Patient leaflet - Ondansetron 2 mg|ml solution for injection
1. What Ondansetron Solution for Injection is and what it is used for
Ondansetron Solution for Injection contains a medicine called ondansetron
(as hydrochloride dihydrate). This belongs to a group of medicines called
anti-emetics.
Ondansetron Solution for Injection is used for:
•Preventing nausea and vomiting caused by chemotherapy (in adults and
children) or radiotherapy for cancer (adults only).
•Preventing nausea and vomiting after surgery.
Ask your doctor, nurse or pharmacist if you would like any further
explanation about these uses.
2. What you need to know before you have Ondansetron Solution for Injection
Do not have Ondansetron Solution for Injection if:
•You are taking apomorphine (used to treat Parkinson’s disease).
•You are allergic to ondansetron or any of the other ingredients of this
medicine (listed in section 6).
If you are not sure, talk to your doctor, nurse or pharmacist before having
Ondansetron Solution for Injection.
Warnings and precautions
Check with your doctor or pharmacist before having Ondansetron Solution
for Injection if:
•You have ever had heart problems (e.g. congestive heart failure which
causes shortness of breath and swollen ankles).
•You have an uneven heartbeat (arrhythmias).
•You are allergic to medicines similar to ondansetron, such as granisetron
or palonosetron.
•You have liver problems.
•You have a blockage in your gut.
•You have problems with the levels of salts in your blood, such as
potassium, sodium and magnesium.
If you are not sure if any of the above apply to you, talk to your doctor,
nurse or pharmacist before having Ondansetron Solution for Injection.
Other medicines and Ondansetron Solution for Injection
Please tell your doctor, nurse or pharmacist if you are taking, or have
recently taken, or might take any other medicines. This includes medicines
that you buy without a prescription and herbal medicines. This is because
Ondansetron Solution for Injection can affect the way some medicines work.
Also some other medicines can affect the way Ondansetron Solution for
Injection works.
In particular, tell your doctor, nurse or pharmacist if you are taking any of
the following medicines:
•Carbamazepine or Phenytoin used to treat epilepsy.
•Rifampicin used to treat infections such as Tuberculosis (TB).
•Antibiotics such as erythromycin or ketoconazole.
•Anti-arrhythmic medicines used to treat an uneven heartbeat.
•Beta-blocker medicines used to treat certain heart or eye problems,
anxiety or prevent migraines.
•Tramadol, a pain killer.
•Medicines that affect the heart (such as haloperidol or methadone).
•Cancer medicines (especially anthracyclines and trastuzumab).
Tell your doctor or pharmacist immediately if you get any of these symptoms during and after the treatment with Ondansetron Solution for Injection
- if you experience sudden chest pain or chest tightness (myocardial ischemia).
Pregnancy and breast-feeding
You should not use Ondansetron Solution for Injection during the first trimester of pregnancy. This is because Ondansetron Solution for Injection can slightly increase the risk of a baby being born with cleft lip and/or cleft palate (openings or splits in the upper lip and/or the roof of the mouth). If you are already pregnant, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before having Ondansetron Solution for Injection or Infusion. If you are a woman of childbearing potential you may be advised to use effective contraception.
There is insufficient information on the excretion of ondansetron/metabolites in human milk or the effects of Ondansetron Solution for Injection on milk production. A risk to the newborns/infants cannot be excluded. Ondansetron Solution for Injection should not be used during breast-feeding.
Important information about sodium content
This medicine contains less than 1 mmol sodium (23mg) per 2-6 ml dose. That is to say essentially ‘sodium-free’. When the dose is greater than 6 ml it cannot be considered ‘sodium-free’ and it should be taken into consideration by patients on a controlled sodium diet. At maximum daily dose (16 ml) this medicine contains 56 mg of sodium. This is equivalent to approximately 2.3% of the recommended daily dietary intake of sodium for an adult.
3. How to have Ondansetron Solution for Injection
Ondansetron Solution for Injection is normally given by a nurse or doctor. The dose you have been prescribed will depend on the treatment you are having. To prevent nausea and vomiting from chemotherapy or radiotherapy in adults
On the day of chemotherapy or radiotherapy
•The usual adult dose is 8 mg given by a slow injection into your vein or muscle, just before your treatment, and another 8 mg twelve hours later. After chemotherapy, your medicine will usually be given by mouth as an 8 mg Ondansetron tablet or 10 ml (8 mg) Ondansetron syrup. On the following days
•The usual adult dose is one 8 mg tablet or 10 ml (8 mg) syrup taken twice a day.
•This may be given for up to 5 days.
If your chemotherapy or radiotherapy is likely to cause severe nausea and vomiting, you may be given more than the usual dose of Ondansetron Solution for Injection.Your doctor will decide this.
