IRBESARTAN MYLAN irbesartan 75 mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
07-07-2017
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
irbesartan, Quantity: 75 mg
Available from:
Viteia Pty Ltd
INN (International Name):
Irbesartan
Pharmaceutical form:
Tablet
Composition:
Excipient Ingredients: croscarmellose sodium; lactose monohydrate; povidone; colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 4000
Administration route:
Oral
Units in package:
5, 14, 7, 3, 56, 98, 30, 28
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
IRBESARTAN MYLAN is indicated for the treatment of hypertension., IRBESARTAN MYLAN is indicated for delaying the progression of renal disease in hypertensive type II diabetics with persistent micro-albuminuria (> 30 mg per 24 hours) or urinary protein in excess of 900 mg per 24 hours.
Product summary:
Visual Identification: A white to off-white film-coated, round, biconvex, bevelled edge tablet debossed with "M" on one side of the tablet and "IN1" on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2013-11-06
Patient Information leaflet
ABISART
_contains the active ingredient (irbesartan)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ABISART.
It does not contain all 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 ABISART against
the benefits expected 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 ABISART IS
USED FOR
ABISART is a trade name
(manufacturer's name) for the
medicine, irbesartan.
ABISART is used to lower high
blood pressure (i.e. 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 ABISART. 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
stren
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Summary of Product characteristics
ABISART
_Irbesartan _
PRODUCT INFORMATION
NAME OF THE MEDICINE
Active ingredient
:
Irbesartan
Chemical name
:
2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro [4,4]
non-1-en-4-one
Structural formula
:
Molecular formula
:
C
25
H
28
N
6
O
Molecular weight
:
428.53
CAS Registry no.
:
138402-11-6
DESCRIPTION
Irbesartan is a white, to practically white, powder that is less than
0.1mg/mL soluble in water and slightly soluble
in alcohol and methylene chloride.
Abisart (irbesartan) is a nonpeptide angiotensin II receptor (AT
1
subtype) antagonist. It is available as 75 mg, 150
mg or 300 mg tablets for oral administration. The inactive ingredients
are: povidone, lactose, microcrystalline
cellulose, croscarmellose sodium, magnesium stearate, colloidal
anhydrous silica and OPADRY II Complete
Film Coating System OY-LS-28908 White (ARTG no. 12435).
PHARMACOLOGY
PHARMACODYNAMICS
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 (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 homeostasis.
ABISART – PRODUCT INFORMATION
2
In healthy subjects, single oral irbesartan doses of up to 300 mg
produced dose-dependent
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