Last update: Dec. 7, 2016

Balsalazide

Very Low Risk for breastfeeding


Safe. Compatible.
Minimal risk for breastfeeding and infant.

Prodrug of Mesalamine: medication compounded by Mesalazine and an inert transporter that is degraded by bacteria into Mesalazine (5-ASA) in the large intestine.

It is badly absorbed by the intestine, serum levels are low with scant excretion into breast milk. 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 Mesalazine compounds different to Balsalazide. 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.

Alternatives

We do not have alternatives for Balsalazide since it is relatively safe.

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

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Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.
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Other names

Balsalazide is also known as


Balsalazide in other languages or writings:

Group

Balsalazide belongs to this group or family:

Tradenames

Main tradenames from several countries containing Balsalazide in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 1 %
Molecular weight 437 daltons
Protein Binding 99 %
Tmax 1 - 2 hours
T1/2 1,9 hours

References

  1. McConnell RA, Mahadevan U. Pregnancy and the Patient with Inflammatory Bowel Disease: Fertility, Treatment, Delivery, and Complications. Gastroenterol Clin North Am. 2016 Abstract
  2. 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
  3. 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)
  4. 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)
  5. Quiros JA, Heyman MB, Pohl JF, Attard TM, Pieniaszek HJ, Bortey E, Walker K, Forbes WP. Safety, efficacy, and pharmacokinetics of balsalazide in pediatric patients with mild-to-moderate active ulcerative colitis: results of a randomized, double-blind study. J Pediatr Gastroenterol Nutr. 2009 Abstract
  6. Dignass AU, Hartmann F, Sturm A, Stein J. Management of inflammatory bowel diseases during pregnancy. Dig Dis. 2009 Abstract
  7. 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)
  8. 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
  9. 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)
  10. 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)
  11. Kanenguiser P, Goyheneche B, Filinger E. Aminosalicilatos: Características de las Formulaciones Orales Utilizadas en el Tratamiento de la Enfermedad Inflamatoria Intestinal. Lat. Am. J. Pharm. 22 (3): 255-60 2003 Full text (link to original source) Full text (in our servers)
  12. 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
  13. Friedman S. Management of inflammatory bowel disease during pregnancy and nursing. Semin Gastrointest Dis. 2001 Abstract
  14. 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)
  15. Prakash A, Spencer CM. Balsalazide. Drugs. 1998 Abstract
  16. Connell WR. Safety of drug therapy for inflammatory bowel disease in pregnant and nursing women. Inflamm Bowel Dis. 1996 Abstract
  17. 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
  18. Ito S, Blajchman A, Stephenson M, Eliopoulos C, Koren G. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993 May;168(5):1393-9. Abstract
  19. Miller LG, Hopkinson JM, Motil KJ, Corboy JE, Andersson S. Disposition of olsalazine and metabolites in breast milk. J Clin Pharmacol. 1993 Abstract
  20. Klotz U, Harings-Kaim A. Negligible excretion of 5-aminosalicylic acid in breast milk. Lancet. 1993 Abstract
  21. Jenss H, Weber P, Hartmann F. 5-Aminosalicylic acid and its metabolite in breast milk during lactation. Am J Gastroenterol. 1990 Abstract
  22. Nelis GF. Diarrhoea due to 5-aminosalicylic acid in breast milk. Lancet. 1989 Abstract
  23. Christensen LA, Jacobsen BA. 5-Aminosalicylic acid derivatives. Clinical and pharmaceutical evaluation. Neth J Med. 1989 Abstract
  24. 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
  25. Klotz U. Clinical pharmacokinetics of sulphasalazine, its metabolites and other prodrugs of 5-aminosalicylic acid. Clin Pharmacokinet. 1985 Abstract

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