CLOBETASOL PROPIONATE cream

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

NuCare Pharmaceuticals,Inc.

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 USP, 0.05% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Περίληψη προϊόντος:

Clobetasol Propionate Cream, USP, 0.05% is supplied in 15-g tubes (NDC 68071-1599-1 ) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Clobetasol propionate cream should not be refrigerated. Rx only Manufactured by: Glenmark Pharmaceuticals Ltd. Village : Kishanpura, Baddi Nalagarh road District : Solan, Himachal Pradesh – 173205 India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1(888)721-7115 www.glenmarkpharma.com/usa August 2018

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE CREAM
NUCARE PHARMACEUTICALS,INC.
----------
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, 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 (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 USP has the empirical formula C
H
CIFO
and a molecular weight of 467. It
is a white to cream-colored crystalline powder insoluble in water.
Clobetasol Propionate Cream USP, 0.05% contains clobetasol propionate
USP 0.5 mg/g in a cream base
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, 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 hydrocorti