CLOBETASOL PROPIONATE emulsion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

CLOBETASOL PROPIONATE

Composition:

CLOBETASOL PROPIONATE 0.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clobetasol propionate cream-emollient is a 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. In the treatment of moderate to severe plaque-type psoriasis, clobetasol propionate cream-emollient applied to 5% to 10% of body surface area can be used up to 4 consecutive weeks. The total dosage should not exceed 50 g/week. When dosing for more than 2 weeks, any additional benefits of extending treatment should be weighed against the risk of HPA suppression. Treatment beyond 4 consecutive weeks is not recommended. Patients should be instructed to use clobetasol propionate cream-emollient for the minimum amount of time necessary to achieve t

Product summary:

Clobetasol Propionate Cream-Emollient, 0.05% is supplied in 30-g tubes (NDC 54868-6305-0). Store between 15° and 30° C (59° and 86° F). Clobetasol propionate cream-emollient should not be refrigerated. Rx Only Distributed by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Manufactured by: DPT Laboratories Ltd San Antonio, TX  78215 Rev. 270:00 10/09 129160-1009 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, OK     74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE EMULSION
PHYSICIANS TOTAL CARE, INC.
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CLOBETASOL PROPIONATE CREAM-EMOLLIENT, 0.05%
RX ONLY
_FOR TOPICAL DERMATOLOGIC USE ONLY - NOT FOR OPHTHALMIC, ORAL, OR_
_INTRAVAGINAL USE._
DESCRIPTION
Clobetasol Propionate Cream-Emollient, 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 cream-emollient contains clobetasol propionate
0.5 mg/g in an emollient base of
cetomacrogol 1000, cetostearyl alcohol, citric acid, dimethicone 360,
imidurea as a preservative,
isopropyl myristate, propylene glycol, purified water, and sodium
citrate.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, clobetasol propionate has
antiinflammatory, 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 A
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 A .
PHARMACOKINETICS
The extent of percutaneous absorption of topical corticosteroids is
determined by many factors,
including the vehicle and integrity of the epidermal barrier.
Occlusive dressing with hydrocortisone for
up to 24 h