Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Codeine

Generic name
Codeine
Brand name
ATC Code
R05DA04

Pharmacokinetics in children

No information

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Non-productive coughing (dry cough)
  • Oral
    • Syrup
      • 12 years up to 18 years
        • 10 mg/dose, as required, max. 4x daily. Max: 40 mg/day.
      • 12 years up to 18 years
        • 10 mg/dose, as required, max. 4x daily. Max: 40 mg/day.
    • Tablet
      • 12 years up to 18 years
        [2] [4]
        • 5 - 30 mg/dose, as required 4x daily. Max: 120 mg/day.

        • Do not use in children with reduced respiratory function.
Diarrhoea
  • Oral
    • ≥ 12 years
      • 15 - 60 mg/dose, as required, max. QID.

      • Only when loperamide does not sort sufficient relief

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Obstipation
(In particular in young children: convulsions and hypotension. Respiratory depression, particularly at high doses and in young children.)
Suppression of cough stimulus (relevant when used for chronic pain or diarrhea)

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in children

Children aged < 12 years.

As an analgesic in children (12-18 years) who have undergone tonsillectomy and/or adenoidectomy to treat obstructive sleep apnoea, because of the greater risk of severe and life-threatening respiratory depression developing.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

In CYP2D6 ultra-rapid metabolizers, accelerated conversion of codeine into morphine can give rise to drowsiness and possibly respiratory depression. This risk seems in particular to be elevated at very young ages and with reduced renal function.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Opium alkaloids and derivatives
R05DA09
R05DA07

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References

  1. Rademaker C.M.A. et al, Geneesmiddelen-formularium voor Kinderen, 2007
  2. Novum Pharma BV, SPC Melrosum Extra sterk (RVG 03732) 09-12-2015, www.cbg-meb.nl, Geraadpleegd 30 juni 2014, http://db.cbg-meb.nl/IB-teksten/h03732.pdf
  3. Ratiopharm Nederland BV, SPC Codeine HCl (RVG 50422/50423/50424) 02-03-2016, www.cbg-meb.nl, Geraadpleegd 30 juni 2014, http://db.cbg-meb.nl/IB-teksten/h50422.pdf
  4. Pharmachemie BV, SmPC Codeinefosfaat (RVG 55441) 04-09-2018, www.geneesmiddeleninformatiebank.nl
  5. Expharma BV, SmPC Codeinefosfaat ( RVG 123632) 17 augustus 2019 , www.geneesmiddeleninformatiebank.nl
  6. Expharma BV, SmPC Codeinefosfaat ( RVG 123632) 17 augustus 2019, www.geneesmiddeleninformatiebank.nl

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Changes

Changes