CLOBETASOL PROPIONATE solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Alembic Pharmaceuticals Inc.

Vartojimo būdas:

TOPICAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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.

Produkto santrauka:

Clobetasol Propionate Topical Solution USP, 0.05% is supplied in white opaque oval shape bottles, 25 mL (NDC 62332-486-25), and 50 mL (NDC 62332-486-50)

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE SOLUTION
ALEMBIC PHARMACEUTICALS INC.
----------
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 USP, 0.05% contains clobetasol
propionate 0.5
mg/g in a base of carbopol 974P, isopropyl alcohol (39.3% 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
25
32
5
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 determi