Apo-Rosuvastatin 10mg tablet

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:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN（国際名）:

ROSUVASTATIN CALCIUM

パッケージ内のユニット:

30tablet Tablets

製:

APOTEX INC

情報リーフレット

APO-ROSUVASTATIN TABLETS
Rosuvastatin Calcium (10mg, 20mg)
1
_Consumer Medication Information Leaflet (RiMUP)_
WHAT IS IN THIS LEAFLET
1.
What Apo-Rosuvastatin is used for
2.
How Apo-Rosuvastatin works
3.
Before you use Apo-Rosuvastatin
4.
How to use Apo-Rosuvastatin
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Apo-
Rosuvastatin
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT APO-ROSUVASTATIN
IS USED FOR
Apo-Rosuvastatin is indicated as an
adjunct treatment in the treatment of
hyperlipidemic or dyslipidemic (high
level of fat and fatty substance) cases,
where diet and exercise is not sufficient
in bringing down your cholesterol level.
HOW APO-ROSUVASTATIN WORKS
Apo-Rosuvastatin is a prescription
medication containing the active
ingredient, rosuvastatin calcium. Apo-
Rosuvastatin is a form of HMG-COA
reductase inhibitor. It works by blocking
an enzyme that is needed by the body to
make cholesterol, so this reduces the
amount of cholesterol in the blood.
BEFORE YOU USE APO-ROSUVASTATIN
-
_When you must not use it_
_ _
Do not use this product if you are
allergic to
_ _
Rosuvastatin Calcium or
any other ingredients in this
medication. (Please refer to
PRODUCT
INFORMATION
)
_ _
_ _
You cannot use this medication if you
have certain medical condition, such
as:
- active liver disease
- kidney impairments
- myopathy (muscle tissue disorder)
_ _
_Pregnancy and lactation _
Do not take Apo-Rosuvastatin if you
are pregnant, trying to get pregnant or
think you may be pregnant.
Do not take Apo-Rosuvastatin if you
are breast-feeding. Ask your doctor or
pharmacist for advice before taking
any medicine.
_ _
-
_Before you start to use it_
_ _
Before taking Apo-Rosuvastatin your
doctor needs to know if you have any
other medical condition that you may
have, including low blood pressure,
kidney, liver disease, and/or any that
involve your muscle tissues.
-
_Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that
you b

製品の特徴

APO‐ROSUVASTATIN TABLETS
ROSUVASTATIN 10MG & 20MG (AS ROSUVASTATIN CALCIUM)
PRODUCT DESCRIPTION
10 mg: Pink, round, biconvex, film‐coated tablet. Engraved “APO”
on
one side, “ROS” over “10” on the other side
20 mg: Pink, round, biconvex, film‐coated tablet. Engraved “APO”
on
one side, “ROS” over “20” on the other side.
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.
PHARMACODYNAMICS
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.
Rosuvastatin is effective in adults with hypercholesterolaemia, with
and without hypertriglyceridaemia, regardless of race, sex, or age and
in special populations such as diabetics, or patients with familial
hypercholesterolaemia.
PHARMACOKINETICS
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
us