CLOBETASOL PROPIONATE solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Akorn

INN (International Name):

CLOBETASOL PROPIONATE

Sammensetning:

CLOBETASOL PROPIONATE 0.4625 mg in 1 mL

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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.

Produkt oppsummering:

Clobetasol Propionate Topical Solution, USP, 0.05% is supplied in plastic squeeze bottles, 25 mL (NDC 50383-266-25), and 50 mL (NDC 50383-266-50). Store between 15° and 30°C (59° and 86°F). Do not use near an open flame. Rx only Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Rev. 266:01 2/10

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE SOLUTION
AKORN
----------
CLOBETASOL PROPIONATE TOPICAL SOLUTION, USP, 0.05% W/W
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
(11ß,16ß)-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
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 determined by many factors, includi