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METOCLOPRAMIDE 5 MG/ML SOLUTION FOR INJECTION

Active substance(s): METOCLOPRAMIDE HYDROCHLORIDE

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Claris Injectables Limited
Artwork Code : 1400006429

Artwork Req. No: 21546

Quality of Paper/Board : Super Sun Shine

Size of Artwork (In mm) : 400x175

Quality of Gum :

GSM of Paper/Board : 60 GSM

Colour Code :

BLACK

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Barcode Information:

Barcode Scan Report:
Packing: 2ml Amp

Plant Location : Injectable

Country: United Kingdom

Language : English
Artwork Control Key No.:

Ref. Code Creation/Blockage Note:
“Controlled Copy” Holder (1)

(2)

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Package leaflet: Information for the patient

Metoclopramide 5 mg/ml Solution for Injection
Metoclopramide Hydrochloride
Read all of this leaflet carefully before you start using
this medicine because it contains important information
for you.
• Keep this leaet. 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 leaet.
What is in this leaflet:
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 of this medicine (listed in
section 6).
• You have bleeding, obstruction or a tear in your
stomach or gut.
• You have or may have a rare tumour of the adrenal
gland, which sits near the kidney (phaeochromocytoma).
• You have ever had involuntary muscle spasms (tardive
dyskinesia), when you have beentreated with a
medicine.
• You have epilepsy
• You have Parkinson's disease
• You are taking levodopa (a medicine for Parkinson's
disease) or dopaminergic agonists (see below "Other
medicines and Metoclopramide 5 mg/ml Injection).
• You have ever had an abnormal blood pigment level
(methaemoglobinaemia) or NADH cytochrome-b5
deciency.
• A child is less than one year of age because of the
increased risk of uncontrollable movements (extrapyramidal disorders)






Any neurological (brain) problems.
A history of abnormal heart beats (QT interval
prolongation), are using other medicines known to
affect the way your heart beats, or have any other heart
problems.
Elderly

Blood tests
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
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

Please tell your doctor or nurse before being given the
injection if you have:
• Recently had an operation on your stomach or
intestine.
• High blood pressure.
• Liver or kidney problems. The dose may be reduced
(see section 3).
• Asthma.
• porphyria
• Problems with the levels of salts in your blood, such as
potassium, sodium and magnesium.

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

&
The following information is intended for healthcare
professionals only:
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.
Dosing table

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.

Claris Injectables Limited
Artwork Code : 1400006429

Artwork Req. No: 21546

Quality of Paper/Board : Super Sun Shine

Size of Artwork (In mm) : 400x175

Quality of Gum :

GSM of Paper/Board : 60 GSM

Colour Code :

BLACK

Pantone

Pantone

Pantone

Pantone

Pantone

Pantone

Pantone

Barcode Information:

Barcode Scan Report:
Packing: 2ml Amp

Plant Location : Injectable

Country: United Kingdom

Language : English
Artwork Control Key No.:






(2)

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, difculty in breathing. These may be signs of an
allergic reaction, which may be severe.
Abnormal blood pigment levels: which may change the
colour of your skin
Involuntary muscle spasms after prolonged use,
particularly in elderly patients

Very common (may affect more than 1 in 10 people)
• Feeling drowsy.
Common (may affect up to 1 in 10 people)
• Symptoms similar to Parkinson's disease (rigidity,
tremor)
• Feeling restless
• Blood pressure decrease (particularly with intravenous
route)
• Diarrhea
• Feeling weak.
• Depression
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 in women
who are not breast-feeding
Irregular periods
Hallucination
Decreased level of consciousness
Slow heartbeat (particularly with intravenous route)

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 development of breasts (gynaecomastia)
• Changes in heart beat, which may be shown on an
ECG test
• Cardiac arrest (particularly with the injectable route)
• Shock (severe decrease of heart pressure) (particularly with the injectable route)
• Fainting (particularly with the intravenous route)
• Injection site inammation and local phlebitis
• Allergic reaction which may be severe (particularly with
the intravenous route)
• very high blood pressure
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 leaet. 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

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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
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 ll 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

1400006429

Ref. Code Creation/Blockage Note:
“Controlled Copy” Holder (1)

This medicinal product is authorised in the
Member States of the EEA under the following names:

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.
Do not store in the refrigerator or freezer
If only part of the ampoule is used, discard the remaining
solution. For single use only
Store ampoule in the original package in order to protect
from light
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.

This leaflet was last revised in month 10/2017

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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%.
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.
Incompatibilities:
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

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