Last update: July 21, 2017

サラゾスルファピリジン

Very Low Risk for breastfeeding


Safe. Compatible.
Minimal risk for breastfeeding and infant.

Prodrug of Mesalazine: medication compounded by union of Sulfapyridine and 5-ASA which is degraded into Mesalazine by bacteria in the large intestine.

Mesalazine is badly absorbed by the intestine, serum levels are low with scant excretion into breast milk. Inactive metabolite N-acetyl-5-ASA was found in small amount in the milk with a relative infant dose not higher than 10%.

No harm effects among breastfed infants from treated mothers have been reported, except for rare cases of diarrhea reported in the 80's with the use of Sulfasalazine. In a review of 121 cases and 121 controls, the authors failed to observe those findings. (Moretti, 1989).

Expert consensus supports the compatibility of Mesalazine and/or its prodrugs during breastfeeding. Sulfapyridine released in the large intestine is 60% absorbed with a protein-binding capacity of 90%, both being a reason for low excretion into breast milk. Mesalazine derivatives that not contain Sulfapyridine are recommended by some authors for use while breastfeeding (see alternative drugs).


See below the information of this related product:

Alternatives

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

サラゾスルファピリジン is Sulfasalazine in Japanese.

Is written in other languages:

サラゾスルファピリジン is also known as

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 15 %
Molecular weight 398 daltons
Protein Binding 99,3 %
VD 7,5 l/Kg
Tmax 6 hours
T1/2 7,6 hours
M/P ratio 0,1 - 0,2 -
Theoretical Dose 0,3 mg/Kg/d
Relative Dose 0,9 %
Relat.Ped.Dose 0,4 - 0,8 %

