Nazione: Tanzania
Lingua: inglese
Fonte: Tanzania Medicinces & Medical Devices Authority
Metformin , Glimepiride
RESONANT PHARMACEUTICALS PVT. LTD., INDIA
Combinations of oral blood glucose lowering drugs
Metformin and Glimepiride
500/2
Tablets
East African (India) Overseas Limited, INDIA
Physical description: Light yellow coloured, elongated, biconvex uncoated tablets scored one side; Local technical representative: Heko Pharmacy Limited (7718)
Registered/Compliant
2021-08-20
Effective date: 03/10/2022 TMDA/DMC/MRE/F/016 REV #:02 THEUNITEDREPUBLICOFTANZANIA MINISTRYOFHEALTH TANZANIAMEDICINES ANDMEDICALDEVICESAUTHORITY PUBLIC ASSESSMENT REPORT FOR MG-2 (METFORMINHYDROCHLORIDE 500 MG AND GLIMEPIRIDE 2MG) TABLETS VERSION NUMBER 01 3 RD JANUARY, 2023 TMDA HEADQUARTERS, PLOT NO. 56/1, BLOCK E, KISASA B CENTRE, SWASWA ROAD, P. O. BOX 1253, DODOMA – TANZANIA, TELEPHONE: +255 (26) 2961989/2061990/+255 (22) 2450512/2450751/2452108, EMAIL: INFO@TMDA.OG.TZ, Website: WWW.TMDA.GO.TZ Toll free: 0800110084 Effective date: 03/10/2022 1 1. INTRODUCTION MG-2 is a generic medicine of AMARYL (Glimepiride Tablets 2 mg) of Sanofi-Aventis U.S. LLC Bridgewater, NJ 08807 and GLUCOPHAGE (Metformin Hydrochloride 500 mg Tablets) of Bristol-Myers Squibb Company Princeton, NJ USA. MG-2 is an antidiabetic medicine belonging to A10B B12 (Blood glucose lowering drugs, excl. insulins: Sulfonamides, urea derivatives) group. Glimepiride is an orally active hypoglycaemic substance belonging to the sulphonylurea group. Glimepiride acts mainly by stimulating insulin release from pancreatic beta cells. As with other sulfonylureas this effect is based on an increase of responsiveness of the pancreatic beta cells to the physiological glucose stimulus. In addition, glimepiride seems to have pronounced extrapancreatic effects also postulated for other sulfonylureas. Sulfonylureas regulate insulin secretion by closing the ATP-sensitive potassium channel in the beta cell membrane. Closing the potassium channel induces depolarisation of the beta cell and results -by opening of calcium channels - in an increased influx of calcium into the cell. This leads to insulin release through exocytosis. Glimepiride binds with a high exchange rate to a beta cell membrane protein which is associated with the ATP-sensitive potassium channel but which is different from the usual sulfonylureas binding site. Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insuli Leggi il documento completo