IRBESARTAN AN irbesartan 150mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Irbesartan

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Irbesartan

Class:

Medicine Registered

Patient Information leaflet

_Doc ID: 108.AN.M.1.0 _
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_Irbesartan AN capsules – Consumer Medicine Information _
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IRBESARTAN AN CAPSULES
_Irbesartan _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Irbesartan AN.
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
benefits
and
risks. Your doctor has weighed the
risks of you taking Irbesartan AN
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT IRBESARTAN AN IS
USED FOR
Irbesartan
AN
lowers
high
blood
pressure,
which
doctors
call
hypertension.
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
often
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 Irbesartan AN. Your doctor may
also have recommended that you
adjust your lifestyle to help to lower
your
high
blood
pressure
(losing
weight, avoiding smoking, reducing
alcohol consumption and restricting
the amount of salt in the diet). Your
doctor may also have encouraged
the
practice
of
regular,
mild
(not
strenuou

Summary of Product characteristics

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_Irebesartan AN tablets Product Information _
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_Scentia Pharmaceuticals Pty Ltd _
Doc ID: 108.AN.P.1.1
Page 1
IRBESARTAN AN
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_(IRBESARTAN AN TABLETS) _
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PRODUCT INFORMATION
NAME OF THE MEDICINE
The name of this medicine is Irbesartan.
CHEMICAL NAME: Irbesartan is
2-butyl-3-[(2'-(1_H_-tetrazol-5-yl)biphenyl-4-yl)methyl]-1,3-
diazaspiro [4,4]
non-1-en-4-one
MOLECULAR FORMULA: C
25
H
28
N
6
O
MOLECULAR WEIGHT: 428.5
CAS registry number: _[138402-11-6] _
DESCRIPTION
Irbesartan is a white or almost white crystalline powder and is
practically insoluble in water,
sparingly soluble in methanol, slightly soluble in methylene chloride.
Irbesartan is a nonpeptide angiotensin II receptor (AT1 subtype)
antagonist. It is
available as
75, 150 or 300 mg film-coated tablets for oral administration. The
inactive
ingredients are:
lactose,
croscarmellose sodium, povidone, magnesium
stearate,
opadry
II
complete
film
coating system
30F58652
white (ARPING
107860 consisting of
hypromellose, macrogol
4000, titanium dioxide)
PHARMACOLOGY
PHARMACODYNAMICS AND MECHANISM OF ACTION
Irbesartan is a specific antagonist of angiotensin II receptors (AT1
subtype). Angiotensin II is
an
important
component
of
the
renin-angiotensin
system
and
is
involved
in
the
pathophysiology of hypertension and in sodium homeostasis. Irbesartan
does not
require
metabolic activation for its activity.
Irbesartan blocks the potent vasoconstrictor and aldosterone-secreting
effects of angiotensin
II
by
selective
antagonism
of
the
angiotensin
II
(AT1
subtype)
receptors
localized on
vascular smooth muscle cells and in the adrenal cortex. It has no
agonist activity at the AT1
receptor and a much greater affinity (more than 8500-fold) for the AT1
receptor than for the
AT2 receptor (a receptor that has not been shown to be associated
with cardiovascular
homeostasis).
Irbesartan does not inhibit enzymes involved in the renin-angiotensin
system (i.e. renin,
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_Irebesartan AN tablets Product Information _
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_Scentia Pharmaceuticals Pty Ltd _
Doc ID: 108