Pharmacokinetics in children

No pharmacokinetic data known for children.

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

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

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.

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

The patient’s acetylator status plays a key role. Slow
acetylators have higher sulfapyridine concentrations and therefore more risk of
side effects. The most commonly occurring side effects are gastrointestinal complaints, anorexia, nausea, vomiting, fever, erythema, headaches, peripheral neuropathy, abnormal blood counts, hypersensitivity reactions, changed serum-immunoglobulin values, hepatic and renal function disorders.
Rare side effects such as toxic epidermal necrolysis (TEN), interstitial nephritis, pneumonitis and pericarditis have also been described in case reports 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

Using sulfasalazine in children with systemic JIA can result in serum sickness-like reactions. Using sulfasalazine in these patients is therefore not recommended.
Children with JIA also seem to be more susceptible to changes in serum immunoglobulin values. Checking serum immunoglobulin levels is therefore recommended during treatment with sulfasalazine.
Because sulfasalazine can cause crystalluria and kidney stone formation, sufficient liquid should be taken during the treatment. Sulfasalazine can also cause folate deficiency due to inhibition of the absorption and metabolism of folic acid. Folic acid supplementation (5 mg/week) is therefore recommended.
Because of the risk of haematological abnormalities, checking the blood count is recommended prior to treatment, every month for the first three months of treatment and then every 2-3 months. Liver and kidney function checks are also recommended prior to and during treatment.
 

Interactions

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

• ALIMENTARY TRACT AND METABOLISM
• ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS

INTESTINAL ANTIINFLAMMATORY AGENTS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

References

1. Turner D, et al, Management of pediatric ulcerative colitis: joint ECCO and ESPGHAN Evidence-Based Consensus Guidelines. , JPGN , 2012, 55(3), 340-61
2. Ferry GD, et al, Olsalazine versus sulfasalazine in mild to moderate childhood ulcerative colitis: results of the Pediatric Gastroenterology Collaborative Research Group Clinical Trial., J Pediatr Gastroenterol Nutr, 1993, 17, 32-8
3. Huang JL, et al, Sulphasalazine in the treatment of children with chronic arthritis, Clin Rheumatol, 1998, 17, 359-63
4. Imundo LF, et al, Sulfasalazine therapy for juvenile rheumatoid arthritis, J Rheumatol, 1996, 23, 360-6
5. Kirschner BS, Ulcerative colitis in children, Pediatr Clin North Am, 1996, 43, 235-54
6. Koutras A, et al, Sulfasalazine and renal tubular function: lack of an effect., J Pediatr Gastroenterol Nutr., 1985, 4, 103-6
7. van Rossum MA, et al, Sulfasalazine in the treatment of juvenile chronic arthritis: a randomized, double-blind, placebo-controlled, multicenter study. Dutch Juvenile Chronic Arthritis Study Group, Arthritis Rheum, 1998, 41, 808-16
8. van Rossum MA, et al, Effects of sulfasalazine treatment on serum immunoglobulin levels in children with juvenile chronic arthritis. Dutch Juvenile Chronic Arthritis Study group, Scand J Rheumatol, 2001, 30, 25-30
9. van Rossum MA, et al, Long-term outcome of juvenile idiopathic arthritis following a placebo-controlled trial: sustained benefits of early sulfasalazine treatment. Dutch Juvenile Idiopathic Arthritis Study group, Ann Rheum Dis., 2007, 66, 1518-24
10. Wilson D, et al, Systematic Review of the Evidence Base for the Medical Treatment of Paediatric Inflammatory Bowel Disease, J Pediatr Gastroenterol Nutr, 2010, 50, S1-S34
11. Pfizer BV, SPC Salazopyrine zetpil 13-6-2013, www.cbg-meb.nl
12. Hagen S et al., Toxic Epidermal Necrolysis in a Pediatric Patient, Minn Med., 2016, May-Jun;99(3), 49-50
13. MMI, Online GL. Gelbe Liste Online, Accessed June 11, 2018.
14. Sanofi-Aventis, SmPC Colo-Pleon 500 mg, magensaftresistente Filmtabletten (6578934.00.00), 03/2016
15. Pfizer, SmPC Azulfidine Tabletten 500 mg, Azulfidine magensaftresistente Tabletten 500 mg (6161281.00.02, 6161281.00.01), 06/2016
16. Sanofi, SmPC Pleon® RA 500 mg, magensaftresistente Filmtabletten (16571.00.00), 03/2016
17. Pfizer, SmPC Azulfidine® RA 500 mg magensaftresistente Filmtabletten (4094.00.00), 06/2016
18. Turner D, et al, Management of pediatric ulcerative colitis: joint ECCO and ESPGHAN Evidence-Based Consensus Guidelines., JPGN, 2012, 55(3), 340-61

Changes

Therapeutic Drug Monitoring

Overdose