DESONIDE lotion

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Alembic Pharmaceuticals Inc.

Podání:

TOPICAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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

Přehled produktů:

Desonide Lotion, 0.05% is supplied in 59 mL and 118 mL bottles containing: 2 fl oz (59 mL)    NDC 62332-550-59 4 fl oz (118 mL)  NDC 62332-550-18   Storage Conditions: Store between 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division), Karakhadi, Vadodara 391450, India. Mfg. License No.: G/25/2216 Revised: 12/2023

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

DESONIDE- DESONIDE LOTION
ALEMBIC PHARMACEUTICALS INC.
----------
DESONIDE LOTION, 0.05%
RX ONLY
FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.
DESCRIPTION
Desonide Lotion, 0.05% contain desonide, USP
(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, USP is C
H
O . It has the following structural formula:
Desonide, USP has the molecular weight of 416.51. It is a white to
almost white
crystalline powder which is practically insoluble in water, sparingly
soluble in ethanol and
in acetone, soluble in chloroform.
Each gram of desonide lotion, 0.05% contains 0.5 mg of desonide, USP
in a base of
cetyl alcohol, edetate disodium, 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
24
32
6
2
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 hydrocortisone for up to 24 hours