APO-Candesartan

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Candesartan cilexetil

Available from:

Apotex Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

APO-CANDESARTAN
TABLETS

_Contains the active ingredient candesartan cilexetil_
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 candesartan. 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.
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-
Candesartan. It contains the active
ingredient candesartan cilexetil.
It is used to treat:
•
high blood pressure, also called
hypertension.
•
heart failure - increase survival,
reduce hospitalisation and
improve symptoms. It is used in
combination with other medicines
to treat your condition.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
_HOW IT WORKS_
Candesartan is a type of medicine
called an angiotensin II receptor
inhibitor (or antagonist).
HYPERTENSION:
All people have blood pressure. This
pressure helps to push blood all
around your body. Your blood
pressure changes during the day,
depending on how busy you are or
how you are feeling.
You

Summary of Product characteristics

Product Information 
– Australia 
APO-Candesartan Tablets  
Page 1 

APO-CANDESARTAN TABLETS  

NAME OF THE MEDICINE 
Candesartan cilexetil 

Chemical Name: 
(±)-1-(cyclohexyloxycarbonyl-oxy) ethyl 2-ethoxy-1-
[[2’-(1H-tetrazol-5-yl) 
biphenyl-4-yl] methyl]-1H-benzimadozole-7-carboxylate 

Structural Formula: 

Molecular Formula: 
C
33
H
34
N
6
O
6 

Molecular Weight: 
610.7 

CAS Registry Number:  145040-37-5 

DESCRIPTION 
It is a white to off white powder and is practically insoluble in water. It has a pKa of 6.3, corresponding to 
deprontonation of the tetrazole
ring. The partition coefficient of candesartan
cilexetil is as follows: 

pH of Aqueous 
Layer 
Partition Coefficient (K at 20°C) 
Ethyl Ether 
1-Octanol 
1.1 
 > 1000 
> 1000 
6.9 
> 1000 
> 1000 
8.9 
141 
> 1000 

K = 
Concentration of Candesartan cilexetil in the organic layer 
Concentration of Candesartan cilexetil in the aqueous layer 

Three  polymorphic  forms  have  been  identified;  crystal  form  I,  crystal  form  II  and  an  amorphous  form. 
Crystalline  form  I  is  used  in  APO-Candesartan.  It  also  contains  the  inactive  ingredients  lactose, 
carmellose  calcium,  starch 
–  maize,  macrogol  8000,  hydroxypropylcellulose,  magnesium  stearate  and 
Pigment  Blend  PB-24880  Pink  (ARTG  108327)  which  contains  iron  oxide  red  and  lactose.    The  tablets 
are gluten free.

PHARMACOLOGY 
PHARMACODYNAMICS 
Angiotensin II is the primary vasoactive hormone of the renin-angiotensin-aldosterone system and plays a 
significant role in the pathophysiology of hypertension, heart failure and other cardiovascular disorders. It 
also  has  an  important  role  in  the  pathogenesis  of