Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK
‘Maxolon’ should not be used during the first three to four days following operations such as pyloroplasty or gut anastomosis as vigorous muscular contractions may not help healing.
If vomiting persists the patient should be reassessed to exclude the possibility of an underlying disorder e.g. cerebral irritation.
Extrapyramidal disorders may occur, particularly in children and young adults, and/or when high doses are used. These reactions occur usually at the beginning of the treatment and can occur after a single administration. Metoclopramide should be discontinued immediately in the event of extrapyramidal symptoms. These effects are generally completely reversible after treatment discontinuation, but may require a symptomatic treatment (benzodiazepines in children and/or anticholinergic anti-Parkinsonian medicinal products in adults).
The time interval of at least 6 hours specified in the section 4.2 should be respected between each metoclopramide administration, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Prolonged treatment with metoclopramide may cause tardive dyskinesia, potentially irreversible, especially in the elderly. Treatment should not exceed 3 months because of the risk of tardive dyskinesia (see section 4.8). Treatment must be discontinued if clinical signs of tardive dyskinesia appear.
Neuroleptic malignant syndrome has been reported with metoclopramide in combination with neuroleptics as well as with metoclopramide monotherapy (see section 4.8). Metoclopramide should be discontinued immediately in the event of symptoms of neuroleptic malignant syndrome and appropriate treatment should be initiated.
Special care should be exercised in patients with underlying neurological conditions and in patients being treated with other centrally-acting drugs (see section 4.3)
Symptoms of Parkinson’s disease may also be exacerbated by metoclopramide.
Methemoglobinemia which could be related to NADH cytochrome b5 reductase deficiency has been reported. In such cases, metoclopramide should be immediately and permanently discontinued and appropriate measures initiated (such as treatment with methylene blue).
There have been reports of serious cardiovascular undesirable effects including cases of circulatory collapse, severe bradycardia, cardiac arrest and QT prolongation following administration of metoclopramide by injection, particularly via the intravenous route (see section 4.8).
Special care should be taken when administering metoclopramide, particularly via the intravenous route to the elderly population, to patients with cardiac conduction disturbances (including QT prolongation), patients with uncorrected electrolyte imbalance, bradycardia and those taking other drugs known to prolong QT interval. Intravenous doses should be administered as a slow bolus (at least over 3 minutes) in order to reduce the risk of adverse effects (e.g. hypotension, akathisia).
In patients with renal impairment or with severe hepatic impairment, a dose reduction is recommended (see section 4.2).
Metoclopramide may cause elevation of serum prolactin levels.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency of glucose-galactose malabsorption should not take this medicine.
Care should be exercised when using Maxolon in patients with a history of atopy (including asthma) or porphyria.
Metoclopramide should not be used in the immediate post-operative period (up to 3-4 days) following pyloroplasty or gut anastomosis, as vigorous gastrointestinal contractions may adversely affect healing.
Special care should be taken when administering Maxolon intravenously to patients with “sick sinus syndrome” or other cardiac conduction disturbances.
There have been very rare reports of abnormalities of cardiac conduction with intravenous metoclopramide. Maxolon should be used with care with other drugs affecting cardiac conduction.
Levodopa or dopaminergic agonists and metoclopramide have a mutual antagonism (see section 4.3).
Alcohol potentiates the sedative effect of metoclopramide.
Due to the prokinetic effect of metoclopramide, the absorption of certain drugs may be modified.
Anticholinergics and morphine derivatives may have both a mutual antagonism with metoclopramide on the digestive tract motility.
Sedative effects of Central Nervous System depressants and metoclopramide are potentiated.
Metoclopramide may have an additive effect with other neuroleptics on the occurrence of extrapyramidal disorders.
The use of metoclopramide with serotonergic drugs such as SSRIs may increase the risk of serotonin syndrome.
Metoclopramide may decrease digoxin bioavailability. Careful monitoring of digoxin plasma concentration is required.
Metoclopramide increases cyclosporine bioavailability (Cmax by 46% and exposure by 22%). Careful monitoring of cyclosporine plasma concentration is required. The clinical consequence is uncertain.
Metoclopramide injection may prolong the duration of neuromuscular block (through inhibition of plasma cholinesterase).
Metoclopramide exposure levels are increased when co-administered with strong CYP2D6 inhibitors such as fluoxetine and paroxetine. Although the clinical significance is uncertain, patients should be monitored for adverse reactions.
‘Maxolon’ may reduce plasma concentrations of atovaquone.
A large amount of data on pregnant women (more than 1000 exposed outcomes) indicates no malformative toxicity nor foetotoxicity. Metoclopramide can be used during pregnancy if clinically needed. Due to pharmacological properties (as other neuroleptics), in case of metoclopramide administration at the end of pregnancy, extrapyramidal syndrome in new born cannot be excluded.
Metoclopramide should be avoided at the end of pregnancy. If metoclopramide is used, neonatal monitoring should be undertaken.
Metoclopramide is excreted in breast milk at low level. Adverse reactions in the breast-fed baby cannot be excluded. Therefore metoclopramide is not recommended during breastfeeding. Discontinuation of metoclopramide in breast-feeding women should be considered.
Maxolon has moderate influence on the ability to drive and use machines. Metoclopramide may cause drowsiness, dizziness, dyskinesia and dystonias which could affect the vision and also interfere with the ability to drive and operate machinery.
Adverse reactions listed by System Organ Class. Frequencies are defined using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to<1/100), rare (≥1/10000 to<1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).
Not known: Methaemoglobinaemia, which could be related to NADH cytochrome b5 reductase deficiency, particularly in neonates (see section 4.4); Sulfhaemoglobinaemia, mainly with concomitant administration of high doses of sulphur-releasing medicinal products
Uncommon: Bradycardia, particularly with intravenous formulation
Not known: Cardiac arrest, occurring shortly after injectable use, and which can be subsequent to bradycardia (see section 4.4); Atrioventricular block, Sinus arrest particularly with intravenous formulation; Electrocardiogram QT prolonged; Torsade de Pointes;
Uncommon: Amenorrhoea, Hyperprolactinaemia,
Rare: Galactorrhoea
Not known: Gynaecomastia
Common: Diarrhoea
Common: Asthenia
Uncommon: Hypersensitivity
Not known: Anaphylactic reaction (including anaphylactic shock particularly with intravenous formulation
Very common: Somnolence
Common: Extrapyramidal disorders (particularly in children and young adults and/or when the recommended dose is exceeded, even following administration of a single dose of the drug) (see section 4.4), Parkinsonism, Akathisia
Uncommon: Dystonia including oculogyric crisis, Dyskinesia, Depressed level of consciousness
Rare: Convulsion especially in epileptic patients
Not known: Tardive dyskinesia which may be persistent, during or after prolonged treatment, particularly in elderly patients (see section 4.4), Neuroleptic malignant syndrome (see section 4.4)
Common: Depression
Uncommon: Hallucination
Rare: Confusional state
Common: Hypotension, particularly with intravenous formulation
Not known: Shock, syncope after injectable use, Acute hypertension in patients with phaeochromocytoma (see section 4.3), Transient increase in blood pressure
* Endocrine disorders during prolonged treatment in relation with hyperprolactinaemia (amenorrhoea, galactorrhoea, gynaecomastia).
The following reactions, sometimes associated, occur more frequently when high doses are used:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Not applicable.
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