VYTORIN 1020 TABLET

Quốc gia: Singapore

Ngôn ngữ: Tiếng Anh

Nguồn: HSA (Health Sciences Authority)

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Tờ rơi thông tin Tờ rơi thông tin (PIL)
04-03-2019

Thành phần hoạt chất:

EZETIMIBE; SIMVASTATIN

Sẵn có từ:

ORGANON SINGAPORE PTE. LTD.

Liều dùng:

10 mg

Dạng dược phẩm:

TABLET

Thành phần:

EZETIMIBE 10 mg; SIMVASTATIN 20 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

Prescription Only

Sản xuất bởi:

MSD INTERNATIONAL GMBH (SINGAPORE BRANCH)

Tình trạng ủy quyền:

ACTIVE

Ngày ủy quyền:

2004-06-18

Tờ rơi thông tin

                                SG-PPI-OG0653A-T-062023
Patient Product Information (PPI)
INFORMATION FOR THE PATIENT
ABOUT VYTORIN™
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 is VYTORIN?
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)
Not all presentations/dosage strengths are available.
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. It is used 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.
How does VYTORIN work?
VYTORIN 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.
VYTORIN does not help you lose
weight.
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 th
                                
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Đặc tính sản phẩm

                                SG-OG0653A-T-062023
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. ACTIVE INGREDIENTS
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. INDICATIONS
Primary Hypercholesterolemia
VYTORIN is indicated as adjunctive therapy to diet for the reduction
of elevated total cholesterol (total-C),
low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B),
triglycerides (TG), and non-high-
density lipoprotein cholesterol (non-HDL-C), and to increase
high-density lipoprotein cholesterol (HDL-C)
in
patients
with
primary
(heterozygous
familial
and
non-familial)
hypercholesterolemia
or
mixed
hyperlipidemia.
Homozygous Familial Hypercholesterolemia (HoFH)
VYTORIN is indicated for the reduction of elevated total-C and LDL-C
levels in patients with HoFH, as an
adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if
such treatments are unavailable.
IV. CLINICAL PHARMACOLOGY
IVa. 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 o
                                
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