TORVASTAT atorvastatin (as calcium) 80 mg film coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

atorvastatin calcium

Available from:

Southern Cross Pharma Pty Ltd

INN (International Name):

Atorvastatin calcium

Authorization status:

Registered

Patient Information leaflet

C:PRODUCTS/ATORVA/CMI TORVASTAT 30DEC11 CLN 30/12/11
TORVASTAT 80MG CMI 301211
1
TORVASTAT
_contains the active ingredient atorvastatin calcium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
more common questions about
TORVASTAT.
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 TORVASTAT
against the benefits he/she
expects it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your
medicine. You may need to read it
again.
WHAT TORVASTAT IS USED
FOR
TORVASTAT is used to lower high
cholesterol levels.
TORVASTAT can be used to help
reduce the risk of having a heart
attack or stroke in people who
have high blood pressure and
coronary heart disease (CHD) or
who are at risk of CHD. Some
examples of risk factors for CHD
are diabetes, a history of stroke, or
small blood vessel disease.
_WHAT IS CHOLESTEROL? _
Everyone has cholesterol in their
blood. It is a type of blood fat
needed by the body for many
things, such as building cell walls,
making bile acids (which help to
digest food) and some hormones.
However, too much cholesterol
can be a problem.
Cholesterol is present in many
foods and is also made in your
body by the liver. If your body
makes too much cholesterol or
you have too much cholesterol in
your diet, then your level becomes
too high.
High cholesterol is more likely to
occur with certain diseases or if
you have a family history of high
cholesterol.
There are different types of
cholesterol. Low Density
Lipoprotein (LDL) is the “bad”
cholesterol that can block your
blood vessels. High Density
Lipoprotein (HDL) cholesterol is
the “good” cholesterol that is
thought to remove the bad
cholesterol from the blood vessels.
When you have high levels of
“bad” cholesterol in your blood, it
may begin to “stick” to the inside of
your b

Summary of Product characteristics

TORVASTAT
PRODUCT INFORMATION
Page 1 of 20
C:Products/Atorva/PI Torvastat_16092013_3
NAME OF THE MEDICINE
Atorvastatin calcium
Chemical name:
[R-(R*,R*)]-2-(4-fluorophenyl)-ß,δ-
dihydroxy-5-(1-methylethyl)-3-phenyl-4-
[(phenylamino) carbonyl] -1H-pyrrole -1-heptanoic acid, calcium salt
(2:1).
Its structural formula is:
Molecular formula: (C
33
H
34
FN
2
O
5
)
2
Ca.
Molecular weight: 1155.3
CAS No.: 134523-03-8
DESCRIPTION
Atorvastatin calcium is a white to off-white amorphous powder.
Atorvastatin calcium
is very slightly soluble in water, slightly soluble in ethanol and
freely soluble in
methanol.
TORVASTAT 80mg tablets contain atorvastatin calcium equivalent to 80mg
atorvastatin. The tablets also contain the following inactive
ingredients: Attapulgite -
activated, microcrystalline cellulose, lactose, starch –
pregelatinised maize,
hydroxypropylcellulose, magnesium stearate, silica – colloidal
anhydrous and Opadry
II White LS-28908 (ARTG ID 2596 containing lactose, hypromellose,
macrogol 4000
and titanium dioxide).
N
N
H
O
H
3
C
CH
3
OH
F
OH
O
O
–
Ca
2+
2
TORVASTAT
PRODUCT INFORMATION
Page 2 of 20
C:Products/Atorva/PI Torvastat_16092013_3
PHARMACOLOGY
MECHANISM OF ACTION
Atorvastatin is a synthetic lipid-lowering agent. Atorvastatin is an
inhibitor of HMG-
CoA reductase, the rate-limiting enzyme that converts
3-hydroxy-3-methyl-glutaryl-
coenzyme A to mevalonate, a precursor of sterols, including
cholesterol.
Triglycerides (TG) and cholesterol in the liver are incorporated into
very low density
lipoprotein (VLDL) and released into the plasma for delivery to
peripheral tissues.
Low density lipoprotein (LDL) is formed from VLDL and is catabolised
primarily
through the high affinity LDL receptor.
Atorvastatin lowers plasma cholesterol and lipoprotein levels by
inhibiting HMG-CoA
reductase and cholesterol synthesis in the liver and by increasing the
number of
hepatic LDL receptors on the cell-surface to enhance uptake and
catabolism of LDL.
Atorvastatin reduces LDL production and the number of LDL particles.