Medication Guide App

OXYCODONE HYDROCHLORIDE 10MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance: OXYCODONE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Oxycodone Hydrochloride 10mg/ml
Solution for Injection or Infusion
(referred to as Oxycodone Injection in this leaflet)
Read all of this leaflet carefully before you start to use this
medicine.
- Keep this leaflet. You may need to read it again while you are
receiving your treatment.
- If you have any further questions, please ask your doctor or
pharmacist.
- This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
- If any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

1. What Oxycodone Injection is and what it is used for
The name of your medicine is Oxycodone Injection.
Oxycodone belongs to a group of medicines known as
opioid analgesics, these are strong painkillers (analgesic).
Oxycodone Injection is used in the treatment of pain
requiring the use of a strong painkiller:
• moderate to severe pain in patients with cancer
• pain following an operation.
2. Before you use Oxycodone Injection
You should not use Oxycodone Injection if you:
• are allergic (hypersensitive) to oxycodone or to any
of the other ingredients in Oxycodone Injection (see
section 6, Further information)
• are having difficulty breathing
• are taking drugs called monoamine oxidase inhibitors
(MAOIs) for depression or have taken them in the last
2 weeks
• are pregnant or breast-feeding
• have a head injury
• have a condition were your small bowel ceases to
function (paralytic ileus)
• have an abnormally high level of carbon dioxide
circulating in the blood (a condition known as hypercarbia)
• have moderate to severe liver or kidney disease
• suffer from a disease of the lung known as chronic
obstructive pulmonary disease
• suffer from heart failure resulting from lung disease (cor
pulmonale)
• suffer from chronic constipation
• suffer from asthma.
Talk to your doctor before using Oxycodone Injection
if you:
• suffer from any problems with your breathing
• suffer from an underactive thyroid gland
• suffer from disease of the gall bladder and bile ducts
• suffer from inflammation of the bowel
• suffer from diseases of the adrenal glands
• suffer from pancreatitis
• have low blood pressure or low blood volume
• have toxic psychoses (mental illness as a reaction to
drugs, toxins or severe illness)
• have an enlarged prostate gland
• have raised intracranial pressure
• have kidney or liver disease
• are intoxicated with alcohol
• are suffering from withdrawal symptoms of alcohol.
Special care should be taken with elderly, debilitated,
weak patients and patients with a history of drug or
alcohol abuse. This medicine can cause dependence,
if you have any concerns about whether this medicine
is suitable for you speak to your doctor or nurse.
Taking other medicines
Please tell your doctor if you are taking or have recently
taken any other medicines, including medicines obtained

1. NAME OF THE MEDICINAL PRODUCT
Oxycodone Hydrochloride10 mg/ml Solution for Injection or Infusion.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains oxycodone hydrochloride 10 mg
(equivalent to 9 mg of oxycodone base).
Each 1 ml ampoule contains oxycodone hydrochloride 10 mg
(equivalent to 9 mg of oxycodone base).
Each 2 ml contains oxycodone hydrochloride 20 mg
(equivalent to 18mg of oxycodone base).
This medicinal product contains less than 1 mmol sodium (23 mg)
per .
For full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection or infusion (injection or infusion).
A Clear, colourless solution practically free of particles.
4. CLINICAL PARTICULARS
4.1 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.
4.2 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 to 1 mg/ml 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.
Doses should not be administered more frequently than every four hours.
i.v. (Infusion): Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water for
injections. A starting dose of 2 mg/hour is recommended.
i.v. (PCA): Dilute to 1 mg/ml 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.
s.c. (Bolus): Use as 10 mg/ml concentration. A starting dose of 5 mg is
recommended, repeated at four-hourly intervals as required.
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.
4.3 Contraindications
Oxycodone injection is contraindicated in patients with known
hypersensitivity to oxycodone or any of the other constituents, or in any
situation where opioids are contraindicated; respiratory depression;
head injury; paralytic ileus; acute abdomen; chronic obstructive airways
disease; cor pulmonale; chronic bronchial asthma; hypercarbia; moderate
to severe hepatic impairment; severe renal impairment (creatinine
clearance <10 ml/min); chronic constipation; concurrent administration of
monoamine oxidase inhibitors or within 2 weeks of discontinuation of their
use; pregnancy; lactation.
4.4 Special warnings and precautions for use
The major risk of opioid excess is respiratory depression. As with all
opioids, a reduction in dosage may be advisable in hypothyroidism. Use
with caution in patients with raised intracranial pressure, hypotension,
hypovolaemia, toxic psychoses, diseases of the biliary tract, inflammatory
bowel disorders, prostatic hypertrophy, adrenocortical insufficiency, acute
alcoholism, delirium tremens, pancreatitis, chronic renal and hepatic
disease or severe pulmonary disease and debilitated, elderly and infirm
patients. Oxycodone injection should not be used where there is a
possibility of paralytic ileus occurring. Should paralytic ileus be suspected
or occur during use, Oxycodone injection should be discontinued
immediately.
The patient may develop tolerance to oxycodone with chronic use
and require progressively higher doses to maintain pain control. The
patient may develop physical dependence, in which case an abstinence
syndrome may be seen following abrupt cessation.
For appropriate patients who suffer with chronic non-malignant pain,
opioids should be used as part of a comprehensive treatment programme
involving other medications and treatment modalities. A crucial part of the
assessment of a patient with chronic non-malignant pain is the patient’s
addiction and substance abuse history. Oxycodone injection should be
used with particular care in patients with a history of alcohol and drug
abuse.

