VASTICURE-10 (Rosuvastatin Tablets 10mg)

国: マレーシア

言語: 英語

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

有効成分:

ROSUVASTATIN CALCIUM

から入手可能:

HEALOL PHARMACEUTICALS SDN. BHD.

INN（国際名）:

ROSUVASTATIN CALCIUM

パッケージ内のユニット:

3 x 10 Tablets

製:

GRACURE PHARMACEUTICALS LTD.

情報リーフレット

_Consumer Medication Information Leaflet (RiMUP) _
VASTICURE-10 (ROSUVASTATIN TABLETS 10MG)
Rosuvastatin Calcium (10mg)
1
WHAT IS IN THIS LEAFLET
1.
What VASTICURE-10 is used
for
2.
How VASTICURE-10 works
3.
Before you use VASTICURE-10
4.
How to use VASTICURE-10
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
VASTICURE-10
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS VASTICURE-10 USED FOR
VASTICURE-10 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-10.
•
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-10 WORKS
VASTICURE-10 works by inhibiting
an enzyme in your liver. This
enzyme is responsible for cholesterol
formation.
BEFORE YOU USE VASTICURE-10
-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-10,
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 you are already on a
cholesterol lowering
medication of the fibrate
class (e.g. gemfibrozil) or
niacin.
If any

製品の特徴

_Gracure Pharmaceuticals Ltd _
NAME OF THE PRODUCT
VASTICURE-10
PART-I
Administrative Data
D3. PROPOSED PACKAGE INSERT
Enclosed
For the use only of a registered Medical Practitioner or a Hospital or
a Laboratory
VASTICURE-10
(ROSUVASTATIN TABLETS 10 MG)
COMPOSITION:
Each film coated tablet contains:
Rosuvastatin Calcium BP 10.4 mg
Eq. to Rosuvastatin 10 mg
DESCRIPTION:
Light 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 prin