CLOBETASOL PROPIONATE ointment

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Torrent Pharmaceuticals Limited

Пут администрације:

TOPICAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Clobetasol propionate ointment, USP 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/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 preparations.

Резиме производа:

Clobetasol propionate ointment USP, 0.05% is supplied in: 15-g (NDC 13668-603-01), 30-g (NDC 13668-603-02), 45-g (NDC 13668-603-04) and 60-g (NDC 13668-603-05) tubes. Store at controlled room temperature 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Do not refrigerate. Manufactured by: TORRENT PHARMACEUTICALS LTD., Pithampur-454775, INDIA. Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. December 2022                                                                                                                    8091169

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE OINTMENT
TORRENT PHARMACEUTICALS LIMITED
----------
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.
Chemically, clobetasol propionate is (11ß,
16ß)-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.
Clobetasol propionate ointment, USP contains clobetasol propionate 0.5
mg/g in a base
of propylene glycol, sorbitan sesquioleate, and white petrolatum.
25
32
5
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 dressing with hydrocortisone for up to 24 hours has
not been
demonstrated to increase penetration; however, occlusion of
hydrocortisone for 96
hours markedly enhan