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MAXOLON INJECTION 5MG/ML
Active substance(s): METOCLOPRAMIDE HYDROCHLORIDE
NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2ml ampoule contains Metoclopramide Hydrochloride BP equivalent to
10mg of the anhydrous substance.
Excipient(s) with known effect
Sodium Metabisulphite- 1.48mg (0.148 % w/v)
For the full list of excipients, see section 6.1
Clear colourless solution for intramuscular or intravenous administration.
Maxolon is indicated in adults for:
- Prevention of post-operative nausea and vomiting (PONV)
- Symptomatic treatment of nausea and vomiting, including acute migraine
induced nausea and Vomiting
- Prevention of radiotherapy induced nausea and vomiting (RINV).
'Maxolon' speeds up the passage of a barium meal by increasing the rate of
gastric emptying, co-ordinating peristalsis and dilating the duodenal bulb.
'Maxolon' also facilitates duodenal intubation procedures.
Maxolon is indicated in children (aged 1-18 years) for:
- Prevention of delayed chemotherapy induced nausea and vomiting (CINV)
as a second line option
- Treatment of established post-operative nausea and vomiting (PONV) as a
second line option
Metoclopramide should not be used in children younger than 1 year as there
are insufficient data regarding efficacy and safety of the product in this
Posology and method of administration
Route of administration:
The solution can be administered intravenously or intramuscularly.
Intravenous doses should be administered as a slow bolus (at least over 3
All indications (adult population)
For prevention of PONV a single dose of 10mg is recommended.
For the symptomatic treatment of nausea and vomiting, including acute
migraine induced nausea and vomiting and for the prevention of radiotherapy
induced nausea and vomiting (RINV): the recommended single dose is 10mg,
repeated up to three times daily.
The maximum recommended daily dose is 30mg or 0.5mg/kg body weight.
The injectable treatment duration should be as short as possible and transfer to
oral or rectal treatment should be made as soon as possible.
All indications (paediatric patients aged 1-18 years)
The recommended dose is 0.1 to 0.15mg/kg body weight, repeated up to three
times daily by intravenous route. The maximum dose in 24 hours is 0.5mg/kg
Up to 3 times daily
Up to 3 times daily
Up to 3 times daily
Up to 3 times daily
Up to 3 times daily
The maximum treatment duration is 48 hours for treatment of established post
operative nausea and vomiting (PONV).
The maximum treatment duration is 5 days for prevention of delayed
chemotherapy induced nausea and vomiting (CINV).
Method of administration:
A minimal interval of 6 hours between two administrations is to be respected,
even in case of vomiting or rejection of the dose (see section 4.4).
A single dose of 'Maxolon' may be given 5-10 minutes before the examination.
Subject to body weight consideration, (see above)
In elderly patients a dose reduction should be considered, based on renal and
hepatic function and overall frailty.
In patients with end stage renal disease (Creatinine clearance ≤15 ml/min), the
daily dose should be reduced by 75%.
In patients with moderate to severe renal impairment (Creatinine clearance 1560ml/min), the dose should be reduced by 50% (see section 5.2).
In patients with severe hepatic impairment, the dose should be reduced by
50% (see section 5.2).
Metoclopramide is contraindicated in children aged less than 1 year (see section 4.3).
- Hypersensitivity to the active substance or to any of the excipients listed in
- Gastrointestinal haemorrhage, mechanical obstruction or gastro-intestinal
perforation for which the stimulation of gastrointestinal motility constitutes
- Confirmed or suspected pheochromocytoma, due to the risk of severe
- History of neuroleptic or metoclopramide-induced tardive dyskinesia
- Epilepsy (increased crises frequency and intensity)
- Parkinson’s disease
- Combination with levodopa or dopaminergic agonists (see section 4.5)
- Known history of methaemoglobinaemia with metoclopramide or of
NADH cytochrome-b5 deficiency.
- Use in children less than 1 year of age due to an increased risk of
extrapyramidal disorders (see section 4.4)
‘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.
Special warnings and precautions for use
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
Symptoms of Parkinson’s disease may also be exacerbated by
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,
Renal and Hepatic Impairment
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.
Care should be exercised when using Maxolon in patients with a history of
atopy (including asthma) or porphyria.
Special care should be taken when administering Maxolon intravenously to
patients with “sick sinus syndrome” or other cardiac conduction disturbances.
Interaction with other medicinal products and other forms of interaction
Levodopa or dopaminergic agonists and metoclopramide have a mutual
antagonism (see section 4.3).
Combination to be avoided
Alcohol potentiates the sedative effect of metoclopramide.
