Patient leaflet - Ondansetron 4 mg solution for injection/infusion in Pre-filled syringe
1. WHAT ONDANSETRON INJECTION IS AND WHAT IT IS USED FOR
Ondansetron Injection contains the active substance ondansetron, which belongs to a group of medicines called anti-emetics.
Ondansetron Injection is used for
preventing nausea (feeling sick) and vomiting (being sick) caused by:
- chemotherapy for cancer in adults and in children aged ≥6 months
- radiotherapy for cancer in adults
- preventing and treatment of nausea and vomiting after surgery in adults and in children aged ≥ 1 month.
Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ONDANSETRON INJECTION
Do not use Ondansetron Injection:
- if you or your child are allergic to ondansetron or any of the other ingredients of this medicine (listed in section 6)
- if you or your child are taking Apomorphine (a medicine used to treat Parkinson’s disease).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Ondansetron Injection if you or your child:
- have a blockage in your gut or suffer from severe constipation as ondansetron can make these conditions worse
- have liver problems
- have ever had a problem with your heart or are taking medicines used to treat heart problems (e.g. congestive heart failure which causes shortness of breath and swollen ankles)
- have an uneven heartbeat (arrhythmias)
- are allergic to medicines similar to ondansetron, such as granisetron or palonosetron
- are having surgery to remove your tonsils, because treatment with ondansetron may hide symptoms of internal bleeding
- 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 or your child, talk to your doctor, nurse or pharmacist before having Ondansetron Injection.
Other medicines and Ondansetron Injection
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor, nurse or pharmacist if you or your child are taking any of the following medicines:
- phenytoin (used to treat epilepsy & heart arrhythmias). The effect of ondansetron may be weakened
- carbamazepine (used to treat epilepsy & neuralgic pain). The effect of ondansetron may be weakened
- rifampicin (used to treat infections such as tuberculosis (TB)). The effect of ondansetron may be weakened
- antibiotics such as erythromycin or ketoconazole
anti-arrhythmic medicines (used to treat an uneven heartbeat) such as amiodarone
- beta-blocker medicines (used to treat certain heart or eye problems, anxiety or prevent migraines) such as atenolol or timolol
- tramadol (used to treat pain). The painkilling effect of Tramadol may be weakened
- apomorphine (medicine used to treat Parkinson’s disease). Strong drop in blood pressure and loss of consciousness with simultaneous application of ondansetron have been reported with apomorphine
- medicines that affect the heart (such as haloperidol or methadone)
- cancer medicines (especially anthracyclines such as doxorubicin, daunorubicin or trastuzumab)
- SSRIs (selective serotonin reuptake inhibitors) used to treat depression and/or anxiety including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram
- SNRIs (serotonin noradrenaline reuptake inhibitors) used to treat depression and/or anxiety including venlafaxine, duloxetine.
Contact your doctor. It may be necessary to adjust the dose.
Ondansetron Injection with food, drink and alcohol
You may use Ondansetron Injection independently of food and drink.
Pregnancy, breast-feeding and fertility
Pregnancy
Only use Ondansetron Injection during the first trimester of pregnancy after discussion with your doctor of the potential benefits and risks to you and your unborn baby of the different treatment options. This is because Ondansetron 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 using Ondansetron Injection. If you are a woman of childbearing potential, you may be advised to use effective contraception.
Breast –feeding
Mothers receiving Ondansetron Injection should not breast-feed their baby because small amounts pass into the mothers’ milk.
If you are breast-feeding, ask your doctor or pharmacist for advice before using Ondansetron Injection.
Fertility
Effects of ondansetron on human fertility is unknown.
Driving and using machines
Ondansetron Injection will not affect your ability to drive or operate machinery.
Ondansetron Injection contains sodium
This medicine contains 3.60 mg sodium (main component of cooking/table salt) per 1 mL solution for injection/infusion in pre-filled syringe. This is equivalent to 0.18% of the recommended maximum daily dietary intake of sodium for an adult. At the maximum daily dose (32mg) this medicine contains 57.6 mg of sodium. This is equivalent to approximately 2.9% of the recommended daily dietary intake of sodium for an adult. To be taken into consideration by patients on a controlled sodium diet.
3. HOW TO USE ONDANSETRON INJECTION
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Ondansetron 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
Adults:
On the day of chemotherapy or radiotherapy the recommended 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. The usual adult intravenous dose does not exceed 8 mg.
On the following days
- after chemotherapy, your medicine will usually be given by mouth as an 8 mg ondansetron tablet or 10ml (8 mg) ondansetron syrup
- oral dosing can commence twelve hours after the last intravenous dose and may be continued for up to 5 days.
If your chemotherapy or radiotherapy is likely to cause severe nausea and vomiting, you or your child may be given more than the usual dose of Ondansetron Injection. Your doctor will decide this.
To prevent nausea and vomiting from chemotherapy
Children aged over 6 months and adolescents:
The doctor will decide the dose based on the child’s weight or size (body surface area).
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 tablets or syrup.
On the following days oral dosing can commence twelve hours after the last intravenous dose and may be continued for up to 5 days.
The following information is intended for healthcare professionals only:
Instructions for use
For intravenous injection or intramuscular injection or intravenous infusion after dilution. Prescribers intending to use ondansetron in the prevention of delayed nausea and vomiting associated with chemotherapy or radiotherapy in adults, adolescents or children should take into consideration current practice and appropriate guidelines.
