METFORMIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METFORMIN HYDROCHLORIDE

Available from:

MELIAPHARM INC

ATC code:

A10BA02

INN (International Name):

METFORMIN

Dosage:

500MG

Pharmaceutical form:

TABLET

Composition:

METFORMIN HYDROCHLORIDE 500MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

BIGUANIDES

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2014-06-25

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
METFORMIN
(Metformin tablets BP as Metformin Hydrochloride)
500MG TABLETS
ANTIHYPERGLYCEMIC AGENT
MELIAPHARM INC
.
DATE OF PREPARATION:
6111 Royalmount Ave, Suite #100
March 16, 2010
Montreal, Quebec
H4P 2T4
Control # 136739
2
PRODUCT MONOGRAPH
PR
METFORMIN
(Metformin tablets BP as Metformin Hydrochloride)
500 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
A
comparative
bioavailability
study
of
metformin
500
mg
tablets
was
performed.
Pharmacokinetic and bioavailabilty data were measured in 22 volunteers
in the
_fasting _
state
and
_fed state. _
The results can be summarized as follows:
SUMMARY OF COMPARATIVE BIOAVAILABILITY DA