Zofran

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ondansetron hydrochloride dihydrate 8mg

Available from:

Novartis New Zealand Ltd

INN (International Name):

Ondansetron hydrochloride dihydrate 8 mg

Dosage:

8 mg

Pharmaceutical form:

Tablet

Composition:

Active: Ondansetron hydrochloride dihydrate 8mg Excipient: Hypromellose Lactose Magnesium stearate Microcrystalline cellulose Opaspray yellow M-1-8429 Pregelatinised maize starch

Units in package:

Blister pack, 4 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Glaxo Wellcome Manufacturing Pte Ltd

Therapeutic indications:

Zofran tablets, Zofran Solution for injection and Zofran Zydis wafers are indicated for: · management of nausea and vomiting induced by cytotoxic chemotherapy in children, adolescents and adults. · management of nausea and vomiting induced by radiotherapy in adults. Zofran Solution for Injection is also indicated for: · prevention of post-operative nausea and vomiting in children, adolescents and adults. Studies have not be conducted on the use of Zofran tablets or Zofran Zydis wafers in the prevention of post-operative nausea and vomiting in the paediatric population.

Product summary:

Package - Contents - Shelf Life: Blister pack, - 4 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 10 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 20 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1990-05-24

Patient Information leaflet

 
1 

CONSUMER MEDICINE INFORMATION 
ZOFRAN
®
 TABLETS 
ONDANSETRON HYDROCHLORIDE DIHYDRATE TABLETS 4MG AND 8MG 
WHAT IS IN THIS LEAFLET? 
Please read this leaflet carefully before you start taking
Zofran. 
This leaflet answers some common
questions about Zofran Tablets. 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. Sometimes new risks are
found even when a medicine 
has been used for many years. Your doctor has weighed the
risks of you taking Zofran 
Tablets against the benefits they expect it will have
for you. 
If you have any concerns about taking
this medicine, ask your doctor or pharmacist. 
KEEP THIS INFORMATION WITH YOUR TABLETS. You may need to read
it again. 
WHAT ZOFRAN TABLETS ARE USED FOR 
Zofran Tablets are used to help stop the nausea
(sick feeling) and vomiting, which can occur 
after certain treatments such as chemotherapy and
radiotherapy. They are also used for the 
prevention of nausea and vomiting, which can
occur after an operation. Zofran Tablets should 
only be used to treat the nausea and vomiting for which
they have been prescribed. 
Zofran Tablets are not addictive. 
Zofran tablets are only available on the prescription of a
doctor. 
BEFORE YOU USE ZOFRAN TABLETS 
_WHEN YOU MUST NOT USE THEM _
•  Do not use Zofran Tablets after the expiry or "use
by" date (EXP) printed on the pack. If 
you take it after the
expiry date it may not work as well.  
•  Do not use Zofran Tablets if the
packaging is torn or shows signs of tampering or if the 
tablets look damaged or discoloured.  
•  Do not use Zofran if you are taking apomorphine (used to
treat Parkinson’s disease) 
•  Do not take Zofran Tablets if you have ever had
an allergic reaction

Summary of Product characteristics

1 
DATA SHEET 
ZOFRAN
®
 TABLETS 
_ONDANSETRON HYDROCHLORIDE DIHYDRATE TABLETS 4 MG AND 8 MG _
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Ondansetron tablets 4 mg: Yellow, oval, film coated
tablet engraved “GXET3” 
on one face and   plain on the other. Each
tablet contains ondansetron 4 mg 
(as hydrochloride dihydrate). 
Ondansetron tablets 8 mg: Yellow, oval, film coated
tablet engraved “GXET5” 
on one face and  plain on the other. Each
tablet contains ondansetron  8 mg 
(as hydrochloride dihydrate). 
PHARMACEUTICAL FORM 
Tablet. 
CLINICAL PARTICULARS 
_THERAPEUTIC INDICATIONS _
Ondansetron tablets are indicated for the management of nausea
and 
vomiting induced by cytotoxic chemotherapy and radiotherapy. 
Ondansetron 
tablets are also indicated for the prevention of post-operative
nausea and 
vomiting. 
_POSOLOGY AND METHOD OF ADMINISTRATION _
Zofran is also available for parenteral use to allow the
route of administration 
and dosing to be flexible. 
•  CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND
VOMITING (CINV 
AND RINV) 
_ADULTS _
The emetogenic potential of cancer treatment varies according to
the doses 
and combinations of chemotherapy and
radiotherapy regimens used.  
The recommended oral dose is 8 mg taken 1-2
hours before chemotherapy or 
radiation treatment, followed by 8 mg orally every 12
hours for a maximum of 
5 days. 
For highly emetogenic chemotherapy a single oral dose of up
to 24 mg Zofran 
taken together with 12 mg oral dexamethasone
sodium phosphate, 1 to 2 
2 
hours before chemotherapy, may be used. After the
first 24 hours, oral 
treatment with Zofran may be continued for up to 5
days after a course of 
treatment. The recommended oral dose is 8 mg to be taken twice
daily. 
_CHILDREN AND ADOLESCENTS (AGED 6 MONTHS TO 17 YEARS) _
In children with a body surface area