- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
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.
PregnancyThe 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.
LactationOxycodone is secreted in breast milk and may cause harmful effects in the newborn (respiratory depression, somnolence, lethargy). Oxycodone is contraindicated during lactation.
Endocrine disorders:Uncommon (>1/1,000, <1/100): syndrome of inappropriate antidiuretic hormone secretion.
Metabolism and nutrition disorders:Common (>1/100, <1/10): anorexiaUncommon (>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.
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.
Symptoms of overdosageSigns 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 overdosagePrimary 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.
Wockhardt UK Ltd
Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF
+44 (0)1978 660 130
+44 (0)1978 661 261