顧糖維膜衣錠850毫克

国: 台湾

言語: 中国語

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

公開評価報告書 公開評価報告書 (PAR)
28-06-2020

有効成分:

METFORMIN HCL (EQ TO METFORMIN HYDROCHLORIDE)

から入手可能:

台灣默克股份有限公司 台北市內湖區堤頂大道2段89號6樓 (23526610)

ATCコード:

A10BA02

医薬品形態:

膜衣錠

構図:

METFORMIN HCL (EQ TO METFORMIN HYDROCHLORIDE) (6820400710) MG

パッケージ内のユニット:

鋁箔盒裝

クラス:

製 劑

処方タイプ:

須由醫師處方使用

製:

MERCK SANTE S.A.S. CENTRE DE PRODUCTION SEMOY,2 RUE DU PRESSOIR VERT, 45400, SEMOY, FRANCE FR

治療領域:

metformin

適応症:

成人及12歲(含)以上的兒童或青少年之第二型糖尿病。

製品概要:

註銷日期: 2017/04/12; 註銷理由: 自請註銷; 有效日期: 2021/12/25; 英文品名: GLUCOPHAGE FILM-COATED TABLETS 850MG

認証ステータス:

已註銷

承認日:

2006-12-25

情報リーフレット

                                GLUCOPHAGE
500 MG
FILM-
COATED TABLETS
GLUCOPHAGE
850 MG
FILM-
COATED TABLETS
GLUCOPHAGE
1000 MG
FILM-
COATED TABLETS
Active ingredient: metformin hydrochloride
COMPOSITION

Each film-coated tablet of Glucophage 500 mg
contains
as
active
ingredient
500 mg
metformin
hydrochloride
(equivalent
to
390 mg metformin base).

Each film-coated tablet of Glucophage 850 mg
contains
as
active
ingredient
850 mg
metformin
hydrochloride
(equivalent
to
663 mg metformin base)

Each
film-coated
tablet
of
Glucophage
1000 mg contains as active ingredient 1000 mg
metformin
hydrochloride
(equivalent
to
780 mg metformin base).
Excipients:
 
Povidone
K30,
magnesium
stearate
and
hypromellose

Povidone
K30,
magnesium
stearate,
hypromellose,
macrogol
400
and
macrogol
8000
PROPERTIES
PHARMACODYNAMICS
Glucophage is an antidiabetic medicine that
belongs to the group of biguanides. Metformin,
the active ingredient in Glucophage, reduces
hepatic glucose production, increases insulin
sensitivity in muscles and delays intestinal
glucose absorption.
A reduction of diabetic complications has been
shown in overweight type 2 diabetic adult
patients treated with Glucophage as first-line
therapy after diet therapy. Glucophage is
associated with either a stable body weight or
modest weight loss.
PHARMACOKINETICS
Absorption:
After an oral dose of metformin hydrochloride
tablet, maximum plasma concentration (C
max
)
is reached in approximately 2.5 hours (t
max
)
between 1.5 and 3.5. Absolute bioavailability
of a 500 mg or 850 mg metformin
hydrochloride tablet is approximately 50-60%
in healthy subjects. After an oral dose, the non-
absorbed fraction recovered in faeces was 20-
30%.
After oral administration, metformin
absorption is saturable and incomplete. It is
assumed that the pharmacokinetics of
metformin absorption is non-linear.
At the recommended metformin doses and
dosing schedules, steady state plasma
concentrations are reached with
                                
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