CLOBETASOL PROPIONATE- clobetasol propionate gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Clobetasol Propionate (UNII: 779619577M) (Clobetasol - UNII:ADN79D536H)

Available from:

Teligent Pharma, 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 gel, 0.05% 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 per 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 gel is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Product summary:

Clobetasol Propionate Gel, 0.05% is supplied in tamper-evident tubes as follows: 15 gram (NDC: 52565-082-15) 30 gram (NDC: 52565-082-30) 60 gram (NDC: 52565-082-60) Store at controlled room temperature 15°-30°C (59°-86°F). DO NOT REFRIGERATE. Manufactured By: Teligent Pharma, Inc. Buena, NJ 08310 Rev 02/2017 

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE GEL
TELIGENT PHARMA, INC.
----------
CLOBETASOL PROPIONATE GEL, 0.05%
(POTENCY EXPRESSED AS CLOBETASOL PROPIONATE)
RX ONLY
FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
DESCRIPTION
Clobetasol propionate gel 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.
Clobetasol propionate is a white to cream-colored crystalline powder
insoluble in water. Chemically, it
is
21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione
17-propionate, and it
has the following structural formula:
Each gram of the 0.05% gel contains 0.5 mg clobetasol propionate in a
base of propylene glycol,
carbomer 934P, sodium hydroxide 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 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 the integrity of the epidermal barrier.
Occlusive dressings with
hydrocortisone for up to 24 hours has not been demonstrated to
increase penetration; however,
occlusion of hydrocortisone for 96 hours markedly enhances
penetration. Topical corticosteroids can
be absorbed from normal intact skin. Inflammation and/or other dis