CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05%- clobetasol propionate cream usp, 0.05% cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Encube Ethicals Private Limited

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clobetasol propionate cream USP, 0.05% is super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g /week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Clobetasol propionate cream USP, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Product summary:

Clobetasol Propionate Cream USP, 0.05% is supplied in: 15 g tube (NDC 21922-016-04) 30 g tube (NDC 21922-016-05) 45 g tube (NDC 21922-016-06) 60 g tube (NDC 21922-016-07) Store cream between 15° and 30°C (59°-86°F). Clobetasol propionate cream should not refrigerated. Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India.   Distributed by: Encube Ethicals Inc. 200 Meredith Avenue, Suite 101A Durham, NC 27713 USA Rev: 00 Sep 2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE CREAM
USP, 0.05%- CLOBETASOL PROPIONATE CREAM USP, 0.05% CREAM
ENCUBE ETHICALS PRIVATE LIMITED
----------
RX ONLY
FOR TOPICAL DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.
DESCRIPTION:
Clobetasol propionate cream USP 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 empirical formula C
H ClFO and a molecular weight of 467. It is a
white to cream-colored crystalline powder insoluble in water.
Clobetasol propionate cream USP, 0.05% contains clobetasol propionate
0.5 mg/g in a cream base of
propylene glycol, mono- and di-glycerides, cetostearyl alcohol,
stearoyl macrogolglycerides, white
wax, chlorocresol, sodium citrate, anhydrous citric acid, and purified
water.
CLINICAL PHARMACOLOGY:
Like other topical corticosteroids, clobetasol propionate has
anti-inflammatory, antipruritic, and
vasoconstrictive properties. The mechanism of the anti-inflammatory
activity of the topical steroids, in
general, is unclear. However, corticosteroids are thought to act by
the induction of phospholipase A2
inhibitory proteins, collectively called lipocortins. It is postulated
that these proteins control the
biosynthesis of potent mediators of inflammation such as
prostaglandins and leukotrienes by inhibiting
the release of their common precursor, arachidonic acid.
Arachidonic acid is released from membrane phospholipids by
phospholipase A2.
PHARMACOKINETICS :
The extent of percutaneous absorption of topical corticosteroids is
determined by
25
32
5
many factors, including the vehicle and the integrity of the epidermal
barrier. Occlusive dressings with
h