VASTICURE-20 (Rosuvastatin Tablets 20mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ROSUVASTATIN CALCIUM

Boleh didapati daripada:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

ROSUVASTATIN CALCIUM

Unit dalam pakej:

30tablet Tablets

Dikeluarkan oleh:

GRACURE PHARMACEUTICALS LTD.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
VASTICURE-20 TABLETS
Rosuvastatin Calcium (20mg)
1
WHAT IS IN THIS LEAFLET
1.
What VASTICURE-20 is used
for
2.
How VASTICURE-20 works
3.
Before you use VASTICURE-20
4.
How to use VASTICURE-20
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
VASTICURE-20
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS VASTICURE-20 USED FOR
VASTICURE-20 belongs to a group
of medicines called statins. You have
been prescribed this medicine
because:

You have a high cholesterol
level. This means you are at
risk from a heart attack or
stroke. You have been
advised to take a statin
because changing your diet
and taking more exercise
were not enough to correct
your cholesterol levels. You
should continue with your
cholesterol-lowering diet
and exercise while you are
taking VASTICURE-20.

You have other factors that
increase your risk of having
a heart attack, stroke or
related health problems.
Heart attack, stroke and
other problems can be
caused by a disease called
atherosclerosis.
Atherosclerosis is due to
build-up of fatty deposits in
your arteries.
HOW VASTICURE-20 WORKS
VASTICURE-20 works by inhibiting
an enzyme in your liver. This
enzyme is responsible for cholesterol
formation.
BEFORE YOU USE VASTICURE-20
-When you must not use it
Do not take this medicine:

If you have ever had an
allergic reaction to
rosuvastatin or similar
medicines or to any of its
ingredients.

If you are pregnant, trying
to become pregnant or are
breast-feeding. If you
become pregnant while
taking VASTICURE-20,
stop taking it immediately
and tell your doctor.

If you have liver disease.

If you have severe kidney
problems.

If you have repeated or
unexplained muscle aches
or pains.

If you take a drug called
ciclosporin (commonly used
after organ transplants)
If any of the above applies to you (or
you are in doubt), please go back and
see your doctor.
-Before you start to use it
Take special car

Ciri produk

_ _
For the use only of a registered Medical Practitioner or a Hospital or
a Laboratory
VASTICURE-20 MG TABLETS
(ROSUVASTATIN TABLETS 20 MG)
COMPOSITION:
Each film coated tablet contains:
Rosuvastatin Calcium 20.8 mg
Eq. to Rosuvastatin 20 mg
DESCRIPTION:
Pink coloured, round, biconvex and film coated tablets.
PHARMACODYNAMICS / PHARMACOKINETICS:
_Mechanism of action_
Rosuvastatin is a selective and competitive inhibitor of HMG-CoA
reductase, the rate-limiting enzyme that converts
3-hydroxy-3-methylglutaryl
coenzyme A to mevalonate, a precursor for cholesterol. The primary
site of action of rosuvastatin is the liver, the target organ for
cholesterol lowering.
Rosuvastatin increases the number of hepatic LDL receptors on the
cell-surface, enhancing uptake and catabolism of LDL and it inhibits
the hepatic
synthesis of VLDL, thereby reducing the total number of VLDL and LDL
particles.
_PHARMACODYNAMIC EFFECTS_
Rosuvastatin reduces elevated LDL-cholesterol, total cholesterol and
triglycerides and increases HDL-cholesterol. It also lowers ApoB,
nonHDL-C,
VLDL-C, VLDL-TG and increases ApoA-I. Rosuvastatin also lowers the
LDL-C/HDL-C, total C/HDL-C and nonHDL-C/HDL-C and the
ApoB/ApoA-I ratios.
._PHARMACOKINETIC PROPERTIES:_
ABSORPTION: Maximum rosuvastatin plasma concentrations are achieved
approximately 5 hours after oral administration. The absolute
bioavailability
is approximately 20%.
DISTRIBUTION: Rosuvastatin is taken up extensively by the liver which
is the primary site of cholesterol synthesis and LDL-C clearance. The
volume of
distribution of rosuvastatin is approximately 134 L. Approximately 90%
of rosuvastatin is bound to plasma proteins, mainly to albumin.
METABOLISM: Rosuvastatin undergoes limited metabolism (approximately
10%). _In vitro_ metabolism studies using human hepatocytes indicate
that
rosuvastatin is a poor substrate for cytochrome P450-based metabolism.
CYP2C9 was the principal isoenzyme involved, with 2C19, 3A4 and 2D6
involved to a lesser extent. The main metabolites identified are the
N-desm