To prevent nausea and vomiting from chemotherapy in children aged over 6 months and adolescents
The doctor will decide the dose depending on the child’s size (body surface area) or weight. Look at the label for more information.
On the day of chemotherapy
•The first dose is given by an injection into the vein, just before your child’s treatment. After chemotherapy, your child’s medicine will usually be given by mouth twelve hours later, as Ondansetron syrup or a Ondansetron tablet.
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Package Leaflet: Information for the Physician
ONDANSETRON 2 mg/ml SOLUTION FOR INJECTION
Please refer to the Summary of Product Characteristics (SPC) for further details on this product.
Trade Name of the Medicinal Product
ONDANSETRON 2 mg/ml SOLUTION FOR INJECTION
Qualitative and Quantitative Composition
Ondansetron injection 2 mg/ml:
- 2 ml ampoules each containing 4 mg ondansetron (as hydrochloride dihydrate) in clear solution for intramuscular or intravenous administration.
- 5 ml ampoules each containing 8 mg ondansetron (as hydrochloride dihydrate) in clear solution for intravenous or intramuscular administration.
Posology and Method of Administration
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 in the range of 8-32 mg a day and selected as shown below. Emetogenic chemotherapy and radiotherapy: Ondansetron can be given either by rectal, oral (tablets or syrup), intravenous or intramuscular administration. For most patients receiving emetogenic chemotherapy or radiotherapy, Ondansetron 8 mg should be administered as a slow intravenous injection (in not less than 30 seconds) or intramuscular injection immediately before treatment, followed by 8 mg orally twelve hourly. To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with Ondansetron should be continued for up to 5 days after a course of treatment. Highly emetogenic chemotherapy: For patients receiving highly emetogenic chemotherapy, e.g. high-dose cisplatin, Ondansetron can be given either by rectal, intravenous or intramuscular administration. Ondansetron has been shown to be equally effective in the following dose schedules over the first 24 hours of chemotherapy:
- A single dose of 8 mg by slow intravenous injection (in not less than 30 seconds) or intramuscular injection immediately before chemotherapy.
- A dose of 8 mg by slow intravenous injection (in not less than 30 seconds) or intramuscular injection immediately before chemotherapy, followed by two further intravenous injections (in not less than 30 seconds) or intramuscular doses of 8 mg four hours apart, or by a constant infusion of 1 mg/hour for up to 24 hours.
- A maximum initial dose of 16 mg diluted in 50-100 ml of saline or other compatible infusion fluid (See Instructions for Use/Handling) and infused over not less than 15 minutes immediately before chemotherapy. The initial dose of Ondansetron may be followed by two additional 8 mg intravenous doses (in not less than 30 seconds) or intramuscular doses four hours apart.
- 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 of the SPC). The selection of dose regimen should be determined by the severity of the emetogenic challenge.
The efficacy of Ondansetron in highly emetogenic chemotherapy may be enhanced by the addition of a single intravenous dose of dexamethasone sodium phosphate, 20 mg administered prior to chemotherapy.
To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment with Ondansetron should be continued for up to 5 days after a course of treatment.
Paediatric Population:
CINV in children aged ≥ 6 months and adolescents
The dose for CINV can be calculated based on body surface area (BSA) or weight – see below.
Ondansetron injection should be diluted in 5% dextrose or 0.9% sodium chloride or other compatible infusion fluid (see Instructions for Use/Handling) and infused intravenously over not less than 15 minutes.
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 single intravenous dose must not exceed 8 mg. Oral dosing can commence 12 hours later and may be continued for up to 5 days (see SPC for dosing tables). The total dose over 24 hours (given as divided doses) 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. Ondansetron should be administered immediately before chemotherapy as a single intravenous dose of 0.15 mg/kg. The single intravenous dose must not exceed 8 mg. Two further intravenous doses may be given in 4-hourly intervals. Oral dosing can commence 12 hours later and may be continued for up to 5 days. The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg. (see SPC for further details).
Elderly
In patients 65 to 74 years of age, the dose schedule for adults can be followed. All intravenous doses should be diluted in 50-100 ml of saline or other compatible infusion fluid (see Instructions for Use/Handling) and infuse over 15 minutes.
In patients 75 years of age or older, the initial intravenous dose of Ondansetron should not exceed 8 mg. All intravenous doses should be diluted in 50-100 ml of saline or other compatible infusion fluid (see Instructions for Use/Handling) and infused over 15 minutes. The initial dose of 8 mg may be followed by two further intravenous doses of 8 mg, infused over 15 minutes and given no less than four hours apart (see SPC).
Post-Operative Nausea and Vomiting (PONV)
Adults
For the prevention of PONV Ondansetron can be administered orally or by intravenous or intramuscular injection. Ondansetron may be administered as a single dose of 4 mg given by intramuscular or slow intravenous injection at induction of anaesthesia. For treatment of established PONV a single dose of 4 mg given by intramuscular or slow intravenous injection is recommended.
