ONSETRON ODT 4 ondansetron 4 mg orally disintegrating tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
29-11-2017
Active ingredient:
ondansetron
Available from:
Medis Pharma Pty Ltd
INN (International Name):
Ondansetron
Authorization status:
Registered
Patient Information leaflet
CMI 030414
ONSETRON
®
ODT
_contains the active ingredient ondansetron _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you start taking ONSETRON
ODT.
This leaflet answers some common
questions about ONSETRON ODT. It
does not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking ONSETRON ODT against
the benefits this medicine is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ONSETRON ODT ARE
USED FOR
ONSETRON ODT belongs to a group
of medicines called antiemetics.
ONSETRON ODT works by helping
to stop the nausea (sick feeling) and
vomiting which can occur after
certain treatments. ODT used in the
product name stands for Oral
Dispersible Tablet. This type of tablet
is placed on the tongue where it is
rapidly dispersed and can then be
swallowed with or without water. It is
easier to swallow than ordinary
tablets. ONSETRON ODT should
only be used to treat the nausea and
vomiting for which it has been
prescribed.
Your doctor may have prescribed
ONSETRON ODT for another
reason.
Ask your doctor if you have any
questions about why ONSETRON
ODT has been prescribed for you.
ONSETRON ODT is not addictive.
BEFORE YOU TAKE ONSETRON
ODT
_WHEN YOU MUST NOT TAKE THEM _
DO NOT TAKE ONSETRON ODT IF
YOU ARE TAKING APOMORPHINE (USED
TO TREAT PARKINSON’S DISEASE).
DO NOT TAKE ONSETRON ODT IF
YOU HAVE EVER HAD AN ALLERGIC
REACTION TO ONDANSETRON OR ANY OF
THE INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Symptoms of an allergic reaction may
be mild or severe. They usually
include some or all of the following:
wheezing, swelling of the lips/mouth,
difficulty in breathing, hayfever,
lumpy rash ("hives") or fainting.
DO NOT TAKE ONSETRON ODT IF
YOU ARE PREGNANT, TRYING TO BECOME
PREGNANT OR BREASTFEEDING, UNLES
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Summary of Product characteristics
Onsetron
®
ODT
PRODUCT INFORMATION
NAME OF THE MEDICINE
The active ingredient is ondansetron.
Chemical name:
(±)1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1_H_-imidazol-1-yl)methyl-4_H_-carbazol-4-one].
Structural formula:
Empirical formula: C
18
H
19
N
3
O
Molecular weight: 293.37
CAS No.: 99614-02-5
DESCRIPTION
Ondansetron is a white to off-white powder with a melting point of
226°C.
Ondansetron base
is freely soluble in glacial acetic acid, is sparingly soluble in
dichloromethane and diluted
hydrochloric acid, is slightly soluble in acetonitrile and methanol
and is practically insoluble in
water.
ONSETRON Ondansetron Oral Dispersible Tablet (ODT) is available in 4
mg and 8 mg
strengths.
ONSETRON ODT contains the following excipients: lactose,
hydroxypropylcellulose,
crospovidone, calcium silicate, aspartame, peppermint NAEFCO P0551
957685 (ARTG
2890) flavour, colloidal anhydrous silica and magnesium stearate.
PHARMACOLOGY
_MODE OF ACTION _
Ondansetron is a potent, highly selective 5HT
3
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 5HT
3
receptors. Ondansetron blocks the initiation of this reflex.
Activation of vagal afferents may also cause a release of 5HT in the
area postrema, located
2
2
PI 180315
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 due to
antagonism of 5HT
3
receptors
on neurones 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. In psychomotor
testing ondansetron
does not impair performance nor cause sedation. Ondansetron does not
alter plasma prolact
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