KYTRON TABLET 1 MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

GRANISETRON HYDROCHLORIDE

Boleh didapati daripada:

DUOPHARMA (M) SDN. BHD.

INN (Nama Antarabangsa):

GRANISETRON HYDROCHLORIDE

Unit dalam pakej:

10 Tablets; 20 Tablets; 30 Tablets

Dikeluarkan oleh:

Natco Pharma Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
KYTRON TABLET 1 MG
Granisetron (1 mg)
WHAT IS IN THE LEAFLET
1.
What
_Kytron_
is used for
2.
How
_Kytron_
works
3.
Before you use
_Kytron_
4.
How to use
_Kytron_
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
_Kytron_
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT _KYTRON_ IS USED FOR
This
medication
is
used
to
prevent
and
stop
the
nausea
(nausea)
or
vomiting.
In
particular, it is useful when you
need
to
undergo
medical
treatment
that
can
lead
to
nausea, nausea or vomiting, for
example,
chemotherapy
or
radiotherapy.
Please
consult
your
doctor
if
you have any questions about
why
this
medicine
has
been
prescribed for you.
HOW _KYTRON_ WORKS
_Kytron_
contains
the
active
ingredient
called
granisetron
hydrochloride.
Kytron belongs to a group of
drugs
called
inhibitors
of
5-
hydroxytryptamine
(5-HT3)
receptors. It works by blocking
one
of
the
body's
natural
substances (serotonin) that will
be stimulated by chemotherapy
and radiotherapy which cause
vomiting.
Ask your doctor if you have any
questions
about
why
this
medicine
has
been
prescribed
for you. Your doctor may have
prescribed it for another reason.
BEFORE YOU USE _KYTRON_
-
_When you must not take it_
_ _
_ _
Do not take this
medicine
if
you have an allergy to:
•
granisetron
•
any
of
the
other
ingredients
listed
at
the
end of this leaflet
_Kytron_
not be taken by children
for prevention and treatment of
nausea and vomiting associated
with
chemotherapy
and
radiotherapy.
Do not take
_Kytron_
after the
expiry date on the pack or if
the
packaging
is
torn
or
shows signs it is open.
If
it
has
expired
or
is
damaged,
return
it
to
your
pharmacist for disposal.
If you are not sure whether
you
should
start
taking
this
medicine, talk to your doctor.
-
_Before you start to use it _
_ _
Tell your doctor if you have
allergies
to
any
other
medicines,
foods,
preservatives or dyes.
Talk
to
your
doctor
before
taking
_Kytron_
if you:
•
experiencing
heart

Ciri produk

A/s: 150 x 210 mm
KYTRON TABLET 1 MG
Literature Malaysia 29/05/19 M code: 372593
DESCRIPTION: KYTRON TABLET 1 MG : White triangular shaped,
biconvex, film coated tablets with debossing of “1GN”on one side
and plain surface on the other side.
COMPOSITION: KYTRON TABLET 1 MG : Each film-coated tablet
contains 1 mg of granisetron (free base equivalent)
PHARMACODYNAMICS:
Pharmacotherapeutic group: protein-tyrosine kinase inhibitor. ATC
code: A04AA02
Mechanism of action
Serotonin receptors of the 5-HT3 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 release serotonin, which stimulates
5-HT3 receptors. This invokes vagal afferent discharge, inducing
vomiting.
Kytron
is
a
potent
anti-emetic
and
highly
selective
antagonist of 5-hydroxytryptamine (5-HT3) receptors. Radioligand
binding studies have demonstrated that Kytron has negligible
affinity for other receptor types including 5-HT and dopamine D2
binding sites.
PHARMACOKINETICS:
Absorption
Absorption of Kytron is rapid and complete, though oral bioavail-
ability is reduced to about 60% as a result of first pass metabolism.
Oral bioavailability is generally not influenced by food.
Distribution
Kytron is extensively distributed, with a mean volume of distribution
of approximately 3 l/kg. Plasma protein binding is approximately
65%.
Metabolism
Biotransformation pathways involve N-demethylation and aromatic
ring oxidation followed by conjugation. In vitro liver microsomal
studies show that granisetron’s major route of metabolism is inhib-
ited by ketoconazole; suggestive of metabolism mediated by the
cytochrome P-450 3A subfamily.
Elimination
Clearance
is
predominantly
by
hepatic
metabolism.
Urinary
excretion of unchanged Kytron averages 12% of dose while that
of metabolites amounts to about 47% of dose. The remainder is
excreted in feces as metabolites. Mean plasma half-life in patients
by the oral route is approximately