On the following days
•2.5 ml (2 mg) syrup twice a day for small children and those weighing 10
kg or less.
•One 4 mg tablet or 5 ml (4 mg) syrup twice a day for larger children and
those weighing more than 10 kg.
•Two 4 mg tablets or 10 ml (8mg) syrup twice a day for teenagers (or those
with a large body surface area).
•These doses can be given for up to five days.
To prevent and treat nausea and vomiting after an operation
Adult:
The usual dose for adults is 4 mg given by a slow injection into your vein or
an injection into your muscle. For prevention, this will be given just before
your operation.
Children:
For children aged over 1 month and adolescents the doctor will decide the
dose. The maximum dose is 4 mg given as a slow injection into the vein.
For prevention, this will be given just before the operation.
Patients with moderate or severe liver problems
The total daily dose should not be more than 8 mg.
If you keep feeling or being sick
Ondansetron Solution for Injection should start to work soon after having the
injection. If you continue to be sick or feel sick, tell your doctor or nurse.
If you have more Ondansetron Solution for Injection than you should
Your doctor or nurse will give you or your child Ondansetron Solution for
Injection so it is unlikely that you will receive too much. If you think you or
your child have been given too much or have missed a dose, tell your doctor
or nurse.
4. Possible side effects
Like all medicines, Ondansetron Solution for injection
can cause side effects, although not everybody gets them.
Some side effects could be serious
Stop taking Ondansetron Solution for Injection and seek medical help
immediately if you or your child experience any of the following:
Allergic reactions
•Sudden wheezing and chest pain or chest tightness.
•Swelling of your eyelids, face, lips, mouth or tongue.
•Skin rash - red spots or lumps under your skin (hives) anywhere on your
body.
•Collapse.
Myocardial ischemia
Signs include:
•sudden chest pain or
•chest tightness
Other side effects include:
Very common (may affect more than 1 in 10 people)
•Headache.
Common (may affect up to 1 in 10 people)
•A feeling of warmth or flushing.
•Constipation.
•Changes to liver function test results (if you have Ondansetron Solution for
Injection with a medicine called cisplatin, otherwise this side effect is
uncommon).
•Irritation and redness at the site of injection.
Uncommon (may affect up to 1 in 100 people)
•Hiccups.
•Low blood pressure, which can make you feel faint or dizzy.
•Uneven heartbeat.
•Slow heart rate.
•Chest pain.
•Fits.
•Unusual body movements or shaking.
Very rare (may affect up to 1 in 10,000 people)
•A widespread rash with blisters and skin peeling on much of the body surface (toxic epidermal necrolysis)
•Poor vision or temporary loss of eyesight, which usually comes back within 20 minutes.
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yel-lowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Ondansetron Solution for Injection
•Keep this medicine out of the sight and reach of children. •Do not use this medicine after the expiry date which is stated on the pack after ‘Exp’. The expiry date refers to the last day of that month. •Do not store above 25°C.
•Store in the original package. Protect from light.
•The solution should be visually inspected prior to use; agitate gently to confirm free from visible particles.
•When Ondansetron Solution for Injection is diluted in intravenous fluids: From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions. Chemical and physical in-use stability has been demonstrated for 5 days at 25°C and 2-8°C, when the product is diluted to a concentration of 0.32 or 0.64 mg/ml and stored in the original plastic containers of the infusion fluids.
•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 Solution for Injection contains:
•The active ingredient is ondansetron (as hydrochloride dihydrate). Each 2 ml ampoule contains ondansetron 4 mg.
Each 5 ml ampoule contains ondansetron 8 mg.
•The other ingredients are citric acid monohydrate, sodium citrate, sodium chloride and Water for Injections.
What Ondansetron Solution for Injection looks like and contents of the pack:
Ondansetron Solution for Injection is a clear, colourless solution. Ondansetron Solution for Injection is available in:
2 ml (4 mg) glass ampoules
5 ml (8 mg) glass ampoules
Ondansetron 2mg/ml Solution for Injection packed in boxes of 5 or 10 ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
JCSH Pharma Limited
Winslade, Shere Road, West Clandon, Surrey,
GU4 8SF, UK
Manufacturer:
JCSH Pharma Limited
5 Millmead, Guildford, Surrey, GU2 4BE, UK.
MA Number: PLGB 46447/0065
This leaflet was last revised in: March 2026
Rare (may affect up to 1 in 1,000 people)
•Feeling dizzy or light headed.
•Blurred vision.
•Disturbance in heart rhythm (sometimes causing a sudden loss of
consciousness).
ONAP4
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Children (aged over 1 month and adolescents)
Injection:
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 0.1 mg/kg up to a maximum of 4 mg 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 0.1 mg/kg up to a maximum of 4 mg. There are no data on the use of Ondansetron in the treatment of PONV in children below 2 years of age.
