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METOCLOPRAMIDE 5 MG/ML SOLUTION FOR INJECTION

Active substance(s): METOCLOPRAMIDE HYDROCHLORIDE / METOCLOPRAMIDE HYDROCHLORIDE

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Package leaet: Information for the patient

Metoclopramide 5 mg/ml Solution for Injection
Metoclopramide Hydrochloride
Read all of this leaet 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.
• If you get any side effects, talk to your doctor or
pharmacist. Thisincludes any possible side effects not
listed in this leaflet.
What is in this leaet:
1. What Metoclopramide Injection is and what it is used
for
2. Before you are given Metoclopramide Injection
3. How to use Metoclopramide Injection
4. Possible side effects
5. How to store Metoclopramide Injection
6. Contents of the pack and other information
1. What Metoclopramide injection is and what it is used
for
Metoclopramide acts on the muscles in your digestive
system which move food through the stomach and
intestine, it also acts as an anti-emetic (stops you from
being sick).
Metoclopramide is indicatedin children (aged 1-18 years)
for:
- Prevention of delayed chemotherapy induced nausea
and vomiting (CINV) as a second line option.
- Treatment of post operative nausea and vomiting
(PONV) as a second line option. This medication
should not be used in children under 1 year old.
Metoclopramide 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 or treatment of nausea and vomiting
(feeling or being sick), including nausea and vomiting
that may result from anticancer medicines (CINV) or
radiation treatment (RINV)
2. Before you are given Metoclopramide Injection
You should NOT be given Metoclopramide Injection if
you:
• Are sensitive or allergic to Metoclopramide or any of
the other ingredients contained in the injection.
Please tell your doctor or nurse before being given the
injection if you have:
• Recently had an operation on your stomach or
intestine.
• A blockage in your stomach, or a stomach bleed or
perforation.
• High blood pressure.
• Liver or kidney problems.
• High blood pressure due to a tumour near the kidney
(phaeochromocytoma).
• Epilepsy or porphyria.
• Asthma.
Other medicines and Metoclopramide Injection
Please tell your doctor or nurse if you are taking or have
recently taken any other medicines, includingmedicines
obtained without a prescription. This is especially

important with the following medicinesas they may interact
with your Metoclopramide
injection:
• Medicines to treat epilepsy.
• Medicines to treat depression including medicines
known as serotonergic drugs(SSRIs).
• Medicines to treat Parkinson's disease (e.g.levodopa,
bromocriptine, cabergoline).
• Medicines to reduce the level of the hormone Prolactin
in your blood (e.g. bromocriptine, cabergoline).
• Drugs for phobias or psychosis or any otherdrugs that
act on the brain.
• Anticholinergic drugs (to treat a 'weakbladder').
• Atovaquone (to treat pneumonia).
• Aspirin or paracetamolor stronger pain killers called
“opiods” (e.g. morphine).
• Any other drugs to treat nausea and vomiting.
• Suxamethonium (to relax your muscles).
• Ciclosporin – a medicine that is used todampen down
the body's immune reactions (e.g. following transplant
operations or in the treatment of rheumatoid arthritis or
certain skin conditions).
Pregnancy, breast-feeding and fertility
Please tell your doctor or nurse before being given this
injection if you are pregnant. The doctor will then decide if
the injection is suitable for you.
Please tell your doctor or nurse before being given this
injection if you are breast feeding –this injection should not
be used by nursing (breast feeding) mothers.
Driving and using machines
Metoclopramide Injection may cause visual disturbances,
make you drowsy or affect your ability to concentrate. You
should not drive or use machinery if you are affected.
Metoclopramide Injection contains sodium
Metoclopramide Injection contains less than 1 mmol
sodium (salt) (23mg) per dose, i.e. is essentially “sodium
free”.
3. How to use Metoclopramide Injection
Your nurse or doctor will give you the injection.
Your doctor will decide the correct dosage for you and how
and when the injection will be given. Since the injection will
be given to you by a doctor or nurse, it is unlikely that you
will be given too much. If you think you have been given too
much, you must tell the person giving you the injection.
4. Possible side effects
Like all medicines, Metoclopramide Injection can cause
side effects, although not everybody gets them.
• You may suffer from movement disorders, which may
make you feel shaky, very restless, your eyes and
tongue may move on their own or your neck may twist
back. If these occur, contact your doctor immediately
for advice.
• Rarely metoclopramide can lead to a condition called
“Neuroleptic Malignant Syndrome” - a condition
associated with high temperature, stiff muscles and
altered consciousness. If this happens stop using
Metoclopramide Injection and contact your doctor
immediately.
• Severe allergic reactions can occur very rarely and
usually happen soon after administration of
Metoclopramide Injection. These can involve difficulty
breathing, tightness in the throat, rapidly spreading

&
The following information is intended for healthcare
professionals only:

Dosing table

Posology and method of administration
The solution can be administered intravenously or
intramuscularly.
Intravenous doses should be administered as a slow bolus
(at least over 3 minutes).
For both adults and children, metoclopramide should only
be used for a maxiumum of 5 days.
All indications (adult patients)
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 10 mg,
repeated up to three times daily
The maximum recommended daily dose is 30 mg 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 0.15 mg/kg body weight,
repeated up to three times daily by intravenous route. The
maximum dose in 24 hours is 0.5 mg/kg body weight.

