CLOBETASOL PROPIONATE ointment

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Physicians Total Care, Inc.

INN (Mezinárodní Name):

CLOBETASOL PROPIONATE

Složení:

CLOBETASOL PROPIONATE 0.5 mg in 1 g

Podání:

TOPICAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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 grams per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children 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 is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Přehled produktů:

Clobetasol Propionate Ointment USP, 0.05% is supplied in Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Do not refrigerate. Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 Revised: August, 2004 PK-1675-2 140

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

CLOBETASOL PROPIONATE - CLOBETASOL PROPIONATE OINTMENT
PHYSICIANS TOTAL CARE, INC.
----------
RX ONLY
FOR EXTERNAL USE ONLY - NOT FOR OPHTHALMIC USE.
DESCRIPTION
Clobetasol Propionate Ointment 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 molecular formula C
H ClFO and a molecular weight of 467. It is a
white to cream-colored crystalline powder insoluble in water.
Each gram of Clobetasol Propionate Ointment USP, 0.05% contains 0.5 mg
clobetasol propionate in an
ointment 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 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 norm