ONDANSETRON 2 MG/ML SOLUTION FOR INJECTION

Active substance: ONDANSETRON HYDROCHLORIDE DIHYDRATE

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Package leaflet: Information for the user

[Ondansetron] 2 mg/ml, Solution for injection/infusion
Ondansetron
Read all of this leaflet carefully before this medicine is administered to you because it
contains important information for you.
• Keep this leaflet. You may need to read it again
• If you have further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not pass it on to others. It may
harm them, even if their signs of illness are the same as yours
• If you get any of the side effects, talk to your doctor , or pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What [Ondansetron] is and what it is used for
2. What you need to know before you are given [Ondansetron]
3. How [Ondansetron] will be used
4. Possible side effects
5. How to store [Ondansetron]
6. Contents of the pack and other information
1. What [Ondansetron] is and what it is used for
Ondansetron belongs to a group of drugs called anti-emetics. Ondansetron inhibits the effect of
the neuro- transmitter serotonin in the brain. Serotonin causes nausea and vomiting.
[Ondansetron] is used for
 preventing and treating nausea and vomiting caused by cytotoxic chemotherapy (CINV) and

radiotherapy (adults and children aged ≥ 6 months)
 preventing and treating nausea and vomiting in patients following an operation (PONV)(in

adults and children aged ≥ 1 month)
Your doctor may have prescribed [Ondansetron] for another use. Always follow your doctor’s
advice.

2. What you need to know before you are given [Ondansetron]
Do not use Ondansetron
If you are allergic to ondansetron or any of the other ingredients of this medicine (listed in
section 6)
• if you are taking apomorphine (used to treat Parkinson’s disease)
•If you have previously experienced allergy to other drugs belonging to the group of serotonin
antagonists (e.g. granisetron, dolasetron). It is, in such case, possible that you are also allergic to
Ondansetron.
Warnings and precautions
Talk to your doctor or nurse before taking [Ondansetron]
-

if you have a blockage of your intestines or constipation, as you will need to be closely
monitored by your doctor.

-

if you are going to have or recently have had your tonsils removed, because treatment with
Ondansetron may hide symptoms of internal bleeding.

-

if you have heart problems (with arrythmias or conduction disorders) and are being treated
with other medication such as anesthetics, anti-arrythmics or beta-blockers at the same
time, because or the limited experience hereby.

-

if you need to pay attention to your sodium intake. However, [Ondansetron] has a low
content of sodium (less than 1 mmol per ampoule).
if it is for children below the age of 6 months or with a body surface of less than 0.6 m2.
if you have liver problems.
if children or adolescents receive ondansetron together with drugs, that may have a harmful
effect on the liver. Careful monitoring of the liver function is recommended.
if you have problems with the levels of salts in your blood, such as potassium and
magnesium.
Please tell your doctor or nurse if you need to have a blood or urine test that you are being treated
with [Ondansetron].
Tell your doctor if any of the above warnings apply to you.
Other medicines and [Ondansetron]
Ondansetron may have an effect on other drugs or other drugs may have an effect on
[Ondansetron].
Tell your doctor or pharmacist if you are taking, or have recently taken or might take, any other
medicines
You must tell your doctor that you are using [Ondansetron], if he/she starts treating you
with the following medicines,
•Drugs for epilepsy (phenytoin, carbamazepine), which may reduce the effect of ondansetron
•Antibiotics and antifungal medicines (e.g. rifampicin, erythromycin or ketoconazole ), which
may reduce the effect of ondansetron
•Pain relieving medicine (tramadol), whose effect may be reduced by ondansetron .
•Medicines inducing heart damage (e.g.anthracyclines or trastuzumab)
•Anti-arrhythmic medicines used to treat an uneven heart beat (e.g. amiodarone)
•Drugs which may result in QT prolongation (heart rhythm disorder)
•Beta-blocker medicines used to treat certain heart or eye problems, anxiety or prevent migraines
(e.g. atenolol or timolol)
•Serotonergic drugs (medicines of the type SSRI or SNRI used in the treatment of depressions)
•Apomorphine (used to treat Parkinson’s disease)
Using [Ondansetron] with food and drink
You may use [Ondansetron] independently of food and drinks.
Pregnancy and Breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this medicine.
Pregnancy:
Use in pregnancy has not been established and is not recommended.
If it is absolutely necessary that ondansetron be given caution should be exercised when
prescribing to pregnant women especially in the first trimester. Your doctor should evaluate the
risk/benefit balance.
Breast-feeding:
Do not take [Ondansetron] if you are breast-feeding, because it is excreted into the milk.

