OXYCODONE-HAMELN

What it is

Oxycodone-hameln is oxycodone hydrochloride available in three strengths: 10 mg in 1 mL, 20 mg in 2 mL, and 50 mg in 1 mL solution for injection or infusion. The injection is a clear colourless solution. Oxycodone is a full opioid agonist whose principal therapeutic action is analgesia.

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

Dosing is for adults and patients over 18 years, with the lowest dose 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 initial bolus dose of 1 to 5 mg is administered slowly over 1–2 minutes, with incremental bolus doses at 5–10 minute intervals as required. For maintenance analgesia, doses should not be administered more frequently than every 4 hours. For intravenous infusion, a starting dose of 2 mg per hour is recommended. For subcutaneous injection, a starting dose of 5 to 10 mg is recommended, repeated at 4-hourly intervals as required. Elderly patients should be treated with caution, with the lowest dose administered and careful titration to pain control; debilitated elderly patients should receive ½ to ½ of the usual doses.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with use of Oxycodone-hameln, with greatest risk during initiation or after dose increases. The risk of life-threatening respiratory depression is higher in elderly, frail or debilitated patients, and in those with renal or hepatic impairment or existing respiratory impairment such as chronic obstructive pulmonary disease or asthma, requiring close monitoring. 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. Patients should be cautioned not to drink alcohol while taking Oxycodone-hameln solution for injection or infusion. Oxycodone-hameln should only be used in patients for whom other treatment options, including non-opioid analgesics, are ineffective, not tolerated or otherwise inadequate, because of risks of hazardous and harmful use which can lead to overdose and death. Oxycodone-hameln contains oxycodone hydrochloride, which is a potential drug of abuse, misuse and addiction; addiction can occur in patients appropriately prescribed at recommended doses.

Contraindications

Oxycodone-hameln is contraindicated in hypersensitivity to opioids or any constituents, acute or 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, severe central nervous system depression, convulsive disorders, delirium tremens, hypercarbia, concurrent monoamine oxidase inhibitors or within 2 weeks of discontinuation, anxiety states under the influence of alcohol or hypnotics, and pregnancy.

Regulatory history

Oxycodone-hameln was first listed on the Australian Register of Therapeutic Goods on 7 October 2021, with three registered variants: 10 mg in 1 mL (ARTG 343480), 20 mg in 2 mL (ARTG 343479), and 50 mg in 1 mL (ARTG 343481) injection solutions.