VYTORIN 10/40 MG TABLET

Država: Malezija

Jezik: angleščina

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

Aktivna sestavina:

EZETIMIBE; SIMVASTATIN

Dostopno od:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (mednarodno ime):

EZETIMIBE; SIMVASTATIN

Enote v paketu:

30Tablet Tablets; 10Tablet Tablets

Izdeluje:

MSD International GmbH (Singapore Branch)

Navodilo za uporabo

_Consumer Medication Information Leaflet (RiMUP)_
VYTORIN
®
Ezetimibe/Simvastatin (10mg/10mg, 10mg/20mg, 10mg/40mg, 10mg/80mg)
1
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
Please read this information
carefully before you start to take
your medicine, even if you have
just refilled your prescription.
Some of the information may have
changed. You should also read any
information provided with other
medicines you are currently taking.
Remember that your doctor has
prescribed this medicine only for
you. Never give it to anyone else.
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 10/80 (ezetimibe
10 mg/simvastatin 80 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. Ev

Lastnosti izdelka

VYTORIN
(ezetimibe/simvastatin)
LPC-MK0653A-T-122018-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
®
10/80
(EZETIMIBE 10 MG/SIMVASTATIN 80 MG)
I. THERAPEUTIC CLASS
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.
II. COMPOSITION
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), 40
mg of simvastatin
(VYTORIN 10/40), or 80 mg of simvastatin (VYTORIN 10/80).
III. CLINICAL PHARMACOLOGY
IIIa. Mechanism of Action
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