PROLADONE

What it is

Proladone suppositories contain oxycodone 30 mg per suppository as the active ingredient. Proladone suppositories consist of an oval, 22 mm x 10 mm compressed cone, which will dissolve in use and which is covered by a wax coating to aid insertion, presented as a smooth, mottled, off-white product. Proladone is a semisynthetic narcotic analgesic.

Approved indications

— Relief of post-operative pain following a wide range of major operative procedures such as major orthopaedic, abdominal, gynaecological and thoracic surgery. — Relief of pain in malignant disease.

Dosing overview

One suppository every six to eight hours; in case of terminal disease, one suppository as required to control pain.

Key safety warnings

Proladone suppositories should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate to provide appropriate management of pain. Serious, life-threatening or fatal respiratory depression may occur with the use of Proladone suppositories. Be aware of situations which increase the risk of respiratory depression, modify dosing in patients at risk and monitor patients closely, especially on initiation or following a dose increase. The risk of life-threatening respiratory depression is higher in elderly, frail, or debilitated patients and in patients with existing impairment of respiratory function (for example, chronic obstructive pulmonary disease; asthma) and in patients with hepatic or renal impairment. Opioids should be used with caution and with close monitoring in these patients. Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Patients should not drink alcohol while taking Proladone suppositories. Proladone suppositories poses risks of hazardous and harmful use which can lead to overdose and death. Assess the patient's risk of hazardous and harmful use before prescribing and monitor the patient regularly during treatment. Addiction can occur in patients appropriately prescribed Proladone suppositories at recommended doses. The risk of addiction is increased in patients with a personal or family history of substance abuse (including alcohol and prescription and illicit drugs) or mental illness. The risk also increases the longer the drug is used and with higher doses. Oxycodone can produce drug dependence and therefore has the potential of being abused. Psychological dependence, physical dependence and tolerance may develop upon repeated administration. Abrupt withdrawal of oxycodone in those physically dependent may precipitate withdrawal symptoms. Therefore, patients on prolonged therapy should be withdrawn gradually from the drug if it is no longer required for pain control. Accidental ingestion or exposure of Proladone suppositories, especially by children, can result in a fatal overdose of oxycodone. Patients and their caregivers should be given information on safe storage and disposal of unused Proladone suppositories.

Contraindications

Proladone is contraindicated in patients with hypersensitivity to opiate narcotics, severe respiratory disease, acute respiratory disease, acute respiratory depression, cor pulmonale, cardiac arrhythmias, bronchial asthma, acute alcoholism, brain tumour, head injuries, increased cerebrospinal or intracranial pressure, severe central nervous system (CNS) depression, convulsive disorders, delirium tremens, suspected surgical abdomen and concomitant monoamine oxidase inhibitors (MAOIs) or within 14 days of such therapy. The use of Proladone suppositories is contraindicated in chronic (long-term) non-cancer pain.

PBS listing

Proladone 30 mg suppository (as pectinate) is listed on the PBS with 2 items, restriction type restricted, at an ex-manufacturer price of A$30.09.

Regulatory history

Proladone oxycodone 30 mg suppository was first listed on the ARTG on 9 September 1991. In July 2019, the PBAC recommended a change for severe disabling pain with a new maximum quantity of 10 for 5 mg capsules and tablets as a restricted benefit listing.