APO-Simvastatin

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

Simvastatin

Доступна з:

Apotex Pty Ltd

Клас:

Medicine Registered

інформаційний буклет

APO-SIMVASTATIN

_10 / 20 / 40 / 80 MG_
_Contains the active ingredient, simvastatin_
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 simvastatin. 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 APO-
Simvastatin 10 / 20 / 40 / 80 mg. It
contains the active ingredient
simvastatin.
It is used to help lower high
cholesterol and triglyceride levels
(together with diet and other lifestyle
changes - discuss these with your
doctor).
Simvastatin is used in people who
have coronary heart disease (CHD)
or who are at high risk of CHD (for
example, if they have diabetes, a
history of stroke, or other blood
vessel disease).
Simvastatin may be used, regardless
of cholesterol level, to:
•
help prolong life by reducing the
risk of a heart attack
•
reduce the risk of stroke
•
reduce the need for surgery to
increase blood flow to the heart
•
reduce the need for
hospitalisation due to angina.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may ha

Характеристики продукта

Product Information 
– Australia 

APO-Simvastatin 10 mg / 20 mg / 40 mg / 80 mg Tablets  
Page 1 

APO-SIMVASTATIN 10 MG 
APO-SIMVASTATIN 20 MG 
APO-SIMVASTATIN 40 MG 
APO-SIMVASTATIN 80 MG 

NAME OF THE MEDICINE 
Simvastatin. 

Chemical Name: 
[1S-[1 ,3 ,7 ,8 (2S*,4S*),8a ]]-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2- 
(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 
2,2-dimethylbutanoate. 

Structural Formula: 

Molecular Formula: 
C
25
H
38
O
5

Molecular Weight: 
418.57 

CAS Registry Number:
  79902-63-9 

Simvastatin  is  a  lipid-lowering  agent  derived  synthetically  from  a  fermentation  product  of  Aspergillus 
terreus. 

DESCRIPTION 
Simvastatin  is  a  white  crystalline  powder,  practically  insoluble  in  water  and  freely  soluble  in  chloroform, 
methanol and ethanol. 

PHARMACOLOGY 
CLINICAL PHARMACOLOGY 
The  involvement  of  low-density  lipoprotein-cholesterol  (LDL-C)  in  atherogenesis  has  been  well 
documented in clinical and pathological studies, as well as in many animal experiments. Epidemiological 
studies  have  established  that  high  LDL-C  and  low  high-density  lipoprotein-cholesterol  (HDL-C)  are  both 
risk factors for coronary heart disease (CHD). 

After oral ingestion, simvastatin, which is an inactive lactone, is hydrolysed to the corresponding  
-hydroxyacid form. This is a principal metabolite and an inhibitor of
3-hydroxy-3-methylglutaryl-coenzyme 
A (HMG-CoA) reductase, an enzyme which catalyses an
early and rate-limiting step in the biosynthesis of 
cholesterol.  As  a  result,  in  clinical  studies  simvastatin  reduced  total  plasma  cholesterol  (total-C),  LDL-C 
and  very  low-density  lipoprotein-cholesterol  (VLDL-C)  concentrations.  In