Metoclopramide oral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of metoclopramide.
Drugs List
Therapeutic Indications
Uses
Diagnosis: radiology and duodenal intubation
Nausea and vomiting
Nausea and vomiting following cancer chemotherapy or irradiation
Post-operative nausea and vomiting: prevention
Indicated in adults for the:
Prevention of delayed chemotherapy induced nausea and vomiting.
Symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting.
Prevention of radiotherapy induced nausea and vomiting.
Used in combination with oral analgesics to improve the absorption of analgesics in acute migraine.
Children aged 1 to 18 for:
Prevention of delayed chemotherapy induced nausea and vomiting as a second line option.
Diagnostic procedures:
Some brands are licensed for speeding up the passage of a barium meal by increasing the rate of gastric emptying, co-ordinating peristalsis and dilating the duodenal bulb. Some brands are also licensed for duodenal intubation procedures.
Dosage
A minimum interval of 6 hours between two administrations should be respected, even in the event of vomiting or rejection of the dose.
Adults
10mg up to three times daily.
Maximum daily dose is 30mg (or 0.5mg per kg bodyweight).
Maximum treatment duration is 5 days.
Diagnostic indications: a single dose may be taken 5 to 10 minutes before the examination, subject to body weight consideration. Consult product literature for further information.
Children
Tablets are not suitable for use in children weighing less than 61kg.
Children aged 1 to 18 years should only be treated as a second-line option for prevention of delayed chemotherapy-induced nausea and vomiting.
Children aged 1 to 18 years
The recommended dose is 0.1mg to 0.15mg per kg bodyweight up to three times a day.
Maximum daily dose: 0.5mg per kg bodyweight.
Maximum treatment duration is 5 days for the prevention of delayed chemotherapy induced nausea and vomiting.
For additional dosing guidance see product literature.
Patients with Renal Impairment
Creatinine clearance 15ml/min to 60ml/min: reduce dose by 50%.
Creatinine clearance less than or equal to 15ml/min: reduce dose by 75%.
Patients with Hepatic Impairment
Severe hepatic impairment: reduce dose by 50%.
Administration
For oral administration of tablets.
For oral, nasogastric or percutaneous endoscopic gastrostomy administration of oral solution.
Contraindications
Children under 1 year
Known or suspected phaeochromocytoma
Epileptic disorder
Gastrointestinal haemorrhage
Gastrointestinal obstruction
Gastrointestinal perforation
History of methaemoglobinaemia
History of tardive dyskinesia
Long QT syndrome
Methaemoglobin reductase deficiency
Parkinson's disease
Torsade de pointes
Within 4 days of gastrointestinal surgery
Precautions and Warnings
Atopy
Children aged 1 to 18 years
Elderly
Family history of long QT syndrome
Asthma
Bradycardia
Breastfeeding
Cardiac conduction defects
Electrolyte imbalance
Galactosaemia
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
History of torsade de pointes
Lactose intolerance
Moderate renal impairment
Neurological disorder
Porphyria
Pregnancy
Severe hepatic impairment
Correct electrolyte disorders before treatment
Reduce dose in patients with hepatic impairment
Reduce dose in patients with renal impairment
Advise patient ability to drive or operate machinery may be impaired
Not all available brands are licensed for all indications
Oral liquid contains propylene glycol
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain hydroxybenzoate
Some formulations contain lactose
Consider monitoring ECG in patients at risk of QT prolongation
Monitor serum electrolytes
Discontinue therapy immediately & permanently if methaemoglobinaemia occurs
May cause extrapyramidal effects in children and young adults
May affect results of some laboratory tests
Discontinue if extrapyramidal effects occur
Discontinue if patient develops neuroleptic malignant syndrome
Discontinue if tardive dyskinesia occurs
Consider reducing dose in elderly
Not licensed for all indications in all age groups
Only recommended for short term use (up to 5 days)
May affect the gastro-intestinal absorption of other drugs
Advise patient to avoid alcohol during treatment
Advise that effects are potentiated by CNS depressants (including alcohol)
Treatment should not be initiated in the immediate post operative period following pyloroplasty or gut anastomosis as gastrointestinal contraction may affect healing.
Monitoring is required in patients with impaired renal or hepatic functions because adverse reactions attributed to propylene glycol have been observed such as renal dysfunction (acute tubular necrosis), acute renal failure and liver dysfunction.
If vomiting persists reassess for possibility of underlying disorders, e.g. cerebral irritation.
Treatment should not exceed 3 months due to the risk of tardive dyskinesia, particularly in the elderly.
Pregnancy and Lactation
Pregnancy
Use metoclopramide with caution during pregnancy.
The manufacturer advises metoclopramide can be used during pregnancy if clinically needed but recommends avoiding metoclopramide at the end of pregnancy, where neonatal monitoring should be undertaken. Administration at the end of pregnancy cannot exclude the presence of extrapyramidal syndrome. There are no indications of malformative toxicity or foetotoxicity.
Lactation
Use metoclopramide with caution during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking metoclopramide, discontinuation of metoclopramide in breastfeeding women should be considered. Available data indicates metoclopramide is expressed in low levels in human breast milk, adverse reactions to the breastfed infant cannot be excluded.
Side Effects
Acute extrapyramidal dystonic reactions
Akathisia
Altered consciousness
Amenorrhoea
Anaphylaxis
Asthenia
Atrioventricular block
Bradycardia
Cardiac arrest
Cardiac conduction disturbances
Confusion
Constipation
Depression
Diarrhoea
Dizziness
Drowsiness
Dry mouth
Dyskinesia
Dyspnoea
Dystonia
Facial muscle spasm
Galactorrhoea
Gynaecomastia
Hallucinations
Headache
Hyperprolactinaemia
Hypersensitivity reactions
Hypotension
Increased blood pressure (transient)
Increased prolactin
Irritability
Methaemoglobinaemia
Nausea
Neuroleptic malignant syndrome
Oculogyric crisis
Oedema
Oligomenorrhoea
Parkinsonism
Pruritus
Rash
Restlessness
Sinus arrest
Sleeplessness
Spasm of extra-ocular muscles including oculogyric crises
Sulfaemoglobinaemia
Tardive dyskinesia
Torsades de pointes
Urticaria
Visual disturbances
Effects on Laboratory Tests
Metoclopramide may cause elevation of serum prolactin levels.
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: January 2021
Reference Sources
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 06 July 2022
Summary of Product Characteristics: Maxolon Tablets 10mg. Advanz Pharma. Revised December 2018.
Summary of Product Characteristics: Metoclopramide Hydrochloride 5mg tablets. Bristol Laboratories Limited. Revised September 2019.
Summary of Product Characteristics: Metoclopramide Hydrochloride 5mg/5ml Oral Solution. Rosemont Pharmaceuticals Ltd. Revised August 2020.
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