Co-codamol for children

Co-codamol is a combination analgesic that contains paracetamol (acetaminophen) and codeine phosphate. It is used for the relief of moderate to severe pain, particularly when simple analgesics (like paracetamol or ibuprofen alone) are insufficient. While co-codamol is a widely prescribed medication for adults, its use in children is highly restricted due to safety concerns, especially around codeine metabolism and respiratory depression.

---

Safety Overview: Co-codamol and Children

Co-codamol is not generally recommended for use in children under 12 years of age. In fact, the use of codeine-containing medicines is contraindicated in this age group across most regulatory bodies, including:

• MHRA (UK Medicines and Healthcare products Regulatory Agency)

• EMA (European Medicines Agency)

• FDA (U.S. Food and Drug Administration)

This restriction is due to the variable metabolism of codeine to morphine, which can lead to life-threatening respiratory depression, particularly in children who are ultra-rapid CYP2D6 metabolizers.

---

Age-Specific Regulatory Guidance

Children under 12 years old

• Contraindicated

• Risk of morphine overdose from unpredictable codeine metabolism

• Alternatives like paracetamol and ibuprofen should be used instead

Children 12 to 18 years old

• Not recommended for treatment of pain following tonsillectomy or adenoidectomy for obstructive sleep apnoea

• Use only if other painkillers are ineffective

• Lowest effective dose for the shortest possible duration

Breastfeeding Mothers

• Contraindicated

• Risk of opioid toxicity in the infant via breast milk, especially if mother is an ultra-rapid metabolizer

---

MHRA Position on Co-codamol and Codeine in Pediatrics

The MHRA issued safety updates in 2013 and 2015 that:

• Banned codeine-containing products (including co-codamol) for children <12

• Restricted use in adolescents (12–18) with compromised respiratory function

• Emphasized avoiding all use after tonsil/adenoid surgery in children

• Required clear labeling and packaging warnings

These updates followed reports of fatal respiratory depression in children, some after routine surgeries like tonsillectomy for obstructive sleep apnoea.

---

Available Strengths of Co-codamol (For Adults)

Typical adult formulations:

• 8/500 mg: 8 mg codeine + 500 mg paracetamol (OTC in some countries)

• 15/500 mg: 15 mg codeine + 500 mg paracetamol

• 30/500 mg: 30 mg codeine + 500 mg paracetamol (prescription-only)

There is no licensed formulation of co-codamol for children in the UK, US, or EU.

---

Pediatric Pain Management Alternatives

For children under 12, preferred medications include:

Mild Pain:

• Paracetamol (acetaminophen): Weight-based dosing (10–15 mg/kg every 4–6 hours)

• Ibuprofen: Anti-inflammatory and analgesic; 5–10 mg/kg every 6–8 hours

Moderate to Severe Pain (under supervision):

• Morphine: Gold standard for severe pediatric pain; dosed per kg

• Oxycodone, hydromorphone (in specialized settings)

• Tramadol: Also restricted in <12s and in certain adolescents by EMA and FDA

---

Why Codeine Is Unsafe for Children

1. Metabolism via CYP2D6

• Codeine is a prodrug that must be converted into morphine by the CYP2D6 enzyme.

• Some children have ultra-rapid metabolism, leading to toxic morphine levels.

• Others may be poor metabolizers, resulting in no analgesia.

2. Respiratory Depression

• Morphine acts on the brainstem to suppress breathing.

• Young children are especially vulnerable to apnoea, hypoxia, and death.

3. Unpredictable Response

• Genetic variability in CYP2D6 is unpredictable without genetic testing.

• Thus, safe use of codeine in children cannot be assured.

---

Professional Recommendations and Guidelines

MHRA (UK)

• Contraindicated in under 12s

• Not recommended in 12–18s unless clearly necessary

• Do not use after adenotonsillectomy

EMA (EU)

• Similar restrictions as MHRA

• Contraindicated in <12 years

• Warning against use in adolescents with asthma or respiratory conditions

FDA (US)

• Boxed warning on all codeine-containing products

• Contraindicated in children <12

• Avoid in under 18s for post-surgical pain management

---

Clinical Summary

• Co-codamol is not licensed for children under 12.

• The codeine component is unsafe due to CYP2D6 polymorphism.

• Safer alternatives like paracetamol and ibuprofen should be used for most pediatric pain.

• In severe pediatric pain, morphine, under close medical supervision, is the opioid of choice.

• Prescribers must follow national guidelines and issue clear communication to caregivers about the risks of codeine-containing medications