KSART HCT 300/25 irbesartan hydrochlorothiazide 300/25 mg tablets blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
01-12-2017
Summary of Product characteristics
(SPC)
01-12-2017
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
hydrochlorothiazide,irbesartan
Available from:
Arrow Pharma Pty Ltd
INN (International Name):
Hydrochlorothiazide,Irbesartan
Authorization status:
Registered
Patient Information leaflet
1
KSART
HCT
_contains the active ingredients irbesartan and hydrochlorothiazide_
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about KSART HCT.
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 KSART HCT
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 KSART HCT is used
for
KSART HCT lowers high blood
pressure, also called
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 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 KSART HCT.
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 strenuous)
exercise such as walking,
swimming, etc.
KSART HCT contains two
medicines, irbesartan an
Read the complete document
Summary of Product characteristics
KSART
®
HCT
150/12.5, 300/12.5, 300/25
(Irbesartan/Hydrochlorothiazide)
Tablets
PRODUCT INFORMATION
NAMES OF THE MEDICINES
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: 428.5 CAS No.: 138402-11-6
HYDROCHLOROTHIAZIDE
The chemical name is
6-chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide.
Its structural formula is:
C
7
H
8
ClN
3
O
4
S
2
Molecular weight: 297.7 CAS No.: 58-93-5
DESCRIPTION
Irbesartan is a white or almost white crystalline powder. It is
practically insoluble in water,
sparingly soluble in methanol and slightly soluble in methylene
chloride.
Hydrochlorothiazide is a white or almost white, crystalline powder. It
is very slightly soluble in
water, soluble in acetone, sparingly soluble in ethanol (96 per cent).
It dissolves in dilute solutions
of alkali hydroxides.
Page 2 of 16
KSART HCT – Product Information
KSART HCT tablets come in three strengths and contain 150 mg of
irbesartan and 12.5 mg of
hydrochlorothiazide, 300 mg of irbesartan and 12.5 mg of
hydrochlorothiazide or 300 mg of
irbesartan and 25 mg of hydrochlorothiazide. The tablets also contain
mannitol, povidone,
microcrystalline cellulose, croscarmellose sodium, silica colloidal
anhydrous, magnesium stearate,
Opadry II complete film coating system 85F34353 Pink (ARTG 107713; 150
mg/12.5 mg strength),
Opadry II complete film coating system 85F342
29 Pink (ARTG 107715; 300 mg/12.5 mg strength)
and Opadry II complete film coating system 85F34230 Dark Pink (ARTG
107714; 300 mg/25 mg
strength). The tablets are gluten free.
PHARMACOLOGY
KSART
HCT
(irbesartan/hydrochlorothiazide)
is
an
oral
antihypertensive
agent
combining
a
nonpeptide angiotensin II receptor (AT1-subtype) antagonist,
irbesartan, and a thiazide diuretic,
hydrochlorothiazide.
Irbesartan is a specific antagonist of angiotensin II receptors
(AT1-subtype). Angiotensin II is an
important component of the r
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