ONSETRON 4 ondansetron (as hydrochloride dihydrate) 4 mg tablet blister pack

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

ondansetron hydrochloride

Boleh didapati daripada:

Medis Pharma Pty Ltd

INN (Nama Antarabangsa):

Ondansetron hydrochloride

Status kebenaran:

Registered

Risalah maklumat

ONSETRON TAB/CMI/160412
1
Onsetron
®
Tablets
contain the active ingredient ondansetron (as hydrochloride dihydrate)
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about ONSETRON.
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 benefits and
risks. Your doctor has weighed the
risks of you taking ONSETRON
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO
YOUR DOCTOR OR PHARMACIST.
Keep this leaflet with your medicine.
You may need to read it again.
What ONSETRON is used
for
ONSETRON is used to help stop the
nausea and vomiting which can
occur after some medical
treatments.
ONSETRON belongs to a group of
medicines called serotonin receptor
-3 antagonists.
Your doctor may have prescribed
ONSETRON for another reason. Ask
your doctor if you have any
questions about why ONSETRON
has been prescribed for you.
ONSETRON is available only with a
doctor's prescription.
There is no evidence that
ONSETRON is addictive.
Before you take ONSETRON
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE ONSETRON IF

you are taking apomorphine (a
medicine used to treat
Parkinson’s disease)
 you are allergic to medicines
containing ondansetron, any
other serotonin receptor
antagonists or any of the
ingredients listed at the end of
this leaflet.

if you are pregnant, trying to
become pregnant or
breastfeeding, unless your
doctor says it is safe.
ONSETRON may affect your
developing baby if you take it
during pregnancy. It also passes
into breast milk and may affect your
baby.

the expiry date (Exp.) printed
on the pack has passed.

the packaging shows signs of
tampering or the tablets do not
look quite right.
BEFORE YOU START TO TAKE IT
TELL YOUR DOCTOR IF

you are allergic to any other
medicines, foods, dyes or
preservatives.

if you have had to stop taking
another medicine for your
nausea and vomiting.

you plan to become

Ciri produk

Onsetron Tablets PI 180315
Onsetron
®
Tablets
PRODUCT INFORMATION
NAME OF THE MEDICINE
Ondansetron (as hydrochloride dihydrate). The chemical name for
ondansetron hydrochloride
dihydrate is (3
RS
)-9-Methyl-3-[(2-methyl-1
H
-imidazol-1-yl)methyl]-1,2,3,9-tetrahydro-4
H
-carbazol-
4-one hydrochloride dihydrate. Its structural formula is:
C
18
H
19
N
3
O.HCl.2H
2
O
Molecular weight: 365.9
Cas No.: 99614-01-4
DESCRIPTION
Ondansetron hydrochloride dihydrate is a white to off-white powder
with a melting point of 177

C.
It is sparingly soluble in water and alcohol, soluble in methanol and
slightly soluble in methylene
chloride. It is soluble in saline (0.9% w/v) to about 8 mg/mL. The pKa
of ondansetron
hydrochloride dihydrate as determined by a solubility procedure is
7.4. The distribution coefficient
between n-octanol and water is pH dependent with log D = 2.2 at a pH
of 10.6 and log D = 0.6 at
a pH of 5.95.
Onsetron tablets come in two strengths and contain either 4 mg or 8 mg
of ondansetron (as
hydrochloride dihydrate). The tablets also contain the following
excipients: lactose, microcrystalline
cellulose, maize starch, magnesium stearate and Opadry Y-1-7000 White.
The tablets are gluten
free.
PHARMACOLOGY
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 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 neurons located both in the peripheral and central
nervous system. The mechanisms of a