CLOBETASOL PROPIONATE ointment

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Preferred Pharmaceuticals, Inc.

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Clobetasol propionate ointment is super-high potency corticosteroid formulations 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.

Produkt oppsummering:

Clobetasol Propionate Ointment USP, 0.05% is supplied in: NDC 68788-7581-01 in tube of 15 g NDC 68788-7581-03 in tube of 30 g NDC 68788-7581-06 in tube of 60 g Store at controlled room temperature 15°-30°C (59°-86°F). DO NOT REFRIGERATE. Call you doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please address medical inquiries to, ([e-mail]) Tel.: [phone].

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE OINTMENT
PREFERRED PHARMACEUTICALS, INC.
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CLOBETASOL PROPIONATE OINTMENT USP, 0.05%
FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR
INTRAVAGINAL USE.
RX ONLY
DESCRIPTION
Clobetasol propionate ointment USP, 0.05% contain 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 C25H32ClFO5 and a
molecular weight
of 467. It is a white to cream crystalline powder and soluble in
acetone, in dimethyl
sulfoxide, in chloroform, in methanol, and in dioxane; sparingly
soluble in ethanol; slightly
soluble in benzene and diethyl ether and practically insoluble in
water.
Clobetasol propionate ointment USP, 0.05% is translucent ointment,
contains clobetasol
propionate, USP 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 th