CODALGIN

What it is

CODALGIN contains 30 mg of codeine phosphate hemihydrate in plain white round biconvex tablets. 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. Its analgesic effect is thought to be due to its partial metabolic conversion to morphine, and 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

Initial dosing requirements will depend on medical and analgesic history of the patient, patient's age, weight and severity of pain, and may need to be reduced in patients who are elderly or debilitated. Adults receive 30 to 60 mg every four to six hours (usual dose 30 mg). 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 CODALGIN. Patients should be made aware of situations which increase the risk of respiratory depression, and patients at risk should be monitored closely, especially on initiation or following a dose increase. Concomitant use of CODALGIN 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 monitored for signs and symptoms of respiratory depression and sedation, and patients should be cautioned not to drink alcohol while taking CODALGIN. CODALGIN poses risks of hazardous and harmful use which can lead to overdose and death, and the patient's risk should be assessed before prescribing and the patient monitored regularly during treatment. CODALGIN contains the opioid codeine and is a potential drug of abuse, misuse and addiction; addiction can occur in patients appropriately prescribed CODALGIN at recommended doses, and the risk of addiction is increased in patients with a personal or family history of substance abuse or mental illness and increases the longer the drug is used and with higher doses.

Contraindications

CODALGIN is 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 (such as 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, and 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. CODALGIN is 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 and/or prolonging the diarrhoea. CODALGIN is contraindicated in patients who are CYP2D6 ultra-rapid metabolisers. CODALGIN is contraindicated for use in patients younger than 12 years. CODALGIN is contraindicated in patients aged between 12 and 18 years in whom respiratory function might be compromised, including post tonsillectomy and/or adenoidectomy for obstructive sleep apnoea, due to an increased risk of developing serious and life-threatening adverse reactions. CODALGIN is contraindicated during breastfeeding.