IRBESARTAN HCT MYLAN 300/25 irbesartan/hydrochlorothiazide 300/25 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)
20-09-2017
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
hydrochlorothiazide,irbesartan
Available from:
Alphapharm Pty Ltd
INN (International Name):
Hydrochlorothiazide,Irbesartan
Authorization status:
Registered
Patient Information leaflet
ABISART HCT
_contains the active ingredient irbesartan/hydrochlorothiazide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ABISART HCT.
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 HCT
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 HCT IS
USED FOR
ABISART HCT is used to treat
hypertension (i.e. high blood
pressure). ABISART HCT is a trade
name (manufacturer's name).
ABISART HCT tablets contain two
medicines, irbesartan and
hydrochlorothiazide.
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 HCT.
One of the active ingredients in
ABISART HCT is irbesartan which
belongs to a class of medicines called
angiotensin-II receptor antagonists.
Angiotensin II is a substance
produced in the body which causes
b
Read the complete document
Summary of Product characteristics
ABISART
HCT
_Irbesartan/Hydrochlorothiazide _
PRODUCT INFORMATION
NAME OF THE MEDICINE
Active ingredient:
Irbesartan
Hydrochlorothiazide
Chemical name:
2-butyl-3-[(2'-(1
_H_
-tetrazol-5-yl)biphenyl-
4-yl)methyl]-1,3-diazaspiro
[4,4]
non-1-
en-4-one
6-chloro-3,4-dihydro-2
_H_
-1,2,4-
benzothiadiazine-7-sulphonamide 1, 1-
dioxide
Structural formula:
Molecular formula:
C
25
H
28
N
6
O
C
7
H
8
N
3
S
2
O
4
Cl
Molecular weight:
428.5
297.7
CAS registry no.:
138402-11-6
58-93-5
DESCRIPTION
ABISART 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 almost-white crystalline powder. It is a
relatively non-polar compound with a partition
coefficient (octanol-water) of 10.1 at a pH of 7.4. Irbesartan is
practically insoluble in water and slightly soluble
in alcohol and methylene chloride.
Hydrochlorothiazide is a white crystalline powder. It is slightly
soluble in water and freely soluble in sodium
hydroxide solution.
ABISART HCT 150/12.5 tablets contain 150 mg of irbesartan and 12.5 mg
of hydrochlorothiazide
ABISART HCT 300/12.5 tablets contain 300 mg of irbesartan and 12.5 mg
of hydrochlorothiazide.
ABISART HCT 300/25 tablets contain 300 mg of irbesartan and 25 mg of
hydrochlorothiazide.
The inactive ingredients in ABISART HCT tablets include: colloidal
anhydrous silica, magnesium stearate,
sodium lauryl sulfate, microcrystalline cellulose, pregelatinized
maize starch, povidone, lactose, croscarmellose
sodium, quinoline yellow aluminum lake, Opadry II complete film
coating system 32F540072 pink (ARTG no
109229) (150/12.5 mg and 300/12.5 mg) and Opadry II complete film
coating system 32F500006 purple (ARTG
no. 109227) (300/25 mg).
ABISART HCT – Product Information
2
PHARMACOLOGY
PHARMACODYNAMICS
Irbesartan is a specific antagonist of angiotensin II receptors (AT
1
subtype). Angiotensin II is an important
component of the renin-angiotensin system an
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