CILOSOL 100mg Tablet

Kraj: Malezja

Język: angielski

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

Składnik aktywny:

CILOSTAZOL

Dostępny od:

MEDISPEC (M) SDN.BHD

INN (International Nazwa):

CILOSTAZOL

Sztuk w opakowaniu:

10 x 10 Tablets

Wyprodukowano przez:

Unison Laboratories Co. Ltd.

Ulotka dla pacjenta

_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
CILOSOL 100
Cilostazol (100 mg) 1
WHAT IS IN THIS LEAFLET
1.
What Cilosol 100 is used for
2.
How Cilosol 100 works
3.
Before you use Cilosol 100
4.
How to use Cilosol 100
5.
While you are using it
6.
Side effects
7.
Storage and Disposal
of Cilosol 100
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT CILOSOL 100 IS USED FOR
Cilosol
100
is
used
to
treat
intermittent
claudication
(a
distinctive type of pain at the legs).
It is usually caused by blockage of
the blood vessels to the leg, hence
the calf muscles are not receiving
enough oxygen. The muscle pain or
cramping
happen
whenever
you
walk
some
distance
but
the
pain
disappears when you rest. Cilosol
100
only
works
if
there
is
no
peripheral tissue death.
It
is
also
used
for
prevention
of
recurrence
of
cerebral
infarction
(lack
of
oxygen
supply
to
brain
tissue),
excluding
cardiogenic
cerebral
embolism
(an
obstruction
in brain artery by a plaque or blood
clot
which
originates
from
the
heart).
HOW CILOSOL 100 WORKS
Cilosol
100
inhibit
platelet
aggregation
and
hence
inhibit
the
formation of blood clot or plaque
that
causing
blockage
in
blood
vessels.
Cilosol 100 increases blood flow in
the occluded ankle, lower limbs and
brain by dilating the blood vessels
and
hence
to
improve
the
blood
circulation.
BEFORE YOU USE CILOSOL 100
_- When you must not use it _
You must not take Cilosol 100 if:
•
You
are
allergic
(hypersensitive)
to
Cilostazol
or
any
other
ingredients
of
Cilosol 100
_ _
•
You have congestive heart failure
of any severity
_ _
•
You
have
active
pathologic
bleeding
such
as
bleeding
stomach
ulcer
and
intracranial
(bleeding to the brain)
_ _
•
You have persistent chest pain at
rest, or have had a “heart attack”
or any heart surgery in the last six
months.
_ _
•
You have severe kidney disease
_ _
•
You have moderate or severe liver
disease.
_ _
•
You are pregnant.
_Pregnancy and breastfeeding _
If you are pregnan

Charakterystyka produktu

ANTITHROMBOTIC AGENT, PLATELET AGGREGATION INHIBITOR
Each tablet contains:
CILOSTAZOL 100 MG
PRODUCT DESCRIPTION:
White, round, flat-faced, bevelled edge tablet with engraved 100 on
one side and plain on the other side
MECHANISM OF ACTION:
_PHARMACOKINETICS_
Absorption
Following multiple doses of Cilostazol 100 mg twice daily in patients
with peripheral vascular disease, steady state is achieved within 4
days.
The C
max
of Cilostazol and its primary circulating metabolites increase less
than proportionally with increasing doses. However, the AUC for
Cilostazol and its metabolites increase approximately
proportionately with dose.
Biotransformation
The apparent elimination half-life of Cilostazol is 10.5 hours. There
are two major metabolites, a dehydro-cilostazol and a 4'-trans-hydroxy
cilostazol, both of which have similar apparent half-lives. The
dehydro metabolite is 4-7 times as active a platelet anti-aggregant as
the parent compound and the 4'-trans-hydroxy metabolite is one fifth
as active. Plasma concentrations (as measured by AUC) of the
dehydro and 4'-trans-hydroxy metabolites are ~41% and ~12% of
Cilostazol concentrations. There is no evidence that Cilostazol
induces hepatic microsomal enzymes.
Elimination
Cilostazol is eliminated predominantly by metabolism and subsequent
urinary excretion of metabolites. The primary isoenzymes involved in
its metabolism are cytochrome P-450 CYP3A4, to a lesser extent,
CYP2C19, and to an even lesser extent CYP1A2. The primary route of
elimination is urinary (74%) with the remainder excreted in the feces.
No measurable amount of unchanged Cilostazol is excreted in
the urine, and less than 2% of the dose is excreted as the
dehydro-Cilostazol metabolite. Approximately 30% of the dose is
excreted in the urine as the 4'-trans-hydroxy metabolite. The
remainder is excreted
as metabolites, none of which exceed 5% of the total excreted.
Distribution
Cilostazol is 95-98% protein bound, predominantly to albumin. The
dehydro metabolite and 4'-trans-hydroxy metabolite are 97.4% and