Skip to Content

UK Edition. Click here for US version.

METOCLOPRAMIDE 5MG/ML INJECTION

Active substance(s): METOCLOPRAMIDE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Metoclopramide 5mg/ml Injection
(metoclopramide hydrochloride)
Read all of this leaflet carefully before you start
using this medicine because it contains
important information for you.
! Keep this leaflet. You may need to read it again
! If you have any further questions ask your
doctor or pharmacist or nurse
! This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours
! If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist. See
section 4.

Your doctor may perform blood tests to check your
blood pigment levels. In cases of abnormal levels
(methaemoglobinemia) the treatment should be
immediately and permanently stopped.
Do not exceed 3-month treatment because of the
risk of involuntary muscle spasms.

What is in this leaflet:
1. What Metoclopramide 5mg/ml Injection is and
what it is used for
2. What you need to know before you are given
Metoclopramide 5mg/ml Injection
3. How to use Metoclopramide 5mg/ml Injection
4. Possible side effects
5. How to store Metoclopramide 5mg/ml Injection
6. Contents of pack and other information

Other medicines and Metoclopramide Injection:
Please tell your doctor or nurse if you are taking or
have recently taken or might take any other
medicines. This is because some medicines can
affect the way metoclopramide works or
metoclopramide can affect how other medicines
work. These medicines include the following:
! Fluoxetine and paroxetine (medicines to treat
depression)
! Medicines to treat Parkinson's disease e.g.
levodopa (see above "You should not be given
metoclopramide injection if")
! Anticholinergics (medicines used to relieve
stomach cramps or spasms)
! Morphine derivatives (medicines used to treat
severe pain)
! Cyclosporine (medicine used to treat certain
problems with the immune system)
! Suxamethonium and mivacurium (medicines
used to relax muscles)
! Digoxin (medicine used to treat heart failure)
! Sedative medicines
! Any medicines used to treat mental health
problems
! Atovaquone (to treat pneumonia)
! Pain killers such as aspirin or paracetamol or
stronger pain killers called opioids.

1. WHAT METOCLOPRAMIDE 5MG/ML
INJECTION IS AND WHAT IT IS USED FOR
Metoclopramide belongs to a group of medicines
called 'antiematics'. It works on a part of your brain
that prevents you from feeling sick (nausea) or
being sick (vomiting).
It is used to treat the following:
! To prevent nausea and vomiting that may occur
after surgery
! To treat nausea and vomiting including nausea
and vomiting which may occur with a migraine
! To prevent nausea and vomiting caused by
radiotherapy.
Paediatric population (aged 1 - 18 years):
This product can be used to treat nausea and
vomiting after surgery or to prevent delayed
nausea and vomiting that may occur after
chemotherapy, in children from the age of 1 year. It
should only be used if other treatment does not
work or cannot be used.
It is not recommended for use in children for any
other indication.
2. WHAT YOU NEED TO KNOW BEFORE YOU
ARE GIVEN METOCLOPRAMIDE 5MG/ML
INJECTION
You should not be given Metoclopramide
Injection if you:
! Are allergic to metoclopramide, or any other
ingredients contained in the injection (see
section 6)
! Have or may have a rare tumour of the adrenal
gland, which sits near the kidney
(phaeochromocytoma)
! Have bleeding, obstruction or a tear in your
stomach or gut
! Have epilepsy
! Have ever had involuntary muscle spasms
(tardive dyskinesia), when you have been
treated with a medicine
! Have Parkinson's disease
! Are taking levodopa (a medicine for
Parkinson's disease) or dopaminergic agonists
(see below "other medicines and
metoclopramide")
! Have ever had an abnormal blood pigment
level (methaemoglobinemia) or NADH
cytochrome-b5 deficiency.
Metoclopramide Injection should not be used in
neonates.

Children and adolescents
Uncontrollable movements (extrapyramidal
disorders) may occur in children and young adults.
This medicine must not be used in children below
1 year of age because of the increased risk of the
uncontrollable movements (see above You should
not be given Metoclopramide Injection if you).

Metoclopramide with alcohol
Alcohol should not be consumed during treatment
with metoclopramide because it increases the
sedative effect of metoclopramide.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or
are planning to have a baby, you should ask your
doctor or pharmacist for advice before you are
given this medicine. If necessary, metoclopramide
may be taken during pregnancy. Your doctor will
decide whether or not you should be given this
medicine.
Metoclopramide is not recommended if you are
breast-feeding because metoclopramide passes
into breast milk and may affect your baby.
Driving and using machines:
You may feel drowsy, dizzy or have uncontrollable
twitching, jerking or writhing movements and
unusual muscle tone causing distortion of the body
after taking metoclopramide. This may affect your
vision and also interfere with your ability to drive
and use machines.
Metoclopramide Injection contains sodium
metabisulphite
This may rarely cause severe hypersensitivity
reactions and bronchospasm.
3. HOW TO USE METOCLOPRAMIDE 5MG/ML
INJECTION
The medicine will normally be given to you by a
doctor or nurse. It will be given as a slow injection
into a vein (over at least 3 minutes) or by injection
into a muscle.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you
are given metoclopramide if:
! You have liver or kidney problems. The dose
may be reduced (see section 3)
! You have a history of abnormal heart beats (QT
interval prolongation) or any other heart
problems
! You are using other medicines known to affect
the way your heart beats
! You have problems with the levels of salts in
your blood, such as potassium, sodium and
magnesium
! You have any neurological (brain) problems.

