Apo-Ondansetron Tablet 8 mg

Ország: Malajzia

Nyelv: angol

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

Aktív összetevők:

Ondansetron Hydrochloride

Beszerezhető a:

PHARMAFORTE (MALAYSIA) SDN. BHD.

INN (nemzetközi neve):

Ondansetron Hydrochloride

db csomag:

10Tablet Tablets; 30Tablet Tablets

Gyártó:

APOTEX INC. - ETOBICOKE SITE

Betegtájékoztató

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
APO-ONDANSETRON TABLET
Ondansetron hydrochloride (4mg, 8mg)
1
WHAT IS IN THIS LEAFLET
1.
What Apo-Ondansetron is used for
2.
How Apo-Ondansetron works
3.
Before you use Apo-Ondansetron
4.
How to use Apo-Ondansetron
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Apo-
Ondansetron
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT APO-ONDANSETRON IS USED FOR
It is used to prevent and manage
nausea (feeling sick) and vomiting
(being sick), which can occur:
•
during treatment for cancer
(chemotherapy or radiotherapy)
•
after an operation
HOW APO-ONDANSETRON WORKS
Apo-Ondansetron belongs to a group
of medicines called anti-emetics.
It works by blocking the action of a
natural substance called serotonin that
may cause nausea and vomiting.
BEFORE YOU USE APO-ONDANSETRON
_-When you must not use it _
Do not take Apo-Ondansetron if you
are allergic (hypersensitive) to
ondansetron or any other ingredients
of Apo-Ondansetron. If you think this
applies to you, do not use Apo-
Ondansetron until you have checked
with your doctor.
_-Before you start to use it _
Before you use Apo-Ondansetron
your doctor needs to know:
•
if you are allergic to medicines
similar to Apo-Ondansetron,
such as medicines containing
granisetron or palonosetron
•
if you have bowel obstruction
problems
•
if you have electrolytes
abnormalities
•
if you have liver disease, your
doctor may lower your dose of
Apo-Ondansetron
Check with your doctor if you think
any of these may apply to you.
Apo-Ondansetron is not
recommended for use during
pregnancy.
•
Tell your doctor if you are
pregnant or planning to become
pregnant.
•
If you do become pregnant
during treatment with Apo-
Ondansetron, tell your doctor.
Breast-feeding is not recommended
during treatment with Apo-
Ondansetron. The ingredients can
pass into your breast milk, and may
affect your baby. Talk to your doctor
about this.
If you are a woman of childbearing
age, your do

Termékjellemzők

APO‐ONDANSETRON TABLET 4MG AND 8MG
ANTIEMETIC
Ondansetron 4mg (as ondansetron HCl): Yellow, oval, unscored,
film‐coated tablets, imprinted “APO” on one side and “OND4”
on
the other side, blister pack in a box of 10 tablets
Ondansetron 8mg (as ondansetron HCl): Yellow, oval, unscored,
film‐coated tablets, imprinted “APO” on one side and “OND8”
on
the other side, blister pack in a box of 10 tablets.
PHARMACODYNAMICS
Ondansetron
is
a
potent,
highly
selective
5HT3
receptor‐
antagonist. Its precise mode of action in the control of nausea and
vomiting
is
not
known.
Chemotherapeutic
agents
and
radiotherapy may cause release of 5HT in the small intestine
initiating a vomiting reflex by activating vagal afferents via 5HT3
receptors.
Ondansetron
blocks
the
initiation
of
this
reflex.
Activation of vagal afferents may also cause a release of 5HT in
the area postrema, located on the floor of the fourth ventricle,
and this may also promote emesis through a central mechanism.
Thus, the effect of ondansetron in the management of the nausea
and
vomiting
induced
by
cytotoxic
chemotherapy
and
radiotherapy is probably due to antagonism of 5HT3 receptors on
neurons
located
both
in
the
peripheral
and
central
nervous
system. The mechanisms of action in post‐operative nausea and
vomiting are not known but there may be common pathways with
cytotoxic induced nausea and vomiting.
Ondansetron does not alter plasma prolactin concentrations.
PHARMACOKINETICS
Following
oral
administration,
ondansetron
is
passively
and
completely
absorbed
from
the
gastrointestinal
tract
and
undergoes first pass metabolism. Peak plasma concentrations of
about 30ng/ml are attained approximately 1.5 hours after an 8mg
dose. For doses above 8mg the increase in ondansetron systemic
exposure with dose is greater than proportional; this may reflect
some reduction in first pass metabolism at higher oral doses.
Bioavailability, following oral administration, is slightly enhanced
by the presence of food but unaffected by antacids. Studies in
hea