I-SARTAN 150 TABLETS 150MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

IRBESARTAN

Boleh didapati daripada:

Generic Health Sdn. Bhd.

INN (Nama Antarabangsa):

IRBESARTAN

Unit dalam pakej:

2x14tablet Tablets

Dikeluarkan oleh:

Lupin Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
I – SARTAN TABLETS
Irbesartan (150 mg and 300 mg.)
1
WHAT IS IN THIS LEAFLET
1.
What I-SARTAN TABLETS_ _is
used for
2.
How I-SARTAN TABLETS
works
3.
Before you use I-SARTAN
TABLETS
4.
How to use I-SARTAN
TABLETS
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of I-
SARTAN TABLETS
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
1. WHAT I-SARTAN TABLETS_ _IS
USED FOR
I-SARTAN TABLETS_ _is used to
treat:

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
2. HOW I-SARTAN TABLETS_ _
WORKS
Irbesartan is in 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. Irbesartan prevents the
binding of angiotensin‑II to these
receptors, causing the blood vessels
to relax and the blood pressure to
lower. Irbesartan slows the decrease
of kidney function in patients with
high blood pressure and type 2
diabetes.
3. BEFORE YOU USE I-SARTAN
TABLETS
-
_When you must not use it _
DO NOT USE I-SARTAN TABLETS

if you are allergic
(hypersensitive) to irbesartan
or any other ingredients

if you are more than 3 months
pregnant. (It is also better to
avoid in early pregnancy
I-SARTAN TABLETS_ _should not
be given to children and adolescents
(under 18 years).
_ _
_Pregnancy and lactation _
Do not take I-SARTAN TABLETS_ _
if you are pregnant, trying to get
pregnant or think you may be
pregnant. If you get pregnant while
taking I-SARTAN TABLETS, stop
taking it immediately and contact
your doctor. Your doctor can
discuss with you the risks of using it
while you are pregnant.
Do not take I-SARTAN TABLETS_ _
if you are breast-feeding. Ask your
doctor or pharmacist for advice
before taking any medicine.
_ _
-
_Bef

Ciri produk

I – SARTAN 150/300 TABLETS
(IRBESARTAN 150 MG/300 MG)
DESCRIPTION
I-SARTAN 150 Tablets 150mg: White to off-white, oval shaped, film
coated tablets with thickness
between 4.95 to 5.95mm, plain on one side and ‘I2’ on the other
side.
I-SARTAN 300 Tablets 300mg: White to off-while, oval shaped, film
coated tablets with thickness
between 6.30 to 7.30mm, plain on one side and ‘I3’ on the other
side.
COMPOSITION
I-SARTAN 150 Tablets 150mg:
Each film coated tablet contains:
Irbesartan Ph.Eur….150mg
I-SARTAN 300 Tablets 300mg
Each film coated tablet contains:
Irbesartan Ph.Eur….300mg
CLINICAL PHARMACOLOGY
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.
PHARMACOKINETIC PROPERTIES
_Absorption _
Irbesartan is rapidly absorbed from the gastrointestinal tract with an
oral bioavailability of 60 to 80%.
Peak plasma concentrations of irbesartan occur 1.5 to 2 hours after an
oral dose. Irbesartan may be
dosed without regards to meals
_Distribution _
Irbesartan is about 96% bound to plasma proteins.
The volume of distribution is 53 - 93 litres
_ _
_Metabolism _
Irbesartan is metabolised in the liver via glucuronide conjugation and
oxidation, primarily by the
cytochrome P450 isoenzyme CYP2C9, to inactive metabolites. The major
circulating metabolite is
irbesartan glucuronide (approximately 6%).
_ _
_Elimination _
It