Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Your medicine comes as a solution for injection or infusion (drip). The active ingredient is ondansetron. The other ingredients are listed in section 6. Ondansetron belongs to a group of medicines called anti-emetics or anti-sickness medicine. Ondansetron can be used to prevent or treat nausea (feeling sick) or vomiting, following an operation, cancer chemotherapy or radiation treatment. Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses.
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• if you have depression or other conditions that are treated with antidepressants, or if you are taking painkillers such as opioids. The use of these medicines together with Ondansetron Injection can lead to serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Ondansetron Injection"). • If you are allergic to medicines similar to ondansetron, such as granisetron (known as 'Kytril') Special precautions should be taken if Ondansetron Injection is to be given to a child receiving medication for cancer treatment which might alter liver function. Other medicines and Ondansetron Injection Please tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines and especially any of the following medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Ondansetron Injection can affect the way some medicines work. Also, some other medicines can affect the way Ondansetron Injection works. * Phenytoin, carbamazepine; to treat epilepsy, as these medicines may reduce the effect of Ondansetron Injection * Antibiotics such as rifampicin or erythromycin, as these medicines may reduce the effect of Ondansetron Injection * Ketoconazole, a medicine used to treat a fungal infection, * Tramadol, a strong painkiller, as Ondansetron Injection may reduce the effect of tramadol * Medicines used to treat an uneven heartbeat (arrhythmias), as these medicines may interact with Ondansetron Injection and affect the rhythm of the heart * Cancer medicines (e.g. anthracyclines or trastuzumab), antibiotics (e.g. erythromycin), antifungals (e.g. ketoconazole) or other medicines which might disturb your heart rhythm, * Beta-blocker medicines used to treat certain heart or eye problems, anxiety or prevent migraines, as these medicines may interact with Ondansetron Injection and affect the rhythm of the heart * Medicines that affect the heart (such as haloperidol or methadone) * Medicines to treat depression such as SSRIs (selective serotonin reuptake inhibitors) including fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, or SNRIs (serotonin and noradrenaline reuptake inhibitors) including venlafaxine, duloxetine or medicines known as opioids/opiates, e.g. buprenorphine used in the treatment of acute or chronic pain, as these may cause serotonin syndrome, a potentially life-threatening reaction. The symptoms of serotonin syndrome may include a combination of the following: nausea (feeling sick), vomiting, agitation, confusion, diarrhoea, high temperature, increased blood pressure, excessive sweating, rapid heartbeat, hallucinations, loss of coordination, overactive reflexes and coma. If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before having Ondansetron Injection. You should not be given this medicine if you are already taking apomorphine (used to treat Parkinson's disease); because severe hypotension (low blood pressure) and loss of consciousness have been reported in patients treated with both apomorphine and Ondansetron Injection at the same time. Ondansetron Injection should not be given in the same syringe or infusion (drip) as any other medication. Pregnancy and breast-feeding 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 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 taking Ondansetron Injection. If you are a woman of childbearing potential, you may be advised to use effective contraception.
• 2 mg syrup twice a day for small children and those weighing 10 kg or less • one 4 mg tablet or 4 mg syrup twice a day for larger children and those weighing more than 10 kg • two 4 mg tablets or 8 mg syrup twice a day for teenagers (or those with a large body surface area) • these doses can be given for up to five days Elderly
• If you are over 65 years of age, your doctor will adjust your dose as required. To prevent and treat nausea and vomiting after an operation Adult
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Do not breast-feed if you are being treated with Ondansetron Injection. This is because small amounts pass into the mother's breast milk. Ask your doctor or midwife for advice. Driving and using machines Ondansetron Injection should not affect your ability to drive or use machines. However, if any of the side effects (see Section 4) affect you (e.g. dizziness, blurred vision) caution is advisable. Do not drive or operate if you are feeling unwell. Ondansetron Injection contains sodium This medicine contains less than 1 mmol sodium (23 mg) per ml of injection, that is to say essentially 'sodium-free'.
