CLOBETASOL PROPIONATE solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

Clobetasol Propionate (UNII: 779619577M) (Clobetasol - UNII:ADN79D536H)

Sẵn có từ:

Rebel Distributors Corp

INN (Tên quốc tế):

Clobetasol Propionate

Thành phần:

Clobetasol Propionate 0.5 mg in 1 mL

Tuyến hành chính:

TOPICAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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/wk 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.

Tóm tắt sản phẩm:

Clobetasol Propionate Topical Solution, USP 0.05%, a colorless, hazy solution, is supplied in 25 mL and 50 mL plastic squeeze bottles. Store at controlled room temperature, 15 °–30 °C (59 °–86 °F). Do not refrigerate. Do not use near an open flame.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE SOLUTION
REBEL DISTRIBUTORS CORP
----------
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
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
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5
The extent of percutaneous absorption of topical corti