without a prescription. The following medicines can affect
or be affected by treatment with Oxycodone Injection:
• tranquilisers and sleeping tablets
• anaesthetics
• anti-depressants
• phenothiazines (often used to treat severe mental illness)
• neuroleptic drugs (often used to treat severe mental
illnesses such as psychosis and schizophrenia)
• alcohol
• other opioid painkillers
• muscle relaxants
• monoamine oxidase inhibitors (MAOIs) (used in
depression) – wait at least 2 weeks after stopping
MOAIs before using this medicine.
Taking Oxycodone Injection with food and drink
As with all medicines that act on the central nervous
system, it is advised that you do not drink alcohol while
using this medicine.
Pregnancy and breast-feeding
You should not use this medicine if you are pregnant or
breast feeding. Babies born to women dependent on this
medicine may experience withdrawal symptoms as well
as breathing difficulties.
Driving and using machinery
Oxycodone Injection may cause drowsiness and reduced
alertness, do not drive or operate machinery while using
this medicine.
Important information about some of the ingredients
in Oxycodone Injection
This medicinal product contains less than 1 mmol sodium
(23 mg) per dose, i.e. essentially ‘sodium-free’.
3. How to use Oxycodone Injection
Your doctor will determine the dose you require. The
usual doses in adults are:
Injected into a vein as a single dose:
• 1-10mg given slowly over 1 to 2 minutes
• this dose may be repeated after 4 hours if required.
Infusion through a drip in a vein:
• starting dose 2mg/hour recommended.
Patient Controlled Analgesia (a drip which allows the
patient to top-up the medicine when required):
• single doses of 0.03mg per kg body weight should be
used with a minimum lock-out time of five minutes.
Injected under the skin as a single dose:
• a starting dose of 5mg is recommended
• repeat every 4 hours as required
Infusion through a drip under the skin:
• in patients new to these painkillers a starting dose of
7.5mg/day is recommended, gradually increasing to
control symptoms
• cancer patients transferring to an infusion from oral
oxycodone may require much higher doses.
Transferring patients from oral Oxycodone to
Oxycodone Injection
The dose should be based on the following ratio (please
note this is only a guide, the dose should be altered
depending on patient’s response to treatment):
• 2mg of oral Oxycodone is equivalent to 1mg of
Oxycodone Injection.



In this leaflet:
1. What Oxycodone Injection is and what it is used for
2. Before you use Oxycodone Injection
3. How to use Oxycodone Injection
4. Possible side effects
5. How to store Oxycodone Injection
6. Further information

