ASPEN

What it is

Aspen Codeine is a plain white round biconvex tablet containing 30 mg of codeine phosphate hemihydrate. Codeine phosphate hemihydrate is an opioid analgesic that binds with stereospecific receptors at many sites within the central nervous system to alter processes affecting both the perceptions of pain and the emotional response to pain, with its analgesic effect thought to be due to its partial metabolic conversion to morphine. Codeine has about one-sixth the analgesic activity of morphine.

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

For adults, the usual dose is 30 to 60 mg every four to six hours, with a usual dose of 30 mg. Initial dosing requirements will depend on the medical and analgesic history of the patient, the patient's age, weight and severity of pain, and may need to be reduced in patients who are elderly or debilitated. If 60 mg of codeine every four to six hours fails to relieve pain, larger doses rarely succeed and may give rise to restlessness and excitement.

Key safety warnings

Serious, life-threatening or fatal respiratory depression may occur with the use of Aspen Codeine tablets, and prescribers 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. 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, and dosages and durations should be limited to the minimum required with close monitoring for signs and symptoms of respiratory depression and sedation. Aspen Codeine tablets poses risks of hazardous and harmful use which can lead to overdose and death, and the patient's risk of hazardous and harmful use should be assessed before prescribing and monitored regularly during treatment. Aspen Codeine tablets contains the opioid codeine and is a potential drug of abuse, misuse and addiction, with addiction able to occur in patients appropriately prescribed the medicine at recommended doses, and the risk increased in patients with a personal or family history of substance abuse or mental illness, and increasing the longer the drug is used and with higher doses. Aspen Codeine tablets are contraindicated for use in patients who are CYP2D6 ultra-rapid metabolisers, as patients with this metaboliser profile have an increased risk of developing opioid toxicity even at commonly prescribed doses, converting codeine into morphine rapidly and resulting in higher than expected serum morphine levels, with general symptoms of opioid toxicity including confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite, and in severe cases including symptoms of circulatory and respiratory depression which may be life-threatening and very rarely fatal.

Contraindications

Aspen Codeine tablets are contraindicated in patients with hypersensitivity to any ingredient. Due to codeine's structural similarity to morphine and oxycodone, patients experiencing systemic allergy to these drugs should not receive codeine. Codeine is contraindicated in respiratory depression (including acute asthma and acute exacerbations of chronic pulmonary disease), especially in the presence of cyanosis and excessive bronchial secretion, and after operations on the biliary tract. Codeine is contraindicated in patients with severe respiratory disease and acute respiratory disease. Codeine is contraindicated in the presence of acute alcoholism, head injuries, and conditions in which intracranial pressure is raised. Codeine should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease. Administration is contraindicated in patients taking monoamine oxidase inhibitors or within ten days of stopping such treatment. Aspen Codeine tablets are contraindicated for use in patients with diarrhoea caused by pseudomembraneous colitis or poisoning until the causative organism or toxic material has been excluded from the gastrointestinal tract, because opioid analgesics may slow elimination of the causative agent, thereby worsening or prolonging the diarrhoea. Aspen Codeine tablets are contraindicated for use in patients younger than 12 years. Aspen Codeine tablets are contraindicated for use in patients aged between 12 and 18 years in whom respiratory function might be compromised, including post tonsillectomy or adenoidectomy for obstructive sleep apnoea. Aspen Codeine tablets are contraindicated during breastfeeding.

PBS listing

Aspen Codeine tablet containing codeine phosphate hemihydrate 30 mg is listed on the PBS with 4 items, subject to restriction, at an ex-manufacturer price of A$3.96.

Regulatory history

Aspen Codeine (codeine phosphate hemihydrate 30 mg tablet) was first listed on the Australian Register of Therapeutic Goods on 31 August 2016.