Olsalazine
Prodrug of Mesalazine: Medication compounded by union of two molecules of 5-ASA resulting in a dimer which is degraded into monomeric Mesalazine (5-ASA) in the large intestine.
Mesalazine is badly absorbed by the intestine, serum levels are low with scant excretion into breast milk. Traces of Olsalazine and/or Mesalazine have not been found in breast milk of treated mothers with Olsalazine. N-acetyl-5-ASA is an inactive metabolite which is excreted into breast milk but not higher than 1% of relative infant's dose.
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 Olsalazine. 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 Olsalazine since it is relatively safe.
Very Low Risk
Compatible. Not risky for breastfeeding or infant.
Low Risk
Moderately safe. Mild risk possible. Follow up recommended. Read the Comment.
High Risk
Poorly safe. Evaluate carefully. Use a safer alternative. Read the Comment.
Very High Risk
Not recommended. Cessation of breastfeeding or alternative.
Synonyms
- Olsalazine Sodium
Writings
- Натрий Ольсалазин (Cyrillic)
- オルサラジンナトリウム (Japanese)
Drug trade names
References
- McConnell RA, Mahadevan U. Pregnancy and the Patient with Inflammatory Bowel Disease: Fertility, Treatment, Delivery, and Complications. Gastroenterol Clin North Am. 2016Abstract
- Kierkuś J, Szymańska E, Szymańska S, Kamińska E. [Influence of inflammatory bowel disease on pregnancy and fertility - optimal treatment and management]. Med Wieku Rozwoj. 2013Abstract
- 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. 2010Abstract Full text (link to original source) Full text (in our servers)
- Dignass AU, Hartmann F, Sturm A, Stein J. Management of inflammatory bowel diseases during pregnancy. Dig Dis. 2009Abstract
- 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. 2009Abstract Full text (in our servers)
- 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. 2007Abstract
- Mahadevan U, Kane S. American gastroenterological association institute technical review on the use of gastrointestinal medications in pregnancy. Gastroenterology. 2006Abstract Full text (link to original source) Full text (in our servers)
- Silverman DA, Ford J, Shaw I, Probert CS. Is mesalazine really safe for use in breastfeeding mothers? Gut. 2005Abstract Full text (link to original source) Full text (in our servers)
- 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)
- 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. 2003Abstract
- Friedman S. Management of inflammatory bowel disease during pregnancy and nursing. Semin Gastrointest Dis. 2001Abstract
- 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)
- Connell WR. Safety of drug therapy for inflammatory bowel disease in pregnant and nursing women. Inflamm Bowel Dis. 1996Abstract
- 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. 1994Abstract
- Miller LG, Hopkinson JM, Motil KJ, Corboy JE, Andersson S. Disposition of olsalazine and metabolites in breast milk. J Clin Pharmacol. 1993Abstract
- Klotz U, Harings-Kaim A. Negligible excretion of 5-aminosalicylic acid in breast milk. Lancet. 1993Abstract
- 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. 1993Abstract
- Jenss H, Weber P, Hartmann F. 5-Aminosalicylic acid and its metabolite in breast milk during lactation. Am J Gastroenterol. 1990Abstract
- Nelis GF. Diarrhoea due to 5-aminosalicylic acid in breast milk. Lancet. 1989Abstract
- 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. 1987Abstract
- Klotz U. Clinical pharmacokinetics of sulphasalazine, its metabolites and other prodrugs of 5-aminosalicylic acid. Clin Pharmacokinet. 1985Abstract