How your Ondansetron Injection is given to you Ondansetron Solution for Injection will usually be given to you by a nurse or doctor by slow injection or infusion (drip) into a vein (intravenously). 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
• A single dose should not be more than 16mg. • 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 tablet or 8 mg Ondansetron syrup. On the following days
• The usual adult dose is one 8 mg tablet or 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. Your doctor will decide this. To prevent nausea and vomiting from chemotherapy in children aged over 6 months to 17 years The doctor will decide the dose depending on the child's size (body surface area) or weight. On the day of chemotherapy
• The first dose (up to 8 mg) 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 an Ondansetron tablet. On the following days
• The usual dose for adults is 4 mg given by a slow injection into your vein or muscle. For prevention, this will be given just before your operation.
Children
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• 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 have blood tests to check how your liver is working, this medicine may affect the results. Ondansetron Injection should start to work soon after you are given the injection. If you continue to be sick or feel sick, tell your doctor or nurse. If you are concerned about how much medicine you have been given or how often you have been given it, please tell your doctor or nurse. If you have more Ondansetron Injection than you should There is limited experience of ondansetron overdose. In a few patients, the following symptoms were observed: visual disturbances, severe constipation, low blood pressure and unconsciousness. In all cases, the symptoms disappeared completely. Tell your doctor if any of these symptoms occur. 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor or a member of the medical staff straight away if you have: - An allergic reaction. 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. If you are allergic to similar medicine you are more likely to suffer these effects. - Fits (seizures) - Disturbances in heart rhythm (sometimes causing a sudden loss of consciousness). Other side effects include: Very Common side effects (may affect more than 1 in 10 people) - Headache. Common side effects (may affect up to 1 in 10 people) - Constipation. If you are constipated tell your doctor, - Feeling flushed or warm, - Redness or irritation at the injection site. - Changes to liver function test results (if you are given Ondansetron Injection with a medicine called cisplatin, otherwise this side effect is uncommon). Uncommon side effects (may affect up to 1 in 100 people) - Spasms in the muscles of the face and eyes, tremor, uncontrollable movements, - Hiccups, - Chest pain, an irregular or slow heartbeat or low blood pressure - Low blood pressure, which can make you feel faint or dizzy,
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- Fits, - Unusual body movements or shaking Rare side effects (may affect up to 1 in 1,000 people) - Blurred vision, - Dizziness when ondansetron is injected quickly into the vein, - Disturbance in heart rhythm (sometimes causing a sudden loss of consciousness). Very rare side effects (may affect up to 1 in 10,000 people) - Temporary loss of eyesight, which usually comes back within 20 minutes, - A widespread rash with blisters and skin peeling on much of the body surface (toxic epidermal necrolysis) Unknown (cannot be estimated from the available data) - myocardial ischemia – signs include sudden chest pain or chest tightness Side effects in children and adolescents were comparable to that seen in adults. 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/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.
Manufacturer Viatris Santé, 1 rue de Turin, 69007 Lyon - France Pharmathen S.A., 6 Dervenakion, 153 51 Pallini, Attikis, Athens – Greece Mylan B.V., Dieselweg 25, 3752 LB Bunschoten – The Netherlands Demo S.A., 21st Km National Road Athens-Lamia, 145 68 Athens – Greece This leaflet was last revised in June 2022. ---------------------------------------------------------------------------------------------------------------------- →
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The following information is intended for healthcare professionals only: Posology and method of administration • Patients with moderate to severe liver problems will not be given more than 8 mg of Ondansetron in a day. • No alteration of daily dosage or frequency of dosing, or route of administration are required. • Ondansetron is also available as a tablet. FOR MOST PATIENTS HAVING EMOTOGENIC CHEMOTHERAPY OR RADIATION TREATMENT Adults (including the elderly) 8 mg of Ondansetron –should be administered as a slow intravenous injection (in not less than 30 seconds) or intramuscular injection, immediately before treatment, followed by an 8 mg tablet 12 hours after treatment. To prevent further sickness after treatment an 8 mg tablet twice a day may be taken for up to 5 days. The selection of dose regimen should be determined by the severity of the emetogenic challenge. FOR PATIENTS HAVING CHEMOTHERAPY THAT CAUSES SEVERE NAUSEA AND VOMITING Adults (including the elderly) The dose range of Ondansetron Solution for Injection or Infusion is 8 to 32 mg a day and selected as shown below. During the first day of treatment, any of the following doses may be given: - 8 mg injected, by slow intravenous injection (in not less than 30 seconds) or intramuscular injection, immediately before treatment, followed by 8 mg orally twelve hourly - 8 mg injected, by slow intravenous injection (in not less than 30 seconds) or intramuscular injection, immediately before chemotherapy, followed by two more 8 mg doses injected 4 hours apart or by intravenous infusion (drip) of 1 mg per hour for up to 24 hours Patients age 75 years or older: - A single dose of 8 mg given as an intravenous infusion (drip), over not less than 15 minutes, immediately before chemotherapy. A single dose greater than 8 mg must not be given. Adult patients younger than 75 years: - A single dose of 16 mg given as an intravenous infusion (drip), over not less than 15 minutes, immediately before chemotherapy. A single dose greater than 16 mg must not be given. All intravenous doses should be diluted in 50-100 mL of saline or other compatible fluid and infused over at least 15 minutes in patients age 65 years or older. Repeat intravenous doses should be given no less than 4 hours apart.
