METHADONE-AFT

What it is

Methadone-AFT contains methadone hydrochloride, a synthetic opioid analgesic with the general properties of morphine. The medicine is available in two strengths: 5 mg tablets and 10 mg tablets.

Approved indications

Methadone-AFT is indicated for the 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. Methadone-AFT is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.

Dosing overview

The usual single dose for adults is 5–10 mg by mouth. The usual initial dose should be 5–10 mg 6–8 hourly, later adjusted to the degree of pain relief obtained. In chronic use Methadone-AFT should not be administered more than twice daily. Caution with repeated dosage should be observed in the very ill or elderly due to its long plasma half-life.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of Methadone-AFT. 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. 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. Limit dosages and durations to the minimum required and monitor patients for signs and symptoms of respiratory depression and sedation. Methadone-AFT 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. Accidental ingestion or exposure of Methadone-AFT, especially by children, can result in a fatal overdose of methadone. Patients and their caregivers should be given information on safe storage and disposal of unused Methadone-AFT.

Contraindications

Methadone-AFT is contraindicated in patients with severe respiratory disease, acute respiratory disease and respiratory depression, especially in the presence of cyanosis and excessive bronchial secretions, and obstructive airways disease. Methadone-AFT should not be given during an attack of bronchial asthma. Concurrent administration with monoamine oxidase inhibitors, or within 2 weeks of discontinuation of treatment with them, is contraindicated. Methadone-AFT is contraindicated in individuals who are hypersensitive to methadone. Methadone-AFT is contraindicated in the presence of acute alcoholism, head injury and raised intracranial pressure. Methadone-AFT is contraindicated in patients with ulcerative colitis, since it may precipitate toxic dilatation or spasm of the colon. Methadone-AFT should not be administered to patients with severe hepatic impairment as it may precipitate hepatic encephalopathy. At the recommended dosages, Methadone-AFT is contraindicated in biliary and renal tract spasm. Methadone is contraindicated in individuals with existing QT prolongation, including those with congenital long QT syndrome.

PBS listing

The 10 mg tablet is listed on the PBS under 2 items with authority required restriction, at an ex-manufacturer price of A$4.93. As of July 2025, the PBS recommended the 5 mg tablet under the same conditions as the 10 mg tablet, priced with reference to 10 mg tablets.

Regulatory history

Methadone-AFT was first registered on the ARTG on 27 February 2023, with two registered variants: the 5 mg tablet (ARTG 380311) and the 10 mg tablet (ARTG 380312). In July 2025, the PBAC recommended Methadone-AFT for chronic severe disabling pain.