Elderly
There is limited experience in the use of Ondansetron in the prevention and treatment of PONV in the elderly, however Ondansetron is well tolerated in patients over 65 years receiving chemotherapy.
For all indications:
Renal impairment
No alteration of daily dosage or frequency of dosing, or route of administration are required.
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.
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.
Special precautions for disposal and other handling
Compatibility with intravenous fluids
Ondansetron injection should only be admixed with those infusion solutions which are recommended:
- Sodium Chloride Intravenous Infusion 0.9% w/v
- Glucose Intravenous Infusion 5% w/v
- Mannitol Intravenous Infusion 10% w/v
- Ringers Intravenous Infusion
- Potassium Chloride 0.3% w/v and Sodium Chloride 0.9% w/v Intravenous Infusion
- Potassium Chloride 0.3% w/v and Glucose 5% w/v Intravenous Infusion
In keeping with good pharmaceutical practice dilutions of Ondansetron injection in intravenous fluids should be prepared at the time of infusion. See further information under ‘Special Precautions for Storage.’
Compatibility studies have been undertaken in polyvinyl chloride infusion bags and polyvinyl chloride administration sets. It is considered that adequate stability would also be conferred by the use of polyethylene infusion bags or Type 1 glass bottles. Dilutions of Ondansetron in sodium chloride 0.9% w/v or in glucose 5% w/v have been demonstrated to be stable in polypropylene syringes. It is considered that Ondansetron injection diluted with other compatible infusion fluids would be stable in polypropylene syringes.
Compatibility with other drugs
Ondansetron may be administered by intravenous infusion at 1 mg/hour, e.g. from an infusion bag or syringe pump. The following drugs may be administered via the Y-site of the Ondansetron giving set for ondansetron concentrations of 16 to 160 micrograms/ml (e.g. 8 mg/500 ml and 8 mg/50 ml respectively);
Cisplatin: Concentrations up to 0.48 mg/ml (e.g. 240 mg in 500 ml) administered over one to eight hours.
5-Fluorouracil: Concentrations up to 0.8 mg/ml (e.g. 2.4 g in 3 litres or 400 mg in 500 ml) administered at a rate of at least 20 ml per hour (500 ml per 24 hours). Higher concentrations of 5-fluorouracil may cause precipitation of ondansetron. The 5-fluorouracil infusion may contain up to 0.045% w/v magnesium chloride in addition to other excipients shown to be compatible.
Carboplatin: Concentrations in the range 0.18 mg/ml to 9.9 mg/ml (e.g. 90 mg in 500 ml to 990 mg in 100 ml), administered over ten minutes to one hour. Etoposide: Concentrations in the range 0.14 mg/ml to 0.25 mg/ml (e.g. 72 mg in 500 ml to 250 mg in 1 litre), administered over thirty minutes to one hour. Ceftazidime: Doses in the range 250 mg to 2000 mg reconstituted with Water for Injections BP as recommended by the manufacturer (e.g. 2.5 ml for 250 mg and 10 ml for 2 g ceftazidime) and given as an intravenous bolus injection over approximately five minutes.
Cyclophosphamide: Doses in the range 100 mg to 1 g, reconstituted with Water for Injections BP, 5 ml per 100 mg cyclophosphamide, as recommended by the manufacturer and given as an intravenous bolus injection over approximately five minutes.
Doxorubicin: Doses in the range 10-100 mg reconstituted with Water for Injections BP, 5 ml per 10 mg doxorubicin, as recommended by the manufacturer and given as an intravenous bolus injection over approximately 5 minutes.
Dexamethasone: Dexamethasone sodium phosphate 20 mg may be administered as a slow intravenous injection over 2-5 minutes via the Y-site of an infusion set delivering 8 or 16 mg of ondansetron diluted in 50-100 ml of a compatible infusion fluid over approximately 15 minutes. Compatibility between dexamethasone sodium phosphate and ondansetron has been demonstrated supporting administration of these drugs through the same giving set resulting in concentrations in line of 32 microgram - 2.5 mg/ml for dexamethasone sodium phosphate and 8 microgram - 1 mg/ml for ondansetron.
Shelf Life
- 5 years (unopened)
- 24 hours (dilutions stored 2-8°C)
Special Precautions for Storage
- Protect from light
- Do not store above 25°C
- The solution should be visually inspected prior to use; agitate gently to confirm free from visible particles
- When Ondansetron Solution for Injection is diluted in intravenous fluids: Chemical and physical in-use stability has been demonstrated for 5 days at 25°C and 2-8°C, when the product is diluted to a concentration of 0.32 or 0.64 mg/ml and stored in the original plastic containers of the infusion fluids. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
This leaflet was last revised in March 2026