帝普爽軟膏

国家: 台湾

语言: 中文

来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

资料单张 资料单张 (PIL)
11-06-2020
公众评估报告 公众评估报告 (PAR)
11-06-2020

有效成分:

BETAMETHASONE (AS DIPROPIONATE);;SALICYLIC ACID

可用日期:

美商默沙東藥廠股份有限公司台灣分公司 台北市信義區信義路五段106號12樓 (86683720)

ATC代码:

D01AE20

药物剂型:

軟膏劑

组成:

BETAMETHASONE (AS DIPROPIONATE) (6804009220) (0.64MG) 0.50MG; SALICYLIC ACID (8428000700) 30.00MG

每包单位数:

管裝

类:

製 劑

处方类型:

須由醫師處方使用

厂商:

SCHERING-PLOUGH CANADA INC. 3535 ROUTE TRANSCANADIENNE, POINTE-CLAIRE, QUEBEC, H9R 1B4 CANADA CA

治疗领域:

combinations

疗效迹象:

牛皮癬、慢性、異位性皮膚炎、神經性皮膚炎(單純苔癬)濕疹、扁平苔癬、汗疱、皮脂漏皮膚炎、尋常魚鱗癬等之發炎症狀解除。

產品總結:

註銷日期: 2017/06/29; 註銷理由: 自請註銷; 有效日期: 2019/04/30; 英文品名: DIPROSALIC OINTMENT

授权状态:

已註銷

授权日期:

1985-04-30

资料单张

                                -
-
(HPA)
-
-
(HPA)
(Cushing's syndrome)
(ACTH)
-
(Cushing's syndrome)
0.64
betamethasone
d i p r o p i o n a t e
0 . 5
( 0 . 0 5 % )
betamethasone30(3%) salicylic acid
Betamethasone dipropionate
2
(
)
DIPROSALIC
® OINTMENT
013453
()
White PetrolatumMineral Oil
1000
25°C
Version: Apr. 2002
Schering-Plough Canada Inc.
3535 Route Transcanadienne, Pointe-
Claire, Quebec, H9R 1B4 Canada
10612
when long-term use is anticipated, particularly in infants and
children.
If excessive dryness or increased skin irritation develops,
discontinue use of this preparation.
DIPROSALIC
®
Ointment is not for ophthalmic use. Avoid contact
with eyes and mucous membranes.
PEDIATRIC USE: Pediatric patients may demonstrate greater
susceptibility to topical corticosteroid-induced hypothalamic-
pituitary-adrenal (HPA) axis suppression and to exogenous
corticosteroid effects than mature patients because of greater
absorption due to a large skin surface area to body weight ratio.
HPA axis suppression, Cushing's syndrome, linear growth
retardation, delayed weight gain, and intracranial hypertension
have been reported in children receiving topical corticosteroids.
Manifestations of adrenal suppression in children include low
plasma cortisol levels and absence of response to ACTH
stimulation. Manifestations of intracranial hypertension include a
bulging fontanelle, headaches and bilateral papilledema.
USE DURING PREGNANCY AND IN NURSING WOMEN:
Since safety of topical corticosteroid use in pregnant women has
not been established, drugs of this class should be used during
pregnancy only if the potential benefit justifies the potential risk
to
the fetus. Drugs of this class should not be used extensively in
large amounts or for prolonged periods of time in pregnant
patients.
Since it is not known whether topical administration of
corticosteroids can result in sufficient systemic absorption to
produce detectable quantities in breast milk, a decision should
be made to discontinue nursing or to discontinue the drug, taking
into account the importan
                                
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