 

Driving and using machines
[Ondansetron] does not affect the ability to use any tools or machines or the ability to drive safely
in traffic.
[Ondansetron] contains sodium
 
[Ondansetron] solution for injection contains less than 1 mmol sodium (23 mg) per ampoule, i.e.
essentially ‘sodium- free’.

3 How [Ondansetron] will be used
Always use this medicine exactly as your doctor or nurse has told you. Check with your doctor or
nurse if you are not sure.
Adults
Your doctor or hospital may chose to give you ondansetron as injections, infusions or tablets. The
dose is individual.
Paediatric population
CINV in children aged ≥ 6 months and adolescents:
Ondansetron injection should be diluted in 5% dextrose or 0.9% sodium chloride or other
compatible infusion fluid and infused into a vein over not less than 15 minutes. Ondansetron
should be administered immediately before chemotherapy as a single dose of 5 mg/m2 or 0.15
mg/kg. injected into a vein. Oral dosing can commence twelve hours later and may be continued
for up to 5 days. The total daily dose must not exceed 32 mg.
PONV in children aged ≥ 1 month and adolescents:
For prevention of PONV in paediatric patients having surgery performed under general
anaesthesia, a single dose of ondansetron may be administered by slow injection into a vein (not
less than 30 seconds) at a dose of 0.1mg/kg up to a maximum of 4mg either prior to, at or after
induction of anaesthesia.
For the treatment of PONV after surgery in paediatric patients having surgery performed under
general anaesthesia, a single dose of ondansetron may be administered by slow injection into a
vein (not less than 30 seconds) at a dose of 0.1mg/kg up to a maximum of 4mg.
There are no data on the use of ondansetron in the treatment of PONV in children below 2 years
of age.
If you receive more [Ondansetron] than you should
Contact your doctor or the hospital if you receive more [Ondansetron] than you should and you
feel uncomfortable. The symptoms of overdose are disturbances of vision, severe constipation,
low blood pressure and disturbances in heart beat rhythm.
 

4. Possible side effects

Like all medicines, Ondansetron injection can have side effects, although not everybody gets
them.
Serious, rare side effects (occur in between 1 and 10 of 10,000 patients treated).
Tell your doctor or nurse immediately if you experience any of the following:
 Swollen tongue and throat
 Difficulty breathing
 Collapse.
Very common side effects (occur in more than 1 of 10 patients treated):
•Headache.
Common side effects (occur in between 1 and 10 of 100 patients treated)
A sensation of reddening and warmth. Constipation. Hypersensitivity reactions at the injection
site (local swelling, pain, redness, tissue hardening).
Uncommon side effects (occur in between 1 and 10 of 1,000 patients treated):
Seizures. Hiccups. Low blood pressure. Irregular heart beats, heart pain and slow pulse.
Involuntary movements. Involuntary eye movements. Sometimes changes in liver function have
been observed.
Rare side effects (occur in between 1 and 10 of 10,000 patients treated):
Nettle rash (urticaria). Dizziness, transient blurred vision predominantly during intravenous
administration.
Anaphylactic shock including collapse, swollen tongue and throat and trouble with breathing.
Abnormally rapid heart rhythm called “Torsade des pointes”. If any of these symptoms occur,
immediately seek medical attention.
 
Very rare side effects (occur in less than 1 of 10.000 patients treated):
Transient blindness predominantly during intravenous administration. Most of these blindness
cases were resolved within 20 minutes.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible
side effects other than those listed in this leaflet.

You can also report side effects directly via Yellow Card Scheme (Website:
www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store [Ondansetron]
Keep out of the sight and reach of children.
Protect from light.
Do not use [Ondansetron] after the expiry date which is stated on the ampoule and the carton.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.

6 Contents of the pack and other information
What [Ondansetron] contains
The active substance in 1 ml solution for injection is 2 mg ondansetron as Ondansetron
hydrochloride dehydrate. Each 2 ml ampoule contains 4 mg Ondansetron. Each 4 ml ampoule
contains 8 mg Ondansetron.

The other ingredients are Sodium chloride (0.15 mmol Na+/ml); Citric acid monohydrate;
Sodium citrate (0.0026mmol Na+/ml); Water for injections.
 