≥ 0.6 m2 to ≤ 1.2 m2 5 mg/m2 IV plus 4 mg syrup or tablet after 12 hours
4 mg syrup or tablet every 12 hours > 1.2 m2 5 mg/m2 or 8 mg IV plus 8 mg syrup or tablet after 12 hours
> 10 kg Up to 3 doses of 0.15 mg/kg IV every 4 hours
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To prevent sickness after treatment an 8 mg tablet twice a day may be taken for up to 5 days. Children (aged 6 months and above) and adolescents - For chemotherapy, the usual dosage is either a single intravenous dose of 5 mg/m2 body surface area or up to 3 doses of 0.15 mg/kg body weight at 4-hourly interval (section 4.4 and 5.1 of the prescribing information). The intravenous dose must not exceed 8 mg. The total daily dose must not exceed adult dose of 32 mg. - There is no recommendation for the use of ondansetron either for the prevention of delayed or prolonged nausea and vomiting induced by chemotherapy or nausea and vomiting caused by radiotherapy. Table 1: BSA-based dosing for Chemotherapy - Children aged ≥ 6 months to 17 years BSA Day 1 (a,b) Days 2-6 (b) < 0.6 m2 5 mg/m2 IV plus 2 mg syrup after 12 hours
2 mg syrup every 12 hours
8 mg syrup or tablet every 12 hours a The intravenous dose must not exceed 8 mg. b 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 (see sections 4.4 and 5.1). Ondansetron should be administered immediately before chemotherapy as a single IV dose of 0.15 mg/Kg. The single intravenous dose must not exceed 8 mg. On Day 1, 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 Table 2). The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg. Table 2: Weight-based dosing for Chemotherapy - Children aged ≥ 6 months to 17 years Weight Day 1 (a,b) Days 2-6 (b) ≤10 kg Up to 3 doses of 0.15 mg/kg IV every 4 hours
2 mg syrup every 12 hours
4 mg syrup or tablet every 12 hours a The intravenous dose must not exceed 8 mg. b The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg. FOR PATIENTS HAVING AN OPERATION Adults (including the elderly) To prevent nausea and vomiting – 4 mg injected by intramuscular or slow intravenous injection before the operation. To treat established PONV nausea and vomiting – 4 mg given by intramuscular or slow intravenous injection. Children (aged 1 month and above) and adolescents
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- For prevention and treatment of post-operative nausea and vomiting after a surgery under general anaesthesia, a single dose of ondansetron at 0.1 mg/kg up to a maximum of 4 mg is administered into a vein during not less than 30 seconds. - There is no recommendation for the use of ondansetron in the treatment of post-operative nausea and vomiting in children under 2 years of age. Patients with kidney problems or who cannot metabolise sparteine/debrisoquine well can take the recommended doses of ondansetron, as detailed above. Instructions for use/handling • Once opened use immediately. • In keeping with good pharmaceutical practice, dilutions of Ondansetron injection in intravenous fluids should be prepared at the time of infusion. Once diluted the solution for infusion should be stored in the original plastic container of the infusion fluid. Chemical and physical in-use stability has been demonstrated for 7 days at 5°C and 25°C when the product is diluted to a concentration of 0.32 or 0.64 mg/ml. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to the 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. • Do not use the injection if the ampoule is damaged or the solution is cloudy or contains particles. • Single use only. Any unused solution should be discarded. • Ondansetron solution for injection should not be autoclaved. • Compatibility with solutions for infusion Ondansetron injection should not be administered in the same syringe or infusion as any other medication. Ondansetron solution for injection should only be admixed with those infusion solutions which are recommended: - Sodium Chloride 9 mg/ml (0.9%) solution for infusion - Glucose 50 mg/ml (5%) solution for infusion - Mannitol 100 mg/ml (10%) solution for infusion - Ringers solution for infusion - Potassium Chloride 3 mg/ml (0.3%) and Sodium Chloride 9 mg/ml (0.9%) solution for infusion - Potassium Chloride 3 mg/ml (0.3%) and Glucose 50 mg/ml (5%) solution for infusion
