البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
METFORMIN HYDROCHLORIDE
TEVA CANADA LIMITED
A10BA02
METFORMIN
500MG
TABLET
METFORMIN HYDROCHLORIDE 500MG
ORAL
100, 500
Prescription
BIGUANIDES
Active ingredient group (AIG) number: 0101773001; AHFS:
CANCELLED POST MARKET
2018-05-18
PRODUCT MONOGRAPH PR TEVA-METFORMIN (metformin hydrochloride) 500 mg and 850 mg Tablets Teva Standard Oral Antihyperglycemic Agent Teva Canada Limited Date of Preparation: July 25, 2013 30 Novopharm Court Toronto, Ontario Canada M1B 2K9 www.tevacanada.com Control Number: 165821 2 PRODUCT MONOGRAPH TEVA-METFORMIN (metformin hydrochloride) 500 mg and 850 mg Tablets THERAPEUTIC CLASSIFICATION Oral Antihyperglycemic Agent ACTIONS AND CLINICAL PHARMACOLOGY TEVA-METFORMIN (metformin hydrochloride) is a biguanide derivative producing an antihyperglycemic effect which can only be observed in man or in the diabetic animal and only when there is insulin secretion. Metformin, at therapeutic doses, does not cause hypoglycemia when used alone in man or in the non-diabetic animal, except when using a near lethal dose. Metformin has no effect on the pancreatic beta cells. The mode of action of metformin is not fully understood. It has been postulated that metformin might potentiate the effect of insulin or that it might enhance the effect of insulin on the peripheral receptor site. This increased sensitivity seems to follow an increase in the number of insulin receptors on cell surface membranes. Metformin absorption is relatively slow and may extend over about 6 hours. The drug is excreted 3 in urine at high renal clearance rate of about 450 mL/min. The initial elimination of metformin is rapid with a half-life varying between 1.7 and 3 hours. The terminal elimination phase accounting for about 4 to 5 % of the absorbed dose is slow with a half-life between 9 and 17 hours. Metformin is not metabolized. Its main sites of concentration are the intestinal mucosa and the salivary glands. The plasma concentration at steady-state ranges about 1 to 2 mcg/mL. Certain drugs may potentiate the effects of metformin (see PRECAUTIONS). A comparative, two-way, single-dose bioavailability study was conducted on two 500 mg metformin hydrochloride tablet products, TEVA-METFORMIN 500 mg and GLUCOPHAGE ® 500 mg tablets. The pharmacokinetic data اقرأ الوثيقة كاملة