OXYCONTIN

What it is

OxyContin is a modified release tablet containing oxycodone hydrochloride, available in strengths of 10 mg, 15 mg, 20 mg, 30 mg, 40 mg and 80 mg. The tablets are designed to provide delivery of oxycodone over 12 hours. OxyContin tablets comprise a matrix formulation with a hydrogelling property, intended to be crush-deterrent and to reduce the rapid release of oxycodone upon accidental or intentional misuse.

Approved indications

— Management of severe pain where other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, the pain is opioid-responsive, and requires daily, continuous, long term treatment. OxyContin is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. OxyContin is not indicated as an as-needed analgesia.

Dosing overview

OxyContin tablets should be taken at 12-hourly intervals. The usual starting dose for opioid-naive patients or patients presenting with severe pain uncontrolled by weaker opioids is 10 mg 12-hourly. The dose should be carefully titrated with longitudinal patient monitoring, and increasing severity of pain may require an increased dosage of OxyContin tablets to achieve a stable dose that provides acceptable pain relief. If higher doses are necessary, increases should be made, where possible, in 25% to 50% increments. OxyContin tablets 80 mg should only be used in opioid-tolerant patients, as these tablet strengths may cause fatal respiratory depression in patients not previously exposed to opioids. For patients with renal or hepatic impairment, the dose initiation should follow a conservative approach, with the recommended adult starting dose reduced by one-third to one-half.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of OxyContin, and situations which increase the risk should be avoided, with dosing modified in patients at risk and patients monitored closely, especially on initiation or following a dose increase. Concomitant use of opioids 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, and dosages should be limited to the minimum required with close monitoring. OxyContin poses risks of hazardous and harmful use which can lead to overdose and death, and the patient's risk should be assessed before prescribing and the patient monitored regularly during treatment. Addiction can occur in patients appropriately prescribed OxyContin at recommended doses. Tolerance and physical and psychological dependence may develop upon repeated administration, repeated use can lead to Opioid Use Disorder, and a higher dose and longer duration of treatment can increase this risk. Opioids can cause sleep-related breathing disorders including central sleep apnoea in a dose-dependent fashion. Hyperalgesia may occur with the use of opioids, particularly at high doses, and may manifest as an unexplained increase in pain or diffuse sensitivity not associated with the original pain.

Contraindications

OxyContin 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, suspected mechanical gastrointestinal obstruction or diseases affecting bowel transit, suspected surgical abdomen, severe renal impairment (creatinine clearance less than 10 mL/min), severe hepatic impairment, delayed gastric emptying, acute alcoholism, brain tumour, increased cerebrospinal or intracranial pressure, head injury, severe central nervous system depression, convulsive disorders, delirium tremens, hypercarbia, and concurrent administration of monoamine oxidase inhibitors or within two weeks of discontinuation of their use. OxyContin is contraindicated in pregnancy.

PBS listing

OxyContin 15 mg controlled release tablets are listed on the PBS with 2 items under a streamlined and authority required restriction, with an ex-manufacturer price of A$17.89. OxyContin 30 mg controlled release tablets are listed on the PBS with 2 items under an authority required and streamlined restriction, with an ex-manufacturer price of A$30.52.

Regulatory history

OxyContin tablets in strengths of 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg were first listed on the ARTG on 22 October 2013.