ZOCOR 40MG TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

SIMVASTATIN

Boleh didapati daripada:

ORGANON MALAYSIA SDN. BHD.

INN (Nama Antarabangsa):

SIMVASTATIN

Unit dalam pakej:

30Tablet Tablets; 60Tablet Tablets; 10 Tablet Tablets

Dikeluarkan oleh:

Organon Pharma (UK) Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ZOCOR
®
_ _
_ Simvastatin (10mg, 20mg, 40mg) _
_ _
1
Copyright 2023 Organon group of companies. All rights reserved.
WHAT IS IN THIS LEAFLET
1.
What
_ZOCOR _
is used for
2.
How
_ZOCOR _
works
_3._
_ _
Before you take
_ZOCOR _
4.
How to take
_ZOCOR_
5.
While you are using
_ZOCOR_
6.
Side effects
_7._
_ _
Storage and Disposal of
_ZOCOR _
8.
Product Description
9.
Manufacturer and product
registration holder
10.
Date of revision
WHAT _ZOCOR _IS USED FOR
Your doctor has prescribed
_ZOCOR _
to reduce the health risks associated
with coronary heart disease (CHD).
If you have CHD, diabetes, history of
stroke, or other vessel disease
(regardless of the amount of
cholesterol in your blood),
_ZOCOR_
:
•
can prolong your life by reducing
the risk of heart attack or stroke
•
reduces the need for surgery to
increase blood flow to the legs and
major organs such as the heart
•
reduces the need for hospitalization
for chest pain (called angina).
_ZOCOR _
reduces the amount of
cholesterol in your blood.
Cholesterol can cause CHD by
clogging the blood vessels that carry
oxygen and nutrients to the heart.
This clogging, or hardening of the
arteries, is called atherosclerosis.
Atherosclerosis can lead to chest pain
(called angina) and heart attack.
_ZOCOR _
also slows the progression of
atherosclerosis and reduces the
development of new atherosclerosis.
HOW _ZOCOR _WORKS
_ZOCOR _
reduces the level of LDL
(bad) cholesterol and fatty substances
called triglycerides in your blood and
raises HDL (good) cholesterol. It is a
member of the class of drugs called
hydroxymethylglutaryl-coenzyme A
(HMG-CoA) reductase inhibitors.
BEFORE YOU TAKE _ZOCOR _
_ _
_-_
_ _
_When you must not take it _
Do not take
_ZOCOR _
if you are:
•
allergic to any of its components
•
diagnosed with active liver disease
•
pregnant or breast-feeding
•
taking any of the following
medicines:
– certain antifungal medicines (such
as itraconazole, ketoconazole,
posaconazole, or voriconazole)
LDL-choleste

Ciri produk

1
LPC-OG0733-T-052023
LOCAL PRODUCT CIRCULAR
Tablets
ZOCOR
®
(simvastatin)
ZOCOR (simvastatin) is a lipid-lowering agent derived synthetically
from a fermentation product
of _Aspergillus terreus_.
After oral ingestion, ZOCOR, an inactive lactone, is hydrolyzed to the
corresponding β-
hydroxyacid form. This is a principal metabolite and an inhibitor of
3-hydroxy-3- methylglutaryl-
coenzyme A (HMG-CoA) reductase, the enzyme that catalyzes an early and
rate-limiting step in
the biosynthesis of cholesterol. Clinical studies show ZOCOR to be
highly effective in reducing
total plasma cholesterol (total-C), low-density lipoprotein
cholesterol (LDL-C), triglycerides (TG),
and very-low-density lipoprotein cholesterol (VLDL-C) concentrations,
and increasing high-
density lipoprotein cholesterol (HDL-C) in heterozygous familial and
non-familial forms of
hypercholesterolemia, and in mixed hyperlipidemia when elevated
cholesterol was cause for
concern and diet alone has been insufficient. Marked responses are
seen within 2 weeks, and
maximum therapeutic responses occur within 4-6 weeks. The response is
maintained during
continuation of therapy. When therapy with ZOCOR is stopped,
cholesterol and lipids return to
pretreatment levels.
The active form of simvastatin is a specific inhibitor of HMG-CoA
reductase, the enzyme which
catalyzes the conversion of HMG-CoA to mevalonate. Because the
conversion of HMG-CoA to
mevalonate is an early step in the biosynthetic pathway of
cholesterol, therapy with ZOCOR would
not be expected to cause an accumulation of potentially toxic sterols.
In addition, HMG-CoA is
also metabolized readily back to acetyl-CoA, which participates in
many biosynthetic processes
in the body.
In animal studies, after oral dosing, simvastatin had
high selectivity for the
liver,
where it
achieved substantially higher concentrations than in non-target
tissues. Simvastatin undergoes
extensive first-pass extraction in the liver, the primary site of
action, with subsequent excretion of
drug in the bile. Systemic expo