ACCORD EZETIMIBE 10 (Ezetimibe Tablets 10 mg)

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

EZETIMIBE

Boleh didapati daripada:

ACCORD HEALTHCARE SDN.BHD.

INN (Nama Antarabangsa):

EZETIMIBE

Unit dalam pakej:

30tablet Tablets; 10tablet Tablets

Dikeluarkan oleh:

INTAS PHARMACEUTICALS LIMITED

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
ACCORD EZETIMIBE 10
Ezetimibe Tablets 10 mg
Page
1
of
3
WHAT IS IN THIS LEAFLET?
1.
What ACCORD EZETIMIBE
is used for
2.
How ACCORD EZETIMIBE
works
3.
Before you use ACCORD
EZETIMIBE
4.
How to take ACCORD
EZETIMIBE
5.
While you are using ACCORD
EZETIMIBE
6.
Side effects
7.
Storage and disposal of
ACCORD EZETIMIBE
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT ACCORD EZETIMIBE IS
USED FOR
ACCORD EZETIMIBE is a tablet
that contains mg of ezetimibe as the
active ingredient.
•
ACCORD
EZETIMIBE
is
a
cholesterol-lowering medicine.
•
ACCORD EZETIMIBE is for
patients
whose
cholesterol
levels are too high and when
diet alone cannot lower these
levels adequately.
•
ACCORD
EZETIMIBE
reduces
elevated
total-
cholesterol,
LDL
(bad)
cholesterol
and
triglycerides
and
increases
HDL
(good)
cholesterol.
•
ACCORD
EZETIMIBE
may
be
taken
with
other
cholesterol-lowering medicines
known as statins or alone, in
addition to diet.
•
ACCORD
EZETIMIBE
may
be
taken
with
fenofibrate,
another
cholesterol-lowering
medicine, in addition to diet.
If
you
have
sitosterolemia,
your
doctor
has
prescribed
ACCORD
EZETIMIBE to lower the level of
plant sterols in your blood.
Sitosterolemia
is
a
hereditary
illness that increases the levels of
plant sterols in your blood.
HOW
ACCORD
EZETIMIBE
WORKS
•
ACCORD EZETIMIBE works
by decreasing the absorption of
cholesterol
in
the
small
intestine.
Statins
and
fenofibrate lower cholesterol in
a different way; they work in
the liver.
•
ACCORD
EZETIMIBE
adds
to
the
cholesterol-lowering
effect
of
statins
and
fenofibrate.
WHY HAS MY DOCTOR PRESCRIBED
ACCORD EZETIMIBE?
Your
doctor
has
prescribed
ACCORD EZETIMIBE to reduce
the
amount
of
cholesterol
and
triglycerides
in
your
blood.
Cholesterol is one of several fatty
substances
found
in
the
bloodstream. Your total cholesterol
is
made
up
mainly
of
LDL
and
HDL cholesterol.
LDL
cholesterol
is
often
called
“bad”
cholesterol
because
it
can
build
up
in
the
walls

Ciri produk

ACCORD EZETIMIBE 10
(Ezetimibe Tablets 10 mg)
● NAME AND STRENGTH OF ACTIVE INGREDIENT
Ezetimibe 10 mg
● PRODUCT DESCRIPTION
ACCORD EZETIMIBE 10: White to off white, capsule shaped, flat faced
with beveled edge, uncoated tablets, debossed with “10” on one
side and plain
on other side.
● PHARMACODYNAMICS & PHARMACOKINETICS
_PHARMACODYNAMIC PROPERTIES_
Pharmacotherapeutic group: Other lipid modifying agents, ATC code:
C10A X09
_MECHANISM OF ACTION: _Ezetimibe is in a new class of lipid-lowering
compounds that selectively inhibit the intestinal absorption of
cholesterol and related
plant sterols. Ezetimibe is orally active, and has a mechanism of
action that differs from other classes of cholesterol-reducing
compounds (e.g. statins,
bile acid sequestrants [resins], fibric acid derivatives, and plant
stanols). The molecular target of ezetimibe is the sterol transporter,
Niemann-Pick
C1-Like 1 (NPC1L1), which is responsible for the intestinal uptake of
cholesterol and phytosterols.
Ezetimibe localises at the brush border of the small intestine and
inhibits the absorption of cholesterol, leading to a decrease in the
delivery of intestinal
cholesterol to the liver; statins reduce cholesterol synthesis in the
liver and together these distinct mechanisms provide complementary
cholesterol
reduction. In a 2-week clinical study in 18 hypercholesterolaemic
patients, Ezetimibe inhibited intestinal cholesterol absorption by
54%, compared with
placebo.
Ezetimibe inhibited the absorption of [
14
C]-cholesterol with no effect on the absorption of triglycerides,
fatty acids, bile acids, progesterone, ethinyl
estradiol, or fat soluble vitamins A and D.
Epidemiologic studies have established that cardiovascular morbidity
and mortality vary directly with the level of total-C and LDL-C and
inversely with the
level of HDL-C.
A beneficial effect of Ezetimibe on cardiovascular morbidity and
mortality has not yet been demonstrated.
_PHARMACOKINETIC PROPERTIES_
_ABSORPTION: _After oral administration, ezetimibe is rapidly absorbed