Vytocor 10mg40mg Tablet

国家: 马来西亚

语言: 英文

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

有效成分:

EZETIMIBE; SIMVASTATIN

可用日期:

Duopharma Marketing Sdn. Bhd.

INN（国际名称）:

EZETIMIBE; SIMVASTATIN

每包单位数:

10 Tablets; 30 Tablets; 100 Tablets

厂商:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

资料单张

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
VYTOCOR 10MG/40MG TABLET
_ _
Ezetimibe/Simvastatin 10mg/40mg
Page 1 of 3
WHAT IS IN THIS LEAFLET
1.
What VYTOCOR is used for
2.
How VYTOCOR works
3.
Before you use VYTOCOR
4.
How to use VYTOCOR
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
VYTOCOR
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT VYTOCOR IS USED FOR
VYTOCOR
is
a
medicine
used
to
lower levels of total cholesterol, LDL
(bad)
cholesterol,
and
fatty
substances called triglycerides in the
blood. In addition, VYTOCOR raises
levels
of
HDL
(good)
cholesterol.
VYTOCOR
is
for
patients
who
cannot control their cholesterol levels
by diet alone. You should stay on a
cholesterol-lowering diet while taking
this medicine.
If you have heart disease, VYTOCOR
reduces the risk of heart attack,
stroke, surgery to increase heart blood
flow, or hospitalization for chest pain
HOW VYTOCOR WORKS
VYTOCOR
works
to
reduce
your
cholesterol in two ways. It reduces
the
cholesterol
absorbed
in
your
digestive
tract,
as
well
as
the
cholesterol your body makes by itself.
VYTOCOR does not help you lose
weight.
BEFORE YOU USE VYTOCOR
-
_When you must not use it _
Do not use it if you:
•
are
hypersensitive
(allergic)
to
ezetimibe, simvastatin, or any of the
other
ingredients
of
VYTOCOR
tablets
•
have active liver disease
•
are pregnant or breast-feeding
•
are
taking
any
of
the
following
medicines:
-
certain antifungal medicines (such
as
itraconazole,
ketoconazole,
posaconazole, or voriconazole)
-
HIV
protease
inhibitors
(such
as
indinavir, nelfinavir, ritonavir, and
saquinavir)
-
hepatitis C antiviral agents (such as
boceprevir, telaprevir, elbasvir, or
grazoprevir)
-
certain
antibiotics
(such
as
erythromycin,
clarithromycin,
or
telithromycin)
-
the antidepressant nefazodone
-
medicines
containing
cobicistat
(used
as
an
enhancer
for
antiretroviral agents)
-
gemfibrozil (a fibric acid medicine
for lowering cholesterol)
-
cyclosporine
(use

产品特点

Pg 1 of 10
VYTOCOR 10MG/40MG TABLET
1
2
I.
DESCRIPTION
3
VYTOCOR 10MG/40MG: White to off-white, 14mm capsule shaped, with
‘40’ marking on one side and ‘10’ on the other side,
4
uncoated tablet.
5
6
II.
COMPOSITION
7
VYTOCOR 10MG/40MG: This tablet contains 40mg of Simvastatin and 10mg
of Ezetimibe.
8
9
III.
PHARMACODYNAMICS
10
VYTOCOR (ezetimibe/simvastatin) is a lipid-lowering product that
selectively inhibits the intestinal absorption of cholesterol
11
and related plant sterols and inhibits the endogenous synthesis of
cholesterol.
12
MECHANISM OF ACTION
13
_VYTOCOR_
14
Contains ezetimibe and simvastatin, two lipid-lowering compounds with
complementary mechanisms of action. VYTOCOR
15
reduces elevated total-C, LDL-C, APO B, TG, and non-HDL-C, and
increases HDL-C through dual inhibition of cholesterol
16
absorption and synthesis.
17 _EZETIMIBE _
18
_ _Ezetimibe inhibits the intestinal absorption of cholesterol.
Ezetimibe is orally active and has a mechanism of action that
19
differs from other classes of cholesterol-reducing compounds (e.g.
statins, bile acid sequestrants [resins], fibric acid
20
derivatives, and plant stanols). The molecular target of ezetimibe is
the sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1),
21
which is responsible for the intestinal uptake of cholesterol and
phytosterols.
22
Ezetimibe localizes at the brush border of the small intestine and
inhibits the absorption of cholesterol, leading to a decrease
23
in the delivery of intestinal cholesterol to the liver; statins reduce
cholesterol synthesis in the liver and together these distinct
24
mechanisms provide complementary cholesterol reduction.
25
_SIMVASTATIN _
26
After oral ingestion, simvastatin, which is an inactive lactone, is
hydrolysed in the liver to the corresponding active β-
27
hydroxyacid form which has a potent activity in inhibiting HMG-CoA
reductase (3 hydroxy- 3 methylglutaryl CoA reductase).
28
This enzyme catalyses the conversion of HMG- CoA to mevalonate, an
early and rate -limiting step in the biosynthesis