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 Injection 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 oral, 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 8mg four hours apart, or by a constant infusion of 1 mg/hour for up to 24 hours
A maximum initial intravenous dose of 16 mg diluted in 50-100 ml of saline or other compatible infusion fluid (see section 6.6 of the SPC) and infused over not less than 15 minutes immediately before chemotherapy. The initial dose of Ondansetron Injection 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 16mg 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.
Dosing by BSA: Ondansetron Injection 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 twelve 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 Injection 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 (see SPC for further details). Ondansetron Injection should be diluted in 5% dextrose or 0.9% sodium chloride or other compatible infusion fluid (see section 6.6 of the SPC) and infused intravenously over not less than 15 minutes.
There are no data from controlled clinical trials on the use of Ondansetron Injection in the prevention of delayed or prolonged CINV. There are no data from controlled clinical trials on the use of Ondansetron Injection for radiotherapy-induced nausea and vomiting in children.
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Ondansetron 8 mg
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Ondansetron 8 mg
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 or your child keep feeling or being sick
Ondansetron Injection should start to work soon after having the injection. If you or your child continue to be sick or feel sick, tell your doctor or nurse.
If you or your child receive more Ondansetron Injection than you should
Your doctor or nurse will give you or your child Ondansetron Injection so it is unlikely that you or your child 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.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
SERIOUS SIDE-EFFECTS
Allergic Reactions
If you or your child have an allergic reaction, tell your doctor or a member of the medical staff straight away. The signs may include:
- 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 ischaemia
Signs include:
- sudden chest pain or
- chest tightness.
Other serious side effects
- seizures (fits or convulsions)
- disturbance in heart rhythm, sometimes causing a sudden loss of consciousness (Torsade de Pointes).
LESS SERIOUS SIDE-EFFECTS
Very common (may affect more than 1 in 10 people)
- headache.
Common (may affect up to 1 in 10 people)
- sensations of flushing or warmth
- constipation
- changes to liver function test results (if you have Ondansetron 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)
- unusual body movements or shaking
- uneven heartbeat
- chest pain
- low blood pressure, which can make you feel faint or dizzy
- hiccups.
Rare (may affect up to 1 in 1,000 people)
- feeling dizzy or light headed
- blurred vision.
Very rare (may affect up to 1 in 10,000 people)
- poor vision or temporary loss of eyesight, which usually comes back within 20 minutes.
Reporting of side effects
If you or your child 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 Website: www.mhra.gov.uk/yellowcard 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 INJECTION
Keep this medicine out of the sight and reach of children.
Expiry
Do not use this medicine after the expiry date, which is stated on the pre-filled syringe or carton after EXP. The expiry date refers to last day of that month.
Storage
This medicinal product does not require any special temperature storage conditions. Keep pre-filled syringe in the outer carton in order to protect from light.
Do not use this medicine if you notice container is damaged or particles / crystals are visible. Do not throw away any medicine 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 Injection contains
The active ingredient in Ondansetron Injection is ondansetron (as hydrochloride dihydrate).
Each ml of solution for injection/infusion contains 2 mg ondansetron (as ondansetron hydrochloride dihydrate).
Each pre-filled syringe of 4 ml contains 8 mg ondansetron (as ondansetron hydrochloride dihydrate).
The other ingredients are citric acid monohydrate, sodium citrate, sodium chloride, sodium hydroxide and/or hydrochloric acid for pH adjustment and water for Injections.
What Ondansetron Injection looks like and contents of the pack
Ondansetron Injection is a clear, colourless solution filled in amber glass pre-filled syringe.
Ondansetron Injection is available in pack containing 1, 5 & 10 pre-filled syringes.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturers:
Marketing Authorisation Holder
Accord, Barnstaple, EX32 8NS, UK
Manufacturer
Accord Healthcare Limited,
Sage House, 319 Pinner Road, North Harrow,
Middlesex, HA1 4HF,
United Kingdom
The leaflet was last revised in January 2022.
Post-operative nausea and vomiting (PONV)
Adults: For the prevention of PONV ondansetron can be administered orally or by intravenous or intramuscular injection.
Ondansetron Injection 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.
Children (aged over 1 month and adolescents)
Oral formulation: No studies have been conducted on the use of orally administered ondansetron in the prevention or treatment of post-operative nausea and vomiting; slow i.v. injection is recommended for this purpose.
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 0.1mg/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 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.
Patients with renal impairment: No alteration of daily dosage or frequency of dosing, or route of administration is required.
Patients with hepatic impairment: Clearance of Ondansetron Injection 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 parental 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 is required.
Incompatibilities
The solution must not be sterilised in an autoclave.
Ondansetron Injection should only be admixed with those infusion solutions, which are recommended: Sodium Chloride Intravenous Infusion BP 0.9%w/v
Glucose Intravenous Infusion BP 5%w/v
Mannitol Intravenous Infusion BP 10%w/v
Ringers Intravenous Infusion
Potassium Chloride 0.3%w/v and Sodium Chloride 0.9%w/v Intravenous Infusion BP Potassium Chloride 0.3%w/v and Glucose 5%w/v Intravenous Infusion BP
The stability of Ondansetron Injection after dilution with the recommended infusion fluids have been demonstrated in concentrations 0.016 mg/ml and 0.64 mg/ml.
Use only clear and colourless solutions.
The diluted solutions should be stored protected from light.
Shelf-life and storage
30 months
This medicinal product does not require any special temperature storage conditions. Keep pre-filled syringe in the outer carton in order to protect from light.
Injection
After first opening, the medicinal product should be used immediately.
Infusion
After dilution with recommended diluents chemical and physical in-use stability has been demonstrated for 7 days at 25°C and 2-8°C.
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.
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