DESONIDE cream

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

DESONIDE (UNII: J280872D1O) (DESONIDE - UNII:J280872D1O)

Disponible depuis:

Cosette Pharmaceuticals, Inc.

DCI (Dénomination commune internationale):

Desonide

Composition:

Desonide 0.5 mg in 1 g

Mode d'administration:

TOPICAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Desonide Cream, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician. Desonide Cream, 0.5% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. Safety and effectiveness in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. HPA axis suppression, Cushing’s syndrome, linear growth retardation

Descriptif du produit:

Desonide Cream, 0.05% is available as follows: 15 g tube (NDC 0713-0661-15) 60 g tube (NDC 0713-0661-60) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0661CPLNC2    Rev.10/2022    VC7685

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

DESONIDE- DESONIDE CREAM
COSETTE PHARMACEUTICALS, INC.
----------
DESONIDE CREAM, 0.05%
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
Desonide Cream, 0.05% contains desonide
(Pregna-1,4-diene-3,20-dione,11,21-
dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11β,16α)) a
synthetic corticosteroid
for topical dermatologic use. The corticosteroids constitute a class
of primary synthetic
steroids used topically as anti-inflammatory and antipruritic agents.
Chemically, desonide, the active ingredient in Desonide Cream, 0.05%
is C
H
O
. It
has the following structural formula:
The molecular weight of desonide is 416.51. It is a white to off-white
powder. The
solubility of desonide in distilled water saturated with ether is 184
mg/L.
Each gram of Desonide Cream, contains 0.5 milligram of desonide
microdispersed in a
compatible vehicle buffered to the pH range of normal skin. It
contains aluminum sulfate,
calcium acetate, cetostearyl alcohol, dextrin, glycerin, light mineral
oil, purified water,
sodium lauryl sulfate, synthetic white wax and white petrolatum.
Preserved with
methylparaben.
CLINICAL PHARMACOLOGY
Like other topical corticosteroids, desonide 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
24
32
6
2
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
dressings with hydrocortisone for up to 24 hours have not been
demonstrate