CLOBETASOL PROPIONATE solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Morton Grove Pharmaceuticals, Inc.

Via de administração:

TOPICAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Clobetasol propionate topical solution is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp. Treatment beyond two 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 children 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.

Resumo do produto:

Clobetasol Propionate Topical Solution, USP 0.05%, a colorless, hazy solution, is supplied in plastic squeeze bottles, 25 mL (NDC 60432-133-25), and 50 mL (NDC 60432-133-50). Store at Controlled Room Temperature, 20° to 25°C (68° to 77°F). Do not refrigerate. Do not use near an open flame.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE SOLUTION
MORTON GROVE PHARMACEUTICALS, INC.
----------
CLOBETASOL PROPIONATE
TOPICAL SOLUTION, USP
0.05%
(POTENCY EXPRESSED AS CLOBETASOL PROPIONATE)
FOR USE ON THE SCALP
FOR DERMATOLOGIC USE ONLY-
NOT FOR OPHTHALMIC USE.
DESCRIPTION
Clobetasol propionate topical solution 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
21-Chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-
diene-3,20-dione 17-propionate, and it has the following structural
formula:
Clobetasol propionate has the molecular formula C
H ClFO and a molecular weight of 466.98. It is
a white to cream-colored crystalline powder insoluble in water.
Clobetasol propionate topical solution contains clobetasol propionate
0.05% (0.5 mg/g) in a base
composed of purified water, isopropyl alcohol (39.3%), carbomer 934P
and sodium hydroxide. It may
also contain hydrochloric acid to adjust pH.
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
25
32
5
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