Ondansetron parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections or infusion of ondansetron.
Drugs List
Therapeutic Indications
Uses
Chemotherapy induced nausea and vomiting
Nausea or vomiting associated with radiotherapy
Prevention/treatment of post-operative nausea and vomiting
Ondansetron is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy.
Ondansetron is indicated for the prevention and treatment of post-operative nausea and vomiting.
Dosage
Adults
The emetogenic potential of cancer chemotherapy varies according to the dose and regimen used. The route and dose of ondansetron should be flexible in the range of 8mg to 32mg a day.
Moderately emetogenic chemotherapy or radiotherapy:
8mg administered as a slow intravenous or intramuscular injection or as an intravenous infusion over 15 minutes, immediately before treatment, then 8mg orally every 12 hours for up to 5 days.
Severely emetogenic chemotherapy:
A single dose of 8mg by slow intravenous or intramuscular injection immediately before chemotherapy. Where necessary followed by two further doses of 8mg four hours apart, or by a constant infusion of 1mg/hour for up to 24 hours.
Alternatively, a single dose of 16mg diluted in 50ml to 100ml of compatible infusion fluid by intravenous infusion over not less than 15 minutes immediately before chemotherapy. This initial dose may be followed by two additional 8mg intravenous or intramuscular doses four hours apart. Single doses greater than 16mg must not be used due to dose dependent increase of QT-prolongation risk.
Intravenous dexamethasone sodium phosphate in a single dose of 20mg, may be used to enhance effect of ondansetron before highly emetogenic chemotherapy.
To protect against delayed or prolonged emesis after the first 24 hours, oral or rectal treatment should be continued for up to 5 days.
Prevention of Post-Operative Nausea and Vomiting:
4mg administered by intramuscular or slow intravenous injection at induction of anaesthesia.
Treatment of Post-Operative Nausea and Vomiting:
4mg by intramuscular or slow intravenous injection once only.
Elderly
Patients aged 75 years or older
The initial dose should not exceed 8mg.
All intravenous doses should be diluted in 50ml to 100ml of saline or other compatible infusion fluid and infused over 15 minutes.
The initial dose of 8mg may be followed by two further intravenous doses of 8mg, infused over 15 minutes and given no less than four hours apart.
Patients aged 65 to 74 years
(See Dosage; Adult)
All intravenous doses should be diluted in 50ml to 100ml of saline or other compatible infusion fluid and infused over 15 minutes.
Children
Ondansetron parenteral preparations are not licensed for use in children under 6 months for the treatment of chemotherapy induced nausea and vomiting or in children under 1 month for the prevention and treatment of post-operative nausea and vomiting. Ondansetron is not licensed for radiotherapy-induced nausea and vomiting in children.
For prevention and treatment of chemotherapy induced nausea and vomiting in children over 6 months :
Ondansetron should be diluted in compatible infusion fluid and infused intravenously over not less than 15 minutes.
Dose can be calculated based on body surface area (BSA) or weight:
Dosing by BSA: 5mg per metre squared (maximum 8mg) intravenously immediately prior to chemotherapy followed after 12 hours by oral preparation up to 5 days.
BSA greater than 1.2metre squared:
Day one: a single intravenous dose of 5mg per metre squared or 8mg followed by 8mg oral dose after 12 hours.
Days two to six: 8mg oral dose every 12 hours.
BSA 0.6 to 1.2metre squared:
Day one: a single intravenous dose of 5mg per metre squared followed by 4mg oral dose after 12 hours.
Days two to six: 4mg oral dose every 12 hours.
BSA less than 0.6metre squared:
Day one: a single intravenous dose of 5mg per metre squared followed by 2mg syrup after 12 hours.
Days two to six: 2mg oral every 12 hours.
The intravenous dose must not exceed 8mg and the total daily dose must not exceed adult dose of 32mg.
Dosing by weight: Weight-based dosing results in higher total daily doses compared to BSA-based dosing. The first dose must be given immediately before chemotherapy. Oral dosing can commence 12 hours later and may be continued for up to 5 days. Up to three doses of 150micrograms/kg repeated every 4 hours, then give by mouth.
Weight greater than 10kg:
Day one: up to 3 doses of 150microgram/kg every 4 hours.
Days two to six: 4mg oral dose every 12 hours.
Weight less than or equal to 10kg:
Day one: up to 3 doses of 150micrograms/kg every 4 hours.
Days two to six: 2mg oral every 12 hours.
The intravenous dose must not exceed 8mg and the total daily dose must not exceed adult dose of 32mg.