References

  1. Sammaritano LR, Bermas BL, Chakravarty EE, Chambers C, Clowse MEB, Lockshin MD, Marder W, Guyatt G, Branch DW, Buyon J, Christopher-Stine L, Crow-Hercher R, Cush J, Druzin M, Kavanaugh A, Laskin CA, Plante L, Salmon J, Simard J, Somers EC, Steen V, Tedeschi SK, et al. 2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases. Arthritis Rheumatol. 2020 Apr;72(4):529-556. Abstract
  2. Flint J, Panchal S, Hurrell A, van de Venne M, Gayed M, Schreiber K, Arthanari S, Cunningham J, Flanders L, Moore L, Crossley A, Purushotham N, Desai A, Piper M, Nisar M, Khamashta M, Williams D, Gordon C, Giles I; BSR and BHPR Standards, Guidelines and Audit Working Group. BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding-Part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 2016 Sep;55(9):1693-7. Abstract Full text (link to original source) Full text (in our servers)
  3. Götestam Skorpen C, Hoeltzenbein M, Tincani A, Fischer-Betz R, Elefant E, Chambers C, da Silva J, Nelson-Piercy C, Cetin I, Costedoat-Chalumeau N, Dolhain R, Förger F, Khamashta M, Ruiz-Irastorza G, Zink A, Vencovsky J, Cutolo M, Caeyers N, Zumbühl C, Østensen M. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016 May;75(5):795-810. Abstract Full text (link to original source) Full text (in our servers)
  4. Nguyen GC, Seow CH, Maxwell C, Huang V, Leung Y, Jones J, Leontiadis GI, Tse F, Mahadevan U, van der Woude CJ; IBD in Pregnancy Consensus Group. The Toronto Consensus Statements for the Management of Inflammatory Bowel Disease in Pregnancy. Gastroenterology. 2016 Abstract Full text (link to original source) Full text (in our servers)
  5. Huang VW, Chang HJ, Kroeker KI, Goodman KJ, Hegadoren KM, Dieleman LA, Fedorak RN. Management of Inflammatory Bowel Disease during Pregnancy and Breastfeeding Varies Widely: A Need for Further Education. Can J Gastroenterol Hepatol. 2016;2016:6193275. Epub 2016 Sep 20. Abstract Full text (link to original source) Full text (in our servers)
  6. McConnell RA, Mahadevan U. Pregnancy and the Patient with Inflammatory Bowel Disease: Fertility, Treatment, Delivery, and Complications. Gastroenterol Clin North Am. 2016 Abstract
  7. van der Woude CJ, Ardizzone S, Bengtson MB, Fiorino G, Fraser G, Katsanos K, Kolacek S, Juillerat P, Mulders AG, Pedersen N, Selinger C, Sebastian S, Sturm A, Zelinkova Z, Magro F; European Crohn’s and Colitis Organization. The second European evidenced-based consensus on reproduction and pregnancy in inflammatory bowel disease. J Crohns Colitis. 2015 Abstract Full text (link to original source) Full text (in our servers)
  8. Damas OM, Deshpande AR, Avalos DJ, Abreu MT. Treating Inflammatory Bowel Disease in Pregnancy: The Issues We Face Today. J Crohns Colitis. 2015 Oct;9(10):928-36. Abstract Full text (in our servers)
  9. Sammaritano LR, Bermas BL. Rheumatoid arthritis medications and lactation. Curr Opin Rheumatol. 2014 Abstract
  10. Nielsen OH, Maxwell C, Hendel J. IBD medications during pregnancy and lactation. Nat Rev Gastroenterol Hepatol. 2014 Feb;11(2):116-27. Abstract
  11. Hassid B, Mahadevan U. The use of biologic therapy in pregnancy: a gastroenterologist's perspective. Curr Opin Rheumatol. 2014 Abstract
  12. PDR. Sulfasalazine. Drug Summary. 2014 Full text (link to original source) Full text (in our servers)
  13. Huang VW, Habal FM. From conception to delivery: managing the pregnant inflammatory bowel disease patient. World J Gastroenterol. 2014 Abstract Full text (link to original source) Full text (in our servers)
  14. Schulze H, Esters P, Dignass A. Review article: the management of Crohn's disease and ulcerative colitis during pregnancy and lactation. Aliment Pharmacol Ther. 2014 Nov;40(9):991-1008. Abstract Full text (link to original source) Full text (in our servers)
  15. Nielsen OH, Maxwell C, Hendel J. IBD medications during pregnancy and lactation. Nat Rev Gastroenterol Hepatol. 2013 Abstract
  16. Yarur A, Kane SV. Update on pregnancy and breastfeeding in the era of biologics. Dig Liver Dis. 2013 Oct;45(10):787-94. Abstract Full text (link to original source) Full text (in our servers)
  17. Kierkuś J, Szymańska E, Szymańska S, Kamińska E. [Influence of inflammatory bowel disease on pregnancy and fertility - optimal treatment and management]. Med Wieku Rozwoj. 2013 Abstract
