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Opioid Analgesia Pregnancy: Caution during pregnancy, especially the first trimester — a possible association with respiratory and cardiac malformations has been reported after first-trimester exposure. Regular use in pregnancy may cause fetal drug dependence and neonatal opioid withdrawal syndrome; administration during labour may depress neonatal respiration (have an antidote ready for the child) and may cause maternal gastric stasis with a risk of inhalation pneumonia. Contraindicated during breastfeeding.

Codeine Phosphate

Brand names: Codeine Linctus, Codeine Phosphate Tablets

Codeine phosphate is an oral opioid analgesic and prodrug of morphine, used for moderate pain in gynaecology and the postnatal period when simple analgesics are insufficient.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Mild to moderate pain: the lowest effective dose for the shortest period of time — the fetched SPC §4.2 states no specific per-dose milligram figure for adults, only the frequency and the daily maximum
Route: Oral
Frequency: Up to 4 times a day, at intervals of not less than 6 hours
Max: Maximum daily dose of codeine should not exceed 240 mg; treatment duration for mild to moderate pain limited to 3 days
EXACT SPC §4.2 WORDING FOR ADULT PAIN: 'Codeine should be used at the lowest effective dose for the shortest period of time. The dose may be taken, up to 4 times a day at intervals of not less than 6 hours. Maximum daily dose of codeine should not exceed 240mg. The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician.' No adult per-dose milligram value is given for pain in this SPC — clinician to confirm the intended per-dose strength (the fetched product is Codeine phosphate 15 mg tablets). OTHER ADULT INDICATIONS STATED IN THE SAME SECTION: dry or painful cough — 15-30 mg three to four times daily; diarrhoea — 30 mg three to four times daily (range 15-60 mg). ELDERLY: dosage should be reduced. BEFORE STARTING: a discussion should be held with the patient to put in place a strategy for ending treatment, to minimise the risk of addiction and drug withdrawal syndrome. CYP2D6: codeine is metabolised to morphine by CYP2D6 — poor metabolisers get inadequate analgesia; ultra-rapid metabolisers are at increased risk of opioid toxicity even at commonly prescribed doses and codeine is contraindicated in known ultra-rapid metabolisers. OBSTETRIC RELEVANCE (this page's specialty): codeine is CONTRAINDICATED in women during breastfeeding — it may be secreted in breast milk and cause respiratory depression in the infant; if symptoms of opioid toxicity develop in mother or infant, stop all codeine-containing medicines and prescribe a non-opioid analgesic. Administration during labour may depress neonatal respiration and an antidote for the child should be readily available; opioids may cause gastric stasis during labour, increasing the risk of maternal inhalation pneumonia. Regular use in pregnancy may cause fetal dependence and neonatal withdrawal. PAEDIATRIC: contraindicated below 12 years of age (risk of opioid toxicity from variable, unpredictable metabolism to morphine, and contraindicated for cough below 12 years); not recommended in 12-18 year olds with compromised respiratory function for cough; contraindicated in all patients 0-18 years undergoing tonsillectomy and/or adenoidectomy for obstructive sleep apnoea. Not recommended for diarrhoea in children. Verify any paediatric use against a children's formulary.

Paediatric dose

Route: Oral
Frequency: Every 6 hours when necessary (children aged 12 years to 18 years only)
Max: Maximum dose of codeine 240 mg daily
RANGE, NOT A SINGLE VALUE — dosePerKg is deliberately null. Exact SPC §4.2 wording: 'The recommended codeine dose for children 12 years and older should be 30-60mg every 6 hours when necessary up to a maximum dose of codeine of 240mg daily. The dose is based on the body weight (0.5-1mg/kg).' STRICTLY CONTRAINDICATED IN CHILDREN UNDER 12 YEARS, and in all patients aged 0-18 years after tonsillectomy and/or adenoidectomy for obstructive sleep apnoea. Not recommended in 12-18 year olds with compromised respiratory function (neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma, extensive surgery). Verify against a children's formulary before use.

Dose adjustments

Renal

Should be avoided, or the dose reduced, in patients with renal impairment (SPC §4.4). No numeric renal dose adjustment is stated in the fetched text.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Acute respiratory depression; comatose patients
  • Hypersensitivity to codeine or other opioid analgesics or to any of the excipients
  • Obstructive airways disease; avoid during an acute asthma attack
  • Liver disease / severe hepatic dysfunction; acute alcoholism
  • Raised intracranial pressure or head injury (use should be avoided — also confounds neurological assessment)
  • Conditions where inhibition of peristalsis is to be avoided, risk of paralytic ileus, abdominal distension, or acute diarrhoeal conditions such as acute ulcerative colitis, antibiotic-associated (pseudomembranous) colitis or diarrhoea caused by poisoning
  • All paediatric patients (0-18 years) undergoing tonsillectomy and/or adenoidectomy for obstructive sleep apnoea; children under 12 years
  • Women who are breastfeeding
  • Patients known to be CYP2D6 ultra-rapid metabolisers

Side effects

  • Constipation, nausea, vomiting, dry mouth, stomach cramps
  • Drowsiness, dizziness, headache (prolonged use of a painkiller for headaches can make them worse); convulsions, especially in infants and children
  • Respiratory depression with large doses; dyspnoea
  • Postural hypotension and facial flushing; large doses produce hypotension; tachycardia, palpitations, bradycardia
  • Drug dependence, tolerance and drug withdrawal syndrome with regular prolonged use; restlessness and irritability on stopping
  • Difficulty with micturition, urinary retention; miosis; confusion, mood changes, hallucinations

Interactions

  • CYP2D6 status (from SPC §4.4 — §4.5 was not retrieved in this fetch): ultra-rapid metabolisers convert codeine to morphine rapidly, giving higher than expected serum morphine and a risk of life-threatening opioid toxicity; poor metabolisers obtain inadequate analgesia
  • Monoamine oxidase inhibitors (MAOIs) — SPC §4.4 begins a caution on administering pethidine and possibly other opioid analgesics to patients taking an MAOI, but the sentence is truncated in the fetched text; check the full SPC §4.5 before co-prescribing
  • Note: eMC §4.5 (Interactions) was not part of this fetch — this list is incomplete and must be completed from the full SPC

Clinical monograph

How it works

It is metabolised by CYP2D6 to morphine, which acts on central mu-opioid receptors to reduce pain perception; metabolic conversion varies widely between individuals.

Prescribing in practice

  • Codeine is contraindicated in breastfeeding because ultra-rapid metabolisers can produce high morphine levels in breast milk, risking serious neonatal sedation and respiratory depression.
  • Use towards the end of pregnancy and during labour can cause neonatal respiratory depression and, with prolonged use, neonatal withdrawal.
  • Avoid in known CYP2D6 ultra-rapid metabolisers and use the lowest effective dose for the shortest time.

Monitoring

Monitor for analgesic efficacy, constipation, sedation and signs of dependence, and assess the breastfed infant for drowsiness or feeding difficulty if exposure has occurred.

Counselling the patient

  • Do not breastfeed while taking codeine unless specifically advised by a clinician.
  • Expect constipation and consider preventive measures.
  • Avoid alcohol and do not drive if drowsy.

Evidence & guidelines

The MHRA advises against codeine in breastfeeding and restricts paediatric use following reports of serious harm linked to ultra-rapid CYP2D6 metabolism.

Reference: MHRA Drug Safety Update (2013) Codeine; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.