CLOBETASOL PROPIONATE ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals 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 ointment 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. 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 ointment, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Product summary:

Clobetasol Propionate Ointment USP, 0.05% contains 0.5 mg per gram of clobetasol propionate, USP. The translucent, unctuous ointment is available as follows: NDC 0378-8190-15 carton containing one 15 g tube NDC 0378-8190-30 carton containing one 30 g tube NDC 0378-8190-45 carton containing one 45 g tube NDC 0378-8190-60 carton containing one 60 g tube Store between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Do not be refrigerate. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: DPT Laboratories, Ltd. San Antonio, TX 78215 U.S.A. 140898-0517 Revised: 5/2017 DPT:CLOPOT:R1

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE OINTMENT
MYLAN PHARMACEUTICALS INC.
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FOR TOPICAL DERMATOLOGIC USE ONLY—
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE
DESCRIPTION
Clobetasol propionate ointment 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, USP 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 ointment USP, 0.05% contains clobetasol
propionate 0.5 mg/g in a base of
propylene glycol, sorbitan sesquioleate, and white petrolatum.
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 dressing 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 abs