Combination to be taken into account
Due to the prokinetic effect of metoclopramide, the absorption of certain drugs
may be modified.
Anticholinergics and morphine derivatives
Anticholinergics and morphine derivatives may have both a mutual
antagonism with metoclopramide on the digestive tract motility.
Central nervous system depressants (morphine derivatives, anxiolytics,
sedative H1 antihistamines, sedative antidepressants, barbiturates, clonidine
Sedative effects of Central Nervous System depressants and metoclopramide
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.
Mivacurium and suxamethonium
Metoclopramide injection may prolong the duration of neuromuscular block
(through inhibition of plasma cholinesterase).
Strong CYP2D6 inhibitors
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
The effects of certain other drugs with potential central stimulant effects, e.g.
monoamine oxidase inhibitors and sympathomimetics, may be modified when
prescribed with metoclopramide and their dosage may need to be adjusted
‘Maxolon’ may reduce plasma concentrations of atovaquone.
Fertility, pregnancy and lactation
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 newborn
cannot be excluded.
Metoclopramide should be avoided at the end of pregnancy.
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
breastfeeding women should be considered.
Effects on ability to drive and use machines
Metoclopramide has moderate influence on the ability to drive and use
Metoclopramide may cause drowsiness, dizziness, dyskinesia and dystonias
which could affect the vision and also interfere with the ability to drive and
Adverse reactions listed by System Organ Class. Frequencies are defined
using the following convention: very common (≥1/10), common (≥1/100,
<1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare
(<1/10000), not known (cannot be estimated from the available data).
System Organ Class Frequency
Blood and lymphatic system disorders
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
Bradycardia, particularly with
Cardiac arrest, occurring shortly after
injectable use, and which can be
subsequent to bradycardia (see section
Atrioventricular block, Sinus arrest
particularly with intravenous
formulation; Electrocardiogram QT
prolonged; Torsade de Pointes
General disorders and administration site conditions
Immune System disorders
Nervous system disorders
Anaphylactic reaction (including
anaphylactic shock particularly with
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
Dystonia, Dyskinesia, Depressed level
Convulsion especially in epileptic
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)
Hypotension, particularly with
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
hyperprolactinaemia (amenorrhoea, galactorrhoea, gynaecomastia).
The following reactions, sometimes associated, occur more frequently when
high doses are used:
- Extrapyramidal symptoms: acute dystonia and dyskinesia, parkinsonian
syndrome, akathisia, even following administration of a single dose of the
medicinal product, particularly in children and young adults (see section
- Drowsiness, decreased level of consciousness, confusion, hallucination.
Reporting of suspected adverse reactions
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 the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.
Extrapyramidal disorders, drowsiness, decreased level of consciousness,
confusion, hallucination, and cardio-respiratory arrest may occur.
In case of extrapyramidal symptoms related or not to overdose, the treatment
is only symptomatic (benzodiazepines in children and/or anticholinergic antiparkinsonian medicinal products in adults).
A symptomatic treatment and a continuous monitoring of the cardiovascular
and respiratory functions should be carried out according to clinical status.
Pharmacotherapeutic group: Agents stimulating gastro-intestinal motility
ATC code: A03FA01
The action of metoclopramide is closely associated with parasympathetic
nervous control of the upper gastro-intestinal tract, where it has the effect of
encouraging normal peristaltic action. This provides for a fundamental
approach to the control of those conditions where disturbed gastro-intestinal
motility is a common underlying factor.
Metoclopramide is metabolised in the liver and the predominant route of
elimination of metoclopramide and its metabolites is via the kidney.
The clearance of metoclopramide is reduced by up to 70% in patients with
severe renal impairment, while the plasma elimination half-life is increased
(approximately 10 hours for a creatinine clearance of 10-50 mL/minute and 15
hours for a creatinine clearance <10 mL/minute).
In patients with cirrhosis of the liver, accumulation of metoclopramide has
been observed, associated with a 50% reduction in plasma clearance.
Preclinical safety data
No additional data available
List of excipients
Water for injection
Special precautions for storage
Do not store above 25°C. If ampoules are removed from their carton, they
should be stored away from light. If inadvertent exposure occurs, ampoules
showing discolouration must be discarded.
Nature and contents of container
Clear glass 2ml ampoules (Ph. Eur. Type I neutral glass) in packs of 1 or 12
ampoules or 1 ampoule plus 12 tablets in an aluminium canister as a home
Not all pack sizes may be marketed
Special precautions for disposal and other handling
Protect from light
Any unused medicinal product or waste material should be disposed of in accordance
with local requirements.
MARKETING AUTHORISATION HOLDER
Amdipharm UK Limited
85 King William Street
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT