CLOBETASOL PROPIONATE cream

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Preferred Pharmaceuticals Inc.

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Clobetasol propionate cream 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 hypothalamicpituitary- 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.

Produkt oppsummering:

Clobetasol Propionate Cream USP, 0.05% is supplied in 15-g tubes (NDC 68788-7212-1), 30-g tubes (NDC 68788-7212-3),), and 60-g tubes (NDC 68788-7212-6),). Store cream between 15° and 30°C (59° and 86°F). Clobetasol propionate cream should not be refrigerated. Rx only Manufactured by : Teligent Pharma, Inc. Buena, NJ 08310 76806 Revised: 08/2017 Relabeled By: Preferred Pharmaceuticals Inc .

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CLOBETASOL PROPIONATE- CLOBETASOL PROPIONATE CREAM
PREFERRED 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 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
CIFO and a molecular weight of
467. It is a white to cream-colored crystalline powder insoluble in
water.
Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in
a cream base
composed of cetyl alcohol, citric acid, 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.
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
25
32
5
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 epi