VYTORIN 1010MG TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

EZETIMIBE; SIMVASTATIN

Boleh didapati daripada:

ORGANON MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

EZETIMIBE; SIMVASTATIN

Unit dalam pakej:

10Tablet Tablets; 30Tablet Tablets

Dikeluarkan oleh:

MSD International GmbH (Singapore Branch)

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
VYTORIN
®
Ezetimibe/Simvastatin (10mg/10mg, 10mg/20mg, 10mg/40mg)
1
Copyright 2023 Organon group of companies. All rights reserved.
WHAT IS IN THIS LEAFLET
1.
What VYTORIN is used for
2.
How VYTORIN works
3.
Before you use VYTORIN
4.
How to use VYTORIN
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
VYTORIN
8.
Product description
9.
Manufacturer and product
registration holder
10.
Date of revision
11.
Serial number
WHAT VYTORIN IS USED FOR
VYTORIN (ezetimibe/simvastatin)
is a tablet that is available in four
strengths:
−
VYTORIN 10/10 (ezetimibe
10 mg/simvastatin 10 mg)
−
VYTORIN 10/20 (ezetimibe
10 mg/simvastatin 20 mg)
−
VYTORIN 10/40 (ezetimibe
10 mg/simvastatin 40 mg)
VYTORIN is a medicine used to
lower levels of total cholesterol,
LDL (bad) cholesterol, and fatty
substances called triglycerides in
the blood. In addition, VYTORIN
raises levels of HDL (good)
cholesterol. VYTORIN 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,
VYTORIN reduces the risk of
heart attack, stroke, surgery to
increase heart blood flow, or
hospitalization for chest pain.
WHY HAS MY DOCTOR PRESCRIBED
VYTORIN?
Your doctor has prescribed
VYTORIN 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 of your
arteries forming plaque. Eventually
this plaque build-up can lead to a
narrowing of the arteries. This
narrowing can slow or block blood
flow to vital organs such as the
heart and brain. This blocking of
blood flow can result in a heart
attack or stroke.
HDL cholesterol is often called
“good” cholesterol because it helps
keep the bad cholesterol from
building up in the arteries and
p

Ciri produk

1
I. THERAPEUTIC CLASS
II.
COMPOSITION
III. CLINICAL PHARMACOLOGY
_IIIA. MECHANISM OF ACTION_
_ _
LPC-OG0653A-T-052023-Malaysia
LOCAL PRODUCT CIRCULAR
TABLETS
VYTORIN
®
10/10
(EZETIMIBE 10 MG/SIMVASTATIN 10 MG)
VYTORIN
®
10/20
(EZETIMIBE 10 MG/SIMVASTATIN 20 MG)
VYTORIN
®
10/40
(EZETIMIBE 10 MG/SIMVASTATIN 40 MG)
VYTORIN (ezetimibe/simvastatin) is a lipid-lowering product that
selectively inhibits the
intestinal absorption of cholesterol and related plant sterols and
inhibits the endogenous
synthesis of cholesterol.
VYTORIN is available for oral use as tablets containing 10 mg of
ezetimibe, and 10 mg of
simvastatin
(VYTORIN
10/10),
20
mg
of
simvastatin
(VYTORIN
10/20)
or
40
mg
of
simvastatin (VYTORIN 10/40).
_VYTORIN _
Plasma
cholesterol
is
derived
from
intestinal
absorption
and
endogenous
synthesis.
VYTORIN
contains
ezetimibe
and
simvastatin,
two
lipid-lowering
compounds
with
complementary mechanisms of action. VYTORIN reduces elevated total-C,
LDL-C, Apo B,
TG, and non-HDL-C, and increases HDL-C through dual inhibition of
cholesterol absorption
and synthesis.
_ _
_EZETIMIBE _
Ezetimibe inhibits the intestinal absorption of cholesterol. 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 localizes 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 hypercholesterolemic patients,
ezetimibe inhibited intestinal
cholesterol absorption by 54%, compared with placebo.
2
_IIIB. PHARMACOKINETICS_
_ _