What Ondansetron Injection looks like and contents of the pack
Ondansetron 2mg/ml Solution for Injection is a clear solution in brown glass ampoules.
Each ampoule contains either 2ml or 4ml of solution.
They are marketed in packs of 1ampoule, 5 ampoules or 5 x 5 ampoules respectively.
Not all pack sizes may be marketed.
Product Licence Holder
Mercury Pharmaceuticals Ltd,
No. 1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT, UK
Manufacturer
Pharmathen S.A, 6. Dervenakion str., 15351 Pallini, Attikis, Greece.
For any information about this medicinal product, please contact the local representative of the
Marketing Authorisation Holder.
This medicinal product is authorised in the Member States of the EEA under the following
names:
Denmark

Ondilia

Ireland

Ondansetron

Germany

Ondansetron Winthrop

United Kingdom

Ondansetron

This leaflet was revised in June 2013 

The following information is intended for medical or healthcare professionals only.
Instructions for use and handling
For injection:
For single use only. Any unused solution should be discarded.
The solution is to be visually inspected prior to use (also after dilution). Only clear solutions
practically free from particles should be used.
For infusion:
May be diluted with solution for infusion containing: Sodium chloride 9 mg/ml (0.9%), Glucose
50 mg/ml (5 %), Mannitol 100 mg/ml (10 %), Potassium chloride 3 mg/ml (0.3%) + Sodium
chloride 9 mg/ml (0.9 %) and
Potassium chloride 3 mg/ml (0.3%) + Glucose 50 mg/ml (5 %) as well as Ringer solution for
infusion.

Should not be mixed with other pharmaceutical products.
From a microbiological point of view, unless the method of opening/reconstitution/dilution
precludes the risk of microbial contamination, the product should be used immediately. If not
used immediately, in-use storage times and conditions are the responsibility of the user, and
these should, if dilution has not been performed controlled and under validated aseptic
conditions, normally not exceed 24 hours at 2-8C.
 
Posology and method of administration
For intravenous injection or after dilution for intravenous infusion.
Chemotherapy and radiotherapy induced nausea and vomiting
Adults
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 and selected as shown below.
Emetogenic chemotherapy and radiotherapy
For patients receiving emetogenic chemotherapy or radiotherapy ondansetron can be given either
by oral or intravenous administration.
For most patients receiving emetogenic chemotherapy or radiotherapy, ondansetron should
initially be administered intravenously immediately before treatment, followed by 8 mg orally
twelve hourly.
To protect against delayed or prolonged emesis after the first 24 hours, oral treatment with
ondansetron should be continued for up to 5 days after a course of treatment.
Highly emetogenic chemotherapy 

Either 8 mg as a slow intravenous bolus injection or as a short-term infusion lasting 15 minutes
immediately before chemotherapy. If this initial dose has insufficient effect it can be
supplemented by either 8 mg (intravenous bolus or 15 minutes' infusion) every 4th hour, at most
twice, or continuous infusion of 1 mg/hour for 24 hours.
A single intravenous dose of 16mg diluted in 50- 100ml of saline or other compatible infusion
fluid and infused over not less than 15 minutes immediately before chemotherapy. A single dose
greater than 16 mg must not be given due to dose dependent increase of QT-prolongation risk
(see sections 4.4, 4.8 and 5.1).
For management of highly emetogenic chemotherapy, a dose of 8 mg of ondansetron may be
administered by slow IV in not less than 30 seconds immediately before chemotherapy, followed
by 2 further IV doses of 8 mg 2 to 4 hours apart, or by a constant infusion of 1 mg/h for up to 24
hours.
The effect of ondansetron may be enhanced by the simultaneous administration of 20 mg
dexamethasone intravenously or an equally potent dose of other glucocorticoids for intravenous
use.

Paediatric Population
Chemotherapy-induced nausea and vomiting in children aged

6 months and adolescents:

The dose for chemotherapy-induced nausea and vomiting can be calculated based on body
surface area (BSA) or weight – see below. Weight-based dosing results in higher total daily doses
compared to BSA-based dosing – see sections 4.4.and 5.1.
There are no data from controlled clinical trials on the use of Ondansetron in the prevention of
delayed or prolonged CINV. There are no data from controlled clinical trials on the use of
Ondansetron for radiotherapy-induced nausea and vomiting in children.

