Zofran Zydis

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ondansetron 4mg

Available from:

Novartis New Zealand Ltd

INN (International Name):

Ondansetron 4 mg

Dosage:

4 mg

Pharmaceutical form:

Wafer

Composition:

Active: Ondansetron 4mg Excipient: Aspartame Gelatin Mannitol Sodium methyl hydroxybenzoate Sodium propyl hydroxybenzoate Strawberry Flavour 17.C5.6217

Units in package:

Blister pack, 4 wafers

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 wafers - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 10 wafers - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1996-09-25

Patient Information leaflet

 
1 
CONSUMER MEDICINE INFORMATION 
ZOFRAN
®
 ZYDIS™ 
ONDANSETRON HYDROCHLORIDE DIHYDRATE WAFERS 4MG AND 8MG 
WHAT IS IN THIS LEAFLET? 
Please read this leaflet carefully before you start taking Zofran
Zydis. 
This leaflet answers some common
questions about Zofran Zydis. 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 Zydis 
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 medication. You may need to read
it again. 
WHAT ZOFRAN ZYDIS ARE USED FOR 
Zofran Zydis is 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 Zydis wafers 
should only be used to treat the nausea
and vomiting for which they have been prescribed. 
Zofran Zydis wafers are not addictive. 
Zofran Zydis is only available on the prescription of a
doctor.  
BEFORE YOU USE ZOFRAN ZYDIS 
_WHEN YOU MUST NOT USE THEM _
•  Do not use Zofran Zydis if you are taking
apomorphine (used to treat Parkinson’s disease) 
•  Do not take Zofran Zydis if you have ever had an
allergic reaction to ondansetron or any of 
the other ingredients in Zofran Zydis which are listed
at the end of this leaflet.  
•  Do not use Zofran Zydis 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 Zydi

Summary of Product characteristics

1 
DATA SHEET 
ZOFRAN
®

_ONDANSETRON ZYDIS™ 4 MG AND 8 MG _
_ _
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Zofran Zydis 4 mg: White, round, plano-convex, freeze
dried, fast dispersing 
oral dosage form. Each Zydis contains ondansetron 4 mg. 
Zofran Zydis 8 mg: White, round, plano-convex, freeze
dried, fast dispersing 
oral dosage form. Each Zydis contains ondansetron 8 mg. 
PHARMACEUTICAL FORM 
Freeze dried, fast dispersing tablets. 
CLINICAL PARTICULARS 
_THERAPEUTIC INDICATIONS _
Zofran
Zydis is indicated for the management of nausea and vomiting induced 
by cytotoxic chemotherapy and radiotherapy.  Zofran
Zydis is 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. 
Place the Zydis on top of the tongue, where it will disperse
within seconds, 
then swallow. 
•  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 
selection of dose regimen should be determined by the
severity of the 
emetogenic challenge. 
2 
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 
hours before chemotherapy, may by 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 AD