Codeine phosphate | Drugs | BNF content published by NICE (2024)

MHRA/CHM advice: Benzodiazepines and opioids: reminder of risk of potentially fatal respiratory depression (March 2020)

The MHRA reminds healthcare professionals that opioids co-prescribed with benzodiazepines and benzodiazepine-like drugs can produce additive CNS depressant effects, thereby increasing the risk of sedation, respiratory depression, coma, and death. Healthcare professionals are advised to only co-prescribe if there is no alternative and, if necessary, the lowest possible doses should be given for the shortest duration. Patients should be closely monitored for signs of respiratory depression at initiation of treatment and when there is any change in prescribing, such as dose adjustments or new interactions. If methadone is co-prescribed with a benzodiazepine or benzodiazepine-like drug, the respiratory depressant effect of methadone may be delayed; patients should be monitored for at least 2 weeks after initiation or changes in prescribing. Patients should be informed of the signs and symptoms of respiratory depression and sedation, and advised to seek urgent medical attention should these occur.

MHRA/CHM advice: Opioids: risk of dependence and addiction (September 2020)

New safety recommendations have been issued following a review of the risks of dependence and addiction associated with prolonged use (longer than 3 months) of opioids for non-malignant pain.

Healthcare professionals are advised to:

• discuss with patients that prolonged use of opioids, even at therapeutic doses, may lead to dependence and addiction;
• agree a treatment strategy and plan for end of treatment with the patient before starting opioids;
• counsel patients and their carers on the risks of tolerance and potentially fatal unintentional overdose, as well as signs and symptoms of overdose;
• provide regular monitoring and support to patients at increased risk, such as those with current or history of substance use disorder (including alcohol misuse) or mental health disorders;
• taper dosage slowly at the end of treatment to reduce the risk of withdrawal effects associated with abrupt discontinuation (tapering high doses may take weeks or months);
• consider hyperalgesia in patients on long-term opioid treatment who present with increased pain sensitivity;
• consult product literature for the latest advice and warnings for opioid use during pregnancy (see also Pregnancy).

The MHRA has also issued a safety leaflet for patients—see Patient and carer advice.

MHRA/CHM advice (July 2013) Codeine for analgesia: restricted use in children due to reports of morphine toxicity

Codeine should only be used to relieve acute moderate pain in children older than 12 years and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen alone. A significant risk of serious and life-threatening adverse reactions has been identified in children with obstructive sleep apnoea who received codeine after tonsillectomy or adenoidectomy:

• in children aged 12–18 years, the maximum daily dose of codeine should not exceed 240mg. Doses may be taken up to four times a day at intervals of no less than 6 hours. The lowest effective dose should be used and duration of treatment should be limited to 3 days
• codeine is contra-indicated in all children (under 18 years) who undergo the removal of tonsils or adenoids for the treatment of obstructive sleep apnoea
• codeine is not recommended for use in children whose breathing may be compromised, including those with neuromuscular disorders, severe cardiac or respiratory conditions, respiratory infections, multiple trauma or extensive surgical procedures
• codeine is contra-indicated in patients of any age who are known to be ultra-rapid metabolisers of codeine (CYP2D6 ultra-rapid metabolisers)
• codeine should not be used in breast-feeding mothers because it can pass to the baby through breast milk
• parents and carers should be advised on how to recognise signs and symptoms of morphine toxicity, and to stop treatment and seek medical attention if signs or symptoms of toxicity occur (including reduced consciousness, lack of appetite, somnolence, constipation, respiratory depression, ’pin-point’ pupils, nausea, vomiting)

MHRA/CHM advice (April 2015) Codeine for cough and cold: restricted use in children

Do not use codeine in children under 12 years as it is associated with a risk of respiratory side effects. Codeine is not recommended for adolescents (12–18 years) who have problems with breathing. When prescribing or dispensing codeine-containing medicines for cough and cold, consider that codeine is contra-indicated in:

• children younger than 12 years old
• patients of any age known to be CYP2D6 ultra-rapid metabolisers
• breastfeeding mothers

MHRA/CHM advice: Codeine linctus (codeine oral solutions): reclassification to prescription-only medicine (February 2024)

Following the results of a public consultation, codeine linctus has been reclassified as a prescription-only medicine (POM) due to the risk of dependence, addiction, and overdose. Healthcare professionals are reminded that codeine linctus is only authorised for the treatment of dry cough, and only considered to be effective for chronic coughs lasting over 8 weeks.