If opioid treatment is considered appropriate for the patient, then the main
aim of treatment is not to minimise the dose of opioid but rather to achieve
a dose which provides adequate pain relief with a minimum of side
effects. There must be frequent contact between physician and patient
so that dosage adjustments can be made. It is strongly recommended
that the physician defines treatment outcomes in accordance with pain
management guidelines. The physician and patient can then agree to
discontinue treatment if these objectives are not met.
Oxycodone has an abuse liability similar to other strong opioids and
should be used with caution in opioid-dependent patients. Oxycodone
may be sought and abused by people with latent or manifest addiction
disorders.
As with other opioids, infants who are born to dependent mothers may
exhibit withdrawal symptoms and may have respiratory depression at
birth. Oxycodone injection contains approximately 5mg sodium per ml i.e.
essentially ‘sodium-free’.
4.5 Interaction with other medicinal products and other forms of
interaction
There is an enhanced CNS depressant effect with drugs such as
tranquillisers, anaesthetics, hypnotics, anti-depressants, sedatives,
phenothiazines, neuroleptic drugs, alcohol, other opioids, muscle
relaxants and antihypertensives. Monoamine oxidase inhibitors are
known to interact with narcotic analgesics, producing CNS excitation or
depression with hypertensive or hypotensive crisis.
Oxycodone is metabolised in part via the CYP2D6 and CYP3A4
pathways. While these pathways may be blocked by a variety of drugs,
such blockade has not yet been shown to be of clinical significance with
this agent.
4.6 Pregnancy and lactation
Pregnancy
The effect of oxycodone in human reproduction has not been adequately
studied. No studies on fertility or the post-natal effects of intrauterine
exposure have been carried out. However, studies in rats and rabbits with
oral doses of oxycodone equivalent to 3 and 47 times an adult dose of
160 mg/day, respectively, did not reveal evidence of harm to the foetus
due to oxycodone. Oxycodone injection is not recommended for use in
pregnancy nor during labour. Infants born to mothers who have received
opioids during pregnancy should be monitored for respiratory depression.
Lactation
Oxycodone is secreted in breast milk and may cause harmful effects in
the newborn (respiratory depression, somnolence, lethargy). Oxycodone
is contraindicated during lactation.
4.7 Effects on ability to drive and use machines
Oxycodone may modify patients’ reactions to a varying extent depending
on the dosage and individual susceptibility. Therefore patients should not
drive or operate machinery, if affected.
4.8 Undesirable effects
Adverse drug reactions are typical of full opioid agonists. Tolerance
and dependence may occur (see Tolerance and Dependence, below).
Constipation may be prevented with an appropriate laxative. If nausea
or vomiting are troublesome, oxycodone may be combined with an
antiemetic.
The adverse drug reactions seen whilst being treated with oxycodone
were:
Endocrine disorders:
Uncommon (>1/1,000, <1/100): syndrome of inappropriate antidiuretic
hormone secretion.
Metabolism and nutrition disorders:
Common (>1/100, <1/10): anorexia
Uncommon (>1/1,000, <1/100): dehydration, weight change, peripheral
oedema, oedema, thirst.
Psychiatric disorders (see tolerance and dependence below):
Common (>1/100, <1/10): abnormal dreams, anxiety, confusion, insomnia,
nervousness, abnormal thinking.
Uncommon (>1/1,000, <1/100): libido decreased, depression,
hallucinations, depersonalisation, euphoria, mood changes, agitation,
emotional lability.
Nervous system disorders:
Very common (>1/10): somnolence, dizziness.
Common (>1/100, <1/10): faintness, asthenia, headache.
Uncommon (>1/1,000, <1/100): abnormal gait, amnesia, hyperkinesia,
hypertonia, hypoaesthesia, hypotonia, speech disorder, stupor, tremor,
twitching, vertigo, epileptic seizures, paraesthesia, withdrawal syndrome,
malaise, muscle contractions involuntary.
Eye disorders:
Uncommon (>1/1,000, <1/100): lacrimation disorder, miosis, abnormal
vision.
Ear and labyrinth disorders:
Uncommon (>1/1,000, <1/100): tinnitus.
Cardiac disorders:
Common (>1/100, <1/10): Orthostatic hypotension.
Uncommon (>1/1,000, <1/100): palpitations (in the context of withdrawal
syndrome), hypotension, syncope.
Vascular disorders:
Uncommon (>1/1,00, < 1/100): vasodilation.
Respiratory, thoracic and mediastinal disorders:
Common (>1/100, <1/10): dyspnoea, bronchospasm.
Uncommon (>1/1,000, <1/100): rhinitis, epistaxis, hiccup, voice alteration,
respiratory depression.
Gastrointestinal disorders:
Very common (>1/10): constipation, nausea, vomiting.
Common (>1/100, <1/10): abdominal pain, anorexia, diarrhoea, dry
mouth, dyspepsia,
Uncommon (>1/1,000, <1/100): dysphagia, flatulence, gastritis, mouth
ulceration, eructation, ileus, stomatitis, biliary spasm, gastrointestinal
disorders, taste perversion.
Skin and subcutaneous tissue disorders:
Very common (>1/10): pruritus.
Common (>1/100, <1/10): rash, sweating.
Uncommon (>1/1,000, <1/100): dry skin, urticaria.
Renal and urinary disorders:
Common (>1/100, <1/10): urinary disorders.
Uncommon (>1/1,000, <1/100): urinary retention, ureteral spasm.

