愛索思乳膏0.5毫克/公克

Country: Թայվան

language: չինարեն

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

active_ingredient:

ISOTRETINOIN

MAH:

荷商葛蘭素史克藥廠股份有限公司台灣分公司 台北市中正區忠孝西路一段66號23-24樓 (86927438)

ATC_code:

D10AD04

pharmaceutical_form:

乳膏劑

composition:

ISOTRETINOIN (8428000691) 0.5MG

units_in_package:

鋁軟管

class:

製　劑

prescription_type:

醫師藥師藥劑生指示藥品

manufactured_by:

STIEFEL LABORATORIES (PTE) LTD, SINGAPORE 103 GUL CIRCLE, SINGAPORE 629589 SG

therapeutic_area:

isotretinoin

therapeutic_indication:

粉刺、尋常性痤瘡。

leaflet_short:

註銷日期: 2016/05/30; 註銷理由: 許可證已逾有效期; 有效日期: 2014/08/11; 英文品名: ISOTREX CREAM 0.05%

authorization_status:

已註銷

authorization_date:

1999-08-11

PIL

ISOTREX
_ _
TM
Cream
DESCRIPTION
ISOTREX Cream 0.05 % and 0.1 % contain isotretinoin 0.05% w/w and 0.1%
w/w
respectively in an aqueous cream base.
EXCIPIENTS
Benzyl alcohol
Butylated hydroxytoluene
Cetostearyl alcohol
Chlorocresol
Di-n-butyl adipate
Light Liquid Paraffin
Polyoxyethylene stearyl ether
PEG-5 glyceryl mono stearate
Carbomer
Propylene glycol
Purified Water
Sodium hydroxide
CLINICAL INFORMATION
INDICATIONS
ISOTREX Cream is indicated for the topical treatment of mild to
moderate acne
vulgaris and is effective in treating both inflammatory and
non-inflammatory lesions.
The cream is particularly suitable for patients with sensitive or dry
skin.
DOSAGE AND ADMINISTRATION
Apply ISOTREX Cream sparingly over the entire affected area once or
twice daily.
The skin should be thoroughly cleansed and dried before application.
Patients should
be advised that 6-8 weeks of treatment may be required before the full
therapeutic
effect is observed.
CONTRAINDICATIONS
•
ISOTREX Cream is contraindicated in patients with known
hypersensitivity to
any of the ingredients.
•
ISOTREX Cream is contraindicated during pregnancy or in women of
childbearing.
WARNINGS AND PRECAUTIONS
Isotretinoin should be used with caution in patients with a history of
local tolerability
reactions or photoallergy.
Use with caution in patients with a personal or family history of skin
cancer.
Contact with the mouth, eyes, mucous membranes, abraded or eczematous
skin should
be avoided.
Care should be taken not to let the medicine accumulate in skin fold
areas and in the
nasolabial folds.
Due to the irritant nature of isotretinoin, caution should be used
when applying to
sensitive areas of skin, such as the neck, or in patients with
concomitant rosacea or
perioral dermatitis.
Concomitant topical acne therapy should be used with caution because a
cumulative
irritant effect may occur. If irritancy or dermatitis occur, reduce
frequency of
application or temporarily interrupt treatment and resume once the
irritation subsides.
Treatment should be disco