CLOBETASOL PROPIONATE- clobetasol propionate solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

A-S Medication Solutions

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 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.

Proizvod sažetak:

Product: 50090-3085 NDC: 50090-3085-0 50 mL in a BOTTLE / 1 in a CARTON

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE SOLUTION
A-S MEDICATION SOLUTIONS
----------
CLOBETASOL PROPIONATE TOPICAL SOLUTION USP, 0.05%
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 cream-colored crystalline powder insoluble in water.
Clobetasol propionate topical solution contains clobetasol propionate
0.5 mg/g in a base of carbomer
974P, isopropyl alcohol (40% w/w), purified water, 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
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32
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The extent of percutaneous absorption of topical corticosteroids,
including clobetasol propionate, is
determined by many factors, i