For the prevention of delayed nausea and vomiting, the
maximum treatment duration is 5 days.
For the treatment of nausea and postoperative vomiting
proven (PONV), the maximum treatment duration is 48
hours.
Method of administration:
For both adults and children, metoclopramide should only
be used for a maximum of 5 days
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 15-60 ml/min), the dose should be
reduced by 50%.










Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly
via (see details below). By reporting side effects you can
help provide more information on the safety of this
medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
5. How to store Metoclopramide Injection
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the label and carton after Exp. Date.
The expiry date refers to the last day of that month.
Protect from light.
Do not store in the refrigerator or freezer
If only part of the ampoule is used, discard the remaining
solution. For single use only
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.
Chemical and physical in-use stability has been
demonstrated for 24 hrs at 25˚ C.

hydrochloride anhydrous
2 ml contains metoclopramide hydrochloride monohydrate
equivalent to 10 mg of metoclopramide hydrochloride
anhydrous.
10 ml contains metoclopramide hydrochloride
monohydrate equivalent to 50 mg of metoclopramide
hydrochloride anhydrous.


The other ingredients are citric acid monohydrate,
sodium citrate, sodium chloride, sodium hydroxide,
hydrochloric acid and water for injections.

What Metoclopramide Injection looks like and contents
of the pack
Clear, colourless, sterile solution
Type I clear glass ampoules of 2 ml and 10 ml fill volume.
Metoclopramide 5 mg/ml solution for injection is available
in glass ampoule containing 2 ml solution and 10 mL
solution which are packed in blister and further packed in
cardboard box pack as below pack style:
5 x 2 mL, 10 x 2 mL and 25 x 2 mL
5 x 10 mL and 10 x 10 mL.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Claris Lifesciences (UK) Limited
Golden Gate Lodge, Crewe Hall, Weston Road,
Crewe, Cheshire CW1 6UL
United Kingdom
Manufacturer
Peckforton Pharmaceuticals Limited
Crewe Hall, Crewe, Cheshire - CW1 6UL
United Kingdom
UAB Norameda
Meistru 8a, 02189,
Vilnius, Lithuania
Tramco Sp. Z.o.o
Wolskie, ul. Wolska 14, 05-860 Plochocin
Poland
SIA Unifarma
Vangazu street 23
Riga, Latvia
This medicinal product is authorised in the Member
States of the EEA under the following names:

1400004551



rashes, dizziness, very fast heart beat or even loss of
consciousness. If this happens stop using
Metoclopramide Injection and contact your doctor
immediately
Rare cases of confusion have been reported during
metoclopramide therapy.
Very rare cases of blood cell disorders have been
reported – these may make you feel weak or breathless
or to have a headache and your lips and skin may
appear blue. If any of these symptoms occur, contact
your doctor immediately for advice.
Other unwanted effects include upset stomach,
drowsiness, dizziness, restlessness, anxiety,
depression and fatigue.
Rarely, blood levels of the hormone Prolactin can be
increased. This can cause production of breast milk
and enlargement of breast glands in men and can
cause irregular periods in women.
Very rarely metoclopramide may affect your heart
causing it to slow down or to stop. You may experience
an increase in your blood pressure. You may also
experience a decrease in your blood pressure and your
heart may then speed up.
Skin reactions can occur including skin rash and itchy
skin. Following administration, redness and swelling
can appear at the site of injection. If you think this
injection is causing you any problems, or you are at all
worried, talk to your doctor, nurse or pharmacist

From a microbiology point of view, the product should be
used immediately. If not used immediately, in-use storage
times and conditions prior to used are the responsibility of
the user and would normally not be longer than 24 hrs at 2
to 8˚ C, unless reconstitution has taken place in controlled
and validated aseptic condition.
6. Contents of the pack and other information
What Metoclopramide Injection contains:
• The active ingredient is metoclopramide
hydrochloride.
One ml of solution contains metoclopramide hydrochloride
monohydrate equivalent to 5 mg of metoclopramide

&
Hepatic impairment:
In patients with severe hepatic impairment, the dose
should be reduced by 50%.
Paediatric population
Metoclopramide is contraindicated in children aged less
than 1 year
A minimal interval of 6 hours between two administrations
is to be respected, even in case of vomiting or rejection of
the dose
Shelf life:
Before opening: 2 Years
Chemical and physical in-use stability has been
demonstrated for 24 hrs at 25˚ C.
From a microbiology point of view, the product should be
used immediately. If not used immediately, in-use storage
times and conditions prior to used are the responsibility of
the user and would normally not be longer than 24 hrs at 2
to 8˚ C, unless reconstitution has taken place in controlled
and validated aseptic condition.
Metoclopramide 5 mg/ml solution for injection is
compatible with the following solutions for infusion for 24
hours:
1) 0.9 % Sodium Chloride Injection
2) 5% Dextrose Injection
3) 4% Dextrose in 0.18 % Sodium chloride
4) Ringer lactate solution

This leaflet was last revised in month 02 / 2017

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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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