ZOFRAN TABLET 8 mg

Land: Singapore

Språk: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv ingrediens:

ONDANSETRON HCl DIHYDRATE EQV ONDANSETRON

Tilgjengelig fra:

SANDOZ SINGAPORE PTE. LTD.

ATC-kode:

A04AA01

Dosering :

10 mg EQV to 8mg Ondansetron

Legemiddelform:

TABLET, FILM COATED

Sammensetning:

ONDANSETRON HCl DIHYDRATE EQV ONDANSETRON 8 mg

Administreringsrute:

ORAL

Resept typen:

Prescription Only

Produsert av:

Aspen Bad Oldesloe GmbH

Autorisasjon status:

ACTIVE

Autorisasjon dato:

1990-10-16

Informasjon til brukeren

ZOFRAN™ TABLETS 

ONDANSETRON HYDROCHLORIDE DIHYDRATE 

QUALITATIVE AND QUANTITATIVE COMPOSITION 

_ZOFRAN_ tablets 8 mg: Each tablet contains ondansetron 8
mg as hydrochloride dihydrate. 

PHARMACEUTICAL FORM 

_ZOFRAN_ tablets 8 mg: Yellow, oval, film-coated
tablet engraved with ‘GXET5’ on one face 
and plain on the other face.  

CLINICAL PARTICULARS 

INDICATIONS 

ADULTS 

_ZOFRAN_ oral formulations are indicated for the management of nausea and
vomiting induced 
by cytotoxic chemotherapy and radiotherapy.  

_ZOFRAN_ is also indicated for the prevention of post-operative
nausea and vomiting. 

PAEDIATRIC POPULATION 
INJECTION AND ORAL FORMULATIONS: 
_ZOFRAN_ is indicated for the management of nausea and
vomiting induced by 
cytotoxic chemotherapy. 

No studies have been conducted on the use of orally administered
ondansetron in the 
prevention or treatment of post-operative nausea and
vomiting; IV injection is 
recommended for this purpose. 

DOSAGE AND ADMINISTRATION 

_ZOFRAN_ is available for oral and parenteral use to
allow the route of administration and 
dosing to be flexible.  

CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING 
(CINV AND RINV)  

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.  

• ADULTS  

EMETOGENIC CHEMOTHERAPY AND RADIOTHERAPY 

The recommended oral dose is 8 mg taken 1 to 2
hours before chemotherapy or radiation 
treatment, followed by 8 mg orally every 12 hours later
_ _
for a maximum of 5 days. 
To protect against delayed or prolonged emesis
after the first 24 hours, oral treatment with 
_ZOFRAN_ should be continued for up to 5
days after a course o

Preparatomtale

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TRADE NAME
Zofran
TM
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
_ _
_ZOFRAN_
tablets 8 mg: Yellow, oval, film-coated tablet engraved with
‘GXET5’ on one face and
plain on the other face. Each tablet contains ondansetron 8 mg as
hydrochloride dihydrate.
ACTIVE SUBSTANCE
Ondansetron
EXCIPIENTS
_ _
Lactose
Microcrystalline cellulose
Pregelatinised maize starch
Magnesium stearate
Methyl hydroxypropylcellulose
Titanium dioxide (E171)
Iron oxide (E172)
INDICATIONS
ADULTS
_ZOFRAN_
oral formulations are indicated for the management of nausea and
vomiting induced by
cytotoxic chemotherapy and radiotherapy.
_ZOFRAN_
is also indicated for the prevention of post-operative nausea and
vomiting.
PAEDIATRIC POPULATION_ _
_ZOFRAN_
is indicated for the management of
nausea and vomiting induced by
cytotoxic
chemotherapy.
No studies have been conducted on the use of orally administered
ondansetron in the prevention
or treatment of post-operative nausea and vomiting; IV injection is
recommended for this purpose.
DOSAGE REGIMEN AND ADMINISTRATION
Page
2
of
13
DOSING REGIMEN
CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING (CINV
AND RINV)
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.
ADULTS
EMETOGENIC CHEMOTHERAPY AND RADIOTHERAPY
The recommended oral dose is 8 mg taken 1 to 2 hours before
chemotherapy or radiation treatment,
followed by 8 mg orally every 12 hours later
_ _
for a maximum of 5 days.
To protect against delayed or prolonged emesis after the first 24
hours, oral treatment with
_ZOFRAN_
should be continued for up to 5 days after a course of treatment. The
recommended oral
dose is 8 mg to be taken twice daily.
HIGHLY EMETOGENIC CHEMOTHERAPY E.G. HIGH-DOSE CISPLATIN
_ZOFRAN_
can be given by oral, intravenous (IV), or intramuscular (IM)
administration.
_ZOFRAN_
has been shown to be equally effective in the fol