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

Interactions
PK
Renal impairment
References

Mesalazine

Generic name
Mesalazine
Brand name
ATC Code
A07EC02

Pharmacokinetics in children

The studies by Wiersma et al. (N=13, 6–16 years), Tolia et al. (N=4, 13–17 years) and Christensen et al. (N=9, 7–13 years) show that the pharmacokinetics of mesalazine in children are similar to those in adults.

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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

Ulcerative colitis, both in the acute phase and for prevention of recurrences
  • Rectal
    • 2 years up to 18 years
      • 25 mg/kg/day in 1 dose. Max: 1 g/day.

      • The maximum dose of mesalazine (oral combined with rectal): 150% of the oral dose, up to a maximum of 6.4 g/day.

         

  • Oral
    • 2 years up to 18 years
      • 60 - 80 mg/kg/day in 1 - 2 doses. Max: 120mg/kg/day, but not exceeding 6.4 g/day.

      • Higher doses (up to 100 mg/kg/day) may be necessary in individual cases. There is no scientific foundation for these higher dosages.
        The maximum dose of mesalazine (oral combined with rectal): 150% of the oral dose,

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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

Nausea, vomiting, dizziness, headaches, abdominal pain, diarrhoea, rash. After rectal administration, local reactions such as pruritus, rectal discomfort and an urgent need to defecate may occur. Rare side effects such as interstitial nephritis, pneumonitis, myopathy and pericarditis have also been described in case reports in children.

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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

No information available on specific contra indications in children.

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

As with all salicylic acid derivatives, caution should be exercised in patients with asthma due to hypersensitivity reactions. Regular monitoring of renal function (serum creatinine) is desirable, especially at the start of treatment. In patients who develop kidney function disorders during treatment, kidney toxicity by mesalazine must be considered.
The gastro-resistant tablets can be given suspended in water via a stomach tube.

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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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Corticosteroids acting locally
A07EA06
Antiallergic agents, excl. corticosteroids
A07EB01
Aminosalicylic acid and similar agents
A07EC01

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References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Christensen LA, et al, Bioavailability of 5-aminosalicyclic acid from slow release 5-aminosalicyclic acid drug and sulfasalazine in normal children, Dig Dis Sci., 1993, 38, 1831-6
  3. Ian D. D\'Agata, et al, Mesalamine in pediatric inflammatory bowel disease: A 10-year experience., Inflamm Bowel Dis, 1996, 2, 229-35
  4. Tolia V, et al, Oral 5-aminosalicyclic acid in children with colonic chronic inflammatory bowel disease: clinical and pharmacokinetic experience, J Pediatr Gastroenterol Nutr., 1989, 8, 333-8
  5. Wiersma H, et al, Pharmacokinetics of mesalazine pellets in children with inflammatory bowel disease, Inflamm Bowel Dis, 2004, 10, 626-31
  6. Turner D, et al, Management of pediatric ulcerative colitis: joint ECCO and ESPGHAN Evidence-Based Consensus Guidelines, JPGN, 2012, 55(3):, 340-61
  7. Tabata N et al, Severe skeletal muscle damage following the administration of mesalazine to a patient with ulcerative colitis, Pediatr Int, 2009, Oct;51(5), 759-60
  8. Falk Pharma, SmPC Salofalk 250mg Tabletten, 2881.00.01, 10/2017
  9. Falk Pharma, SmPC Salofalk 1g Tabletten, 96061.00.00, 10/2017
  10. Falk Pharma, SmPC Salofalk Granu-Stix 500mg/1000mg/1,5g/3g Retardgranulat, 50315.00.00, 10/2017
  11. Recordati Pharma, Claversal 4g/60ml Klysmen, 4015 7.00.00, 10/2017
  12. Recordati Pharma, SmPC Claversal 250mg/500mg Suppositorien, 5697.00.00, 10/2017
  13. Recordati Pharma, SmPC Claversal 1g Rektalschaum, 42197.00.00, 10/2017
  14. Recordati Pharma, SmPC Claversal 250mg Tabletten, 5697.00.01, 10/2017
  15. Falk Pharma, SmPC Salofalk 2g/30ml Klysmen, 16629.00.00, 10/2017
  16. Falk Pharma, SmPC Salofalk 4g/60ml Klysmen, 2881.00.02, 10/2017
  17. Ferring Pharma, SmPC Pentasa 1000mg Klystiere, 13913.00.00, 01/2018
  18. Falk Pharma, SmPC Salofalk 1g Rektalschaum,65717.00.00, 10/2017
  19. Ferring Pharma, SmPC Pentasa 1000mg Zäpfchen, 16944.00.02, 01/2018
  20. Falk Pharma, SmPC Salofalk 250mg Suppositorien, 2881.00.00, 10/2017
  21. Falk Pharma, SmPC Salofalk 500mg Suppositorien, 2881.01.00, 10/2017
  22. Falk Pharma, SmPC Salofalk 1g Suppositorien, 74251.00.00, 10/2017
  23. Online GL. Gelbe Liste Online, https://www.gelbe-liste.de/, Accessed April 11, 2018
  24. Falk Pharma, SmPC Salofalk 500mg Tabletten, 2881.01.01, 10/2017
  25. Tillotts Pharma, SmPC Asacol 400mg Tabletten, 7135.00.00, 07/2017
  26. Tillotts Pharma, SmPC Asacol 800ng Tabletten, 89227.00.00, 07/2017
  27. Recordati Pharma, SmPC Claversal 500mg Tabletten, 5697.01.01, 10/2017
  28. Recordati Pharma, SmPC Claversal 1,5g Mikropellets,42197.00.01, 10/2017
  29. Ferring Pharma, SmPC Pentasa Sachet 4g Retardgranulat, 91296.00.00, 02/2016
  30. Ferring Pharma, Pentasa Sachet 1000mg/Xtend 2g Retardgranulat, 44367.00.00, 02/2016

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Changes

Changes