COVASTIN TABLET 40MG

Land: Malaysia

Språk: engelska

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

Aktiva substanser:

SIMVASTATIN

Tillgänglig från:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

INN (International namn):

SIMVASTATIN

Enheter i paketet:

3 x 10 Tablets; 100 Tablets

Tillverkad av:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

Bipacksedel

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
_ _
_ _
WHAT IS IN THIS LEAFLET
1.
What is Covastin used for
2.
How Covastin works
3.
Before you use Covastin
4.
How to use Covastin
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Covastin
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
_ _
11.
Serial Number
_ _
WHAT IS COVASTIN USED FOR
It is used to treat high cholesterol levels
and helps to reduce risk of heart disease
problems (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), COVASTIN:
a. can prolong your life by reducing the
risk of heart attack or stroke
b. reduces the need for surgery to increase
blood flow to the legs and major organs
such as the heart
c. reduces the need for hospitalization for
chest pain (called angina)
HOW COVASTIN WORKS
Simvastatin
is
the
drug
classified
as
statins. It works by blocking HMG-CoA
enzyme
that
involves
in
cholesterol
production. Therefore, less cholesterol is
made and reduces cholesterol levels in the
blood.
Simvastatin
lowers
the
level
of
total cholesterol, ‘bad’ cholesterol (LDL,
low
density
lipoprotein)
and
fatty
substances called triglycerides. It raises
‘good’
cholesterol
(HDL,
high
density
lipoprotein).
BEFORE YOU TAKE COVASTIN
_When you must not use it _
Do not take Covastin if you:
•
have acute liver disease.
•
are
pregnant
or
plan
to
become
pregnant.
•
are
breast-feeding
or
plan
to
start
breast-feeding.
•
taking
potent
CYP3A4
inhibitors,
gemfibrozil, ciclosporin or danazol
•
have
homozygous
familial
hypercholesterolaemia
and
taking
lomitapide
with
more
than
40mg
simvastatin dose
•
are
allergic
(hypersensitive)
to
Simvastatin or any ingredients in this
medicine.
_Before start to take it _
Tell your doctor or pharmacist:
-
If you are allergic (hypersensitivity) to
simvastatin or any other ingredients in
this medicine.
-
If you are pregnant or plan to become
pregnant.
-

Produktens egenskaper

COVASTIN TABLET
(10MG, 20MG & 40MG)
COMPOSITION
Covastin Tablet 10mg: Each film coated tablet contains Simvastatin
10mg
Covastin Tablet 20mg: Each film coated tablet contains Simvastatin
20mg
Covastin Tablet 40mg: Each film coated tablet contains Simvastatin
40mg
PHARMACODYNAMICS
Mechanism of action
After oral ingestion, simvastatin which is an inactive lactone, is
hydrolysed in the liver to
the corresponding active beta-hydroxyacid form which has a potent
activity in inhibiting
HMG-CoA
reductase
(3
hydroxy
–
3
methylglutaryl
CoA
reductase).
This
enzyme
catalyses the conversion of HMG-CoA to mevalonate, an early and
rate-limiting step in the
biosynthesis of cholesterol.
Simvastatin has been shown to reduce both normal and elevated LDL-C
concentrations.
LDL is formed from very-low-density protein (VLDL) and is catabolised
predominantly by
the high affinity LDL receptor. The mechanism of the LDL-lowering
effect of simvastatin
may involve both reduction of VLDL-cholesterol (VLDL-C) concentration
and induction
of the LDL receptor, leading to reduced production and increased
catabolism of LDL-C.
Apolipoprotein B also falls substantially during treatment with
simvastatin. In addition,
simvastatin moderately increases HDL-C and reduces plasma TG. As a
result of these
changes the ratios of total- to HDL-C and LDL- to HDL-C are reduced.
PHARMACOKINETICS
Simvastatin is absorbed from the gastrointestinal tract and must be
hydrolysed to its active
β-hydroxyacid form. Other active metabolites have been detected and
several inactive
metabolites are also formed. Simvastatin is a substrate for the
cytochrome P450 isoenzyme
CYP3A4 and undergoes extensive first-pass metabolism in the liver, its
primary site of
action. Less than 5 % of the oral dose has been reported to reach the
circulation as active
metabolites. Both simvastatin and its β-hydroxyacid metabolite are
about 95 % bound to
plasma proteins. Simvastatin is mainly excreted in the faeces via the
bile as metabolites.
About 10 to 15 % is recovered in the urine, mainly i