ROSUVASTATIN ARW rosuvastatin (as calcium) 10 mg tablets blister pack

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

rosuvastatin calcium

Pieejams no:

Arrow Pharma Pty Ltd

SNN (starptautisko nepatentēto nosaukumu):

Rosuvastatin calcium

Autorizācija statuss:

Registered

Lietošanas instrukcija

CROSUVA
CONSUMER MEDICINE INFORMATION
Version: 1.0
-2016- Page 1 of 5
CROSUVA
(ROSUVASTATIN FILM-COATED TABLETS 5, 10, 20 AND 40 MG)
_Rosuvastatin calcium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask
about Crosuva. It does not
contain all the information that is
known about Crosuva.
It does not take the place of
talking to your doctor and
pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of you taking
Crosuva against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT CROSUVA IS FOR
Crosuva is used to lower high
cholesterol levels.
Even though you may have
normal cholesterol, Crosuva can
also be used to reduce the risk of
you having a stroke or heart
attack if you are a man 50 or
more years old or a women 60 or
more years old and have at least
2 risk factors for having a heart
attack or stroke, such as high
blood pressure, low levels of
good cholesterol (HDL),
smoking or a family history of
premature coronary heart disease.
Your doctor may also do a blood
test to measure a substance called
C Reactive Protein to help
decide if you should be given
Crosuva for this use.
_ _
_CHOLESTEROL AND TRIGLYCERIDES _
Everyone has cholesterol and
triglycerides in their blood. They
are fatty substances needed by
the body for many things.
Triglycerides are an energy
source for the body. Cholesterol
is used for such things as
building cells, making bile acids
(which help to digest foods) and
making some hormones.
There are different types of
cholesterol. Too much of the
"bad" cholesterol (LDL) can
block the blood vessels that
supply your heart and brain with
blood, and can cause heart
attack, angina and stroke. The
"good" cholesterol (HDL) helps
to remove the bad cholesterol
from the blood vessels. High
levels of triglycerides can be
associated with a low level of
"good"

Produkta apraksts

Crosuva (Rosuvastatin film-coated tablets 5, 10, 20 and 40 mg)
-2017-
Page 1 of 29 CROSUVA 5, 10, 20 AND 40
_ROSUVASTATIN (AS CALCIUM) _
PRODUCT INFORMATION
NAME OF THE MEDICINE
The active ingredient in Crosuva
is rosuvastatin, as rosuvastatin calcium.
The chemical name is bis [(
_E_
)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl (methylsulfonyl)
amino] pyrimidin-5-yl] (3
_R_
, 5
_S_
)-3,5-dihydroxyhept-6-enoic acid] calcium salt.
Crosuva,
rosuvastatin calcium, is a HMG-CoA reductase inhibitor for the
treatment of
dyslipidaemia.
The chemical structure of rosuvastatin calcium is:
CAS Number:
147098-20-2
Molecular formula:
(C
22
H
27
FN
3
O
6
S)
2
Ca
Molecular weight:
1001.14
DESCRIPTION
Rosuvastatin calcium is white or almost white, hygroscopic powder,
which is slightly soluble
in water (7.8 mg/mL at 37°C) and has a pKa of 4.6. Rosuvastatin
calcium is the (3R, 5S, 6E)
enantiomer.
Crosuva
film-coated tablets contain 5 mg, 10 mg, 20 mg and 40 mg of
rosuvastatin (as
calcium). The tablets also contain the following inactive ingredients:
lactose, lactose
monohydrate, microcrystalline cellulose, light magnesium oxide,
crospovidone, magnesium
stearate, triacetin, hypromellose, titanium dioxide.
The 5 mg tablets also contain iron oxide yellow.
The 10 mg and 20 mg tablets also contain iron oxide red, quinoline
yellow aluminum lake,
brilliant blue FCF aluminum lake.
Crosuva (Rosuvastatin film-coated tablets 5, 10, 20 and 40 mg)
-2017-
Page 2 of 29
The 40 mg tablets also contain sunset yellow FCF aluminum lake, allura
red AC aluminum
lake and brilliant blue FCF aluminum lake.
PHARMACOLOGY
Rosuvastatin is a fully synthetic competitive inhibitor of HMG-CoA
reductase, the rate-
limiting enzyme that converts 3-hydroxy-3-methylglutaryl coenzyme A to
mevalonate, a
precursor of cholesterol. Triglycerides (TG) and cholesterol in the
liver are incorporated,
with apolipoprotein B (ApoB), into very low density lipoprotein (VLDL)
and released into
the plasma for delivery to peripheral tissues. VLDL particles are
TG-rich.
Cholesterol-ric