CLOBETASOL PROPIONATE ointment

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Northstar Rx LLC

Laluan pentadbiran:

TOPICAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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.

Ringkasan produk:

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° to 86°F) [See USP Controlled Room Temperature]. Do not refrigerate and avoid freezing. Manufactured for: Northstar Rx LLC Memphis, TN 38141. Toll number: 1-800-206-7821 Manufactured by: Glenmark Pharmaceuticals Limited Baddi, Himachal Pradesh – 173205 India May 2021

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE OINTMENT
NORTHSTAR RX LLC
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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. 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 integrity of the epidermal barri