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OXYCODONE HYDROCHLORIDE 50 MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): OXYCODONE HYDROCHLORIDE

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3. How to use Oxycodone Injection
A doctor or nurse will usually prepare and
administer the injection for you. The injection
should be used immediately after opening. The
dose and how often the injection is given may be
adjusted according to the severity of your pain.
The usual starting dose for adults over 18 years
old is dependent upon how the injection is
administered. The usual starting doses are as
follows:
• As a single injection into a vein, the usual dose
is 1 to 10 mg given slowly over 1 to 2 minutes.
This can be repeated every 4 hours.
• As an infusion into a vein, the usual starting
dose is 2 mg/hour.
• As a single injection through a fine needle into
the tissue under the skin, the usual starting
dose is 5 mg repeated at 4-hourly intervals if
needed.
• As an infusion through a fine needle into the
tissue under the skin, the usual starting dose is
7.5 mg/day.
• If given by patient controlled analgesia (PCA),
the dose is worked out according to your weight
(0.03 mg per kg of body weight). Your doctor or
nurse will set a suitable frequency.
The dose recommended by the doctor should not
be exceeded. Check with the doctor, pharmacist
or nurse if you are unsure.
If you find that you are still in pain whilst being given
Oxycodone Injection discuss this with your doctor.
If you use more Oxycodone Injection than you
should, or if someone else uses your injection
Call your doctor or hospital straight away. People
who have been given an overdose may feel very
sleepy and sick. They may also have breathing
difficulties leading to unconsciousness or even
death and may need emergency treatment in
hospital. When seeking medical attention make
sure that you take this leaflet and any remaining
injection with you to show to the doctor.


Information for Healthcare Professionals
Oxycodone Hydrochloride 50 mg/ml Solution for Injection or
Infusion
Please refer to the Summary of Product Characteristics (SmPC) for
further details on this product.
Qualitative and Quantitative Composition
Each ml contains oxycodone hydrochloride 50 mg (equivalent to
45 mg of oxycodone base).
This medicinal product contains less than 1 mmol sodium (23 mg)
per dose.
For the full list of excipients, see Section 6.1.
Pharmaceutical Form
Solution for injection or infusion (injection or infusion).
A clear, colourless solution practically free of particles.
Therapeutic indications
For the treatment of moderate to severe pain in patients with cancer
and post-operative pain. For the treatment of severe pain requiring
the use of a strong opioid.
Posology and method of administration
Route of administration:
Subcutaneous injection or infusion.
Intravenous injection or infusion.
Posology:
The dose should be adjusted according to the severity of pain, the
total condition of the patient and previous or concurrent medication.
Adults over 18 years:
The following starting doses are recommended. A gradual increase
in dose may be required if analgesia is inadequate or if pain
severity increases.
i.v. (Bolus): Dilute in 0.9% saline, 5% dextrose or water for injections.
Administer a bolus dose of 1 to 10 mg slowly over one to two minutes
in opioid naive patients.
Doses should not be administered more frequently than every
four hours.
i.v. (Infusion): Dilute in 0.9% saline, 5% dextrose or water for
injections. A starting dose of 2 mg/hour is recommended for opioid
naive patients.

