TEVA-METFORMIN TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

METFORMIN HYDROCHLORIDE

Dostupné s:

TEVA CANADA LIMITED

ATC kód:

A10BA02

INN (Mezinárodní Name):

METFORMIN

Dávkování:

500MG

Léková forma:

TABLET

Složení:

METFORMIN HYDROCHLORIDE 500MG

Podání:

ORAL

Jednotky v balení:

100, 500

Druh předpisu:

Prescription

Terapeutické oblasti:

BIGUANIDES

Přehled produktů:

Active ingredient group (AIG) number: 0101773001; AHFS:

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2018-05-18

Charakteristika produktu

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