ANAMORPH

What it is

ANAMORPH is morphine sulfate pentahydrate available in isotonic preparations of 2 milligram/1 mL, 5 milligram/1 mL, 10 milligram/1 mL, 15 milligram/1 mL and 30 milligram/1 mL. It is a sterile solution of morphine sulfate pentahydrate and sodium chloride in water for injections. ANAMORPH is a solution for injection.

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. — Pre-operative medication. — Analgesic adjunct in general anaesthesia.

Dosing overview

ANAMORPH may be given by the subcutaneous, intramuscular or intravenous route. Adults are usually administered 5 to 20 milligrams by intramuscular or subcutaneous injection, depending on the cause of pain and patient response, with doses repeated every 4 to 6 hours. When a rapid onset of action is desired, ANAMORPH may be given intravenously in the range of 2.5 to 15 milligrams diluted in 4 to 5 mL of Water for Injections, given slowly over 4 to 5 minutes. Children are given 0.1 to 0.2 milligram/kg bodyweight to a maximum of 15 milligrams by intramuscular or subcutaneous injection, with injection repeated every 4 to 6 hours.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of ANAMORPH. Situations which increase the risk of respiratory depression should be identified, dosing modified in at-risk patients, and patients monitored closely, especially on initiation or following a dose increase. Concomitant use of ANAMORPH with other opioids, 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. Dosages and durations should be limited to the minimum required and patients monitored for signs and symptoms of respiratory depression and sedation. ANAMORPH poses risks of hazardous and harmful use which can lead to overdose and death. The patient's risk of hazardous and harmful use should be assessed before prescribing and the patient monitored regularly during treatment. Because of the risks associated with the use of opioids, ANAMORPH 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.

Contraindications

ANAMORPH is contraindicated in patients with known hypersensitivity to morphine or other opioids; severe respiratory disease, acute respiratory disease and respiratory depression or failure, especially in the presence of cyanosis and/or increased bronchial secretions; 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 where there is a danger of coma; severe liver disease or incipient hepatic encephalopathy; following biliary tract surgery or surgical anastomosis; biliary colic; gastrointestinal obstruction; paralytic ileus; suspected surgical abdomen; acute diarrhoeal conditions associated with antibiotic-induced pseudomembranous colitis; diarrhoea caused by poisoning until the toxic material has been eliminated; 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 in convulsive states such as status epilepticus, tetanus or strychnine poisoning. ANAMORPH is contraindicated in premature infants or during labour for delivery of premature infants. Administration of ANAMORPH via patient-controlled analgesia to children less than six years of age and adults with poor cognitive function is contraindicated.

Regulatory history

ARTG 34032, an ANAMORPH Morphine Sulphate 30 mg tablet blister pack sponsored by Arrotex Pharmaceuticals, was first listed on 11 December 1991. ARTG 64384, an ANAMORPH morphine sulfate pentahydrate 10 mg tablet blister pack, was first listed on 14 May 1998.