Elderly and patients with kidney and liver disease
The lowest dose needed for symptom control should be
used.
Not to be used in patients under 18 years of age
If you take more Oxycodone Injection than you should
This medicine will be given to you by your doctor so it
is unlikely you will receive too much. Your doctor has
information on how to recognise and treat an overdose.
If you stop using Oxycodone Injection
Patients can become tolerant to the effects of oxycodone
if used over a long time or if they are already using
Oxycodone and may require progressively higher doses
in order to maintain pain control.
Prolonged use of this medicine may also lead to
dependence and if treatment is stopped abruptly the
patient may experience withdrawal symptoms. These
symptoms include restlessness, running nose and eyes,
yawning, sweating, chills, muscle pain, abdominal pain,
diarrhoea and prolonged dilation of the pupils. When
a patient no longer requires this medicine it is advised
to stop treatment gradually over some time in order to
prevent withdrawal symptoms.
4. Possible side effects

If you experience any side effects or feel that the medicine
is affecting you badly tell your doctor or nurse immediately.

5. How to store Oxycodone Injection
Keep out of the reach and sight of children.
•  his medicinal product does not require any special
T
storage conditions
• Do not use after the expiry date (shown as Exp. on the
packaging). The expiry date refers to the last day of
the month, your doctor or nurse will check for this.
• This medicine should be used immediately after
opening. Medicines should not be disposed of via
wastewater or household waste. These measures will
help protect the environment.

Like all medicines, Oxycodone Injection can cause side
effects, although not everybody gets them. As can happen
with any medicine, a few people may develop an allergic
reaction. If you experience any of the following, seek
medical help immediately:
• rash, itching, difficulty breathing, problems swallowing,
anaphylaxis (severe allergy).
6. Further information
Side effects that have been reported with Oxycodone
What Oxycodone Injection contains
Injection are:
The active ingredient is oxycodone hydrochloride. Each
Very Common (more than 1 in 10 patients)
ml contains oxycodone hydrochloride 10mg (equivalent
• sleepiness
• dizziness
to 9mg oxycodone base).
• constipation
• nausea
Each 1 ml ampoule contains oxycodone hydrochloride
• vomiting
• itching.
10 mg (equivalent to 9 mg of oxycodone base).
Common (occurs in more than 1 in 100 patients)
Each 2 ml contains oxycodone hydrochloride 20 mg
• abnormal thinking
• breathlessness
(equivalent to 18mg of oxycodone base).
• wheezing
• stomach pains
The other ingredients are: citric acid monohydrate,
• loss of appetite
• diarrhoea
sodium citrate, sodium chloride, hydrochloric acid,
• dry mouth
• indigestion
sodium hydroxide and water for injections.
• rash
• sweating
What Oxycodone Injection looks like and the contents
• problems passing water • fever
of the pack
• chills
• abnormal dreams
Oxycodone Injection is a clear colourless solution and is
• anxiety
• confusion
supplied in packs of 5 containing either 1ml or 2ml clear
• problems sleeping
• faintness
glass ampoules.
• extreme fatigue
• headache
• nervousness
• low blood pressure on
Marketing Authorisation Holder: Wockhardt UK Ltd,
• anorexia standing.
Ash Road North, Wrexham, LL13 9UF, UK.
Uncommon (occurs in fewer than 1 in 100 patients)
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North,
• hormone disturbances • mouth ulcers
Wrexham, LL13 9UF, UK.
• weight change
• change of taste
This medicinal product is authorised in the Member
• decreased sex-drive
• inflammation of the mouth
States of the EEA under the following names:
• hallucinations
• hives or itchy rash
UK: Oxycodone Hydrochloride 10mg/ml
• memory loss
• impotence
Solution for Injection or Infusion
• fits
• chest pain
Ireland: Oxycodone Hydrochloride 10mg/ml
• euphoria
• anaphylaxis
Solution for Injection or Infusion
• twitching
• dehydration
Cyprus: Oxycodone Hydrochloride 10mg/ml
• speech problems
• swelling of the legs
Solution for Injection or Infusion
• decreased muscle tone • depression
Malta: Oxycodone Hydrochloride 10mg/ml
• excitedness
• problems walking
Solution for Injection or Infusion
• mood changes
• agitation
Poland: Oxycodone Hydrochloride Wockhardt
• general malaise
• vertigo
• constricted pupils
• depersonalisation
Other formats:
• ringing in the ears
• involuntary movements
To listen to or request a copy of this leaflet in Braille,
• low blood pressure
• increased muscle tone
large print or audio please call, free of charge: 0800 198
• dilated blood vessels
• drug dependence
5000 (UK Only). Please be ready to give the following
• hiccups
• unresponsiveness
information:
• difficulty breathing
• withdrawel
Product name
Reference number
• flatulence
• running eyes
• abnormal vision
• problems swallowing
Oxycodone 10mg/ml
PL 29831/0359
• abnormal heart rhythm • inflammation of stomach
Solution for Injection
• blackouts
• belching
This is a service provided by the Royal National Institute
• nosebleeds
• stops menstrual period
of Blind People.
• voice alteration
• allergy
For the Republic of Ireland please call +353 52 36253.
• gall bladder problems
• hanged or reduced
c
• dry skin 3
sensation Leaflet Prepared: July 2010
• inability to pass water 3