  18. Selinger CP, Leong RW, Lal S. Pregnancy related issues in inflammatory bowel disease: evidence base and patients' perspective. World J Gastroenterol. 2012 Abstract Full text (link to original source) Full text (in our servers)
  19. Habal FM, Huang VW. Review article: a decision-making algorithm for the management of pregnancy in the inflammatory bowel disease patient. Aliment Pharmacol Ther. 2012 Abstract Full text (link to original source) Full text (in our servers)
  20. Makol A, Wright K, Amin S. Rheumatoid arthritis and pregnancy: safety considerations in pharmacological management. Drugs. 2011 Abstract
  21. Jain V, Gordon C. Managing pregnancy in inflammatory rheumatological diseases. Arthritis Res Ther. 2011 Abstract
  22. Zrour-Hassen S, Jguirim M, Aouam K, Korbaa W, Younes M, Bejia I, Touzi M, Bergaoui N. [Safety of rheumatic disease drugs at childbearing age]. Therapie. 2010 Abstract
  23. van der Woude CJ, Kolacek S, Dotan I, Oresland T, Vermeire S, Munkholm P, Mahadevan U, Mackillop L, Dignass A; European Crohn's Colitis Organisation (ECCO). European evidenced-based consensus on reproduction in inflammatory bowel disease. J Crohns Colitis. 2010 Abstract Full text (link to original source) Full text (in our servers)
  24. Correia LM, Bonilha DQ, Ramos JD, Ambrogini O, Miszputen SJ. Inflammatory bowel disease and pregnancy: report of two cases treated with infliximab and a review of the literature. Eur J Gastroenterol Hepatol. 2010 Abstract
  25. Van Assche G, Dignass A, Reinisch W, van der Woude CJ, Sturm A, De Vos M, Guslandi M, Oldenburg B, Dotan I, Marteau P, Ardizzone A, Baumgart DC, D'Haens G, Gionchetti P, Portela F, Vucelic B, Söderholm J, Escher J, Koletzko S, Kolho KL, Lukas M, Mottet C, et al. The second European evidence-based Consensus on the diagnosis and management of Crohn's disease: Special situations. J Crohns Colitis. 2010 Abstract Full text (in our servers)
  26. Mottet C, Vader JP, Felley C, Froehlich F, Gonvers JJ, Juillerat P, Stockbrügger R, Angelucci E, Seibold F, Michetti P, Pittet V; EPACT II Study Group. Appropriate management of special situations in Crohn's disease (upper gastro-intestinal; extra-intestinal manifestations; drug safety during pregnancy and breastfeeding): Results of a multidisciplinary international expert panel-EPACT II. J Crohns Colitis. 2009 Abstract Full text (in our servers)
  27. Weber JC, Kuhnert C. Traitements de fond des affections inflammatoires systémiques au cours de l’allaitement. [Breastfeeding and drug management in connective tissue and rheumatic diseases]. Rev Med Interne. 2008 Abstract
  28. Weber JC, Kuhnert C. [Breastfeeding and drug management in connective tissue and rheumatic diseases]. Rev Med Interne. 2008 Abstract
  29. Østensen M, Motta M. Therapy insight: the use of antirheumatic drugs during nursing. Nat Clin Pract Rheumatol. 2007 Abstract
  30. Mottet C, Juillerat P, Pittet V, Gonvers JJ, Froehlich F, Vader JP, Michetti P, Felley C. Pregnancy and breastfeeding in patients with Crohn's disease. Digestion. 2007 Abstract
  31. Heetun ZS, Byrnes C, Neary P, O'Morain C. Review article: Reproduction in the patient with inflammatory bowel disease. Aliment Pharmacol Ther. 2007 Abstract Full text (link to original source) Full text (in our servers)
  32. Mahadevan U, Kane S. American gastroenterological association institute technical review on the use of gastrointestinal medications in pregnancy. Gastroenterology. 2006 Jul;131(1):283-311. Review. Abstract Full text (link to original source) Full text (in our servers)
  33. Østensen M, Khamashta M, Lockshin M, Parke A, Brucato A, Carp H, Doria A, Rai R, Meroni P, Cetin I, Derksen R, Branch W, Motta M, Gordon C, Ruiz-Irastorza G, Spinillo A, Friedman D, Cimaz R, Czeizel A, Piette JC, Cervera R, Levy RA, et al. Anti-inflammatory and immunosuppressive drugs and reproduction. Arthritis Res Ther. 2006 Abstract Full text (link to original source) Full text (in our servers)
  34. Silverman DA, Ford J, Shaw I, Probert CS. Is mesalazine really safe for use in breastfeeding mothers? Gut. 2005 Abstract Full text (link to original source) Full text (in our servers)
  35. Temprano KK, Bandlamudi R, Moore TL. Antirheumatic drugs in pregnancy and lactation. Semin Arthritis Rheum. 2005 Abstract
  36. Sánchez-Marín B, Grasa JM. Trombosis del seno longitudinal superior en un lactante: ¿secundaria a una exposición prolongada a mesalazina? [Thrombosis of the superior sagittal sinus in an infant: secondary to prolonged exposure to mesalazine?]. Rev Neurol. 2004 Jan 16-31;38(2):200. Spanish. (No abstract) Abstract
