APX-ONDANSETRON ondansetron (as hydrochloride dihydrate) 4 mg tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
31-01-2022
Summary of Product characteristics
(SPC)
30-08-2022
Public Assessment Report
(PAR)
29-11-2017
Active ingredient:
ondansetron hydrochloride dihydrate, Quantity: 4.986 mg
Available from:
Arrow Pharma Pty Ltd
INN (International Name):
Ondansetron hydrochloride dihydrate
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: magnesium stearate; pregelatinised maize starch; lactose; titanium dioxide; hypromellose; microcrystalline cellulose; triacetin
Administration route:
Oral
Units in package:
10, 30, 4, 90
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Ondansetron is indicated for the prevention and treatment of nausea and vomiting induced by cytotoxic therapy and radiotherapy.
Product summary:
Visual Identification: White to off-white, oval shaped, film-coated tablets debossed with 'E' on one side and '01' on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Registered
Authorization date:
2011-09-29
Patient Information leaflet
APX-ONDANSETRON
CONSUMER MEDICINE INFORMATION
Ondansetron (as hydrochloride dihydrate) 4 mg and 8 mg film-coated
tablets
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you use APX-ONDANSETRON.
This leaflet answers some common questions about APX-ONDANSETRON. 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
expected benefits of you taking
APX-ONDANSETRON against the risks this medicine could 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 APX-ONDANSETRON IS USED FOR
APX-ONDANSETRON contains a medicine called ondansetron. This belongs
to a group of
medicines called serotonin receptor-3 antagonists.
APX-ONDANSETRON is used to help stop the nausea (sick feeling) and
vomiting which can occur
after medical treatments and operations.
APX-ONDANSETRON should only be used to treat the nausea and vomiting
for which they have
been prescribed.
Your doctor may have prescribed APX-ONDANSETRON for another reason. If
you want more
information, ask your doctor.
APX-ONDANSETRON
is not addictive.
BEFORE YOU TAKE APX-ONDANSETRON
_ _
_DO NOT TAKE IF: _
You must not take APX-ONDANSETRON if:
•
YOU ARE TAKING APOMORPHINE (USED TO TREAT PARKINSON’S DISEASE);
•
YOU HAVE EVER HAD AN ALLERGIC REACTION TO ONDANSETRON OR ANY OF THE
INGREDIENTS LISTED
TOWARD THE END OF THIS LEAFLET (SEE "INGREDIENTS");
•
YOU ARE PREGNANT, TRYING TO BECOME PREGNANT OR BREASTFEEDING, UNLESS
YOUR DOCTOR
SAYS IT IS SAFE;
•
THE EXPIRY DATE PRINTED ON THE PACK HAS PASSED; OR
•
THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING.
_TELL YOUR DOCTOR IF: _
You must tell your doctor if:
•
YOU ARE ALLERGIC TO FOODS, DYES, PRESERVATIVES OR ANY OTHER MEDICINES;
•
YOU HAVE HAD TO STOP TAKING ANOTHER MEDICINE FOR YOUR NAUSEA OR
VOMITING;
•
YOU
ARE
TAKING
ANY
OTHER
MEDICINES,
INCLUDING
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Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION
APX-ONDANSETRON
(ondansetron hydrochloride dihydrate) tablets
1
NAME OF THE MEDICINE
Ondansetron hydrochloride dihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APX-ONDANSETRON is available as tablets containing 4 mg or 8 mg of
ondansetron as hydrochloride
dihydrate.
Excipient of known effect: Contains sugars as lactose
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
APX-ONDANSETRON (4MG): White to off-white, oval shaped, film-coated
tablets debossed with ‘E’
on one side and ‘01’ on the other side.
APX-ONDANSETRON (8MG): Yellow coloured, oval shaped, film-coated
tablets debossed with ‘E’ on
one side and ‘02’ on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Ondansetron is indicated for the prevention and treatment of nausea
and vomiting induced by
cytotoxic therapy and radiotherapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The emetogenic potential of cancer treatment varies according to the
doses and combinations of
chemotherapy and radiotherapy regimens used. The route of
administration and dose of
ondansetron should be flexible in the range of 8-32 mg a day and
selected as shown below. The
lowest effective dose should be used.
2
ADULTS
_ _
_EMETOGENIC CHEMOTHERAPY AND RADIOTHERAPY _
For the control of chemotherapy or radiotherapy induced emesis or
nausea in adults, two oral doses
of 8 mg each at 12 hourly intervals may be given, the first dose being
administered 2 hours prior to
chemotherapy or radiotherapy.
To protect against delayed emesis after the first 24 hours,
ondansetron should be continued orally at
a dosage of 8 mg twice daily.
CHILDREN
_ _
_EMETOGENIC CHEMOTHERAPY AND RADIOTHERAPY _
Experience is currently limited but ondansetron was effective and well
tolerated in children over 4
years of age following chemotherapy, oral therapy at doses of 4 mg
twice daily for up to five days
can be given.
_PONV IN CHILDREN AND ADOLESCENTS (AGED 1 MONTH TO 17 YEARS) _
_ _
_Oral Formulations _
No studies
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