CHEMMART PRAVASTATIN pravastatin sodium 40 mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pravastatin sodium

Available from:

Apotex Pty Ltd

INN (International Name):

pravastatin sodium

Patient Information leaflet

CHEMMART PRAVASTATIN
1
CHEMMART PRAVASTATIN
_Contains the active ingredient pravastatin (as pravastatin sodium) _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about pravastatin. 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 they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Chemmart. It contains the active
ingredient pravastatin (as pravastatin
sodium).
It is used to treat:

people who have high blood
cholesterol levels (in combination
with changes in diet)

people who have had a heart
attack (including people whose
blood cholesterol levels are
normal)

people who have had an episode
of unstable angina.
In these people, pravastatin can
reduce the risk of having a stroke,
further heart disease, or needing a
bypass operation.
It is also used to treat children and
adolescent patients aged 8 years and
older who have heterozygous familial
hypercholesterolaemia (an inherited
disorder which produces high blood
cholesterol levels). This is in
combination with diet and lifestyle
changes.
Ask your doctor if you have any
questions about why this medicine
has been

Summary of Product characteristics

Product Information – Australia
Chemmart Pravastatin tablets
Page 1
CHEMMART PRAVASTATIN
NAME OF THE MEDICINE
Pravastatin sodium.
Chemical Name: sodium
(3R,5R)-7-[(1S,2S,6S,8S,8aR)-1,26,7,8,8a-hexahydro-6-hydroxy-2-methyl-8-
[(S)-2-methylbutyryloxy-1-naphthyl]]-3,5-dihydroxyheptanoic acid.
Structural Formula:
Molecular Formula:
C
23
H
35
NaO
7
Molecular Weight:
446.52
CAS Registry Number: 81131-70-6
DESCRIPTION
Pravastatin sodium is one of a class of lipid-lowering compounds, the
HMG-CoA reductase inhibitors,
that
reduce
cholesterol
biosynthesis.
These
agents
are
competitive
inhibitors
of
3-hydroxy-3-
methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalysing
the early rate-limiting step in
cholesterol biosynthesis, conversion of HMG-CoA to mevalonate.
Pravastatin sodium is an odourless, white to yellowish-white powder or
crystalline powder. It is a
relatively polar hydrophilic compound with a partition co-efficient
(octanol/water) of 0.59 at a pH of 7.0.
It is soluble in methanol and water (> 300 mg/mL), slightly soluble in
isopropanol and practically insoluble
in acetone, chloroform and ether.
Each Tablet contains 10mg, 20mg, 40mg or 80mg of Pravastatin sodium,
as the active ingredient in
addition, each tablet contains the following inactive ingredients:
lactose, microcrystalline cellulose,
croscarmellose sodium, magnesium stearate, iron oxide red (only in 10
mg tablets), iron oxide yellow
(only in 20 mg, 40 mg and 80 mg tablets), brilliant blue FCF (only in
40 mg tablets).
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
Pravastatin produces its lipid lowering effect in two ways. Firstly,
as a consequence of its reversible
inhibition
of
HMG-CoA
reductase
activity,
it
affects modest
reductions
in
intracellular
pools
of
cholesterol. This results in an increase in the number of low density
lipoprotein (LDL) receptors on cell
surfaces and enhanced receptor mediated catabolism and clearance of
circulating LDL. Secondly,
Product Information – Australia
Chemmart Pravastatin tablets
Page 2
pravastatin inhibits LDL p