PMS-GLICLAZIDE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

GLICLAZIDE

Pieejams no:

PHARMASCIENCE INC

ATĶ kods:

A10BB09

SNN (starptautisko nepatentēto nosaukumu):

GLICLAZIDE

Deva:

80MG

Zāļu forma:

TABLET

Kompozīcija:

GLICLAZIDE 80MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

SULFONYLUREAS

Produktu pārskats:

Active ingredient group (AIG) number: 0119934001; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2007-05-08

Produkta apraksts

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 (