For prevention and treatment of radiotherapy-induced nausea and vomiting (unlicensed)
Children aged 6 months to 18 years:
BSA 1.3metre squared and over: 8mg by intravenous infusion over 15 minutes immediately before radiotherapy, then give by mouth.
Or
150micrograms/kg immediately before radiotherapy (maximum single dose 8mg) repeated every 4 hours for 2 further doses, then give by mouth.
Maximum total daily dose 32mg.
BSA up to 1.3metre squared: 5mg per metre squared by intravenous infusion immediately before radiotherapy (maximum single dose 8mg), then give by mouth.
Or
150micrograms/kg immediately before radiotherapy (maximum single dose 8mg) repeated every 4 hours for two further doses, then give by mouth.
Maximum total daily dose 32mg.
Prevention and treatment of post-operative nausea and vomiting in children over 1 month :
100micrograms/kg (maximum 4mg), as a single dose via slow intravenous injection over at least 30 seconds before, during, or after induction of anaesthesia.
Patients with Hepatic Impairment
Adults:
Do not exceed total daily dose of 8mg in patients with moderate to severe hepatic impairment.
Administration
For intramuscular or intravenous injection or intravenous infusion.
Ondansetron should be diluted in compatible infusion fluid and infused intravenously over not less than 15 minutes.
Contraindications
Neonates under 1 month
Breastfeeding
First trimester of pregnancy
Long QT syndrome
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
Females of childbearing potential
Patients over 75 years
Bradyarrhythmia
Congestive cardiac failure
Electrolyte imbalance
History of torsade de pointes
Moderate hepatic impairment
Second trimester of pregnancy
Subacute gastrointestinal obstruction
Third trimester of pregnancy
Correct electrolyte disorders before treatment
May mask occult bleeding in adenotonsillar surgery patients
Reduce dose in patients with hepatic impairment
Correct hypokalaemia before treatment
Correct hypomagnesaemia prior to administration
Perform ECG before and during treatment
Monitor patients with signs of sub-acute intestinal obstruction
Monitor respiratory function
Monitor serum electrolytes
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Not licensed for all indications in all age groups
Advise patient not to take St John's wort concurrently
Female: Ensure adequate contraception during treatment
Paediatric patients receiving ondansetron with hepatotoxic chemotherapeutic agents should be monitored closely for impaired hepatic function.
Pregnancy and Lactation
Pregnancy
Ondansetron is contraindicated during the 1st trimester of pregnancy but may be used with caution during the 2nd and 3rd trimester.
Use of ondansetron during the 1st trimester of pregnancy is contraindicated by the manufacturer. Use during the first trimester has been associated with an increased risk of oral clefts with conflicting evidence also suggesting the risk of cardiac malformations. Briggs (2015) notes that most human and animal data suggests the risk of birth defects are low but these studies typically take place after the first trimester.
Lactation
Ondansetron is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking ondansetron. Available data indicates ondansetron is expressed in human breast milk, but the quantity is unknown. However, LactMed (2021) suggests that the amount of milk expressed in breast milk is likely to be much lower than therapeutic dose. Schaefer (2015) suggests that the antiemetic of choice during breastfeeding is meclizine.
Effects on exposed infants are unknown.
Side Effects
Altered liver function tests
Anaphylaxis
Arrhythmias
Blindness (temporary)
Blurred vision
Bradycardia
Chest pain
Constipation
Depression
Dizziness
Dyskinesia
Dystonia
Extrapyramidal effects
Flushing
Headache
Hiccups
Hypersensitivity reactions
Hypotension
Injection site reactions
Itching
Movement disturbances
Myocardial ischaemia
Oculogyric crisis
Prolongation of QT interval
Rash
Seizures
Sensation of warmth
ST segment depression
Torsades de pointes
Urticaria
Visual disturbances
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: February 2022
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Ondansetron 2mg/ml solution for injection or infusion. Accord Healthcare Ltd. Revised December 2019.
Summary of Product Characteristics: Ondansetron 2mg/ml solution for injection. Hameln Pharmaceuticals Ltd. Revised May 2020.
Summary of Product Characteristics: Zofran injection. Novartis Pharmaceuticals UK Ltd. Revised January 2022.
Summary of Product Characteristics: Zofran Flexi-Amp injection. Novartis Pharmaceuticals UK Ltd. Revised January 2022.
NICE Evidence Services Available at: www.nice.org.uk
Last accessed: 12 January 2022
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Ondansetron. Last revised: 15 February 2021
Last accessed: 12 January 2022
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