CLOBETASOL PROPIONATE cream

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

NuCare Pharmaceuticals,Inc.

Njia ya uendeshaji:

TOPICAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Clobetasol Propionate Cream, USP 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 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 cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations. Safety and effectiveness of clobetasol propionate cream in pediatric patients has not been established. Use in children under 12 years of age is not recommended. Because of a higher ratio of sk

Bidhaa muhtasari:

Clobetasol Propionate Cream, USP 0.05% is supplied in: 30 g (1.1 oz) tubes (NDC 68071-2268-3) Store at 20°– 25°C (68°–77°F) [see USP Controlled Room Temperature]. Do not refrigerate. Manufactured by: G&W Laboratories, Inc. 111 Coolidge St. South Plainfield, NJ 07080 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. 08/2013 8-0665ACT1

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE CREAM
NUCARE PHARMACEUTICALS,INC.
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CLOBETASOL PROPIONATE CREAM, USP 0.05%
FOR TOPICAL USE ONLY - NOT FOR OPHTHALMIC,
ORAL, OR INTRAVAGINAL USE
DESCRIPTION
Clobetasol Propionate Cream, 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
21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna 1,4-
diene-3,20-dione, 17-propionate and it has the following structural
formula:
Clobetasol propionate has the molecular formula C
H
CIFO
and a molecular weight of 466.97. It
is a white to cream-colored crystalline powder insoluble in water.
Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in
a cream base of propylene
glycol, glyceryl monostearate, cetostearyl alcohol, glyceryl stearate
SE, PEG 100 stearate, white wax,
chlorocresol, sodium citrate, citric acid, 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
.
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32
5
2
2
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