GLICLAZIDE-80 TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

GLICLAZIDE

Sẵn có từ:

PRO DOC LIMITEE

Mã ATC:

A10BB09

INN (Tên quốc tế):

GLICLAZIDE

Liều dùng:

80MG

Dạng dược phẩm:

TABLET

Thành phần:

GLICLAZIDE 80MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

SULFONYLUREAS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2020-03-29

Đặc tính sản phẩm

PRODUCT MONOGRAPH
PR
GLICLAZIDE - 80
Gliclazide 80 mg Tablets
Mfr Standard
Hypoglycemic sulfonylurea
ORAL HYPOGLYCEMIC AGENT
PRO DOC LTÉE
2925, boul. Industriel
Laval, Québec
H7L 3W9
Submission Control No.: 234456
Date of Revision:
January 14, 2020
Gliclazide PM EN
Pg. 1
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_GLICLAZIDE _
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PRODUCT MONOGRAPH
Pr
GLICLAZIDE - 80
Gliclazide 80 mg tablets
Mfr Standard
Oral Hypoglycemic Agent
ACTION AND CLINICAL PHARMACOLOGY
GLICLAZIDE (gliclazide) is a hypoglycemic agent of the sulfonylurea
group.
The hypoglycemic action of 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.
A comparative, two-way, single-dose non-fasting bioavailability study
was performed with
GLICLAZIDE 80 mg Tablets and DIAMICRON
®
80
mg Tablets in 18 healthy male volunteers.
Gliclazide PM EN
Pg. 2
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The pharmacokinetic data calculated for glicl