lUNLICENSED USENot licensed for use in children for
gastro-oesophageal reflux disease.IMPORTANT SAFETY INFORMATION
MHRA/CHM ADVICE—DOMPERIDONE: RISK OF CARDIAC SIDE-
EFFECTS—RESTRICTED INDICATION, NEW CONTRA-INDICATIONS,
REDUCED DOSE AND DURATION OF USE
The benefits and risks of domperidone have been
reviewed. As domperidone is associated with a small
increased risk of serious cardiac side-effects, the
following restrictions to indication, dose and duration of
treatment have been made, and new contra-indications
added:
.Domperidone should only be used for the relief of the
symptoms of nausea and vomiting;
.Domperidone should be used at the lowest effective
dose for the shortest possible duration (max.
treatment duration should not normally exceed
1 week);
.Domperidone is contra-indicated for use in conditions
where cardiac conduction is, or could be impaired, or
where there is underlying cardiac disease, when
administered concomitantly with drugs that prolong
the QT interval or potent CYP 3 A 4 inhibitors, and in
severe hepatic impairment;
.The recommended dose in adults and adolescents over
12 years and over 35 kg is 10 mg up to 3 times daily;
.The recommended dose in children under 35 kg is
250 micrograms/kg up to 3 times daily;
.Oral liquid formulations should be given via an
appropriately designed, graduated oral syringe to
ensure dose accuracy.
This advice does not apply to unlicensed uses of
domperidone (e.g. palliative care).lCONTRA-INDICATIONSCardiac disease.gastro-intestinal
haemorrhage.mechanical obstruction.mechanical
perforation.predisposition to cardiac conduction
disorders.prolactinoma
lCAUTIONSChildren.if there are cardiac concerns, obtain
ECG before and during treatment
lINTERACTIONS→Appendix 1 : domperidone
lSIDE-EFFECTS
▶Common or very commonDry mouth
▶UncommonAnxiety.asthenia.breast abnormalities.
diarrhoea.drowsiness.headache.lactation disorders.
libido loss
▶Frequency not knownArrhythmias.depression.
gynaecomastia.menstrual cycle irregularities.movement
disorders.oculogyric crisis.QT interval prolongation.
seizure.sudden cardiac death.urinary retention
lPREGNANCYUse only if potential benefit outweighs risk.
lBREAST FEEDINGAmount too small to be harmful.
lHEPATIC IMPAIRMENTAvoid in moderate or severe
impairment.
lRENAL IMPAIRMENT
Dose adjustmentsReduce frequency.
lPATIENT AND CARER ADVICE
ArrhythmiaPatients and their carers should be told how to
recognise signs of arrhythmia and advised to seek medical
attention if symptoms such as palpitation or syncope
develop.
Medicines for Children leaflet: Domperidone for gastro-
oesophageal refluxwww.medicinesforchildren.org.uk/
domperidone-for-gastro-oesophageal-refluxlMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug. Forms available from special-order
manufacturers include: oral suspension
Oral suspension
CAUTIONARY AND ADVISORY LABELS 22
▶Domperidone (non-proprietary)A
Domperidone 1 mg per 1 mlDomperidone 1 mg/ml oral suspension
sugar free sugar-free| 200 mlP£ 13. 43 DT = £ 13. 43
Tablet
CAUTIONARY AND ADVISORY LABELS 22
▶Domperidone (non-proprietary)A
Domperidone (as Domperidone maleate) 10 mgDomperidone
10 mg tablets| 30 tabletP£ 2. 71 DT = £ 0. 79 | 100 tabletP
£ 9. 04 DT = £ 2. 63
▶Motilium(Zentiva)A
Domperidone (as Domperidone maleate) 10 mgMotilium 10 mg
tablets| 30 tabletP£ 2. 71 DT = £ 0. 79 | 100 tabletP£ 9. 04 DT
=£ 2. 63Metoclopramide hydrochloride 21-Nov-2016
lINDICATIONS AND DOSE
Second-line option for treatment of established
postoperative nausea and vomiting|Prevention of
delayed chemotherapy-induced nausea and vomiting
▶BY MOUTH, OR BY INTRAMUSCULAR INJECTION, OR BY
INTRAVENOUS INJECTION
▶Child: 100 – 150 micrograms/kg up to 3 times a day
(max. per dose 10 mg), when administered by slow
intravenous injection, to be given over at least
3 minuteslUNLICENSED USEMaxolon®tablets not licensed for use in
children.IMPORTANT SAFETY INFORMATION
MHRA/CHM ADVICE—METOCLOPRAMIDE: RISK OF NEUROLOGICAL
ADVERSE EFFECTS—RESTRICTED DOSE AND DURATION OF USE
(AUGUST 2013)
The benefits and risks of metoclopramide have been
reviewed by the European Medicines Agency’s
Committee on Medicinal Products for Human Use, which
concluded that the risk of neurological effects such as
extrapyramidal disorders and tardive dyskinesia
outweigh the benefits in long-term or high-dose
treatment. To help minimise the risk of potentially
serious neurological adverse effects, the following
restrictions to indications, dose and duration of use have
been made:
.In children aged 1 – 18 years, metoclopramide should
only be used as a second-line option for prevention of
delayed chemotherapy-induced nausea and vomiting
and for treatment of established postoperative nausea
and vomiting;
.Use of metoclopramide is contra-indicated in children
aged under 1 year;
.Metoclopramide should only be prescribed for short-
term use (up to 5 days);
.Recommended dose is 100 – 150 micrograms/kg (max.
10 mg), repeated up to 3 times daily;
.Intravenous doses should be administered as a slow
bolus over at least 3 minutes;
.Oral liquid formulations should be given via an
appropriately designed, graduated oral syringe to
ensure dose accuracy.
This advice does not apply to unlicensed uses of
metoclopramide (e.g. palliative care).lCONTRA-INDICATIONS 3 – 4 days after gastrointestinal
surgery.gastro-intestinal haemorrhage.gastro-intestinal
obstruction.gastro-intestinal perforation.
phaeochromocytoma262 Nausea and labyrinth disorders BNFC 2018 – 2019
Nervous system4