البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
GLICLAZIDE
PHARMASCIENCE INC
A10BB09
GLICLAZIDE
80MG
TABLET
GLICLAZIDE 80MG
ORAL
100
Prescription
SULFONYLUREAS
Active ingredient group (AIG) number: 0119934001; AHFS:
APPROVED
2007-05-08
Page 1 of 32 PRODUCT MONOGRAPH PR PMS-GLICLAZIDE (GLICLAZIDE TABLETS, BP) 80 MG TABLETS HYPOGLYCEMIC SULFONYLUREA ORAL HYPOGLYCEMIC AGENT PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montreal, Quebec H4P 2T4 www.pharmascience.com DATE OF PREPARATION: May 2, 2017 Submission Control No.: 204012 Page 2 of 32 PRODUCT MONOGRAPH PR PMS-GLICLAZIDE (GLICLAZIDE TABLETS, BP) 80 MG TABLETS Oral hypoglycemic agent ACTIONS AND CLINICAL PHARMACOLOGY pms-GLICLAZIDE (gliclazide) is a hypoglycemic agent of the sulfonylurea group. The hypoglycemic action of pms-GLICLAZIDE (gliclazide) is related to an improvement in insulin secretion from the functioning beta cells of the pancreas. It potentiates the insulin release, improves the dynamics of insulin. Hemobiological properties of gliclazide have been observed in pharmacology studies. These are attributed to gliclazide action on the platelet behaviour, prostaglandin equilibrium and fibrinolysis. Gliclazide is rapidly absorbed from the gastro-intestinal tract and the plasma peak of gliclazide occurs between 4 and 6 hours. In man it is highly bound to plasma proteins, about 94%. The mean elimination half-life in man approximates 10.4 hours. Following oral administration the unchanged gliclazide in plasma is extensively metabolized with little of the unchanged compound (< 1%) appearing in the urine. Gliclazide metabolites and conjugates are primarily eliminated via kidneys: 60 to 70% and about 10 to 20% via faeces. Some five principal metabolites have been identified in urine, essentially oxidized and hydroxylated derivatives, some as glucuronic acid conjugates. Page 3 of 32 INDICATIONS Control of hyperglycemia in gliclazide responsive diabetes mellitus of stable, mild, non-ketosis prone, maturity onset or adult type which cannot be controlled by proper dietary management and exercise, or when insulin therapy is not appropriate. CONTRAINDICATIONS - Known hypersensitivity or allergy to pms-GLICLAZIDE, other sulfonylureas, sulfonamides, or to any of the excipients of this product ( اقرأ الوثيقة كاملة