GLIMEPIRIDE SANDOZ glimepiride 2 mg tablet bottle

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

ダウンロード 製品の特徴 (SPC)
16-10-2017
ダウンロード 公開評価報告書 (PAR)
30-11-2017

有効成分:

Glimepiride

から入手可能:

Sandoz Pty Ltd

INN(国際名):

Glimepiride

製品の特徴

                                _Product Information _
_ _
_Page 1 of 14 _
_Glimepiride Sandoz 1mg / 2mg / 3mg / 4mg tablets _
_10/2017_
_Sandoz Pty Ltd _
PRODUCT INFORMATION
GLIMEPIRIDE SANDOZ 1MG / 2MG / 3MG / 4MG TABLETS
NAME OF THE MEDICINE
Generic name: glimepiride
Chemical name: trans-1-{4-[2- (3-ethyl-4-methyl- 2-oxo-3-pyrroline- 1
carboxamido)
ethyl]- phenylsulfonyl}-3- (4-methylcyclohexyl) urea
Chemical structure:
_ _
CAS [93479-97-1]
Empirical formula: C
24
H
34
N
4
O
5
S
_ _
_ _
MW: 491
_ _
_ _
DESCRIPTION
Glimepiride is a white odourless, crystalline powder, practically
insoluble in methanol
and water, slightly soluble in ethanol and sparingly soluble in
methylene chloride.
_ _
Active: glimepiride 1mg / 2mg / 3mg / 4mg
Inactive: Lactose, cellulose microcrystalline, sodium starch
glycollate, povidone and
magnesium stearate. Additionally, each strength contains the following
colouring
agents: 1mg tablet: iron oxide red; 2mg tablet: iron oxide yellow and
indigo carmine;
3mg tablet: iron oxide yellow; 4mg tablet: indigo carmine.
_ _
_ _
PHARMACOLOGY
PHARMACODYNAMICS
Glimepiride is a member of the sulfonylurea group of oral antidiabetic
agents.
Glimepiride
is
a
sulfonylurea
antidiabetic
agent
which
decreases
blood
glucose
concentrations.
The
primary
mechanism
of
action
of
glimepiride
appears
to
be
dependent on stimulating the release of insulin from functioning
pancreatic beta cells.
Glimepiride acts in concert with glucose by improving the sensitivity
of beta cells to
physiological glucose stimulus, resulting in insulin secretion in the
rhythm of meals.
_Product Information _
_ _
_Page 2 of 14 _
_Glimepiride Sandoz 1mg / 2mg / 3mg / 4mg tablets _
_10/2017_
_Sandoz Pty Ltd _
In addition, extrapancreatic effects (e.g. reduction of basal hepatic
glucose production
and increased peripheral tissue sensitivity to insulin and glucose
uptake) may also
play a limited role in the activity of glimepiride.
In
non-fasting
diabetic
patients,
the
hypoglycaemic
action
of
a
single
dose
of
glimepiride persists for 24 hours.
Evidence from
_in vitro_
and a
                                
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