Stavid Tablet 80 mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

SIMVASTATIN

Boleh didapati daripada:

HOVID BERHAD

INN (Nama Antarabangsa):

SIMVASTATIN

Unit dalam pakej:

10tablet Tablets; 30tablet Tablets; 100tablet Tablets

Dikeluarkan oleh:

HOVID BERHAD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
STAVID TABLET
Simvastatin (20 mg, 40 mg, 80 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Stavid is used for
2.
How Stavid works
3.
Before you use Stavid
4.
How to use Stavid
5.
While you are using Stavid
6.
Side effects
7.
Storage and Disposal of Stavid
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT STAVID IS USED FOR
Stavid is used:
•
To reduce cholesterol level or
elevated fat levels in your blood
(primary hypercholesterolaemia or
mixed hyperlipidaemia) when
response to diet and other non-
pharmacological measures is not
sufficient.
•
To reduce inherited high levels of
cholesterol (homozygous familial
hypercholesterolaemia) together
with diet and other non-dietary
measures when response to these is
not adequate.
•
For coronary heart disease (CHD).
Stavid may reduce the risk of death
associated with heart disease,
reduce the risk to undergo heart
surgery, and slow the progression
of the arteries being clogged up by
fatty substances (atherosclerosis),
even if your cholesterol is normal.
You should stay on a cholesterol-
lowering diet while taking this
medicine.
HOW STAVID WORKS
Stavid belongs to a group of medicine
called statins. These work by inhibiting
the enzyme HMG-CoA reductase,
which controls the rate of cholesterol
synthesis in the body. Stavid lowers
levels of “bad” cholesterol (LDL
cholesterol and VLDL cholesterol), and
triglycerides in the blood. Stavid also
raises levels of “good” cholesterol
(HDL cholesterol).
BEFORE YOU USE STAVID
_- When you must not use it _
Do not take this medicine if:
•
you are allergic (hypersensitive) to
simvastatin or any of the other
ingredients listed at the end of the
leaflet
•
you currently have liver problem
or unexplained persistent
elevations of serum transaminase
(liver enzyme)
•
you have inherited blood disorder
called porphyria
•
you are pregnant or breast-feeding
•
you are taking one or more than
one of the following drugs at the
same time:
o
itrac

Ciri produk

DESCRIPTION
STAVID TABLET 20MG: Oval, peach film-coated
tablet, shallow convex with "HD" and break bar
embossed on one face.
STAVID TABLET 40MG: Oval, red film-coated
tablet, shallow convex and scored on one
face.
STAVID TABLET 80MG: Caplet-shape, red film-
coated tablet, bevel-edged, shallow convex
and scored on one face.
COMPOSITION
STAVID TABLET 20MG:
Each tablet contains simvastatin 20mg.
STAVID TABLET 40MG:
Each tablet contains simvastatin 40mg.
STAVID TABLET 80MG:
Each tablet contains simvastatin 80mg.
ACTIONS AND PHARMACOLOGY
Hydrolyzed form of simvastatin, beta-hydroxy
acid
inhibits
enzyme
HMG-CoA
reductase.
Inhibition
of
HMG-CoA
reductase
prevents
conversion of HMG-CoA to mevalonate, the
rate-limiting step in cholesterol biosynthesis.
Inhibition of cholesterol synthesis in the liver
leads to upregulation of LDL receptors and an
increase
in
catabolism
of
LDL-cholesterol.
Simvastatin reduces LDL-cholesterol, VLDL-
cholesterol, and to a lesser extent, plasma
triglyceride
concentrations,
and
slightly
increase
high-density
lipoprotein
(HDL)
concentrations.
PHARMACOKINETICS
Simvastatin
is
absorbed
from
the
gastrointestinal tract and is hydrolysed to its
active beta-hydroxy acid form. Other active
metabolites have been detected and a number
of
inactive
metabolites
are
also
formed.
Simvastatin
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. The half-life of the active
metabolite is 1.9 hours. Both simvastatin and
its beta-hydroxy acid metabolite are about
95% bound to plasma proteins. The maximum
plasma concentration of inhibitors occurred
within 1.3 to 2.4 hours of administration. It is
mainly excreted in the faeces via the bile as
metabolites. About 10 to 15% is recovered in
the urine, mainly in inactive forms.
INDICATIONS
•
CORONARY HEART DISEASE:
In patients with coronary heart disease with
plasma cholesterol level of 5.5 mmol/L or
greater, simvastatin is indicated to:
-
Reduc