i.v. (PCA): Dilute in 0.9% saline, 5% dextrose or water for injections.
Bolus doses of 0.03 mg/kg should be administered with a minimum
lock-out time of five minutes for opioid naive patients.
s.c. (Bolus): Dilute in 0.9% saline, 5% dextrose or water for
injections. A starting dose of 5 mg is recommended, repeated at
four-hourly intervals as required for opioid naive patients.
s.c. (Infusion): Dilute in 0.9% saline, 5% dextrose or water for injections
if required. A starting dose of 7.5 mg/day is recommended in opioid
naïve patients, titrating gradually according to symptom control.
Cancer patients transferring from oral oxycodone may require much
higher doses (see below). 
Transferring patients between oral and parenteral oxycodone:
The dose should be based on the following ratio: 2 mg of oral
oxycodone is equivalent to 1 mg of parenteral oxycodone. It must be
emphasised that this is a guide to the dose required. Inter-patient
variability requires that each patient is carefully titrated to the
appropriate dose.
Elderly:
Elderly patients should be treated with caution. The lowest dose
should be administered with careful titration to pain control.
Patients with renal and hepatic impairment:
Patients with mild to moderate renal impairment and/or mild hepatic
impairment should be treated with caution. The lowest dose should
be given with careful titration to pain control.
Children under 18 years:
There are no data on the use of Oxycodone injection in patients
under 18 years of age.
Use in non-malignant pain:
Opioids are not first-line therapy for chronic non-malignant pain, nor
are they recommended as the only treatment. Types of chronic pain
which have been shown to be alleviated by strong opioids include
chronic osteoarthritic pain and intervertebral disc disease. The need
for continued treatment in non-malignant pain should be assessed
at regular intervals.
Cessation of therapy:
When a patient no longer requires therapy with oxycodone, it may
be advisable to taper the dose gradually to prevent symptoms of
withdrawal.

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605856

26/10/2015
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Oxycodone infusion 50mg/ml leaflet
Description

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Do not use Oxycodone Injection:
• if you are allergic (hypersensitive) to oxycodone,
or any of the other ingredients of this medicine
(listed in section 6);
• if you have breathing problems, such as
respiratory depression, chronic obstructive
airways disease, chronic bronchial asthma or
severe pulmonary disease, unless otherwise
recommended by your doctor;
• if you have a head injury that causes a
severe headache or makes you feel sick.
This is because the injection may make these
symptoms worse or hide the extent of the head
injury;
• if you have a condition where the small bowel
does not work properly (paralytic ileus) or you
have severe pain in your abdomen;
• if you have a heart problem after long-term lung
disease (cor pulmonale);
• if you have severe kidney problems or moderate
to severe liver problems. If you have other long
term kidney or liver problems you should only
use Oxycodone Injection if recommended by
your doctor;
• if you have ongoing problems with constipation;
• if you are taking a type of medicine known as a
monoamine oxidase inhibitor (examples include
tranylcypromide, phenelzine, isocarboxazid,
moclobemide and linezolid), or you have taken
this type of medicine in the last two weeks.
Children and adolescents under 18 years old
should not use the injection.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
using Oxycodone Injection:
• if you have an under-active thyroid gland
(hypothyroidism), as you may need a lower dose
of Oxycodone Injection;
• if you have a severe headache or feel sick as
this may indicate that the pressure in your skull
is increased;
• if you have low blood pressure (hypotension);
• if you have a mental disorder as a result of an
infection (toxic psychosis);
• if you have inflammation of the pancreas
(pancreatitis) or problems with your gall bladder;
• if you have inflammatory bowel disease;
• if you have prostate problems;
• if you have poor adrenal gland function;
• if you are or have ever been addicted to alcohol
or drugs;
• if you have previously suffered from withdrawal
symptoms such as agitation, anxiety, shaking or
sweating upon stopping taking alcohol or drugs.
Other medicines and Oxycodone Injection
Please tell your doctor, pharmacist or nurse if
you are taking or have recently taken any other
medicines, including medicines obtained without
a prescription. If you use Oxycodone Injection with
some other medicines, the effect of Oxycodone
Injection or the other medicines may be changed.

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2. What you need to know before you use
Oxycodone Injection

Wockhardt UK Limited

This injection has been prescribed for you by your
doctor to relieve moderate to severe pain.
It contains the active ingredient oxycodone which
belongs to a group of medicines called strong
analgesics or ‘painkillers’. The other ingredients
are listed in section 6 of this leaflet.

