Codeine 30mg uses in Australia
The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has reached a consensus on the implementation of new measures aimed at reducing the risk of serious side effects associated with the use of codeine-containing medicines for treating cough and cold in children. The newly agreed measures dictate that the use of codeine 30mg for cough and cold in children below 12 years is now contraindicated in Australia, meaning it must not be used in this patient group. Additionally, the use of codeine for cough and cold is not recommended in children and adolescents between 12 and 18 years who have breathing problems.
This decision is based on the understanding that the effects of codeine 30mg are attributed to its conversion into morphine in the body. Some individuals metabolize codeine into morphine at a faster rate than normal, resulting in elevated levels of morphine in their blood, which can lead to serious effects, such as breathing difficulties.
Pharmacovigilance Risk Assessment Committee
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) conducted a review and concluded that while morphine-induced side effects may occur in patients of all ages, the way in which codeine is converted into morphine in children below 12 years is more variable and unpredictable, placing this population at a particular risk of such side effects. Moreover, children with pre-existing breathing problems may be more susceptible to respiratory issues due to codeine.
In addition to the restrictions for children, codeine should not be used in individuals known to metabolize codeine into morphine at a faster rate than normal (ultra-rapid metabolisers) or in breastfeeding mothers, as it can pass into breast milk and potentially harm the baby.
These measures were established following a comprehensive review, which was initiated when similar considerations to those for the use of codeine for pain relief in children were identified for its use in cough and cold. This new review aligns with the previous recommendations for codeine 30mg when used for pain relief in Australia.
Since the CMDh has collectively agreed on the PRAC measures, Member States where the medicines are authorized will directly implement the measures according to an agreed timetable.
Descriptions of Codeine 30mg in Australia
Codeine 30mg is utilized in Australia to alleviate mild to moderate pain and is classified as a narcotic analgesic. It operates on the central nervous system to provide pain relief. Prolonged use of codeine 30mg may lead to habit formation, resulting in mental or physical dependence. However, individuals experiencing persistent pain should not refrain from using narcotics to relieve their pain due to concerns about dependency. Mental dependence, or addiction, is unlikely to occur when narcotics are used for pain management. Physical dependence may cause withdrawal symptoms if treatment is abruptly discontinued, but gradual dose reduction can typically prevent severe withdrawal effects. This medication is only accessible through a restricted distribution program known as the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program. It is available in various dosage forms.
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