  37. Barriuso LM, Yoldi-Petri ME, Olaciregui O, Iceta-Lizarraga A, Goñi-Orayen C. Trombosis del seno longitudinal superior en un lactante: ¿secundaria a una exposición prolongada a mesalazina? [Thrombosis of the superior sagittal sinus in a breast fed infant: secondary to prolonged exposure to mesalazine?]. Rev Neurol. 2003 Jun 16-30;36(12):1142-4. Spanish. Abstract
  38. WHO / UNICEF. BREASTFEEDING AND MATERNAL MEDICATION Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs. Department of Child and Adolescent Health and Development (WHO/UNICEF) 2002 Full text (link to original source) Full text (in our servers)
  39. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Abstract Full text (link to original source) Full text (in our servers)
  40. Chin KG, McPherson CE 3rd, Hoffman M, Kuchta A, Mactal-Haaf C. Use of anti-infective agents during lactation: Part 2--Aminoglycosides, macrolides, quinolones, sulfonamides, trimethoprim, tetracyclines, chloramphenicol, clindamycin, and metronidazole. J Hum Lact. 2001 Feb;17(1):54-65. Abstract
  41. Janssen NM, Genta MS. The effects of immunosuppressive and anti-inflammatory medications on fertility, pregnancy, and lactation. Arch Intern Med. 2000 Abstract Full text (link to original source) Full text (in our servers)
  42. Moretti Myla Emily. Prospective follow-up of infants exposed to 5-aminosalicylic acid containing drugs through maternal milk. Thesis. Department of Pharmacology \ University of Toronto 1998 Full text (link to original source) Full text (in our servers)
  43. Gran JT, Ostensen M. Spondyloarthritides in females. Baillieres Clin Rheumatol. 1998 Abstract
  44. Connell WR. Safety of drug therapy for inflammatory bowel disease in pregnant and nursing women. Inflamm Bowel Dis. 1996 Abstract
  45. Burakoff R, Opper F. Pregnancy and nursing. Gastroenterol Clin North Am. 1995 Abstract
  46. Christensen LA, Rasmussen SN, Hansen SH. Disposition of 5-aminosalicylic acid and N-acetyl-5-aminosalicylic acid in fetal and maternal body fluids during treatment with different 5-aminosalicylic acid preparations. Acta Obstet Gynecol Scand. 1994 May;73(5):399-402. Abstract
  47. Miller LG, Hopkinson JM, Motil KJ, Corboy JE, Andersson S. Disposition of olsalazine and metabolites in breast milk. J Clin Pharmacol. 1993 Abstract
  48. Klotz U, Harings-Kaim A. Negligible excretion of 5-aminosalicylic acid in breast milk. Lancet. 1993 Abstract
  49. Ostensen M. Treatment with immunosuppressive and disease modifying drugs during pregnancy and lactation. Am J Reprod Immunol. 1992 Abstract
  50. Jenss H, Weber P, Hartmann F. 5-Aminosalicylic acid and its metabolite in breast milk during lactation. Am J Gastroenterol. 1990 Abstract
  51. Nelis GF. Diarrhoea due to 5-aminosalicylic acid in breast milk. Lancet. 1989 Abstract
  52. Goldsmith DP. Neonatal rheumatic disorders. View of the pediatrician. Rheum Dis Clin North Am. 1989 Abstract
  53. Esbjörner E, Järnerot G, Wranne L. Sulphasalazine and sulphapyridine serum levels in children to mothers treated with sulphasalazine during pregnancy and lactation. Acta Paediatr Scand. 1987 Abstract
  54. Ambrosius Christensen L, Rasmussen SN, Hansen SH, Bondesen S, Hvidberg EF. Salazosulfapyridine and metabolites in fetal and maternal body fluids with special reference to 5-aminosalicylic acid. Acta Obstet Gynecol Scand. 1987 Abstract
  55. Byron MA. Treatment of rheumatic diseases. Br Med J (Clin Res Ed). 1987 Abstract Full text (link to original source) Full text (in our servers)
  56. Branski D, Kerem E, Gross-Kieselstein E, Hurvitz H, Litt R, Abrahamov A. Bloody diarrhea--a possible complication of sulfasalazine transferred through human breast milk. J Pediatr Gastroenterol Nutr. 1986 Mar-Apr;5(2):316-7. Abstract
  57. Klotz U. Clinical pharmacokinetics of sulphasalazine, its metabolites and other prodrugs of 5-aminosalicylic acid. Clin Pharmacokinet. 1985 Abstract
  58. Berlin CM Jr, Yaffe SJ. Disposition of salicylazosulfapyridine (Azulfidine) and metabolites in human breast milk. Dev Pharmacol Ther. 1980 Abstract
  59. Järnerot G, Into-Malmberg MB. Sulphasalazine treatment during breast feeding. Scand J Gastroenterol. 1979 Abstract
  60. Khan AK, Truelove SC. Placental and mammary transfer of sulphasalazine. Br Med J. 1979 Abstract

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