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:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

INN (International ime):

clobetasol propionate

Sastav:

clobetasol propionate 0.5 mg in 1 mL

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Clobetasol propionate topical solution USP, 0.05% 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:

Clobetasol Propionate Topical Solution USP, 0.05% is supplied in plastic squeeze bottle as follows:                 NDC 0168-0269-50                50 mL plastic bottle Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. Do not refrigerate. Do not use near an open flame. KEEP OUT OF THE REACH OF CHILDREN. E. FOUGERA & CO. A division of FOUGERA PHARMACEUTICALS INC. Melville, New York 11747 46258829A R10/2019 #244

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE SOLUTION
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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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
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 USP, 0.05% contains: 0.5 mg/g
clobetasol
propionate in a base composed of purified water, isopropyl alcohol
(39.3%), carbomer
934P and sodium hydroxide (for pH adjustment).
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
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32
5
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: The extent of percutaneous absorption of topical
corticoste