Reproductive system and breast disorders:
Uncommon (>1/1,000, <1/100): impotence, amenorrhoea.
General disorders and administration site conditions:
Common (>1/100, <1/10): fever, chills.
Uncommon (>1/1,000, <1/100): chest pain, allergic reaction, anaphylactic
reaction, anaphylactoid reaction, drug dependence.
Tolerance and Dependence:
The patient may develop tolerance to the drug with chronic use and
require progressively higher doses to maintain pain control. Prolonged
use of Oxycodone injection may lead to physical dependence and a
withdrawal syndrome may occur upon abrupt 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. The opioid
abstinence or withdrawal syndrome is characterised by some or all of the
following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration,
chills, myalgia and mydriasis. Other symptoms also may develop,
including: irritability, anxiety, backache, joint pain, weakness, abdominal
cramps, insomnia, nausea, anorexia, vomiting, diarrhoea, or increased
blood pressure, respiratory rate or heart rate.
The development of psychological dependence (addiction) to opioid
analgesics in properly managed patients with pain has been reported to
be rare. However, data are not available to establish the true incidence of
psychological dependence (addiction) in chronic pain patients.
Oxycodone injection should be used with particular care in patients with a
history of alcohol and drug abuse.
4.9 Overdose
Symptoms of overdosage
Signs of oxycodone toxicity and overdosage are pin-point pupils,
respiratory depression, hypotension and hallucinations. Nausea and
vomiting are common in less severe cases. Non-cardiac pulmonary
oedema and rhabdomyolysis are particularly common after intravenous
injection of opioid analgesics. Circulatory failure and somnolence
progressing to stupor or coma, skeletal muscle flaccidity, bradycardia and
death may occur in more severe cases.
The effects of overdosage will be potentiated by the simultaneous
ingestion of alcohol or other psychotropic drugs.
Treatment of overdosage
Primary attention should be given to the establishment of a patent airway
and institution of assisted or controlled ventilation.
In the case of massive overdosage, administer naloxone intravenously
(0.4 to 2mg for an adult and 0.01mg/kg body weight for children) if the
patient is in a coma or respiratory depression is present. Repeat the
dose at 2 minute intervals if there is no response. If repeated doses are
required then an infusion of 60% of the initial dose per hour is a useful
starting point. A solution of 10 mg made up in 50 ml dextrose will produce
200 micrograms/ml for infusion using an IV pump (dose adjusted to the
clinical response). Infusions are not a substitute for frequent review of the
patient’s clinical state.
Intramuscular naloxone is an alternative in the event that IV access is
not possible. As the duration of action of naloxone is relatively short,
the patient must be carefully monitored until spontaneous respiration is
reliably re-established. Naloxone is a competitive antagonist and large
doses (4 mg) may be required in seriously poisoned patients.
For less severe overdosage, administer naloxone 0.2 mg intravenously
followed by increments of 0.1 mg every 2 minutes if required.
The patient should be observed for at least 6 hours after the last dose of
naloxone.
Naloxone should not be administered in the absence of clinically
significant respiratory or circulatory depression secondary to oxycodone
overdosage. Naloxone should be administered cautiously to persons
who are known, or suspected, to be physically dependent on oxycodone.
In such cases, an abrupt or complete reversal of opioid effects may
precipitate pain and an acute withdrawal syndrome.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Natural opium alkaloids
ATC code: N02A A05
Oxycodone is a full opioid agonist with no antagonist properties. It has an
affinity for kappa, mu and delta opioid receptors in the brain and spinal
cord. Oxycodone is similar to morphine in its action. The therapeutic effect
is mainly analgesic, anxiolytic, antitussive and sedative.
Opioids may influence the hypothalamic-pituitary-adrenal or gonadal axes.
Some changes that can be seen include an increase in serum prolactin
and decreases in plasma cortisol and testosterone. Clinical symptoms
may be manifest from these hormonal changes.
In vitro and animal studies indicate various effects of natural opioids,
such as morphine, on components of the immune system; the clinical
significance of these findings is unknown. Whether oxycodone, a
semisynthetic opioid, has immunological effects similar to morphine is
unknown.
5.2 Pharmacokinetic properties
Pharmacokinetic studies in healthy subjects demonstrated an equivalent
availability of oxycodone from Oxycodone injection when administered
by the intravenous and subcutaneous routes, as a single bolus dose or a
continuous infusion over 8 hours.
Following absorption, oxycodone is distributed throughout the entire body.
Approximately 45% is bound to plasma protein. It is metabolised in the
liver to produce noroxycodone, oxymorphone and various conjugated
glucuronides. The analgesic effects of the metabolites are clinically
insignificant.
The active drug and its metabolites are excreted in both urine and faeces.
The plasma concentrations of oxycodone are only minimally affected by
age, being 15% greater in elderly as compared to young subjects.
Female subjects have, on average, plasma oxycodone concentrations up
to 25% higher than males on a body weight adjusted basis.
The drug penetrates the placenta and can be found in breast milk.
When compared to normal subjects, patients with mild to severe hepatic
dysfunction may have higher plasma concentrations of oxycodone and
noroxycodone, and lower plasma concentrations of oxymorphone. There

