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:

Alembic Pharmaceuticals Inc.

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Clobetasol propionate cream, 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 cream USP, 0.05% is 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 available as a white to off-white cream. It is supplied as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Clobetasol Propionate Cream USP, 0.05% should not be refrigerated. Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Aleor Dermaceuticals Ltd., Karakhadi, Vadodara 391450, India. Mfg. License No.: G/25/2216 Revised: 12/2023

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE CREAM
ALEMBIC PHARMACEUTICALS INC.
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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% contain 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 Pregna-1,4-diene-3,20-dione,
21-chloro-9-
fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-, (11β,16β), and it
has the following
structural formula:
Clobetasol propionate, USP has the molecular formula C
H
ClFO and a molecular
weight of 466.97. It is a white to almost white crystalline powder
insoluble in water.
Clobetasol Propionate Cream USP, 0.05% contains clobetasol propionate,
USP 0.5 mg/g
in a cream base composed of anhydrous citric acid, cetyl alcohol,
glycol stearate, lanolin
oil, methylparaben, PEG-8 stearate, polysorbate 60, propylene glycol,
propylparaben,
purified water, sodium citrate, stearyl alcohol, and white petrolatum.
Sodium hydroxide
may be used to adjust pH.
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 t