TERRY WHITE CHEMISTS ATORVASTATIN atorvastatin (as calcium trihydrate) 80 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

atorvastatin calcium trihydrate

Available from:

Apotex Pty Ltd

INN (International Name):

atorvastatin calcium trihydrate

Authorization status:

Registered

Patient Information leaflet

TERRY WHITE CHEMISTS
ATORVASTATIN
_Contains the active ingredient, atorvastatin calcium trihydrate_
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 Terry White
Chemists 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 Terry
White Chemists 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
live

Summary of Product characteristics

Product Information – Australia
Terry White chemists Atorvastatin Tablets
Page 1
TERRY WHITE CHEMISTS ATORVASTATIN TABLETS
NAME OF THE MEDICINE
Atorvastatin calcium trihydrate.
Chemical Name:
Calcium (3_R_,5_R_)-7-[2-(4-fluorophenyl)-5-(1-methylethyl)-3-
phenyl-4-
(phenylcarbamoyl) -1_H_-pyrrol-1-yl]-3,5-dihydroxyheptanoate
trihydrate.
Structural Formula:
Molecular Formula:
C
66
H
68
CaF
2
N
4
O
10
,3H
2
O
Molecular Weight:
1209
CAS Registry Number:
344423-98-9
DESCRIPTION
Atorvastatin calcium trihydrate is a white to off-white crystalline
powder that is insoluble in aqueous
solutions of pH 4.0 and below. Atorvastatin calcium trihydrate 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 trihydrate as the active
ingredient. In addition each tablet contains
the following inactive ingredients: lactose monohydrate,
microcrystalline cellulose, calcium carbonate,
croscarmellose sodium, hyprolose, polysorbate 80, magnesium stearate,
Opadry YS-1-7040 White (ARTG
No. 2695) and Antifoam AF Emulsion Q7-2587 (ARTG No. 1515). 10, 20 and
40mg tablets contain
Candelilla Wax.
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 catab