IRBESARTAN AMNEAL irbesartan 150 mg tablets 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

Authorization status:

Registered

Patient Information leaflet

IRBESARTAN AMNEAL CMI V5.0
1
Irbesartan Amneal
_contains the active ingredient irbesartan _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about IRBESARTAN
AMNEAL.
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
AMNEAL 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 AMNEAL
is used for
IRBESARTAN AMNEAL lowers high
blood pressure, also called
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 IRBESARTAN AMNEAL. 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

Summary of Product characteristics

_Irbesartan AMNEAL tablets Product Information _
_ _
_Amneal Pharma Australia Pty Ltd _
Irbesartan AMNEAL PI v3.0
Page 1 of 13
Irbesartan AMNEAL
PRODUCT INFORMATION
NAME OF THE MEDICINE
Irbesartan. The chemical name for
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. Its structural formula
is:
C
25
H
28
N
6
O
Molecular weight: 428.53
CAS No.: 138402-11-6
DESCRIPTION
Irbesartan is a white or almost white crystalline powder that is
practically insoluble in water,
sparingly soluble in methanol and slightly soluble in methylene
chloride.
Irbesartan is a nonpeptide angiotensin II receptor (AT
1
subtype) antagonist. IRBESARTAN AMNEAL
film-coated tablets come in 3 strengths and contain 75 mg, 150 mg or
300 mg of irbesartan. The
tablets also contain microcrystalline cellulose, magnesium stearate,
croscarmellose sodium,
hypromellose, mannitol, colloidal anhydrous silica and Opadry
20F280002 white (ARTG 109119).
The tablets are gluten free.
PHARMACOLOGY
Irbesartan is a specific antagonist of angiotensin II receptors (AT
1
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 (AT
1
subtype) receptors localized on vascular smooth
muscle cells and in the adrenal cortex. It has no agonist activity at
the AT
1
receptor and a much
greater affinity (more than 8500-fold) for the AT
1
receptor than for the AT
2
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,
angiotensin converting enzyme [ACE]) or affect other hormone receptors
or ion channels involved
in the cardiovascular regulation of blood pressure and sodium
homeost