IRBEMAC H 30012.5 TABLETS (IRBESARTAN 300MG & HYDROCHLOROTHIAZIDE 12.5MG)

国: マレーシア

言語: 英語

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

有効成分:

Irbesartan; HYDROCHLOROTHIAZIDE

から入手可能:

SYNERRV SDN BHD

INN（国際名）:

Irbesartan; HYDROCHLOROTHIAZIDE

パッケージ内のユニット:

28 Tablets

製:

Macleods Pharmaceuticals Limited

情報リーフレット

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
IRBEMAC H 300/12.5 TABLETS
IRBEMAC H 300/25 TABLETS
Irbesartan/ Hydrochlorothiazide Tablet (300mg/12.5mg, 300mg/25mg)
Page 1 of 3
WHAT IS IN THIS LEAFLET?
1)
What IRBEMAC H is used for
2)
How IRBEMAC H works
3)
Before you use IRBEMAC H
4)
How to use IRBEMAC H
5)
While you are using IRBEMAC H
6)
Side effects
7)
Storage and Disposal of IRBEMAC
H
8)
Product Description
9)
Manufacturer
and
Product
Registration Holder
10)
Date of Revision
1. WHAT IRBEMAC H IS USED FOR:
IRBEMAC
H
is
used
to
treat
high
blood pressure (
_essential hypertension_
),
when
treatment
with
irbesartan
or
hydrochlorothiazide
alone
did
not
provide adequate control of your blood
pressure.
2. HOW IRBEMAC H WORKS:
Irbesartan tablets belong 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.
Irbesartan
prevents
the
binding
of
angiotensin-II
to
these
receptors,
causing the blood vessels to relax and
the
blood
pressure
to
lower.
Hydrochlorothiazide is one of a group
of medicines (called thiazide diuretics)
that causes increased urine output and
so causes a lowering of blood pressure
3. BEFORE YOU USE IRBEMAC H:
_- When you must not use it _
•
are
allergic
to
irbesartan
or
hydrochlorothiazide, or any of the other
ingredients
of
this
medicine,
or
to
medicines
chemically
related
to
sulfonamide
(ask
your
doctor
or
pharmacist for further clarification).
• are more than 3 months pregnant. (It
is also better to avoid IRBEMAC H
tablets in early pregnancy
• have severe liver or kidney problems.
• have difficulty in producing urine.
• have a condition which is associated
with persistently high calcium or low
potassium levels in your blood.
•
have
diabetes
or
impaired
kidney
function
and
you
are
treated
with
a
blood
pressure
lowering
medicine
containing aliskiren
_- Before you start to use it _
Talk
to
your
doctor
before
u

製品の特徴

MACLEODS PHARMACEUTICALS LTD.
FOR THE USE ONLY OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR
A LABORATORY
IRBEMAC H 300/12.5 TABLET (
Irbesartan 300mg & Hydrochlorothiazide 12.5mg)
IRBEMAC H 300/25 TABLET (
Irbesartan 300mg & Hydrochlorothiazide 25mg)
COMPOSITION:
Each film coated tablet contains:
Irbesartan Ph.Eur
300 mg
Hydrochlorothiazide Ph.Eur 12.5 mg
Each film coated tablet contains:
Irbesartan Ph.Eur
300 mg
Hydrochlorothiazide Ph.Eur 25 mg
DESCRIPTION:
300/12.5 mg: Peach coloured, oval, film coated tablets debossed with
“ML 33” on one side and
plain on other side.
300/25 mg: Pink coloured, oval, film coated tablets debossed with
“ML 32” on one side and
plain on other side.
PHARMACOKINETICS
Concomitant
administration
of
Hydrochlorothiazide
and
Irbesartan
has
no
effect
on
the
pharmacokinetics of either medicinal product.
Irbesartan
and
hydrochlorothiazide
are
orally
active
agents
and
do
not
require
biotransformation
for
their
activity.
Following
oral
administration
of
irbesartan/hydrochlorothiazide, the absolute oral bioavailability is
60-80 % and 50-80 % for
irbesartan and hydrochlorothiazide, respectively. Food does not affect
the bioavailability of
irbesartan/hydrochlorothiazide. Peak plasma concentration occurs at
1.5-2 hours after oral
administration for irbesartan and 1-2.5 hours for hydrochlorothiazide.
Plasma protein binding of irbesartan is approximately 96 %, with
negligible binding to cellular
blood
components.
The
volume
of
distribution
for
irbesartan
is
53-93
litres.
MACLEODS PHARMACEUTICALS LTD.
Hydrochlorothiazide
is
68
%
protein-bound
in
the
plasma,
and
its
apparent
volume
of
distribution is 0.83-1.14 l/kg.
Irbesartan exhibits linear and dose proportional pharmacokinetics .The
total body and renal
clearance are 157-176 and 3.0-3.5 ml/min, respectively. The terminal
elimination half-life of
irbesartan is 11-15 hours. Steady-state plasma concentrations are
attained within 3 days after
initiation of a once-daily dosing regimen. Limited accumulation of
irbesartan (< 20 %) is
obser