Avapro HCT

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

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Download Vara einkenni (SPC)
10-06-2024

Virkt innihaldsefni:

Hydrochlorothiazide; Irbesartan

Fáanlegur frá:

Sanofi-Aventis Australia Pty Ltd

Tegund:

Medicine Registered

Upplýsingar fylgiseðill

                                AVAPRO
®
 HCT TABLETS
 
_Irbesartan plus Hydrochlorothiazide_
CONSUMER MEDICINE INFORMATION
   
 
 
WHAT IS IN THIS LEAFLET
Read this leaflet carefully before
taking AVAPRO HCT. This leaflet
answers some common questions
about AVAPRO HCT. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist. Do not
throw this leaflet away. You may
need to refer to it again later.
ALWAYS FOLLOW THE INSTRUCTIONS THAT
YOUR DOCTOR AND PHARMACIST GIVE
YOU ABOUT AVAPRO HCT. IF YOU
HAVE ANY CONCERNS ABOUT TAKING
AVAPRO HCT, ASK YOUR DOCTOR OR
PHARMACIST.
WHAT IS AVAPRO HCT
AVAPRO HCT is a trade name
(manufacturer's name). AVAPRO
HCT tablets contain two medicines,
irbesartan and hydrochlorothiazide.
Both these medicines are in the
tablets your doctor has prescribed for
you.
_WHAT AVAPRO HCT IS USED_
_FOR_
AVAPRO HCT lowers high blood
pressure, which doctors call
hypertension.
Your doctor measured your blood
pressure and found it to be too high.
Everyone has blood pressure. This
pressure helps get your blood all
around your body. Your blood
pressure may be different at different
times of the day, depending on how
busy or worried you are. You have
hypertension (high blood pressure)
which means your blood pressure
stays high, even when you are calm
and relaxed.
There are usually no symptoms of
high blood pressure. The only way of
knowing that you have hypertension
is to have your blood pressure
checked on a regular basis. High
blood pressure, if not treated, can
damage blood vessels in several
organs such as the heart, the kidneys,
the brain and the eyes. This may lead
to heart attacks, heart or kidney
failure, strokes, or blindness. There
are usually no symptoms of high
blood pressure before damage
occurs, so your doctor needs to
measure your blood pressure to see if
it is too high.
High blood pressure can be treated
and controlled with medicines such
as AVAPRO HCT. Your doctor may
also have recommended that you
adjust your lifestyle to help to lower
your high blood p
                                
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                                avapro-hct-ccdsv8-piv5-10may13 
1 
 
PRODUCT INFORMATION 
AVAPRO HCT (IRBESARTAN/HYDROCHLOROTHIAZIDE]
 
 
 
NAME OF THE MEDICINE 
 
AUSTRALIAN APPROVED NAME 
Irbesartan/Hydrochlorothiazide 
 
Irbesartan: 2-butyl-3-[(2'-(1H-tetrazol-5-yl)biphenyl-4-yl)methyl]-1,3-diazaspiro [4,4] non-1-en-
4-one. 
 
Hydrochlorothiazide:  6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide  1,1-
dioxide. 
 
CHEMICAL STRUCTURE 
The chemical structure of irbesartan 
is: 
 
 
 
 
 
 
 
 
 
 
IRBESARTAN 
 
CAS number: 138402-11-6 
 
The 
chemical 
structure 
of 
hydrochlorothiazide is: 
 
 
 
 
 
 
HYDROCHLOROTHIAZIDE 
 
CAS number: CAS-58-93-5 
 
 
DESCRIPTION 
 
Avapro  HCT  (irbesartan/hydrochlorothiazide)  is  an  oral  antihypertensive  agent  combining  a 
nonpeptide angiotensin II receptor (AT
1
 subtype) antagonist, irbesartan, and a thiazide diuretic, 
hydrochlorothiazide. 
 
Irbesartan is a white to off-white crystalline powder.  It is a relatively non-polar compound with  a 
N
N
O
(CH
2
)
3
CH
3
N
N
N
N
H
 
 
 
N
N
S
CL
H
H
O
O
S
H
2
N
O
O
 
MW = 428.5 
C
25
H
28
N
6
O 
C
7
H
8
ClN
3
O
4
S
2
 
MW = 297.7 
avapro-hct-ccdsv8-piv5-10may13 
2 
partition  coefficient  (octanol-water)  of  10.1  at  a  pH  of  7.4.    Irbesartan  is  slightly  soluble  in 
alcohol and methylene chloride, and practically insoluble in
water. 
 
Hydrochlorothiazide  is  a  white  crystalline  powder.    It  is  slightly  soluble  in  water  but  freely 
soluble in sodium hydroxide solution. 
 
Avapro HCT 150/12.5 tablets contain 150mg of irbesartan and
12.5mg of hydrochlorothiazide 
and are peach to mottled peach coloured, biconvex, oval-shaped, film-coated tablets debossed 
with a heart on one side and the number “2875” on the other
side. 
 
Avapro HCT 300/12.5 tablets contain 300mg of irbesartan and
12.5mg of h
                                
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