CLOBETASOL PROPIONATE cream

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Glenmark Pharmaceutcials Inc., USA

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Clobetasol propionate cream is a super-high potency corticosteroid formulations 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 cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Proizvod sažetak:

Clobetasol Propionate Cream USP, 0.05% is supplied in 15 g tubes (NDC 68462-529-17), 30 g tubes (NDC 68462-529-35), 45 g tubes (NDC 68462-529-47) and 60 g tubes (NDC 68462-529-65). 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 . Rx only 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 July 2020

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE CREAM
GLENMARK PHARMACEUTCIALS INC., USA
----------
CLOBETASOL PROPIONATE CREAM USP, 0.05%
RX ONLY
FOR TOPICAL DERMATOLOGIC USE ONLY-
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE.
DESCRIPTION:
Clobetasol Propionate Cream 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 molecular formula C
H
CIFO 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 Cream USP, 0.05% contains clobetasol propionate,
USP 0.5 mg/g
in a cream base composed of cetostearyl alcohol, chlorocresol, citric
acid monohydrate,
glyceryl monostearate, glyceryl stearate and PEG 100 stearate,
propylene glycol, purified
water, sodium citrate anhydrous and white wax.
CLINICAL PHARMACOLOGY:
Like other topical corticosteroids, clobetasol propionate has
anti-inflammatory,
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5
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 .