Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
glibenclamide
Sanofi-Aventis Australia Pty Ltd
Registered
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 Lees het volledige document