CLOBETASOL PROPIONATE ointment

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

NuCare Pharmaceuticals,Inc.

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 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 Ointment, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. Safety and effectiveness of Clobetasol Propionate Ointment in pediatric patients have not been established. Use in children under 12 years of age is not recommended. Because of a hig

Proizvod sažetak:

Clobetasol Propionate Ointment, USP 0.05% is supplied in: 30 g tubes (NDC 68071-1600-3) Store at 20°- 25°C (68°-77°F) [See USP Controlled Room Temperature]. Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street South Plainfield, NJ 07080 Rev. 05/2017 8-0656GW3

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE OINTMENT
NUCARE PHARMACEUTICALS,INC.
----------
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% 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,
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
ClFO
and a molecular weight of 466.98.
Each gram of the 0.05% ointment contains clobetasol propionate 0.5 mg
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
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32
5
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 pen