Dolased

What it is

Dolased 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.

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, the patient's age, weight and severity of pain, and may need to be reduced in patients who are elderly or debilitated. For adults, the dose is 30 to 60 mg every four to six hours, with a usual dose of 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 Dolased. 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. Limit dosages and durations to the minimum required and monitor patients for signs and symptoms of respiratory depression and sedation. Caution patients not to drink alcohol while taking Dolased. Because of the risks associated with the use of opioids, Dolased 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. Dolased contains the opioid codeine and is a potential drug of abuse, misuse and addiction. Addiction can occur in patients appropriately prescribed Dolased at recommended doses. Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient is an extensive or ultra-rapid metaboliser, there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses. These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels.

Contraindications

Dolased is contraindicated in patients with hypersensitivity to any ingredient. Dolased is contraindicated for use in patients younger than 12 years and 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. Dolased is contraindicated in patients who are CYP2D6 ultra-rapid metabolisers. 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 the presence of acute alcoholism, head injuries, and conditions in which intracranial pressure is raised. Administration is contraindicated in patients taking monoamine oxidase inhibitors or within ten days of stopping such treatment. Dolased is contraindicated during breastfeeding.

Regulatory history

Dolased received initial approval on 1 October 1992. ARTG registration 157880 for Dolased tablet blister pack was first listed on 15 December 2008.