Dosing by BSA:
Ondansetron should be administered immediately before chemotherapy as a single intravenous
dose of 5 mg/m2. The intravenous dose must not exceed 8 mg.
Oral dosing can commence twelve hours later and may be continued for up to 5 days - see Table
1 below.
Table 1: BSA-based dosing for Chemotherapy - Children aged

6 months and adolescents

BSA

Day 1 a,b

Days 2-6b

< 0.6 m2

5 mg/m2 i.v. plus

2 mg syrup every 12 hrs

2 mg syrup after 12 hrs
0.6 m2

5 mg/m2 i.v. plus
4 mg syrup or tablet after 12 hrs

4 mg syrup or tablet every 12
hrs

a The intravenous dose must not exceed 8mg.
b The total daily dose must not exceed adult dose of 32 mg
Dosing by bodyweight:
Weight-based dosing results in higher total daily doses compared to BSA-based dosing (see
sections 4.4. and 5.1).
Ondansetron should be administered immediately before chemotherapy as a single intravenous
dose of 0.15 mg/kg. The intravenous dose must not exceed 8 mg.
Two further intravenous doses may be given in 4-hourly intervals. The total daily dose must not
exceed adult dose of 32 mg. Oral dosing can commence twelve hours later and may be continued
for up to 5 days (see Table 2 below).

Table 2: Weight-based dosing for Chemotherapy - Children aged
Weight

Day 1 a,b

Days 2-6b

6 months and adolescents

10 kg

Up to 3 doses of 0.15 mg/kg every
4 hrs

2 mg syrup or tablet every 12
hrs

> 10 kg

Up to 3 doses of 0.15 mg/kg every
4 hrs

4 mg syrup or tablet every 12
hrs

a The intravenous dose must not exceed 8mg.
b The total daily dose must not exceed adult dose of 32 mg.
Elderly
Ondansetron is well tolerated by patients over 65 years and no alteration of dosage, dosing
frequency or route of administration are required.
Patients with renal impairment
No alteration of daily dosage or frequency of dosing, or route of administration are required.
Patients with hepatic impairment
Clearance of Ondansetron is significantly reduced and serum half life significantly prolonged in
subjects with moderate or severe impairment of hepatic function. In such patients a total daily
dose of 8 mg should not be exceeded and therefore parenteral or oral administration is
recommended.
Patients with Poor sparteine / debrisoquine metabolism
The elimination half-life of ondansetron is not altered in subjects classified as poor metabolisers
of sparteine and debrisoquine. Consequently, in such patients repeat dosing will give drug
exposure levels no different from those of the general population. No alteration of daily dosage or
frequency of dosing are required.
Post-operative nausea and vomiting (PONV)
Adults
For prevention of PONV ondansetron can be administered orally or intramuscular or by slow
intravenous injection at the induction of anesthesia.
Ondansetron may be administered as a single dose of 4mg given by intramuscular or slow
intravenous injection at induction of anaesthesia.
For treatment of established PONV a single dose of 4mg given by intramuscular or slow
intravenous injection is recommended.
Paediatric population
Post-operative nausea and vomiting in children aged 1 month and adolescents
For prevention of PONV in paediatric patients having surgery performed under general
anaesthesia, a single dose of ondansetron may be administered by slow intravenous injection (not
less than 30 seconds) at a dose of 0.1mg/kg up to a maximum of 4mg either prior to, at or after
induction of anaesthesia.

For the treatment of PONV after surgery in paediatric patients having surgery performed under
general anaesthesia, a single dose of ondansetron may be administered by slow intravenous
injection (not less than 30 seconds) at a dose of 0.1mg/kg up to a maximum of 4mg.
There are no data on the use of ondansetron in the treatment of of post-operative nausea and
vomiting in children below 2 years of age.
Elderly
There is limited experience in the use of ondansetron in the prevention and treatment of postoperative nausea and vomiting (PONV) in the elderly, however ondansetron is well tolerated in
patients over 65 years receiving chemotherapy.
Patients with renal impairment
No alteration of daily dosage or frequency of dosing, or route of administration are required.
Patients with hepatic impairment
Clearance of Ondansetron is significantly reduced and serum half life significantly prolonged in
subjects with moderate or severe impairment of hepatic function. In such patients a total daily
dose of 8 mg should not be exceeded and therefore parenteral or oral administration is
recommended.
Patients with poor sparteine/debrisoquine metabolism
The elimination half-life of ondansetron is not altered in subjects classified as poor metabolisers
of sparteine and debrisoquine. Consequently in such patients, repeat dosing will give medicinal
product exposure levels no different from those of the general population. No alteration of daily
dosage or frequency of dosing are required.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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