In adult patients
For the treatment of nausea and vomiting including
nausea and vomiting which may occur with a
migraine and for the prevention of nausea and
vomiting caused by radiotherapy: the
recommended single dose is 10mg, repeated up to
3 times daily.
The maximum recommended dose per day is
30mg or 0.5mg/kg body weight.
For the prevention of nausea and vomiting that
may occur after surgery prevention: a single dose
of 10mg is recommended.

INFORMATION FOR HEALTHCARE
PROFESSIONALS

Posology and method of administration
Administration: by intramuscular or intravenous
injection.

PLEASE DETACH BEFORE HANDING ABOVE
SECTION TO THE PATIENT

Metoclopramide Injection may be mixed with the
following substances for intravenous infusion:
Sodium chloride intravenous infusion BP 0.9% w/v,

Intravenous doses should be administered as a
slow bolus (at least over 3 minutes).

Metoclopramide 5mg/ml Injection
Below is a summary of information to assist in the
administration of Metoclopramide Injection.
! Please refer to SPC for complete prescribing
information.
Presentation
Metoclopramide Injection is a clear and colourless
sterile aqueous solution in an amber glass
ampoule containing 5mg of anhydrous
metoclopramide hydrochloride per ml. Each 2ml
ampoule contains 10mg of metoclopramide
hydrochloride.
Preparation of infusion
Intravenous solutions should be prepared as near
as possible to the time of infusion. However
Metoclopramide Injection has been shown to be
stable in the solutions listed below for at least 24
hours at room temperature.
Metoclopramide Injection can be mixed with the
following substances for intravenous infusion:
Sodium Chloride intravenous infusion BP (0.9%
w/v)
Glucose intravenous infusion BP (5%w/v)
Sodium chloride and glucose intravenous infusion
BP (sodium chloride 0.18%w/v; glucose 4%w/v)
Potassium chloride (0.15% or 0.3%)

Adults
For prevention of Post operative nausea and
vomiting (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.
Treatment duration should be as short as possible
and transfer to oral or rectal treatment should be
made as soon as possible.
Children
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.

Symptoms similar to Parkinson's
disease (rigidity, tremor)
Feel restless
Blood pressure decrease (particularly
with intravenous route)
Diarrhoea
Feeling weak.

Glucose intravenous infusion BP (5%w/v) Sodium
chloride and glucose intravenous infusion BP
(sodium chloride 0.18%w/v; glucose 4%w/v)
Potassium chloride (0.15% or 0.3%)

!

Metoclopramide Injection will be prepared just
before use.

!
!

Paediatric population (aged 1-18 years):
The recommended dose is 0.1 to 0.15mg/kg body
weight, repeated up to 3 times daily, given by slow
injection into a vein.
The maximum dose in 24 hours is 0.5mg/kg body
weight.

Uncommon (may affect up to 1 in 100
people)
! Raised levels of a hormone called
prolactin in the blood which may
cause: milk production in men, and
women who are not breast-feeding
! Irregular periods
! Hallucination
! Decreased level of consciousness
! Slow heart beat (particularly with intravenous
route)
! Allergy.

Dosing table
Age
Body weight
1-3 years
10-14kg
3-5 years
15-19kg
5-9 years
20-29kg
9-18 years 30-60kg
15-18 years Over 60kg

