METFORMIN TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

METFORMIN HYDROCHLORIDE

Disponível em:

SORRES PHARMA INC

Código ATC:

A10BA02

DCI (Denominação Comum Internacional):

METFORMIN

Dosagem:

850MG

Forma farmacêutica:

TABLET

Composição:

METFORMIN HYDROCHLORIDE 850MG

Via de administração:

ORAL

Unidades em pacote:

100/500

Tipo de prescrição:

Prescription

Área terapêutica:

BIGUANIDES

Resumo do produto:

Active ingredient group (AIG) number: 0101773002; AHFS:

Status de autorização:

CANCELLED POST MARKET

Data de autorização:

2014-06-20

Características técnicas

PRODUCT MONOGRAPH PR
METFORMIN
(Metformin tablets BP
as Metformin Hydrochloride) 850 MG TABLETS
ANTIHYPERGLYCEMIC AGENT
SORRES PHARMA INC
.
DATE OF PREPARATION:
6111 Royalmount Ave, Suite #100
March 30, 2010
Montreal, Quebec
H4P 2T4
CONTROL # 137546
2
PRODUCT MONOGRAPH
PR
METFORMIN
(Metformin tablets BP
as Metformin Hydrochloride)
850 mg
THERAPEUTIC CLASSIFICATION
Anti hyperglycemic Agent
ACTIONS AND CLINICAL PHARMACOLOGY
Metformin 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 nondiabetic
animal, except when using a near lethal dose. Metformin has no effects
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 peripheral
receptor sites. 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 in
urine at a 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 µg/mL.
Certain drugs may potentiate
the effects of metformin (see
PRECAUTIONS).
3
SUMMARY OF COMPARATIVE BIOAVAILABILITY DATA
[single 850 mg tablet oral administration in the fasting state]
Metformin 850 mg Tablets (Lot# P-0152)
_versus _
Glucophage 850 mg Tablets (Hoechst Marion Roussel Canada Inc., Canada,
Lot# 9559)
MEASURED DATA
GEOMETRIC MEAN
RAT