IMDEX CR TABLET 60 mg

দেশ: সিঙ্গাপুর

ভাষা: ইংরেজি

সূত্র: HSA (Health Sciences Authority)

সক্রিয় উপাদান:

ISOSORBIDE-5-MONONITRATE

থেকে পাওয়া:

DUOPHARMA (SINGAPORE) PTE LTD

এটিসি কোড:

C01DA14

ডোজ:

60mg

ফার্মাসিউটিকাল ফর্ম:

TABLET, FILM COATED

রচনা:

ISOSORBIDE-5-MONONITRATE 60mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

Prescription Only

Manufactured by:

DUOPHARMA MANUFACTURING (BANGI) SDN.BHD.

অনুমোদন অবস্থা:

ACTIVE

অনুমোদন তারিখ:

1998-12-08

পণ্য বৈশিষ্ট্য

60 MG CR TABLETS
COMPOSITION
lmdex
TM
is a controlled release formulation of
Isosorbide-5-mononitrate.
The
active
substance is released independently of pH.
Each
lmdex
TM
60
mg
CR
tablet
contains
60
mg
Isosorbide-5-mononitrate,
excipients
and
colouring
agents
(iron
oxide,
titanium
dioxide
and
quinoline
yellow
aluminium
lake), qs.
PHARMACOLOGY/
PHARMACOKINETICS
The
principal
pharmacological
action
of
Isosorbide-5-mononitrate
is
relaxation
of
vascular smooth muscle, producing significant
vasodilator activity; the strongest effect being
exerted on the venous system and a lesser
effect
on
the
arterial
circulation.
As
a
consequence,
the
heart
has
less
work
to
perform
against
diminished
resistance
and
therefore oxygen requirement is reduced.
Isosorbide-5-mononitrate is readily absorbed
from the gastro-intestinal tract and does not
undergo
first-pass
hepatic
metabolism
and
bioavailability
is
nearly
100%. The
rate
of
absorption
is
slowed
by
food
but
overall
bioavailability
is
unchanged.
Kinetics
of
Isosorbide-5-mononitrate are not significantly
influenced
by
advancing
age,
hepatic
or
renal disease.
Isosorbide-5-mononitrate is widely distributed
with
a
large
apparent
volume
of
distribution.
It
undergoes
nearly
total
elimination
in
the
liver
by
denitration
and
conjugation
to
form
lsosorbide
and
lsosorbide
glucuronide
as
inactive
metabolites.
Only
2%
of
Isosorbide
mononitrate
is
excreted
unchanged
in
the
urine with an elimination half-life of around
5 hours.
INDICATIONS
lmdex
TM
tablets
are
indicated
for
the
prophylaxis and long-term treatment of angina
pectoris
due
to
coronary
artery
disease.
Development
of
tolerance
may
occur
with
all
forms
of
nitrate
therapy
particularly
with
the
long
acting
nitrate
preparations
that
maintain
continuously
high
plasma
nitrate concentration.
SIDE EFFECTS/ADVERSE REACTIONS
Most
adverse
effects
are
dose-related.
Tachycardia,
palpitations
and
orthostatic
hypotension are common symptoms. These
symptoms
generally
disappear
during
continued
treatment.
Headache
may
occur
during
initial
treatment,