Customer

1. What Oxycodone Injection is and what it
is used for

Tell your doctor, pharmacist or nurse:
• if you are taking medicines to help you sleep (for
example tranquillisers, hypnotics or sedatives);
• if you have recently been given an anaesthetic;
• if you are taking medicines to treat depression;
• if you are taking medicines to treat psychiatric
or mental disorders;
• if you are taking other strong analgesics or
‘painkillers’;
• if you are taking muscle relaxants;
• if you are taking medicines to treat high blood
pressure;
• if you are taking a type of medicine known as a
monoamine oxidase inhibitor (examples include
tranylcypromide, phenelzine, isocarboxazid,
moclobemide and linezolid), or you have taken
this type of medicine in the last two weeks.
Oxycodone Injection with alcohol
Drinking alcohol during your treatment with
Oxycodone Injection may make you sleepy. If you
are affected you should avoid drinking alcohol.
Pregnancy and breastfeeding
Do not use Oxycodone Injection if you are
pregnant or breastfeeding.
Ask your doctor, pharmacist or nurse for advice
before taking any medicine.
Driving and using machines
You may feel sleepy when you first start using
Oxycodone Injection, or when increasing to a
higher dose. If you are affected you should not
drive or use machinery.
This medicine can affect your ability to drive.
Do not drive whilst taking this medicine until you
know how this medicine affects you.
It may be an offence to drive if your ability to drive
safely is affected.
There is further information for patients who are
intending to drive in Great Britain - go to
http://www.gov.uk/drug-driving-law
Oxycodone Injection contains sodium
This injection contains less than 1 mmol sodium
(23 mg) per 1 ml, i.e. it is essentially “sodium-free”.

Measure bar should be 150mm at 100% scale

The name of your medicine is Oxycodone
Hydrochloride 50 mg/ml Solution for Injection
or Infusion. In the rest of this leaflet it is called
Oxycodone Injection.
In this leaflet:
1. What Oxycodone Injection is and what it is
used for
2. What you need to know before you use
Oxycodone Injection
3. How to use Oxycodone Injection
4. Possible side effects
5. How to store Oxycodone Injection
6. Contents of the pack and other information

Keylines (non-printing)

Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, 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 you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.

Process Black

Colours Used

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Oxycodone Hydrochloride 50 mg/ml
Solution for Injection or Infusion


Pharmaceutical Particulars
Excipients: Citric acid monohydrate, sodium citrate, sodium
chloride, hydrochloric acid (for pH adjustment), sodium hydroxide
(for pH adjustment) and water for injections.
Incompatibilities
This medicinal product must not be mixed with other medicinal
products except those mentioned below (special precautions for
disposal/handling).
Cyclizine at concentrations of 3 mg/ml or less, when mixed with
oxycodone injection, either undiluted or diluted with water for
injections, shows no sign of precipitation over a period of 24 hours
storage at room temperature. Precipitation has been shown to occur
in mixtures with oxycodone injection at cyclizine concentrations
greater than 3 mg/ml or when diluted with 0.9% saline. It is
recommended that Water for Injections be used as a diluent when
cyclizine and oxycodone hydrochloride are co-administered, as
cyclizine will precipitate in the presence of 0.9% saline.
Prochlorperazine is chemically incompatible with Oxycodone
injection.
Shelf life and special precautions for storage/handling
Unopened: 24 months.
The injection should be given immediately after opening the
ampoule. Once opened, any unused portion should be discarded.
Chemical and physical in-use stability has been demonstrated for
24 hours at room temperature.
From a microbiological point of view, the product should be used
immediately. If not used immediately, in-use storage times and
conditions prior to use are the responsibility of the user and
would normally not be longer than 24 hours at 2 to 8°C, unless
reconstitution, dilution, etc has taken place in controlled and
validated aseptic conditions.

