ORDINE

What it is

ORDINE oral solution is available in four strengths containing morphine hydrochloride trihydrate: 1 mg/mL, 2 mg/mL, 5 mg/mL, and 10 mg/mL. It is a clear, colourless or pale yellow aqueous solution supplied in 200 mL bottles.

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

Dosage must be titrated to the patient's needs because of the wide inter-individual variability in plasma concentration required to achieve analgesia. The usual adult dosage is 5–20 mg (2.5–10 mL of the 2 mg/mL mixture) every 4 hours, with treatment starting at 5 mg every 4 hours and further increments as required. The initial dose will depend largely on the patient's previous treatment and should be the lowest compatible with pain control. With repeated administration, tolerance may develop and the dose may need to be increased gradually in order to control the pain. Dosage should be lower in elderly patients, those with respiratory, hepatic or renal impairment and in patients receiving CNS depressants. Dosage in children should be adjusted according to body weight, 0.1–0.2 mg/kg every 4 hours.

Key safety warnings

ORDINE oral solution 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. ORDINE oral solution poses risks of hazardous and harmful use which can lead to overdose and death. Patients should be assessed for risk of hazardous and harmful use before prescribing and monitored regularly during treatment. Serious, life-threatening or fatal respiratory depression may occur with the use of ORDINE oral solution. Situations which increase the risk of respiratory depression should be identified, dosing should be modified in patients at risk and patients should be monitored 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. Dosages and durations should be limited to the minimum required; and patients should be monitored for signs and symptoms of respiratory depression and sedation. Patients should be advised not to drink alcohol while taking ORDINE oral solution.

Contraindications

Morphine is contraindicated in patients hypersensitive to opioids or any of the excipients; in children under one year of age including premature infants or during labour or delivery of premature infants; following biliary tract surgery or surgical anastomosis; paralytic ileus; and concomitant monoamine oxidase inhibitors (MAOIs), or within 14 days of such therapy. Morphine is contraindicated in severe respiratory disease, acute respiratory disease and respiratory depression. Morphine should not be given to patients with acute bronchial asthma or other obstructive airway disease, heart failure secondary to chronic pulmonary disease (cor pulmonale), cardiac arrhythmias, severe CNS depression, acute alcoholism, delirium tremens, head injuries, brain tumour, raised cerebrospinal or intracranial pressure, suspected surgical and acute abdomen, or paralytic ileus.

PBS listing

Three PBS items are listed for the 5 mg/mL strength at an ex-manufacturer price of A$80.00, with streamlined restriction. Three PBS items are listed for the 10 mg/mL strength at an ex-manufacturer price of A$125.00, with streamlined restriction. Two PBS items are listed for the 2 mg/mL strength at an ex-manufacturer price of A$40.00, with restricted access.

Regulatory history

ORDINE oral solution was first registered on the Australian Register of Therapeutic Goods on 26 August 2008. All four strengths (1 mg/mL, 2 mg/mL, 5 mg/mL and 10 mg/mL) were registered on the same date under licence category RE.