Rostatin 10 mg 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:

AVERROES PHARMACEUTICALS SDN. BHD.

INN（国際名）:

ROSUVASTATIN CALCIUM

パッケージ内のユニット:

10tablet Tablets; 30 Tablets; 100 Tablets

製:

Maple Pharmaceuticals (Pvt.) Limited

情報リーフレット

_Consumer Medication Information Leaflet (RiMUP)_
ROSTATIN TABLETS
Rosuvastatin
(5mg, 10mg, 20mg)
_ _
__________________________________________________________________________________________________________
_______________________________________________________________________________________________
1
1
. WHAT IS IN THIS LEAFLET?
•
What Rostatin is used for
•
Before you take Rostatin
•
How to take Rostatin
•
While you are using Rostatin
•
Side Effects
•
Storage
and
Disposal
of
Rostatin
•
Product Description
•
Ingredients
•
Manufacturer
and
Product
Registration Holder
•
Date of revision
2.
WHAT ROSTATIN IS USED FOR
Rostatin
belongs
to
a
group
of
medicines called statins.
You
have
been
prescribed
Rostatin
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 Rostatin.
Or
 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.
3
. BEFORE YOU TAKE ROSTATIN
BEFORE YOU TAKE ROSTATIN
_WHEN YOU MUST NOT TAKE IT _
Do not take Rostatin:

If
you
have
ever
had
an
allergic
reaction to Rostatin or similar medicines
or
to
any
of
its
ingredients.
Rostatin
contains
lactose,
which
may
cause
a
problem in a small number of patients
who are allergic to lactose.
 If you are pregnant, trying to become
pregnant or are breast-feeding. If you
become pregnant while taking Rostatin
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
(used,
for
ex

製品の特徴

ROSTATIN TABLET
ROSUVASTATIN CALCIUM
DESCRIPTION
Rostatin 5mg Tablet: White round tablet mark maple leaf on one side
and plain on the other
side (core). Dark pink round film coated tablet mark maple leaf on one
side and plain on the
other side (coated).
Rostatin 10mg Tablet: White round tablet mark maple leaf on one side
and plain on the other
side (core). Light pink round film coated tablet mark maple leaf on
one side and other side
plain (coated).
Rostatin 20mg Tablet: White round tablet mark maple leaf on one side
(core). White round
film coated tablet mark maple leaf on one side.
COMPOSITION
Each Tablet contains Rosuvastatin Calcium 5mg, 10mg and 20mg.
MODE 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 of cholesterol.
SUMMARY OF PHARMACODYNAMICS AND PHARMACOKINETICS
Administration of rosuvastatin with food decreased the rate of drug
absorption by 20% as
assessed by Cmax, but there was no effect on the extent of absorption
as assessed by AUC.
Plasma concentrations of rosuvastatin do not differ following evening
or morning drug
administration.
Significant LDL-C reductions are seen when rosuvastatin is given with
or without food, and
regardless of the time of day of drug administration.
Distribution: Mean volume of distribution at steady-state of
rosuvastatin is approximately
134 L. Rosuvastatin is 88% bound to plasma proteins, mostly albumin.
This binding is
reversible and independent of plasma concentrations.
Metabolism:
Rosuvastatin
is
not
extensively
metabolised;
approximately
10%
of
a
radiolabeled
dose
is
recovered
as
metabolite.
The
major
metabolite
is
N-desmethyl
rosuvastatin, which is formed principally by cytochrome P-450 2C9.
Overall, >90% of active
plasma HMG-CoA reductase inhibitory activity is accounted for by
rosuvastatin.
Excretion:
Following
oral
administration,
rosuvastatin
and
its
metabolite
are
primarily
excreted in the faeces (90%). The elimination h