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 I 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 medicinal products Dexamethasone-21-dihydrogenphosphate disodium: 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. Ondansetron may be administered by intravenous infusion by 1 mg/hour. The following medicinal products may be administered only via a Y-site of an infusion set in concentrations of ondansetron of 16 to 160 micrograms/ml (e.g. 8 mg/ 500 ml and 8 mg/ 50 ml respectively):
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Cisplatin: Concentrations up to 0.48 mg/ml (e.g. 240 mg in 500 ml) administered over one to eight hours. Carboplatin: Concentrations not exceeding the range of 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. 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. Etoposide: Concentrations not exceeding the range of 0.144 mg/ml to 0.250 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 of 250 mg to 2000 mg reconstituted with water for injections 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 of 100 mg to 1 g, reconstituted with water for injections, 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 of 10 mg to 100 mg reconstituted with water for injections, 5 ml per 10 mg doxorubicin, as recommended by the manufacturer and given as an intravenous bolus injection over approximately 5 minutes. Overdose Symptoms and Signs: There is limited experience of Ondansetron overdose. In the majority of cases symptoms were similar to those already reported in patients receiving recommended doses (see section 4.8 of the prescribing information). Manifestations that have been reported include visual disturbances, severe constipation, hypotension and a vasovagal episode with transient second-degree AV block. Ondansetron prolongs QT interval in a dose-dependent fashion. ECG monitoring is recommended in cases of overdose. Cases consistent with serotonin syndrome have been reported in young children following oral overdose. There is no specific antidote to ondansetron; for that reason, if overdose is suspected, only the symptoms should be treated. Using a drug inducing vomiting (ipecacuanha) is not recommended. ECG monitoring is recommended.
Ondansetron 2 mg/ml Solution for Injection comes as injection containing 2mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Ondansetron 2 mg/ml Solution for Injection is ondansetron hydrochloride dihydrate.
Medicines with the same active substance, strength and form include: Ondansetron 2 mg/ml Solution for Injection, Ondansetron 2 mg/ml solution for injection/infusion, Ondansetron 2 mg/ml solution for injection/infusion. In total there are 4 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Ondansetron 2 mg/ml Solution for Injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Adults:
Ondansetron is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention and treatment of post-operative nausea and vomiting (PONV).
Paediatric population:
Ondansetron is indicated for the management of chemotherapy-induced nausea and vomiting (CINV) in children aged ≥ 6 months, and for the prevention and treatment of post-operative nausea and vomiting (PONV) in children aged ≥ 1 month.
Ondansetron 4 mg / 2 ml Solution for Injection / Ondansetron 8 mg / 4 ml Solution for Injection:
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 in the range of 8-32 mg a day 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 8 mg should be administered as a slow intravenous injection (in not less than 30 seconds) or as a short-time intravenous infusion over 15 minutes 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
For patients receiving highly emetogenic chemotherapy, e.g. high-dose cisplatin, Ondansetron can be given either by oral, rectal or intravenous 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 intravenous dose of 16 mg diluted in 50-100 ml of 0.9% Sodium Chloride Injection or other compatible infusion fluid (see section 6.6) 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).
