Lipitor

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

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Hent Indlægsseddel (PIL)
03-06-2024
Hent Produktets egenskaber (SPC)
03-06-2024

Aktiv bestanddel:

Atorvastatin calcium

Tilgængelig fra:

Pfizer Australia Pty Ltd

Klasse:

Medicine Registered

Indlægsseddel

                                LIPITOR
®
 
_Atorvastatin calcium_
CONSUMER MEDICINE INFORMATION
   
 
 
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
more common questions about
Lipitor.
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 risks and
benefits. Your doctor has weighed
the risks of you taking Lipitor 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 LIPITOR IS USED
FOR
Lipitor is used to lower high
cholesterol levels.
Lipitor is also 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.
Examples of risk factors for CHD
include 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 the cell lining, 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. LDL, or low-density
lipoprotein, is the 'bad' cholesterol
that can block your blood vessels.
HDL, or high density lipoprotein,
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
blood vessels instead of being carried
to the parts of the body where it is
needed. Over time, this can form
hard
                                
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Produktets egenskaber

                                Version: pfplipit10613 
Supersedes: pfplipit10512 
 
Page 1 of 20 
PRODUCT INFORMATION 
LIPITOR
®
 (ATORVASTATIN CALCIUM) 
NAME OF THE MEDICINE 
LIPITOR atorvastatin (as calcium) 10 mg, 20 mg, 40 mg and
80 mg tablets. 
LIPITOR  contains  the  active  ingredient  atorvastatin  calcium.    The  structural  formula  of 
atorvastatin calcium is shown below: 
NHC
N
O
CH
CH
3
CH
3
CH
2
CH
2
CH
2
CH
2
CH
CH
C
O
O
-
F
2
•Ca
•3H O
2
2+
OH
OH
 
Chemical name: 
[R-(R*,R*)]-2-(4-fluorophenyl)-ß,

-dihydroxy-5-(1-methylethyl)- 
3-phenyl-4-[(phenylamino) carbonyl] -1H-pyrrole -1-heptanoic 
acid, calcium salt (2:1) 
Molecular formula: 
(C
33
H
34
FN
2
O
5
)
2
Ca.3H
2
O 
Molecular weight: 
1209.42 
CAS registry number: 
134523-03-8. 
DESCRIPTION 
Atorvastatin calcium is a white to off-white crystalline powder that is practically insoluble in 
aqueous  solutions  of  pH 4  and  below.    Atorvastatin  calcium  is  very  slightly  soluble  in 
distilled  water,  pH 7.4  phosphate  buffer,  and  acetonitrile,  slightly  soluble  in  ethanol  and 
freely soluble in methanol. 
LIPITOR tablets contain atorvastatin calcium equivalent to 10, 20, 40 and 80 mg atorvastatin.
 
The  tablets  also  contain  the  following  inactive  ingredients:  calcium  carbonate, 
microcrystalline 
cellulose, 
lactose, 
croscarmellose 
sodium, 
polysorbate 80, 
hydroxypropylcellulose,  magnesium  stearate,  Opadry  White  YS-1-7040  and  Simethicone 
Emulsion. 
Version: pfplipit10613 
Supersedes: pfplipit10512 
 
Page 2 of 20 
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  
                                
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