CLOBETASOL PROPIONATE- clobetasol propionate solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

INN (International Name):

Clobetasol Propionate

Composition:

Clobetasol Propionate 0.5 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Clobetasol Propionate Topical Solution, USP 0.05% is supplied in plastic squeeze bottles. 25 mL (NDC 0472-0402-25) 50 mL (NDC 0472-0402-50) Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Do not refrigerate. Do not use near an open flame. Rx only Manufactured by: Cosette Pharmaceuticals, Inc. 111 Coolidge St., South Plainfield, NJ 07080 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. 08/2019                    8-0323ACT4

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE SOLUTION
ACTAVIS PHARMA, 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 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
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,
25
32
5
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 facto