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:
Chemotherapy-induced nausea and vomiting (CINV) in children aged ≥ 6 months to 17 years
The dose for CINV can be calculated based on body surface area (BSA) or weight – see below. In paediatric clinical studies, ondansetron was given by IV infusion diluted in 25 to 50 ml of saline or other compatible infusion fluid and infused over not less than 15 minutes.
Weight-based dosing results in higher total daily doses compared to BSA-based dosing – see sections 4.4 and 5.1.
Ondansetron injection should be diluted in 5% dextrose or 0.9% sodium chloride or other compatible infusion fluid (see section 6.6) 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 Table 1)
The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg.
Table 1: BSA-based dosing for Chemotherapy - Children aged ≥ 6 months to 17 years
BSA
Day 1 (a,b)
Days 2-6 (b)
< 0.6 m2
5 mg/m2 IV plus 2 mg syrup after 12 hours
2 mg syrup every 12 hours
≥ 0.6 m2 to ≤ 1.2 m2
5 mg/m2 IV plus 4 mg syrup or tablet after 12 hours
4 mg syrup or tablet every 12 hours
> 1.2 m2
5 mg/m2 or 8 mg IV plus 8 mg syrup or tablet after 12 hours
8 mg syrup or tablet every 12 hours
a The intravenous dose must not exceed 8 mg.
b 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 (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 single intravenous dose must not exceed 8 mg.
On Day 1, 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 Table 2).
The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg.
Table 2: Weight-based dosing for Chemotherapy - Children aged ≥ 6 months to 17 years
Weight
Day 1 (a,b)
Days 2-6 (b)
≤10 kg
Up to 3 doses of 0.15 mg/kg IV every 4 hours
2 mg syrup every 12 hours
> 10 kg
Up to 3 doses of 0.15 mg/kg IV every 4 hours
4 mg syrup or tablet every 12 hours
a The intravenous dose must not exceed 8 mg.
b The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg.
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 0.9% Sodium Chloride Injection or other compatible infusion fluid (see section 6.6) and infused 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 0.9% Sodium Chloride Injection or other compatible infusion fluid (see section 6.6) 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 section 5.2).
Please refer also to 4.2.3 “Special Populations”.
Post-Operative Nausea and Vomiting (PONV)
Adults:
Prevention of PONV
For the prevention of PONV: Ondansetron can be administered orally or by intravenous injection.
Ondansetron may be administered as a single dose of 4 mg given by slow intravenous or intramuscular injection at induction of anaesthesia.
Treatment of established PONV
For treatment of established PONV: A single dose of 4 mg given by intramuscular or slow intravenous injection is recommended.
Paediatric population:
PONV in children aged ≥ 1 month to 17 years
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 is 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.
Please refer also to 4.2.3 “Special Populations”.
Special Populations
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 intravenously 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 is required.
Hypersensitivity to ondansetron or to other selective 5-HT3-receptor antagonists (e.g. granisetron, dolasetron) or to any of the excipients listed in section 6.1.
Based on reports of profound hypotension and loss of consciousness when ondansetron was administered with apomorphine hydrochloride, concomitant use with apomorphine is contraindicated (see section 4.5).
Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5HT3 receptor antagonists.
Respiratory events should be treated symptomatically and clinicians should pay particular attention to them as precursors of hypersensitivity reactions.
Ondansetron prolongs the QT interval in a dose-dependent manner (see section 5.1). In addition, post-marketing cases of Torsade de Pointes have been reported in patients using ondansetron. Avoid ondansetron in patients with congenital long QT syndrome. Ondansetron should be administered with caution to patients who have or may develop prolongation of QTc, including patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmias, conduction disturbances and in patients taking anti-arrhythmic agents or beta-adrenergic blocking agents or other medicinal products that lead to QT prolongation or electrolyte abnormalities.
Hypokalemia and hypomagnesemia should be corrected prior to ondansetron administration.
