Drugs List

Therapeutic Indications

Uses

Nausea and vomiting

Unlicensed Uses

Gastro-intestinal pain in palliative care
Gastro-oesophageal reflux disease

Contraindications

Cardiac disorder
Gastrointestinal haemorrhage
Gastrointestinal obstruction
Gastrointestinal perforation
Long QT syndrome
Moderate hepatic impairment
Prolactinoma
Torsade de pointes

Precautions and Warnings

Children under 12 years
Family history of long QT syndrome
Patients over 60 years
Breastfeeding
Electrolyte imbalance
Galactosaemia
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
History of torsade de pointes
Lactose intolerance
Pregnancy
Severe renal impairment

Correct electrolyte disorders before treatment
Reduce dose in patients with severe renal impairment
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain hydroxybenzoate
Some formulations contain lactose
Perform ECG before and during treatment
Monitor serum electrolytes
Advise patient to report any signs of cardiac arrhythmias
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Discontinue treatment if arrhythmias occur
Maintain treatment at the lowest effective dose
Not licensed for all indications in all age groups
Avoid use for more than 1 week
Maintain treatment for the shortest possible duration
Advise patient grapefruit products may increase plasma level

Domperidone increases the risk of serious ventricular arrhythmias or sudden cardiac death, especially in patients older than 60 years, or patients taking a daily dose greater than 30mg.

The risk of neurological side effects is higher in young children since metabolic functions and in the blood brain barrier are not fully developed in the first months of life.

Pregnancy and Lactation

Pregnancy

Use domperidone with caution in pregnancy.

There is limited data on the use of domperidone in pregnant women, the potential risk to humans is unknown.

Studies in animals have shown reproductive toxicity at maternally toxic doses.

The manufacturer recommends only using domperidone when it can be justified by the therapeutic benefit.

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

Use domperidone with caution in breastfeeding.

Domperidone is excreted in human breast milk and breastfed infants receive less than 0.1% of the maternal weight-adjusted dose. Occurrence of adverse effects, in particular cardiac effects cannot be excluded after exposure via breast milk. No adverse effects have been found in a limited number of published cases of breastfed infants whose mothers were taking domperidone.

The manufacturers recommend making a decision whether to discontinue breastfeeding or to discontinue/abstain from domperidone therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Caution should be exercised in case of QTc prolongation risk factors in breast-fed infants.

Domperidone is sometimes used as a galactagogue to increase milk supply by increasing maternal serum prolactin. The clinical value in increasing milk supply in this way is questionable, and its benefit in women who continue to have insufficient milk production after nursing technique and frequency have been optimised has not been adequately studied. There is no officially established dosage for increasing milk supply.

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

Agitation
Allergic reaction
Altered liver function tests
Amenorrhoea
Anaphylactic reaction
Anaphylactic shock
Angioedema
Anxiety
Asthenia
Breast pain
Breast tenderness
Convulsions
Diarrhoea
Dry mouth
Extrapyramidal effects
Galactorrhoea
Gynaecomastia
Headache
Increased prolactin
Nervousness
Oculogyric crisis
Prolongation of QT interval
Pruritus
Rash
Reduced libido
Somnolence
Sudden cardiac death
Torsades de pointes
Urinary retention
Urticaria
Ventricular arrhythmias

Presentation

Oral formulations of domperidone.

Drugs List

Therapeutic Indications

Uses

Nausea and vomiting

Unlicensed Uses

Gastro-intestinal pain in palliative care
Gastro-oesophageal reflux disease

Dosage

Domperidone is recommended to be taken before meals.

Adults

Children

Neonates

Patients with Renal Impairment

Contraindications

Cardiac disorder
Gastrointestinal haemorrhage
Gastrointestinal obstruction
Gastrointestinal perforation
Long QT syndrome
Moderate hepatic impairment
Prolactinoma
Torsade de pointes

Precautions and Warnings

Children under 12 years
Family history of long QT syndrome
Patients over 60 years
Breastfeeding
Electrolyte imbalance
Galactosaemia
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
History of torsade de pointes
Lactose intolerance
Pregnancy
Severe renal impairment

Correct electrolyte disorders before treatment
Reduce dose in patients with severe renal impairment
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain hydroxybenzoate
Some formulations contain lactose
Perform ECG before and during treatment
Monitor serum electrolytes
Advise patient to report any signs of cardiac arrhythmias
Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
Discontinue treatment if arrhythmias occur
Maintain treatment at the lowest effective dose
Not licensed for all indications in all age groups
Avoid use for more than 1 week
Maintain treatment for the shortest possible duration
Advise patient grapefruit products may increase plasma level

Domperidone increases the risk of serious ventricular arrhythmias or sudden cardiac death, especially in patients older than 60 years, or patients taking a daily dose greater than 30mg.

The risk of neurological side effects is higher in young children since metabolic functions and in the blood brain barrier are not fully developed in the first months of life.

Pregnancy and Lactation

Pregnancy

Use domperidone with caution in pregnancy.

There is limited data on the use of domperidone in pregnant women, the potential risk to humans is unknown.

Studies in animals have shown reproductive toxicity at maternally toxic doses.

The manufacturer recommends only using domperidone when it can be justified by the therapeutic benefit.

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

Use domperidone with caution in breastfeeding.

Domperidone is excreted in human breast milk and breastfed infants receive less than 0.1% of the maternal weight-adjusted dose. Occurrence of adverse effects, in particular cardiac effects cannot be excluded after exposure via breast milk. No adverse effects have been found in a limited number of published cases of breastfed infants whose mothers were taking domperidone.

The manufacturers recommend making a decision whether to discontinue breastfeeding or to discontinue/abstain from domperidone therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. Caution should be exercised in case of QTc prolongation risk factors in breast-fed infants.

Domperidone is sometimes used as a galactagogue to increase milk supply by increasing maternal serum prolactin. The clinical value in increasing milk supply in this way is questionable, and its benefit in women who continue to have insufficient milk production after nursing technique and frequency have been optimised has not been adequately studied. There is no officially established dosage for increasing milk supply.

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

Agitation
Allergic reaction
Altered liver function tests
Amenorrhoea
Anaphylactic reaction
Anaphylactic shock
Angioedema
Anxiety
Asthenia
Breast pain
Breast tenderness
Convulsions
Diarrhoea
Dry mouth
Extrapyramidal effects
Galactorrhoea
Gynaecomastia
Headache
Increased prolactin
Nervousness
Oculogyric crisis
Prolongation of QT interval
Pruritus
Rash
Reduced libido
Somnolence
Sudden cardiac death
Torsades de pointes
Urinary retention
Urticaria
Ventricular arrhythmias

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 2018

Reference Sources

Summary of Product Characteristics: Domperidone 1mg/ml Suspension. Wockhardt UK Ltd. Revised October 2019.
Summary of Product Characteristics: Domperidone 10mg Film-coated Tablets. Wockhardt UK Ltd. Revised March 2018.
Summary of Product Characteristics: Domperidone 1mg/ml oral suspension. Zentiva. Revised August 2018.
Summary of Product Characteristics: Domperidone 10mg Tablets. Aurobindo Pharma Ltd. Revised November 2019.
Summary of Product Characteristics: Motilium 10mg tablets. Zentiva. Revised September 2020.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 08 April 2021

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Domperidone. Last revised: 02 July 2018