DESONIDE cream DESONIDE lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

INN (International Name):

DESONIDE

Composition:

DESONIDE 0.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Desonide Cream and Lotion are low to medium potency corticosteroids indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Desonide Cream and Lotion are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Product summary:

Desonide Cream 0.05% is supplied in a tube containing: 15 g NDC 0472-0804 -15 60 g NDC 0472-0804 -60 Desonide Lotion 0.05% is supplied in bottles containing: 2 fl oz NDC 0472-0803 -02 4 fl oz NDC 0472-0803 -04 Storage Conditions: Store between 2° and 30°C (36° and 86°F). Marketed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Made in Canada P53355-1 Rev. March 2018

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DESONIDE- DESONIDE CREAM
DESONIDE- DESONIDE LOTION
ACTAVIS PHARMA, INC.
----------
DESONIDE RX ONLY
CREAM 0.05%
AND LOTION 0.05%
FOR DERMATOLOGIC USE ONLY –
NOT FOR OPHTHALMIC USE –
DESCRIPTION:
Desonide Cream 0.05% and Lotion 0.05% contain desonide
(Pregna-1,4-diene-3,20-dione,11,21-
dihydroxy-16,17 [(1-methylethylidene)bis(oxy)]-,(11β,16α)- a
synthetic nonfluorinated corticosteroid
for topical dermatologic use. The corticosteroids constitute a class
of primarily synthetic steroids used
topically as anti-inflammatory and anti-pruritic agents.
Chemically, desonide is C
H O . It has the following structural formula:
Desonide has the molecular weight of 416.51. It is a white to off
white odorless powder which is
soluble in methanol and practically insoluble in water.
Each gram of Desonide Cream contains 0.5 mg of desonide in a base of
citric acid, emulsifying wax,
isopropyl palmitate, polysorbate 60, potassium sorbate, propyl
gallate, propylene glycol, purified
water, sodium hydroxide, sorbic acid, stearic acid, and synthetic
beeswax.
Each gram of Desonide Lotion contains 0.5 mg of desonide in a base of
cetyl alcohol, edetate sodium,
glyceryl stearate SE, light mineral oil, methylparaben, propylene
glycol, propylparaben, purified water,
sodium lauryl sulfate, sorbitan monostearate, and stearyl alcohol. May
contain citric acid and/or sodium
hydroxide for pH adjustment.
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 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 .