MYLAN-GLICLAZIDE TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

GLICLAZIDE

Prieinama:

MYLAN PHARMACEUTICALS ULC

ATC kodas:

A10BB09

INN (Tarptautinis Pavadinimas):

GLICLAZIDE

Dozė:

80MG

Vaisto forma:

TABLET

Sudėtis:

GLICLAZIDE 80MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

60/100

Recepto tipas:

Prescription

Gydymo sritis:

SULFONYLUREAS

Produkto santrauka:

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

Autorizacija statusas:

CANCELLED POST MARKET

Leidimo data:

2017-12-12

Prekės savybės

Page 1 of 32
PRODUCT MONOGRAPH
PR
MYLAN-GLICLAZIDE
(GLICLAZIDE TABLETS, BP)
80 MG TABLETS
HYPOGLYCEMIC SULFONYLUREA
ORAL HYPOGLYCEMIC AGENT
MYLAN PHARMACEUTICALS ULC
85 Advance Road,
Etobicoke Ontario
M8Z 2S6
Date of Revision: January 12, 2017
Control Number: 201111
Page 2 of 32
PRODUCT MONOGRAPH
PR
MYLAN-GLICLAZIDE
(GLICLAZIDE TABLETS, BP)
80 MG TABLETS
Oral hypoglycemic agent
ACTIONS AND CLINICAL PHARMACOLOGY
MYLAN-GLICLAZIDE (gliclazide) is a hypoglycemic agent of the
sulfonylurea group.
The hypoglycemic action of MYLAN-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
MYLAN-GLICLAZIDE,
other
sulfonylureas,
sulfonamides, or to any of the excipients of this product (for a
complete listing, s