Store at 20-25o C (68-77o F) [see USP Controlled Room Temperature]. Do not refrigerate.   Do not use near an open flame.   Rx only Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 PI0286000101 Iss. 03/2015

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE SOLUTION
NOVEL LABORATORIES, INC.
----------
CLOBETASOL PROPIONATE TOPICAL SOLUTION USP, 0.05%
(SCALP APPLICATION)
RX ONLY
FOR TOPICAL DERMATOLOGIC USE ONLY - NOT FOR OPHTHALMIC, ORAL, OR
INTRAVAGINAL USE
DESCRIPTION
Clobetasol propionate topical solution USP, 0.05% contains the active
compound clobetasol
propionate, a synthetic corticosteroid, for topical dermatologic use.
Clobetasol, an analog of
prednisolone, has a high degree of glucocorticoid activity and a
slight degree of mineralocorticoid
activity.
Chemically, clobetasol propionate is
(11β,16β)-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 almost white colored crystalline powder insoluble in water.
Clobetasol propionate topical solution, USP contains clobetasol
propionate 0.5 mg/g in a base of
purified water, isopropyl alcohol (39.3%), carbomer 934P and sodium
hydroxide.
CLINICAL PHARMACOLOGY
The corticosteroids are a class of compounds comprising steroid
hormones secreted by the adrenal
cortex and their synthetic analogs. In pharmacologic doses,
corticosteroids are used primarily for their
anti-inflammatory and/or immunosuppressive effects. Topical
corticosteroids such as clobetasol
propionate are effective in the treatment of corticosteroid-responsive
dermatoses primarily because of
their anti-inflammatory, antipruritic, and vasoconstrictive actions.
However, while the physiologic,
pharmacologic, and clinical effects of the corticosteroids are well
known, the exact mechanisms of
their actions in each disease are uncertain.
Clobetasol propionate, a corticosteroid, has been shown to have
topical (dermatologic) and systemic
pharmacologic and metabolic effects characteristic of this class of
drugs.
PHARMACOKINETICS
25
32
5
The extent of percutaneous absorption of topical corticosteroids,
including clobetasol propionate, is