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:

Quagen Pharmaceuticals LLC

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:

Clobetasol Propionate Topical Solution USP, 0.05% is supplied in plastic squeeze bottles. 25 mL (NDC 70752-153-20) 50 mL (NDC 70752-153-04). Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Do not use near an open flame. Rx Only Manufactured by: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 52029 Rev. 03/2022

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE SOLUTION
QUAGEN PHARMACEUTICALS LLC
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CLOBETASOL PROPIONATE TOPICAL SOLUTION USP, 0.05% W/W
RX ONLY
SCALP APPLICATION
FOR TOPICAL DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE
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
The extent of percutaneous absorption of topical corticosteroids,
including clobetasol
propionate, is determined by many factors, including the vehicle, the
integrity of the
epidermal barrier, and the use of occlusive dressings (see DOSAGE AND
ADMINISTRATION).
As with all topical corticosteroids, clobetasol propionate can be
absorbed from normal
intact skin. Inflammation and/or other disease processes in the skin
may increase
percutaneous absorption. Occlusive dressings substantially increase
the percutaneous
absorption of topical corticosteroids (see DOSAGE AND ADMINISTRATION).
Once absorbed through the skin, topical corticosteroids enter
pharmacokinetic
pathways similarly to systemically administered corticosteroids.
Corticosteroids are
bound to plasma proteins in varying degrees. Corticosteroids are
metabolized primarily
in the liver and are then excreted by the kidneys. Some of the topical
corticosteroids,
including clo