CLOBETASOL PROPIONATE solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Physicians Total Care, Inc.

INN (Kansainvälinen yleisnimi):

CLOBETASOL PROPIONATE

Koostumus:

CLOBETASOL PROPIONATE 0.462 mg in 1 mL

Antoreitti:

TOPICAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Clobetasol propionate topical solution is indicated for shortterm 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.

Tuoteyhteenveto:

Clobetasol Propionate Topical Solution, USP, 0.05% is supplied in plastic squeeze bottles, 50 mL  (NDC 54868-5292-0 ). Store between 15° and 30°C (59° and 86°F). Do not use near an open flame. Rx only Distributed by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Rev. 266:00 10/09 129162-1009 Relabeling of "Additional Barcode" label by: Physicians Total Care, Inc. Tulsa, OK       74146

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE SOLUTION
PHYSICIANS TOTAL CARE, 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
(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
934P, 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 corticosteroidresponsive
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 factor