- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
No pharmacokinetic data known for children.
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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
| Proctitis |
|---|
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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
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.
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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
Systemic JIA because of severe hypersensitivity reactions.
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.
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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 | ||
|---|---|---|
| A07EC02 | ||
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References
- Turner D, et al, Management of pediatric ulcerative colitis: joint ECCO and ESPGHAN Evidence-Based Consensus Guidelines. , JPGN , 2012, 55(3), 340-61
- 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
- Huang JL, et al, Sulphasalazine in the treatment of children with chronic arthritis, Clin Rheumatol, 1998, 17, 359-63
- Imundo LF, et al, Sulfasalazine therapy for juvenile rheumatoid arthritis, J Rheumatol, 1996, 23, 360-6
- Kirschner BS, Ulcerative colitis in children, Pediatr Clin North Am, 1996, 43, 235-54
- Koutras A, et al, Sulfasalazine and renal tubular function: lack of an effect., J Pediatr Gastroenterol Nutr., 1985, 4, 103-6
- 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
- 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
- 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
- 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
- Pfizer BV, SPC Salazopyrine zetpil 13-6-2013, www.cbg-meb.nl
- Hagen S et al., Toxic Epidermal Necrolysis in a Pediatric Patient, Minn Med., 2016, May-Jun;99(3), 49-50
- MMI, Online GL. Gelbe Liste Online, Accessed June 11, 2018.
- Sanofi-Aventis, SmPC Colo-Pleon 500 mg, magensaftresistente Filmtabletten (6578934.00.00), 03/2016
- Pfizer, SmPC Azulfidine Tabletten 500 mg, Azulfidine magensaftresistente Tabletten 500 mg (6161281.00.02, 6161281.00.01), 06/2016
- Sanofi, SmPC Pleon® RA 500 mg, magensaftresistente Filmtabletten (16571.00.00), 03/2016
- Pfizer, SmPC Azulfidine® RA 500 mg magensaftresistente Filmtabletten (4094.00.00), 06/2016
- Turner D, et al, Management of pediatric ulcerative colitis: joint ECCO and ESPGHAN Evidence-Based Consensus Guidelines., JPGN, 2012, 55(3), 340-61
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Changes
Changes
