Destron Tablet 1mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

GRANISETRON HYDROCHLORIDE

Boleh didapati daripada:

PHARMANIAGA MANUFACTURING BERHAD

INN (Nama Antarabangsa):

GRANISETRON HYDROCHLORIDE

Unit dalam pakej:

10 Tablets; 10 Tablets

Dikeluarkan oleh:

PHARMANIAGA MANUFACTURING BERHAD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DESTRON TABLET
Granisetron Hydrochloride 1mg
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Destron Tablet is used for
2.
How Destron Tablet works
3.
Before you use Destron Tablet
4.
How to use Destron Tablet
5.
While you are using Destron
Tablet
6.
Side effects
7.
Storage and disposal of Destron
Tablet
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT DESTRON TABLET IS USED FOR
Destron
tablet
_ _
is
a
tablet
that
contains
1
mg
of
granisetron
hydrochloride
as
the
active
ingredient.
Destron tablet is used to prevent
and
stop
you
feeling
sick
(nauseous)
or
being
sick
(vomiting). It is useful when you
need
to
have
medical
treatment
such
as
chemotherapy
or
radiotherapy that may cause you to
feel or be sick.
HOW DESTRONTABLET WORKS
Granisetron belongs to a class of
medications called 5-HT
3
blockers.
It works by blocking one of the
body's
natural
substances
(serotonin)
that
can
cause
vomiting.
BEFORE YOU USE DESTRON TABLET
_ _
_-When you must not use it_
Do not take Destron tablet if you
have an allergy to:
•
any
medicine
containing
granisetron
•
any of the ingredients listed at the
end of this leaflet.
Do not take Destron Tablet after the
expiry date provided on the pack or
if the packaging is torn or show
signs of tampering.
_-Before you start to use it_
Before you take Destron Tablet,
tell your doctor or pharmacist if:
•
you
have
signs
of
intestinal
obstruction
•
you have a heart condition related
to changes in its the rhythm or
rate.
•
you
are
pregnant
or
plan
to
become pregnant or are breast-
feeding.
Your doctor can discuss with you
the risks and benefits of taking
Destron
Tablet
if
you
are
pregnant or breast-feeding
•
you
have
rare
hereditary
problems
of
sugar
intolerance
such
as
galactose
intolerance,
lactase
deficiency
or
glucose-
galactose malabsorption.
•
you
have
used
Destron
Tablet
before and you became unwell.
You
may
need
to
be
given
another medication instead.
If you are not sure if any of the
above a

Ciri produk

DESTRON TABLET 1MG
Granisetron 1mg
COMPOSITION
Each
film-coated
tablet
contains
granisetron
hydrochloride 1.12 mg equivalent to 1 mg of
granisetron.
DESCRIPTION
White to off white, triangular film-coated tablet
with ‘G1’ on one side and plain on the other.
PHARMACODYNAMICS
Serotonin receptors of the 5-HT
3
type are located
peripherally in vagal nerve terminals and centrally
in the chemoreceptor trigger zone of the area
postrema.
During
chemotherapy-induced
vomiting, mucosal enterochromaffin cells releases
serotonin, which stimulates 5-HT
3
receptors. This
invokes
vagal
afferent
discharge
inducing
vomiting. Destron is a potent anti-emetic and
highly
selective
antagonist
of
5-hydroxytryptamine
(5-HT
3
)
receptors.
Radioligand binding studies have demonstrated
that
Destron
has
negligible
affinity
for
other
receptor types including 5-HT and dopamine D
2
binding sites.
PHARMACOKINETICS
_Absorption_
Absorption of Destron is rapid and complete,
though oral bioavailability is reduced to about
60% as a result of first pass metabolism. Oral
bioavailability is generally not influenced by food.
_Distribution_
Destron is extensively distributed, with a mean
volume of distribution of approximately 31/kg.
Plasma protein binding is approximately 65%.
_Metabolism _
Biotransformation
pathways
include
N-demethylation
and
aromatic
ring
oxidation
followed by conjugation. In vitro liver microsomal
studies
show
that
granisetron
major
route
of
metabolism
is
inhibited
by
ketoconazole,
suggestive
of
metabolism
mediated
by
the
cytochrome P-450 3A subfamily
_Elimination_
Clearance
is
predominantly
by
hepatic
metabolism.
Urinary
excretion
of
unchanged
Destron
averages
12%
of
dose
while
that
of
metabolites amount to about 47% of dose. The
remainder is excreted in faeces as metabolites.
Mean plasma half-life in patients by the oral route
is apparently 9 hours with a wide inter-subject
variability. The pharmacokinetics of oral Destron
demonstrate no marked deviations from linear
pharmacokinetics at oral doses up to 2.5-fold and
intravenous