OXYNORM

What it is

OxyNorm is oxycodone hydrochloride . The solution for injection or infusion is available in strengths of 10 mg in 1 mL and 20 mg in 2 mL for intravenous or subcutaneous administration, and 50 mg in 1 mL for intravenous or subcutaneous infusion in palliative care settings . A 200 mg/20 mL solution for injection is also available .

Approved indications

— Short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain .

Dosing overview

For adults, elderly and children over 18 years, the lowest dose should be administered with careful titration to pain control . The dose should be adjusted according to the severity of pain, the total condition of the patient and previous or concurrent medication .

For intravenous injection, an intravenous bolus dose of 1 to 5 mg should be administered slowly over 1–2 minutes, with incremental bolus doses at 5–10 minute intervals as needed, with patient monitoring . For maintenance analgesia, doses should not be administered more frequently than every 4 hours . For intravenous infusion, a starting dose of 2 mg/hour is recommended . For subcutaneous injection, a starting dose of 5 to 10 mg is recommended, depending on age and medical status, repeated at 4-hourly intervals as required . For the 50 mg/1 mL solution in palliative care settings for opioid-tolerant patients, starting doses will vary with age, medical status, opioid tolerance, concomitant medications, individual tolerability, severity of pain and indication, with a gradual increase in dose if analgesia is inadequate or pain severity increases . The 50 mg/1 mL solution should not be used for more than 4 consecutive weeks .

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with OxyNorm, with the greatest risk during initiation of therapy or following a dose increase, requiring close patient monitoring . The risk of life-threatening respiratory depression is higher in elderly, frail or debilitated patients, in patients with renal and hepatic impairment and in patients with existing impairment of respiratory function such as chronic obstructive pulmonary disease or asthma, and opioids should be used with caution and close monitoring in these patients . Concomitant use of OxyNorm with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system depressants including alcohol may result in profound sedation, respiratory depression, coma and death, requiring limitation of dosages and durations to the minimum required and monitoring for signs of respiratory depression and sedation . Patients should be cautioned not to drink alcohol while taking OxyNorm . OxyNorm poses risks of hazardous and harmful use which can lead to overdose and death . OxyNorm contains oxycodone hydrochloride and is a potential drug of abuse, misuse and addiction, with addiction occurring in patients appropriately prescribed at recommended doses . Patients should be assessed for their risks for opioid abuse and addiction prior to prescription, and all patients receiving opioids should be routinely monitored for signs of misuse and abuse . Tolerance and physical and psychological dependence may develop upon repeated administration, with repeated use leading to Opioid Use Disorder, and higher dose and longer duration of opioid treatment increasing the risk . Neuroadaptation of opioid receptors can produce tolerance (the need for increasing doses to maintain analgesia) and physical dependence, which can occur after several days to weeks of continued use and results in withdrawal symptoms if the opioid is ceased abruptly or the dose is significantly reduced . Accidental ingestion or exposure of OxyNorm, especially by children, can result in a fatal overdose of oxycodone, and patients and caregivers should be given information on safe storage and disposal .

Contraindications

OxyNorm is contraindicated in hypersensitivity to opioids or any constituents, acute respiratory disease, severe respiratory disease, respiratory depression, cor pulmonale, cardiac arrhythmias, acute asthma or other obstructive airways disease, paralytic ileus, suspected surgical abdomen, severe renal impairment (creatinine clearance less than 10 mL/min), moderate to severe hepatic impairment, acute abdominal pain, chronic constipation, delayed gastric emptying, acute alcoholism, coma, brain tumour, increased cerebrospinal or intracranial pressure, head injury due to risk of raised intracranial pressure, severe central nervous system depression, convulsive disorders, delirium tremens, hypercarbia, concurrent administration of monoamine oxidase inhibitors or within 2 weeks of discontinuation of their use, anxiety states under the influence of alcohol or hypnotics and pregnancy .

PBS listing

OxyNorm oxycodone hydrochloride 5 mg capsules are listed on the PBS with a restricted benefit, with 2 items listed at an ex-manufacturer price of A$5.50 . OxyNorm oral solution containing oxycodone hydrochloride 1 mg per mL is listed on the PBS with a restricted benefit, with 2 items listed at an ex-manufacturer price of A$12.31 . In July 2019, the PBAC recommended a restricted benefit listing for a new maximum quantity of 10 for 5 mg capsules for severe disabling pain short-term use .

Regulatory history

OxyNorm oxycodone hydrochloride capsules (5 mg, 10 mg and 20 mg) were first registered on the ARTG on 8 November 2000 . OxyNorm oral solution containing 1 mg/mL oxycodone hydrochloride was first registered on the ARTG on 12 December 2001 . OxyNorm solution for injection containing 10 mg in 1 mL and 20 mg in 2 mL were first registered on the ARTG on 10 November 2005 . OxyNorm solution for injection containing 50 mg in 1 mL and 200 mg in 20 mL were first registered on the ARTG on 12 May 2010 .