KAPANOL

What it is

KAPANOL is a morphine sulfate pentahydrate capsule formulation available in strengths of 10 mg, 20 mg, 50 mg, and 100 mg.

Approved indications

— Severe pain — Cancer pain — Severe disabling pain

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of morphine sulfate injection. Clinicians should 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. Morphine sulfate injection poses risks of hazardous and harmful use which can lead to overdose and death. Clinicians should assess the patient's risk of hazardous and harmful use before prescribing and monitor the patient regularly during treatment. Concomitant use of opioids with benzodiazepines, gabapentinoids, sedatives, hypnotics, antipsychotics, antihistamines, tricyclic antidepressants, centrally-active anti-emetics, general anaesthetics, tranquilisers, beta blockers, cannabis or other central nervous system depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.

Contraindications

Morphine sulfate pentahydrate is contraindicated in patients with known hypersensitivity to morphine or other opioids; severe respiratory disease, acute respiratory disease and respiratory depression or failure; asthma or other obstructive airways disease; conditions where respiratory reserve is depleted such as emphysema, chronic bronchitis or kyphoscoliosis; cor pulmonale; severe depressed level of consciousness; diabetic ketoacidosis; severe liver disease or incipient hepatic encephalopathy; following biliary tract surgery or surgical anastomosis; biliary colic; gastrointestinal obstruction or paralytic ileus; suspected surgical abdomen; acute diarrhoeal conditions associated with antibiotic-induced pseudomembranous colitis; diarrhoea caused by poisoning; patients taking or who have taken MAO inhibitors within the previous fourteen days; phaeochromocytoma; arrhythmias; cardiac failure secondary to pulmonary disease; acute alcoholism or delirium tremens; comatose patients; head injuries; brain tumour; increased intracranial or cerebrospinal pressure; and convulsive states such as status epilepticus, tetanus or strychnine poisoning. Morphine is contraindicated in premature infants or during labour for delivery of premature infants.

Regulatory history

KAPANOL morphine sulfate pentahydrate capsules were first registered on the Australian Register of Therapeutic Goods on 21 July 1994, initially in 20 mg, 50 mg, and 100 mg strengths, with a 10 mg strength added on 31 March 1999. In July 2024, the Pharmaceutical Benefits Scheme Advisory Committee recommended KAPANOL for listing for the treatment of severe pain, cancer pain, and severe disabling pain.