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Metoclopramide oral

Presentation

Oral formulations of metoclopramide.

Drugs List

  • MAXOLON 10mg tablets
  • metoclopramide 10mg tablets
  • metoclopramide 5mg tablets
  • metoclopramide 5mg/5ml solution sugar-free
  • 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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