SEMI-DAONIL glibenclamide 2.5mg tablet

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

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Download Productkenmerken (SPC)
01-12-2017

Werkstoffen:

glibenclamide

Beschikbaar vanaf:

Sanofi-Aventis Australia Pty Ltd

Autorisatie-status:

Registered

Productkenmerken

                                Daonil and Semi-Daonil – Glibenclamide
daonil-semi-daonil-ccdsv10-piv9-01sep16
Page 1
PRODUCT INFORMATION
NAME OF THE MEDICINE
Daonil
®
and Semi-Daonil
®*
AUSTRALIAN APPROVED NAME
Glibenclamide.
CHEMICAL STRUCTURE
Glibenclamide belongs to the sulphonylurea group of oral
antidiabetics. Earlier members of this
group are carbutamide, tolbutamide, acetohexamide and chlorpropamide.
Chemically, it is 1-{4 - [2
- (5 -chloro-2-methoxy-benzamido) ethyl] benzenesulphonyl} - 3 -
cyclohexylurea. It has a
molecular weight of 494 and an empirical formula of C
23
H
28
ClN
3
O
5
S. It is a white odourless,
crystalline powder, practically insoluble in water and in ether,
slightly soluble in alcohol and
sparingly soluble in chloroform.
CAS REGISTRY NUMBER
10238-21-8
DESCRIPTION
DAONIL
Each tablet contains 5 mg of glibenclamide. Excipients are lactose
monohydrate, maize starch,
pregelatinised maize starch, purified talc, colloidal anhydrous silica
and magnesium stearate.
SEMI-DAONIL
*
Each tablet contains 2.5 mg of glibenclamide. Excipients are lactose
monohydrate, maize starch,
purified talc, colloidal anhydrous silica and magnesium stearate.
Daonil and Semi-Daonil – Glibenclamide
daonil-semi-daonil-ccdsv10-piv9-01sep16
Page 2
PHARMACOLOGY
Oral hypoglycaemia.
PHARMACODYNAMICS
MECHANISM OF ACTION
Daonil appears to lower the blood glucose acutely in healthy
individuals and patients with type 2
diabetes by stimulating the release of insulin from the pancreas, an
effect dependent upon
functioning beta cells. It acts in concert with glucose (improved
sensitivity of beta cells to
physiological glucose stimulus) and leads to an insulin secretion in
the rhythm of meals. Other
mechanisms of the hypoglycaemic action associated with short term
therapy appear to include
reduction of basal hepatic glucose production and enhancement of
peripheral insulin action at post-
receptor (probably intracellular) sites.
With chronic administration of Daonil
and Semi-Daonil
in patients with type 2 diabetes, the
improvement in glucose tolerance persi
                                
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