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:

Glenmark Pharmaceuticals Inc., USA

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 grams 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 is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Proizvod sažetak:

Clobetasol Propionate Ointment USP, 0.05% is available as follows: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not refrigerate and avoid freezing. Manufactured by: Glenmark Pharmaceuticals Limited Baddi, Himachal Pradesh 173205, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 [phone] www.glenmarkpharma-us.com August 2020

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE OINTMENT
GLENMARK PHARMACEUTICALS INC., USA
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CLOBETASOL PROPIONATE OINTMENT USP, 0.05%
RX ONLY
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 USP,
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 USP 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 USP has the empirical formula of C
H ClFO and a molecular weight of
466.97 g/mol. It is a white to almost white, crystalline powder,
practically insoluble in water, slightly
soluble in benzene and diethyl ether; sparingly soluble in ethanol;
freely soluble in acetone, in
dimethylsulfoxide, in chloroform, in methanol and in dioxane.
Clobetasol Propionate Ointment USP, 0.05% 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 integri