Irbisat 150mg tablet

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Irbesartan

Available from:

SM PHARMACEUTICALS SDN. BHD.

INN (International Name):

Irbesartan

Units in package:

2x14 Tablets

Manufactured by:

SM PHARMACEUTICALS SDN. BHD.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ IRBISAT 150MG TABLET IRBISAT 300MG TABLET
Irbesartan (150mg & 300mg)
_______________________________________________________________________________________________________________
_______________________________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1. What Irbisat is used for
2. How Irbisat works
3. Before you take Irbisat
4. How to take Irbisat
5. While you are using Irbisat
6. Side Effects
7. Storage and Disposal of Irbisat
8. Products Descriptions
9. Manufacturer and Product Registration
Holder
10. Date of revision
11.RiMUP serial no. WHAT IRBISAT IS USED FOR
•
To treat high blood pressure (essential
hypertension)
•
To protect the kidney in patients with
high blood pressure, type 2 diabetes
and laboratory evidence of impaired
kidney function
HOW IRBISAT WORKS
Irbisat belongs to a group of medicines
known as angiotensin-II receptor
antagonists. Angiotensin-II is a substance
produced in the body which binds to
receptors in blood vessels causing them
to tighten. This results in an increase in
blood pressure. Irbisat prevents the
binding of angiotensin-II to these
receptors, causing the blood vessels to
relax and the blood pressure to lower.
Irbisat slows the decrease of kidney
function in patients with high blood
pressure and type 2 diabetes
BEFORE YOU TAKE IRBISAT
_-When you must not take it _
•
If you are allergic (hypersensitive) to
irbesartan or any other ingredients of
Irbisat
•
If you are more than 3 months
pregnant. (It is also better to avoid Irbisat
in early pregnancy.
Irbisat should not be given to children
and adolescents (under 18 years).
_ _
_ _
_ _
_ _
_ _
_-Before you start to take it _
Please tell your doctor or pharmacist:_ _
•
if you have diabetes or impaired kidney
function and you are treated with a blood
pressure lowering medicine containing
aliskiren
_ _
_-Taking other medicines _
Please tell your doctor or pharmacist if
you are taking or have recently taken any

Summary of Product characteristics

SM PHARMACEUTICALS SDN BHD
IRBISAT 150 MG TABLETS
IRBISAT 300 MG TABLETS
DESCRIPTION
Irbisat 150 MG:
White
to
off-white,
oval
shaped,
film
coated
tablets, plain on one side and “I2” on the other
side.
Irbisat 300 MG:
White
to
off-white,
oval
shaped,
film
coated
tablets, plain on one side and “I3” on the other
side.
COMPOSITION:
Irbisat 150 MG
Each
tablet
contains:
Irbesartan
150
mg
Irbisat 300 MG:
Each
tablet
contains:
Irbesartan
300
mg
PHARMACOLOGICAL PROPERTIES:
PHARMACODYNAMICS:
Mechanism of action
Irbesartan
is
a
potent,
orally
active,
selective
angiotensin-II receptor (type AT1) antagonist. It is
expected
to
block
all
actions
of
angiotensin-II
mediated by the AT1 receptor, regardless of the
source or route of synthesis of angiotensin-II. The
selective antagonism of the angiotensin-II (AT1)
receptors results in increases in plasma renin levels
and angiotensin-II levels, and a decrease in plasma
aldosterone concentration. Serum potassium levels
are not significantly affected by irbesartan alone at
the recommended doses. Irbesartan does not inhibit
ACE
(kininase-II),
an
enzyme
which
generates
angiotensin-II
and
also
degrades
bradykinin
into
inactive
metabolites.
Irbesartan
does
not
require
metabolic activation for its activity.
Clinical Efficacy
_Hypertension _
Irbesartan
lowers
blood
pressure
with
minimal
change
in
heart
rate.
The
decrease
in
blood
pressure is dose-related for once a day doses with a
tendency towards plateau at doses above 300 mg.
Doses of 150-300 mg once daily lower supine or
seated blood pressures at trough (i.e. 24 hours after
dosing)
by
an
average
of
8-13/5-8
mm
Hg
(systolic/diastolic)
greater
than
those
associated
with placebo.
Peak
reduction
of
blood
pressure
is
achieved
within 3-6 hours after administration and the blood
pressure lowering effect is maintained for at least
24
hours.
At
24
hours
the
reduction
of
blood
pressure was 60-70% of the corresponding peak
diastolic
and
systolic
responses
at
the
recommended doses. Once-daily dosing with 150
mg produced trough and mean 24 ho