MYLAN-GLICLAZIDE TABLET

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

GLICLAZIDE

থেকে পাওয়া:

MYLAN PHARMACEUTICALS ULC

এটিসি কোড:

A10BB09

INN (আন্তর্জাতিক নাম):

GLICLAZIDE

ডোজ:

80MG

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

GLICLAZIDE 80MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

60/100

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

SULFONYLUREAS

পণ্য সারাংশ:

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

অনুমোদন অবস্থা:

CANCELLED POST MARKET

অনুমোদন তারিখ:

2017-12-12

পণ্য বৈশিষ্ট্য

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