Cases of myocardial ischemia have been reported in patients treated with ondansetron. In some patients, especially in the case of intravenous administration, symptoms appeared immediately after administration of ondansetron. Patients should be alerted to the signs and symptoms of myocardial ischemia.
There have been post-marketing reports describing patients with potentially life-threatening serotonin syndrome (including altered mental status, autonomic instability, neuromuscular abnormalities and/or gastrointestinal symptoms) following the concomitant use of ondansetron and other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRI) and serotonin noradrenaline reuptake inhibitors (SNRIs) and opioid/opiate medicines (e.g. buprenorphine)). If concomitant treatment with ondansetron and other serotonergic drugs is clinically warranted, appropriate observation of the patient is advised.
As ondansetron is known to increase large bowel transit time, patients with signs of sub-acute intestinal obstruction should be monitored following administration.
In patients with adenotonsillar surgery prevention of nausea and vomiting with ondansetron may mask occult bleeding. Therefore, such patients should be followed carefully after ondansetron.
Paediatric Population:
Paediatric patients receiving ondansetron with hepatotoxic chemotherapeutic agents should be monitored closely for impaired hepatic function.
CINV:
When calculating the dose on a mg/kg basis and administering three doses at 4-hour intervals, the total daily dose will be higher than if one single dose of 5 mg/m2 followed by an oral dose is given. The comparative efficacy of these two different dosing regimens has not been investigated in clinical trials. Cross-trial comparison indicates similar efficacy for both regimens (see section 5.1).
Excipient:
This medicine contains less than 1 mmol sodium (23 mg) per ml of injection, that is to say essentially 'sodium-free'.
However, if a solution of common salt (0.90% w/v sodium chloride solution) is used for the dilution of Ondansetron prior to administration then the dose of sodium received would be higher.
There is no evidence that ondansetron either induces or inhibits the metabolism of other drugs commonly co-administered with it. Specific studies have shown that there are no interactions when ondansetron is administered with alcohol, temazepam, furosemide, alfentanil, tramadol, morphine, lidocaine, thiopental or propofol.
Ondansetron is metabolised by multiple hepatic cytochrome P-450 enzymes: CYP3A4, CYP2D6 and CYP1A2. Due to the multiplicity of metabolic enzymes capable of metabolising ondansetron, enzyme inhibition or reduced activity of one enzyme (e.g. CYP2D6 genetic deficiency) is normally compensated by other enzymes and should result in little or no significant change in overall ondansetron clearance or dose requirement.
Caution should be exercised when ondansetron is coadministered with drugs that prolong the QT interval (including some cytotoxics) and/or cause electrolyte abnormalities. (See section 4.4).
Use of ondansetron with QT prolonging drugs may result in additional QT prolongation.
Concomitant use of ondansetron with cardiotoxic drugs (e.g. anthracyclines (such as doxorubicin, daunorubicin) or trastuzumab), antibiotics (such as erythromycin), antifungals (such as ketoconazole), antiarrhythmics (such as amiodarone) and beta blockers (such as atenolol or timolol)) may increase the risk of arrhythmias (see section 4.4).
Serotonergic Drugs (e.g. SSRIs and SNRIs)
There have been post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the concomitant use of ondansetron and other serotonergic drugs (including SSRIs and SNRIs). There are also reports of serotonin syndrome when ondansetron is used concomitantly with opioid/opiate medicines, e.g. buprenorphine. (See section 4.4).
Apomorphine
Based on reports of profound hypotension and loss of consciousness when ondansetron was administered with apomorphine hydrochloride, concomitant use with apomorphine is contraindicated.
Phenytoin, Carbamazepine and Rifampicin:
In patients treated with potent inducers of CYP3A4 (i.e. Phenytoin, Carbamazepine and Rifampicin), the oral clearance of ondansetron was increased and ondansetron blood concentrations were decreased.
Tramadol:
Data from small studies indicate that ondansetron may reduce the analgesic effect of tramadol.
Women of childbearing potential
Women of childbearing potential should consider the use of contraception.
Pregnancy
Based on human experience from epidemiological studies, ondansetron is suspected to cause orofacial malformations when administered during the first tirmester of pregnancy.
