ROSUVASTATIN-DRLA rosuvastatin (as calcium) 20 mg film-coated tablets blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
25-02-2019
Summary of Product characteristics
(SPC)
25-02-2019
Public Assessment Report
(PAR)
19-10-2017
Active ingredient:
rosuvastatin calcium
Available from:
Dr Reddys Laboratories Australia Pty Ltd
INN (International Name):
Rosuvastatin calcium
Authorization status:
Registered
Patient Information leaflet
ROSUVASTATIN-DRLA
1
ROSUVASTATIN-DRLA
_Contains the active ingredient rosuvastatin (as calcium)_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some of the
common questions about
rosuvastatin. It does not contain all
the information that is known about
rosuvastatin.
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 this
medicine 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 THIS MEDICINE IS
USED FOR
The name of your medicine is
Rosuvastatin-DRLA. It contains the
active ingredient rosuvastatin.
Rosuvastatin is used to lower high
cholesterol levels.
Even though you may have normal
cholesterol, rosuvastatin 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
rosuvastatin 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 t
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Summary of Product characteristics
PRODUCT INFORMATION
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ROSUVASTATIN-DRLA
NAME OF THE MEDICINE
Rosuvastatin (as calcium) tablets
C h e m i c a l name: bis
[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)
amino]pyrimidin-5-yl] (3R, 5S)-3,5-dihydroxyhept-6-enoic acid] calcium
salt.
Structural Formula:
F
OH
OH
O
2+
N
O
Ca
N
N
SO
2
Me
2
CAS Number:
147098-20-2
Molecular formula: (C
22
H
27
FN
3
O
6
S)
2
Ca
Molecular weight:
1001.14
Rosuvastatin calcium, is a HMG-CoA reductase inhibitor for the
treatment of dyslipidaemia.
DESCRIPTION
Rosuvastatin calcium is an amorphous solid, which is soluble in
dimethyl formamide,
dimethyl suplhoxide and acetonitrile. Slightly soluble in acetone,
water, ethanol and
methanol and has a pKa of 3.8 (carboxylic acid group), 4.9 and 5.5
(amine groups).
The partition coefficient is octanol/water 0.13 (pH 7.0). Rosuvastatin
calcium is the
(3_R_,5_S_,6_E_) enantiomer.
ROSUVASTATIN-DRLA 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:
crospovidone, lactose, microcrystalline cellulose, magnesium
stearate,
and meglumine. The 5 mg tablets
also contain opadry II complete film coating
system 32K520046 YELLOW (PI 108958) whereas the 10 mg, 20 mg and 40 mg
tablets contain opadry II complete film coating system 32K540017 PINK
(PI
108959).
PRODUCT INFORMATION
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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-rich low density lipoprotein (LDL)
is formed from
VLDL and is cleared primarily through the high affinity LDL receptor
in the liver.
Rosuvastatin produces its lipid-modifying effects in two ways; it
increases the
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