APO-ONDANSETRON ondansetron (as hydrochloride dihydrate) 4 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ondansetron hydrochloride

Available from:

Arrow Pharma Pty Ltd

INN (International Name):

Ondansetron hydrochloride

Authorization status:

Registered

Patient Information leaflet

APO-ONDANSETRON
1
APO-ONDANSETRON
_Contains the active ingredient, ondansetron (as hydrochloride
dihydrate) _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about ondansetron.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:

if there is anything you do not
understand in this leaflet,

if you are worried about taking
your medicine, or

to obtain the most up-to-date
information.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Ondansetron. It contains the active
ingredient, ondansetron.
It is used to help stop the nausea and
vomiting which can occur after some
medical treatments.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
Your doctor may have prescribed
ondansetron for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS _
Ondansetron belongs to a group of
medicines called serotonin receptor -
3 antagonists.
There is no evidence that this
medicine is addictive.
_USE IN CHILDREN _
There is not enough information to
recommend the use of this medicine
in children four years of age and
under.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF:

YOU ARE TAKING APOMORPHINE
(USED TO TREAT PARKINSON'S
DISEASE)

YOU ARE HYPERSENSITIVE TO, OR
HAVE HAD AN ALLERGIC

Summary of Product characteristics

Product Information
APO-ONDANSETRON
Page 1 of 11
APO-ONDANSETRON
NAME OF THE MEDICINE
Ondansetron (as hydrochloride dihydrate).
Chemical Name:
(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
Structural Formula:
Molecular Formula:
C
18
H
20
ClN
3
O,2H
2
O
Molecular Weight:
365.9
CAS Number:
99614-01-4
DESCRIPTION
Ondansetron hydrochloride dihydrate is a white to off-white powder
with a melting point of 177
⁰
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.
Apo-Ondansetron 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 action in postoperative nause