CHEMMART ATORVASTATIN atorvastatin (as calcium propylene glycol solvate) 20 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

atorvastatin calcium propylene glycol solvate

Available from:

Apotex Pty Ltd

INN (International Name):

Atorvastatin calcium propylene glycol solvate

Authorization status:

Registered

Patient Information leaflet

CHEMMART ATORVASTATIN
_Contains the active ingredient, atorvastatin calcium_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Chemmart
Atorvastatin.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
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.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
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
Chemmart Atorvastatin. It contains
the active ingredient atorvastatin.
Atorvastatin lowers high cholesterol
levels.
It is also used in people who have
high blood pressure and coronary
heart disease (CHD) or who are at
risk of CHD (for example, if they
have diabetes, a history of stroke, or
small blood vessel disease). In these
people, this medicine is used to
reduce the risk of having a heart
attack or stroke.
_WHAT IS CHOLESTEROL?_
Everyone has cholesterol in their
blood. It is a type of 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 y

Summary of Product characteristics

Product Information – Australia
Chemmart Atorvastatin Tablets
Page 1
CHEMMART ATORVASTATIN TABLETS
NAME OF THE MEDICINE
Atorvastatin calcium propylene glycol solvate.
Chemical Name:
calcium
bis((3_R_,5_R_)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-
phenyl-1_H_-pyrrol-1-yl]-3,5-dihydroxyheptanoate)propylene glycol
solvate.
Structural Formula:
Molecular Formula:
C
69
H
76
CaF
2
N
4
O
12
Molecular Weight:
1231.45
CAS Registry Number:
134523-03-8 (Atorvastatin calcium)
DESCRIPTION
Atorvastatin calcium propylene glycol solvate is a white to off-white
crystalline powder that is insoluble in
aqueous solutions of pH 4.0 and below. Atorvastatin calcium propylene
glycol solvate is slightly soluble in
distilled water and pH 7.4 phosphate buffer, very slightly soluble in
acetonitrile, practically insoluble in
ethanol and sparingly soluble in methanol.
Each tablet contains atorvastatin calcium propylene glycol solvate as
the active ingredient. In addition
each tablet contains the following inactive ingredients: calcium
acetate, croscarmellose sodium, sodium
carbonate
anhydrous,
microcrystalline
cellulose,
magnesium
stearate,
colloidal
anhydrous
silica,
hypromellose, hydroxypropylcellulose, macrogol 8000, and titanium
dioxide..
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
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