Last update July 3, 2025

A07EC03

Compatible

Safe product and/or breastfeeding is the best option.

Mesalazine prodrug: a drug composed of two 5-ASA molecules joined together to form a dimer that is broken down by colon bacteria, releasing mesalazine (5-ASA) there. Administered orally two to three times a day.

No levels of olsalazine or mesalamine were found in the milk of mothers who took olsalazine (Miller 1993, Ambrosius 1987). An inactive metabolite, N-acetyl-5-ASA, was found in milk in small amounts not exceeding 1% of the relative dose. (Miller 1993)

An infant whose mother took olsalazine did not present any clinical problems. (Miller 1993)

Mesalazine is known for its low intestinal absorption, negligible excretion in breast milk, and absence of side effects in infants (Moretti 1998), except for some isolated cases of diarrhoea. (Ito 1993, Nelis 1989)

There is consensus among experts that mesalazine or its prodrugs are compatible with breastfeeding. (Torres 2023, Russell 2023, Nguyen 2016, McConnell 2016, Mahadevan 2015, van der Woude 2015, Nielsen 2014)


See below the information of these related products:

Alternatives

We do not have alternatives for A07EC03 since it is relatively safe.

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

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

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Other names

A07EC03 is Olsalazine Sodium in ATC Code/s.

Is written in other languages:

Group

A07EC03 belongs to this group or family:

Tradenames

Main tradenames from several countries containing A07EC03 in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 2.4 - 5 %
Molecular weight 346 daltons
Protein Binding 99 %
VD 0.07 l/Kg
pKa 2.93 -
Tmax 1 hours
T½ 0.9 hours
Theoretical Dose 0.06 mg/Kg/d
Relative Dose 0.4 %

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. 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)
  3. 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 (link to original source) Full text (in our servers)
  4. Dignass AU, Hartmann F, Sturm A, Stein J. Management of inflammatory bowel diseases during pregnancy. Dig Dis. 2009 Abstract
  5. 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
  6. 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)
  7. 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)
  8. 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)
  9. 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
  10. 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 Abstract Full text (link to original source) Full text (in our servers)
  11. Connell WR. Safety of drug therapy for inflammatory bowel disease in pregnant and nursing women. Inflamm Bowel Dis. 1996 Abstract
  12. 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
  13. Miller LG, Hopkinson JM, Motil KJ, Corboy JE, Andersson S. Disposition of olsalazine and metabolites in breast milk. J Clin Pharmacol. 1993 Abstract
  14. 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
  15. Klotz U, Harings-Kaim A. Negligible excretion of 5-aminosalicylic acid in breast milk. Lancet. 1993 Abstract
  16. Jenss H, Weber P, Hartmann F. 5-Aminosalicylic acid and its metabolite in breast milk during lactation. Am J Gastroenterol. 1990 Abstract
  17. Nelis GF. Diarrhoea due to 5-aminosalicylic acid in breast milk. Lancet. 1989 Abstract
  18. 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
  19. Klotz U. Clinical pharmacokinetics of sulphasalazine, its metabolites and other prodrugs of 5-aminosalicylic acid. Clin Pharmacokinet. 1985 Abstract

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