Drugs List

Therapeutic Indications

Uses

Chemotherapy induced nausea and vomiting
Nausea or vomiting associated with radiotherapy
Post-operative nausea and vomiting: prevention

Contraindications

Children under 6 months
Breastfeeding
Pregnancy

Precautions and Warnings

Family history of long QT syndrome
Galactosaemia
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
History of torsade de pointes
Hypocalcaemia
Hypokalaemia
Hypomagnesaemia
Lactose intolerance
Long QT syndrome
Moderate hepatic impairment
Phenylketonuria
Subacute gastrointestinal obstruction

May mask occult bleeding in adenotonsillar surgery patients
Reduce dose in patients with hepatic impairment
Some formulations contain aspartame - caution in phenylketonuria
Not all available brands are licensed for all age groups
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain lactose
Monitor ECG in patients at risk of QT prolongation
Monitor patients with signs of sub-acute intestinal obstruction
May cause changes to ECG
Advise patient not to take St John's wort concurrently

Pregnancy and Lactation

Pregnancy

Ondansetron is contraindicated in pregnancy.

Safety in human pregnancy has not been established.

In reproductive studies in rats and rabbits at intravenous doses of up to 4mg/kg/day there were no adverse effects on fertility or on the foetus observed. The largest study published at the time of writing involved 176 pregnancies exposed to ondansetron between the fifth and ninth weeks of gestation. There was no difference from the control group with regard to foetal outcome and major malformations. Epidemiological studies report a small, but significant, increased risk of orofacial malformations when ondansetron was used during the first trimester of pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Ondansetron is contraindicated in breastfeeding.

Ondansetron is excreted in rat milk, because of this and its molecular weight, excretion into human milk is expected. No reports describing the use of ondansetron during human lactation have been located. If ondansetron is indicated during lactation, the child should be observed for unexpected symptoms.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Altered liver function tests
Anaphylaxis
Arrhythmias
Blindness (temporary)
Blurred vision (transient)
Bradycardia
Chest pain
Constipation
Dyskinesia
Dystonia
ECG changes
Extrapyramidal effects
Flushing
Headache
Hiccups
Hypersensitivity reactions
Hypotension
Movement disturbances
Oculogyric crisis
Prolongation of QT interval
Seizures
Sensation of warmth
ST segment depression
Torsades de pointes

Presentation

Oral formulations containing ondansetron

Drugs List

Therapeutic Indications

Uses

Chemotherapy induced nausea and vomiting
Nausea or vomiting associated with radiotherapy
Post-operative nausea and vomiting: prevention

Dosage

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 8 to 32 mg a day.

Adults

Children

Patients with Hepatic Impairment

Contraindications

Children under 6 months
Breastfeeding
Pregnancy

Precautions and Warnings

Family history of long QT syndrome
Galactosaemia
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
History of torsade de pointes
Hypocalcaemia
Hypokalaemia
Hypomagnesaemia
Lactose intolerance
Long QT syndrome
Moderate hepatic impairment
Phenylketonuria
Subacute gastrointestinal obstruction

May mask occult bleeding in adenotonsillar surgery patients
Reduce dose in patients with hepatic impairment
Some formulations contain aspartame - caution in phenylketonuria
Not all available brands are licensed for all age groups
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain lactose
Monitor ECG in patients at risk of QT prolongation
Monitor patients with signs of sub-acute intestinal obstruction
May cause changes to ECG
Advise patient not to take St John's wort concurrently

Pregnancy and Lactation

Pregnancy

Ondansetron is contraindicated in pregnancy.

Safety in human pregnancy has not been established.

In reproductive studies in rats and rabbits at intravenous doses of up to 4mg/kg/day there were no adverse effects on fertility or on the foetus observed. The largest study published at the time of writing involved 176 pregnancies exposed to ondansetron between the fifth and ninth weeks of gestation. There was no difference from the control group with regard to foetal outcome and major malformations. Epidemiological studies report a small, but significant, increased risk of orofacial malformations when ondansetron was used during the first trimester of pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Ondansetron is contraindicated in breastfeeding.

Ondansetron is excreted in rat milk, because of this and its molecular weight, excretion into human milk is expected. No reports describing the use of ondansetron during human lactation have been located. If ondansetron is indicated during lactation, the child should be observed for unexpected symptoms.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Altered liver function tests
Anaphylaxis
Arrhythmias
Blindness (temporary)
Blurred vision (transient)
Bradycardia
Chest pain
Constipation
Dyskinesia
Dystonia
ECG changes
Extrapyramidal effects
Flushing
Headache
Hiccups
Hypersensitivity reactions
Hypotension
Movement disturbances
Oculogyric crisis
Prolongation of QT interval
Seizures
Sensation of warmth
ST segment depression
Torsades de pointes

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: July 2013

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of Product Characteristics: Demorem 4mg/5ml oral solution. Kipping Ltd. Revised December 2009
Summary of Product Characteristics: Ondemet Tablets 4mg. Beacon. Revised March 2006
Summary of Product Characteristics: Ondemet Tablets 8mg. Beacon. Revised March 2006
Summary of Product Characteristics: Ondansetron tablets. Goldshield plc. Revised February 2007
Summary of Product Characteristics: Ondansetron tablets. Wockhardt UK Ltd. Revised November 2012
Summary of Product Characteristics: Ondansetron orodispersible tablets 4mg, Bluefish Pharmaceuticals, Revised December 2009
Summary of Product Characteristics: Ondansetron orodispersible tablets 8mg, Bluefish Pharmaceuticals, Revised December 2009
Summary of Product Characteristics: Zofran Tablets 4mg. GlaxoSmithKline. Revised September 2013
Summary of Product Characteristics: Zofran Tablets 8mg. GlaxoSmithKline. Revised September 2013
Summary of Product Characteristics: Zofran syrup. GlaxoSmithKline. Revised December 2013
Summary of Product Characteristics: Zofran melt 4mg. GlaxoSmithKline. Revised September 2013
Summary of Product Characteristics: Zofran melt 8mg. GlaxoSmithKline. Revised September 2013
Summary of Product Characteristics: Setofilm 4mg Orodispersible Films. Revised January 2013
Summary of Product Characteristics: Setofilm 8mg Orodispersible Films. Revised January 2013

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 September 2017