ROSUVASTATIN AMNEAL rosuvastatin (as calcium) 40 mg tablet blister pack

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

rosuvastatin calcium

Disponible des:

Amneal Pharma Australia Pty Ltd

Designació comuna internacional (DCI):

Rosuvastatin calcium

Estat d'Autorització:

Registered

Informació per a l'usuari

ROSUVASTATIN AMNEAL CMI V2.0
1
Rosuvastatin AMNEAL
_contains the active ingredient rosuvastatin (as calcium) _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about ROSUVASTATIN
AMNEAL.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking ROSUVASTATIN
AMNEAL against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your
medicine. You may need to read it
again.
What ROSUVASTATIN
AMNEAL is used for
ROSUVASTATIN AMNEAL is used to
lower high cholesterol levels.
Even though you may have normal
cholesterol, ROSUVASTATIN
AMNEAL 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
AMNEAL 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. 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 b

Fitxa tècnica

_Rosuvastatin AMNEAL tablets Product Information Amneal Pharma
Australia Pty Ltd _
Rosuvastatin AMNEAL PI v2.0
Page 1 of 22
ROSUVASTATIN AMNEAL
_ _
_ROSUVASTATIN (AS CALCIUM) TABLETS _
_ _
PRODUCT INFORMATION
NAME OF THE MEDICINE
Rosuvastatin (as rosuvastatin calcium). The chemical name for
rosuvastatin calcium 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. Its structural formula is:
(C
22
H
27
FN
3
O
6
S)
2
Ca
Molecular weight: 1001.14
CAS No.: 147098-20-2
DESCRIPTION
Rosuvastatin calcium is an amorphous solid, which is slightly soluble
in methanol, ethanol and water
(7.8 mg/mL at 37◦C) and has a pKa of 4.6. Rosuvastatin calcium is
the (3_R_,5_S_,6_E_) enantiomer.
ROSUVASTATIN AMNEAL film-coated tablets come in four strengths and
contain 5 mg, 10 mg, 20 mg
or 40 mg of rosuvastatin (as calcium). The tablets also contain:
microcrystalline cellulose,
crospovidone, calcium hydrogen phosphate dihydrate, lactose
monohydrate, magnesium stearate,
Opadry II Complete film coating system 33G28435 White (ARTG 107124, 5
mg tablet only) and
Opadry II Complete film coating system 33G240007 Pink (ARTG 107544, 10
mg, 20 mg and 40 mg
tablets only). The tablets are gluten free.
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
_Rosuvastatin AMNEAL tablets Product Information Amneal Pharma
Australia Pty Ltd _
Rosuvastatin AMNEAL PI v2.0
Page 2 of 22
formed from VLDL and is cleared primarily through the high affinity
LDL receptor in the liver.
Rosuvastatin produces its lipid-modifying effec