Special precautions for disposal
Oxycodone injection has been shown to be compatible with the
following drugs:
Hyoscine butylbromide
Hyoscine hydrobromide
Dexamethasone sodium phosphate
Haloperidol
Midazolam hydrochloride
Metoclopramide hydrochloride
Levomepromazine hydrochloride
Oxycodone injection, undiluted or diluted to 1 mg/ml with
0.9% w/v saline, 5% w/v dextrose or water for injections,
is physically and chemically stable when in contact with
representative brands of polypropylene or polycarbonate
syringes, polyethylene or PVC tubing, and PVC or EVA infusion
bags, over a 24 hour period at room temperature.
Inappropriate handling of the undiluted solution after opening of the
original ampoule, or of the diluted solutions may compromise the
sterility of the product.
Any unused medicinal product or waste material should be
disposed of in accordance with local requirements.
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
Marketing Authorisation Number
PL 29831/0367
PA 1339/25/2
Date of Revision of Text: November 2015

Do not store above 25°C. Keep the ampoule in the outer carton in
order to protect from light.
Nature and contents of container
Type I neutral glass ampoules: 1 ml. Pack size: 5 ampoules.

105940/4

26/10/2015
Date

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Artwork No.

605856

1

English
Language

Proof No.

UK
Market

matt.pirie-scott

6pt (main body) / 7pt (variables)
Min. Point Size

Proof By

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.

460 x 150mm
Size

artwork.leicester@multipkg.com

Clearly mark any amendments on one proof and return to MPS

n-a

105940/4
Item Code

Profile

Oxycodone infusion 50mg/ml leaflet
Description

Pharma
Code

71

Text Free Area (non-printing)

Keylines (non-printing)

