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MAXOLON INJECTION 5MG/ML

Active substance(s): METOCLOPRAMIDE HYDROCHLORIDE / METOCLOPRAMIDE HYDROCHLORIDE / METOCLOPRAMIDE HYDROCHLORIDE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Maxolon Injection

2

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

3

PHARMACEUTICAL FORM
Clear colourless solution for intramuscular or intravenous administration.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Adult population
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).
Diagnostic procedures:
Radiology
Duodenal intubation
'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.
Paediatric population
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
population.
4.2

Posology and method of administration
Posology:
Route of administration:
The solution can be administered intravenously or intramuscularly.
Intravenous doses should be administered as a slow bolus (at least over 3
minutes).
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
body weight.
Dosing table
Age
1-3 years
3-5 years
5-9 years
9-18 years
15-18 years

Body Weight
10-14 kg
15-19 kg
20-29 kg
30-60 kg
Over 60kg

Dose
1 mg
2 mg
2.5 mg
5 mg
10 mg

Frequency
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).
Diagnostic indications:
A single dose of 'Maxolon' may be given 5-10 minutes before the examination.
Subject to body weight consideration, (see above)
Special population
Elderly

In elderly patients a dose reduction should be considered, based on renal and
hepatic function and overall frailty.
Renal impairment:
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).
Hepatic impairment:
In patients with severe hepatic impairment, the dose should be reduced by
50% (see section 5.2).
Paediatric population
Metoclopramide is contraindicated in children aged less than 1 year (see section 4.3).

4.3

Contraindications
- Hypersensitivity to the active substance or to any of the excipients listed in
section 6.1
- Gastrointestinal haemorrhage, mechanical obstruction or gastro-intestinal
perforation for which the stimulation of gastrointestinal motility constitutes
a risk
- Confirmed or suspected pheochromocytoma, due to the risk of severe
hypertension episodes
- 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.

4.4

Special warnings and precautions for use
Neurological Disorders
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
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).
Cardiac Disorders
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).
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.
4.5

Interaction with other medicinal products and other forms of interaction

Contraindicated combination
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
and related).
Sedative effects of Central Nervous System depressants and metoclopramide
are potentiated.
Neuroleptics
Metoclopramide may have an additive effect with other neuroleptics on the
occurrence of extrapyramidal disorders.
Serotonergic drugs
The use of metoclopramide with serotonergic drugs such as SSRIs may
increase the risk of serotonin syndrome.
Digoxin
Metoclopramide may decrease digoxin bioavailability. Careful monitoring of
digoxin plasma concentration is required.
Cyclosporine
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
reactions.
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
accordingly.
‘Maxolon’ may reduce plasma concentrations of atovaquone.
4.6

Fertility, pregnancy and lactation
Pregnancy

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.

If

Breastfeeding
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.
4.7

Effects on ability to drive and use machines

4.8

Metoclopramide 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.
Undesirable effects
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).
Adverse reactions
System Organ Class Frequency
Blood and lymphatic system disorders
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
Cardiac disorders
Uncommon
Not known

Bradycardia, particularly with
intravenous formulation
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
Endocrine disorders*
Uncommon

Amenorrhoea, Hyperprolactinaemia,

Rare

Galactorrhoea

Not known

Gynaecomastia

Gastrointestinal disorders
Common

Diarrhoea

General disorders and administration site conditions
Common
Asthenia
Immune System disorders
Uncommon
Not known

Nervous system disorders
Very
common
Common

Uncommon
Rare
Not known

Hypersensitivity
Anaphylactic reaction (including
anaphylactic shock particularly with
intravenous formulation
Somnolence
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
of consciousness
Convulsion especially in epileptic
patients
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)

Psychiatric disorders
Common

Depression

Uncommon

Hallucination

Rare

Confusional state

Common:

Hypotension, particularly with
intravenous formulation

Not known

Shock, syncope after injectable use Acute

Vascular disorder

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).

with

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
4.4).
- 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.

4.9

Overdose
Symptoms
Extrapyramidal disorders, drowsiness, decreased level of consciousness,
confusion, hallucination, and cardio-respiratory arrest may occur.
Management
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.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
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.
5.2

Pharmacokinetic properties
Biotransformation:
Metoclopramide is metabolised in the liver and the predominant route of
elimination of metoclopramide and its metabolites is via the kidney.
Renal impairment

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).
Hepatic impairment
In patients with cirrhosis of the liver, accumulation of metoclopramide has
been observed, associated with a 50% reduction in plasma clearance.

5.3

Preclinical safety data
No additional data available

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sodium Chloride
Sodium Metabisulphite
Water for injection

6.2

Incompatibilities
Not applicable

6.3

Shelf life
60 months

6.4

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.

6.5

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
visit pack.
Not all pack sizes may be marketed

6.6

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.

7

MARKETING AUTHORISATION HOLDER
Amdipharm UK Limited
Capital House
85 King William Street
London
EC4N 7BL
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 20072/0051

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/06/1995

10

DATE OF REVISION OF THE TEXT
15/09/2016

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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