105210/2

may be an increase in the elimination half-life of oxycodone and this may
be accompanied by an increase in drug effects.
When compared to normal subjects, patients with mild to severe renal
dysfunction may have higher plasma concentrations of oxycodone and
its metabolites. There may be an increase in the elimination half-life of
oxycodone and this may be accompanied by an increase in drug effects.
5.3 Preclinical safety data
Oxycodone was not mutagenic in the following assays: Ames Salmonella
and E. Coli test with and without metabolic activation at doses of up
to 5000 μg, chromosomal aberration test in human lymphocytes (in
the absence of metabolic activation and with activation after 48 hours
of exposure) at doses of up to 1500 μg/ml, and in the in vivo bone
marrow micronucleus assay in mice (at plasma levels of up to 48 μg ml).
Mutagenic results occurred in the presence of metabolic activation
in the human chromosomal aberration test (at greater than or equal
to 1250 μg ml) at 24 but not 48 hours of exposure and in the mouse
lymphoma assay at doses of 50 μg/ml or greater with metabolic activation
and at 400 μg/ml or greater without metabolic activation. The data from
these tests indicate that the genotoxic risk to humans may be considered
low.
Studies of oxycodone in animals to evaluate its carcinogenic potential
have not been conducted owing to the length of clinical experience with
the drug substance.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Citric acid monohydrate
Sodium citrate
Sodium chloride
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)
Water for injections
6.2 Incompatibilities
This medicinal product must not be mixed with other medicinal products
except those mentioned in section 6.6.
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 either intravenously or subcutaneously as an infusion.
Prochlorperazine is chemically incompatible with Oxycodone injection.
6.3 Shelf life
Unopened: 2 years.
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 as
taken place in controlled and validated aseptic conditions.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
Type I clear glass ampoules: 1 ml and 2 ml.
Pack size: 5 ampoules.
6.6 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.
The injection, whether undiluted or diluted to 1 mg/ml in the infusion fluids
used in these studies and contained in the various assemblies, does not
need to be protected from light.
Inappropriate handling of the undiluted solution after opening of the
original ampoule, or of the diluted solutions may compromise the sterility
of the product.
7. MARKETING AUTHORISATION HOLDER
Wockhardt UK Ltd
Ash Road North
Wrexham
LL13 9UF
UK
8. MARKETING AUTHORISATION NUMBER(S)
PL 29831/0359
PA 1339/25/1
MA 154/05101
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
UK: 07/05/2010
Ireland: 16/07/2010
10. DATE OF REVISION OF THE TEXT 08/2010

105210/2

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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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