Dose
1mg
2mg
2.5mg
5mg
10mg

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 treatment should not exceed 48 hours for
treatment of nausea and vomiting that has
occurred after surgery.
The treatment should not exceed 5 days for the
prevention of delayed nausea and vomiting that
may occur after chemotherapy.
Older people
The dose may need to be reduced depending on
kidney problems, liver problems and overall health.
Other pharmaceutical forms/strengths may be
more appropriate for administration.
Adults with kidney problems
Talk to your doctor if you have kidney problems.
The dose should be reduced if you have moderate
or severe kidney problems.
Other pharmaceutical forms/strengths may be
more appropriate for administration.
Adults with liver problems
Talk to your doctor if you have liver problems. The
dose should be reduced if you have severe liver
problems.
Other pharmaceutical forms/strengths may be
more appropriate for administration.
Children and adolescents
Metoclopramide must not be used in children aged
less than 1 year (see section 2).
If you are given too much Metoclopramide
Injection
Since the injection will be given to you by a doctor
or nurse, it is unlikely that you will be given too
much. However, if you think that you have been
given too much, you should tell the person giving
you the injection immediately. You may experience
uncontrollable movements (extrapyramidal
disorders), feel drowsy, decreased levels of
consciousness, be confused, have hallucinations
and heart problems. Your doctor may prescribe
you a treatment for these signs if necessary.
If you stop taking Metoclopramide Injection
Your doctor will decide when you need to stop
taking this medicine.
If you forget to take Metoclopramide Injection
As this medicine is given by a doctor or nurse it is
unlikely that a dose will be missed. If however, you
think a dose has been missed you should talk to
the doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Metoclopramide Injection can
cause side effects, although not everybody gets
them.
Stop the treatment and talk straight away to your
doctor, pharmacist or nurse if you experience one
of the following signs while having this medicine:
! Uncontrollable movements (often involving
head or neck). These may occur in children or
young adults and particularly when high doses
are used. These signs usually occur at the
beginning of treatment and may even occur
after one single administration. These
movements will stop when treated
appropriately
! High fever, high blood pressure, convulsions,
sweating, production of saliva. These may be
signs of a condition called neuroleptic
malignant syndrome
! Itching or skin rashes, swelling of the face, lips
or throat, difficulty in breathing. These may be
signs of an allergic reaction, which may be
severe.
Very common (may affect more than 1 in 10
people)
! Feeling drowsy.
Common (may affect up to 1 in 10 people)
! Depression
! Uncontrollable movements such as tics,
shaking, twisting movements or muscle
contracture (stiffness, rigidity)

Dosing table
Age
1-3
years
3 5
years
5 9
years
9 18
years
15 18
years

Body weight Dose
10-14 kg
1 mg

Frequency
Up to 3 times daily

15-19 kg

2 mg

Up to 3 times daily

20-29 kg

2.5 mg

Up to 3 times daily

30-60 kg

5 mg

Up to 3 times daily

Over 60 kg

10 mg

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).

!
!

Rare (may affect up to 1 in 1,000 people)
! Confusional state
! Convulsion (especially in patients with
epilepsy).
Not known (frequency cannot be estimated from
the available data)
! Abnormal blood pigment levels: which may
change the colour of your skin
! Abnormal development of breasts
(gynaecomastia)
! Involuntary muscle spasms after prolonged
use, particularly in elderly patients
! High fever, high blood pressure, convulsions,
sweating, production of saliva. These may be
signs of a condition called neuroleptic
malignant syndrome
! Changes in heart beat, which may be shown on
an ECG test
! Cardiac arrest (particularly with injection route)
! Shock (severe decrease of heart pressure)
(particularly with injection route)
! Fainting (particularly with intravenous route)
! Allergic reaction which may be severe
(particularly with intravenous route)
! Very high blood pressure.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellow card
By reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE METOCLOPRAMIDE
5MG/ML INJECTION
Your injection will be stored in a cool place and
need to protected from light. The nurse or doctor
will check that the injection is not past its expiry
date before giving you the injection.
The expiry date refers to the last day of that month.
Keep out of the sight and reach of children.
6. CONTENTS OF PACK AND OTHER
INFORMATION
What Metoclopramide Injection contains:
The injection contains an active ingredient called
metoclopramide hydrochloride.
Each 1 ml of solution contains metoclopramide
hydrochloride equivalent to 5 mg anhydrous
metoclopramide hydrochloride in a sterile solution
for injection.
The injection contains the following inactive
ingredients:
E223 - Sodium metabisulphite
Sodium chloride
Water for injection.
What Metoclopramide Injection looks like and
the content of the pack:
The injection is supplied in 2ml and 20ml amber
glass ampoules.
The 2ml product is available as a pack size of 5
and/or 10 ampoules.
The 20ml product is available as a pack size of 10
ampoules.
Marketing Authorisation Holder:
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
Manufacturer:
SALF SpA Laboratorio Farmacologico
Via Marconi 2, 24069 Cenate Sotto (Bergamo),
Italy.
This leaflet was last revised January 2016.

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 at
www.mhra.gov.uk/yellowcard.
Toxicity and treatment of 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
anti-parkinsonian medicinal products in adults).

Metoclopramide injection should not be used in
children aged less than 1 year.

A symptomatic treatment and a continuous
monitoring of the cardiovascular and respiratory
functions should be carried out according to clinical
status.

Elderly
In elderly patients a dose reduction should be
considered, based on renal and hepatic function
and overall frailty.

Special precautions for storage
Store in a cool dry place. Protect from light. If only
part of the ampoule is used, discard the remaining
solution. For single use only.

Renal impairment
In patients with end stage renal disease
(Creatinine clearance = 15ml/min), the daily dose
should be reduced by 75%.
In patients with moderate to severe renal
impairment (Creatinine clearance 15 60ml/min),
the dose should be reduced by 50% .

An expiry date is given on the outer carton and
ampoule label of the product. It should not be used
after this date.

Hepatic impairment:
In patients with severe hepatic impairment, the
dose should be reduced by 50%.

Product licence number
PL 40147/0059

Nature and contents of the container
10mg/2ml injection: box of 5 ampoules

Expand view ⇕

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.

Hide