ENDONE

What it is

ENDONE is oxycodone hydrochloride , available as a solution for injection or infusion in strengths of 10 mg in 1 mL, 20 mg in 2 mL, and 50 mg in 1 mL . The 10 mg/1 mL, 20 mg/2 mL and 200 mg/20 mL solutions are clear, colourless solutions, practically free from particulates, while the 50 mg/1 mL solution is a clear, colourless to pale yellow solution .

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

The lowest dose should be administered with careful titration to pain control. ENDONE should not be used in patients under 18 years as there are no data on use in children under 18 years of age. For intravenous injection to establish analgesia, an intravenous bolus dose of 1 to 5 mg is administered slowly over 1–2 minutes, with incremental bolus doses required at 5–10 minute intervals. For intravenous infusion, a starting dose of 2 mg/hour is recommended. For intravenous patient-controlled analgesia, a starting PCA bolus dose of up to 0.03 mg/kg (for example, 1–2 mg per 70 kg) is administered with a minimum lock-out time of 5 minutes. For subcutaneous injection, a starting dose of 5 to 10 mg is recommended, repeated at 4-hourly intervals as required. In elderly patients who are debilitated, doses should be reduced to ⅓ to ½ of the usual doses. In patients with renal impairment (creatinine clearance less than 60 mL/min) or hepatic impairment, doses should be reduced to ⅓ to ½ of the usual doses.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of ENDONE, with 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 ENDONE 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. ENDONE contains oxycodone hydrochloride and is a potential drug of abuse, misuse and addiction, and addiction can occur in patients appropriately prescribed at recommended doses. The risk of addiction is increased in patients with a personal or family history of substance abuse or mental illness, and also increases the longer the drug is used and with higher doses. Accidental ingestion or exposure of ENDONE, especially by children, can result in a fatal overdose of oxycodone.

Contraindications

ENDONE is contraindicated in hypersensitivity to opioids or any of the 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

ENDONE tablets containing oxycodone hydrochloride 5 mg are listed on the PBS as 2 items with restriction type restricted, at an ex-manufacturer price of A$2.25.

Regulatory history

ENDONE oxycodone hydrochloride 5 mg tablets were first listed on the ARTG on 1991-09-09.