Process Black

Colours Used
Wockhardt UK Limited

Like all medicines, Oxycodone Injection can cause
side effects, although not everybody gets them.
All medicines can cause allergic reactions,
although serious allergic reactions are rare.
Tell your doctor immediately if you get any sudden
wheeziness, difficulties in breathing, swelling of
the eyelids, face or lips, rash or itching especially
those covering your whole body.
The most serious side effect is a condition where
you breathe more slowly or weakly than expected
(respiratory depression).
As with all strong painkillers, there is a risk
that you may become addicted or reliant on
Oxycodone Injection.
Very common side effects
5. How to store Oxycodone Injection
(Probably affecting more than 1 in 10 people
Keep out of the sight and reach of children.
using Oxycodone Injection)
Accidental overdose by a child is dangerous and
Most people will have constipation when they use may be fatal.
Oxycodone Injection. Your doctor can prescribe a
Do not use Oxycodone Injection after the expiry
laxative to overcome this problem.
date which is stated on the ampoule label and
You may feel sick or vomit (be sick) when using
carton after EXP. The expiry date refers to the last
this injection, this should normally wear off after
day of that month.
a few days however your doctor can prescribe
Do not store above 25°C. Keep the ampoule in
an anti-vomiting medicine if it continues to be a
the outer carton in order to protect from light.
problem.
The injection should be given immediately after
You may find that you feel more sleepy than
opening the ampoule. Once opened, any unused
normal when you start using your injection or
portion should be discarded. Chemical and
when your dose is increased. This should wear off physical in-use stability has been demonstrated
after a few days.
for 24 hours at room temperature.
The following side effects have also been very
Medicines should not be disposed of via
commonly reported in patients treated with
wastewater or household waste. Ask your
Oxycodone Injection:
pharmacist how to dispose of medicines no longer
• Dizziness
required. These measures will help to protect the
• Itchy skin.
environment.
Common side effects
6. Contents of the pack and other information
(Probably affecting more than 1 in 100 people
using Oxycodone Injection)
What Oxycodone Injection contains
• Dry mouth, loss of appetite, indigestion,
The active ingredient is oxycodone hydrochloride.
abdominal pain or discomfort, diarrhoea
The other ingredients are: Citric acid
• Headache, confusion, a feeling of unusual
monohydrate, sodium citrate, sodium chloride,
weakness, a feeling of ‘faintness’ especially on hydrochloric acid (dilute), sodium hydroxide
standing up, anxiety, nervousness, difficulty in
(dilute) and water for injections.
sleeping, abnormal thoughts or dreams
What Oxycodone Injection looks like and
• Difficulty in breathing or wheezing, shortness
contents of the pack
of breath
Oxycodone Injection is a clear, colourless solution
• Difficulty in passing urine
practically free of particles supplied in clear glass
• Rash
ampoules. The 50 mg/ml strength is available as
• Sweating, high temperature, chills.
1 ml of solution, containing 50 mg of oxycodone
Uncommon side effects
hydrochloride (equivalent to 45mg of oxycodone
(Probably affecting fewer than 1 in 100 people
base). It is available in packs of 5 ampoules.
using Oxycodone Injection)
Marketing Authorisation Holder and
• Difficulty in swallowing, belching, hiccups,
Manufacturer
wind, a condition where the small bowel (part
Marketing Authorisation Holder
of your gut) does not work properly (ileus),
gastrointestinal disorders (e.g. upset stomach), Wockhardt UK Ltd, Ash Road North, Wrexham,
LL13 9UF, UK
changes in taste, mouth ulcers, sore mouth
• A condition which causes abnormal production Manufacturer
of antidiuretic hormone (syndrome of
CP Pharmaceuticals Ltd, Ash Road North,
inappropriate antidiuretic hormone secretion)
Wrexham, LL13 9UF, UK
• A feeling of dizziness or ‘spinning’,
Other formats:
hallucinations, mood changes, depression,
To listen to or request a copy of this leaflet in
a feeling of extreme happiness, agitation,
Braille, large print or audio please call, free of
generally feeling unwell, loss of memory,
charge:
shaking, difficulties with speech, reduced
0800 198 5000 (UK only).
sensitivity to pain or touch, tingling or
numbness, seizures, fits or convulsions, blurred Please be ready to give the following information:
vision, abnormal manner or style of walking,
Product name
Reference number
feeling detached from oneself, being unusually
Oxycodone
overactive, reduced consciousness, twitching,
Hydrochloride 50 mg/ml
involuntary muscle contractions
PL 29831/0367
Solution for Injection or
• Impotence, decreased sexual drive, absence of
Infusion
menstrual periods
• Low blood pressure, flushing of the skin
This is a service provided by the Royal National
• Dehydration, weight change, thirst, swelling of
Institute of Blind People.
the hands, ankles or feet
For patients in the Republic of Ireland, please call
• Dry skin
UK +44 1978 669272
• Tear disorder, reduction in size of the pupils in
This medicinal product is authorised in the
the eye
Member States of the EEA under the following
• A need to take increasingly higher doses to
names:
gain the same level of pain relief (tolerance)
• Withdrawal symptoms such as agitation, anxiety, UK and Ireland: Oxycodone Hydrochloride
50 mg/ml Solution for Injection or Infusion.
palpitations, shaking or sweating upon stopping
This leaflet was last revised in 11/2015.
using Oxycodone Injection.
• A ringing or buzzing sound in the ears
• Runny nose, nose bleeds, voice alteration
105940/4
• Chest pain.

Customer

4. Possible side effects

Uncommonly, Oxycodone Injection may affect the
results of blood tests to check that your liver is
working properly.
Reporting of side effects
If you get any side effects,
talk to your doctor, or
pharmacist or nurse. This
includes any possible side
effects not listed in this
leaflet. You can also report
side effects directly via the
national reporting systems
listed below:
United Kingdom:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland:
HPRA Pharmacovigilance
Earlsfort Terrace, IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie
By reporting side effects you can help provide
more information on the safety of this medicine.

Measure bar should be 150mm at 100% scale

If you stop using Oxycodone Injection
You should not suddenly stop using this injection
unless your doctor tells you to. If you want to stop
using your injection, discuss this with your doctor
first. They will tell you how to do this, usually
by reducing the dose gradually so you do not
experience unpleasant effects.
If you have any further questions on the use of
Oxycodone Injection, ask your doctor or pharmacist.

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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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