In one cohort study including 1.8 million pregnancies, first trimester ondansetron use was associated with an increased risk of oral clefts (3 additional cases per 10,000 women treated; adjusted relative risk, 1.24, (95% CI 1.03-1.48)).
The available epidemiological studies on cardiac malformations show conflicting results.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity
Ondansetron should not be used during the first trimester of pregnancy.
Pregnancy testing
Pregnancy status should be verified in women of child-bearing potential prior to starting the retreatment with Ondansetron.
Breast-feeding
There is insufficient information on the excretion of ondansetron/metabolites in human milk or the effects of Ondansetron on milk production. Tests have shown that ondansetron passes into the milk of lactating animals. It is therefore recommended that mothers receiving Ondansetron should not breast-feed their babies.
Fertility
There is no information on the effects of ondansetron on human fertility.
Ondansetron has no or negligible influence on the ability to drive and use machines.
In psychomotor testing ondansetron does not impair performance nor cause sedation. No detrimental effects on such activities are predicted from the pharmacology of ondansetron.
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) very rare (<1/10,000) and unknown (cannot be estimated from the available data). Very common, common and uncommon events were generally determined from clinical trial data. The incidence in placebo was taken into account. Rare and very rare events were generally determined from post-marketing spontaneous data. The following frequencies are estimated at the standard recommended doses of Ondansetron according to indication and formulation.
Immune system disorders
Rare: immediate hypersensitivity reactions, sometimes severe, including anaphylaxis.
Nervous system disorders
Very common: Headache.
Uncommon: Seizures, movement disorders (including extrapyramidal reactions such as dystonic reactions, oculogyric crisis and dyskinesia (1).
Rare: Dizziness predominantly during rapid IV administration.
Eye Disorders
Rare: Transient visual disturbances (e.g. blurred vision) predominantly during rapid IV administration.
Very rare: Transient blindness predominantly during intravenous administration(2).
Cardiac disorders
Uncommon: Arrhythmias, chest pain, with or without ST segment depression, bradycardia.
Rare: QTc prolongation (including Torsade de Pointes).
Unknown: Myocardial ischemia (see section 4.4)
Vascular disorders
Common: Sensation of warmth or flushing.
Uncommon: Hypotension.
Respiratory, thoracic and mediastinal disorders
Uncommon: Hiccups.
Gastrointestinal disorders
Common: Constipation.
Hepatobiliary disorders
Uncommon: asymptomatic increases in liver function tests (3).
Skin and subcutaneous tissue disorders
Very rare: Toxic skin eruption, including toxic epidermal necrolysis
General disorders and administration site conditions
Common: Local IV injection site reactions.
(1). Observed without definitive evidence of persistent clinical sequelae.
(2). The majority of the blindness cases reported resolved within 20 minutes. Most patients had received chemotherapeutic agents, which included cisplatin. Some cases of transient blindness were reported as cortical in origin.
(3). These events were observed commonly in patients receiving chemotherapy with cisplatin.
Paediatric population:
The adverse event profiles in children and adolescents were comparable to that seen in adults.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms and Signs
There is limited experience of ondansetron overdose. In the majority of cases, symptoms were similar to those already reported in patients receiving recommended doses (see section 4.8). Manifestations that have been reported include visual disturbances, severe constipation, hypotension and a vasovagal episode with transient second degree AV block.
Ondansetron prolongs the QT interval in a dose-dependent manner. ECG monitoring is recommended in cases of overdose.
Paediatric population
Paediatric cases consistent with serotonin syndrome have been reported after inadvertent oral overdoses of ondansetron (exceeded estimated ingestion of 4 mg/kg) in infants and children aged 12 months to 2 years.
Treatment
There is no specific antidote for ondansetron, therefore in all cases of suspected overdose, symptomatic and supportive therapy should be given as appropriate.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
The use of ipecacuanha to treat overdose with Ondansetron is not recommended, as patients are unlikely to respond due to the anti-emetic action of Ondansetron itself.
Ask anything about Ondansetron 2 mg/ml Solution for Injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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