DESONIDE OINTMENT, 0.05% ointment

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Encube Ethicals Private Limited

관리 경로:

TOPICAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Desonide Ointment, 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 Ointment, 0.05% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

제품 요약:

Desonide Ointment, 0.05% is available as follows: 15 g tube (NDC 21922-004-04) 60 g tube (NDC 21922-004-07) Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C1, Madkaim Ind. Estate, Madkaim, Post Mardol, Ponda, Goa-403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Avenue, Suite 101A Durham, NC 27713 USA Rev: 04 December 2019

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

DESONIDE OINTMENT, 0.05% - DESONIDE OINTMENT, 0.05% OINTMENT
ENCUBE ETHICALS PRIVATE LIMITED
----------
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
Desonide Ointment, 0.05% contains desonide
(Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-
methylethylidene)bis(oxy)]-,(11ß,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 Ointment,
0.05% is C
H
O . It has the following
structural formula:
The molecular weight of desonide is 416.51. It is white to off-white
powder. The solubility of desonide in
distilled water saturated with the ether is 184 mg/L.
Each gram of Desonide Ointment, 0.05% contains 0.5 milligram of
desonide microdispersed in a base of white
petrolatum.
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 .
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 demonstrated to increase penetration; however, occlusion
of hydrocortisone for 96 hours
markedly enhances penetration. Topical corticosteroids can be absorbed
from normal intact skin. Inflammation
and/or other disease processes in the ski