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<script type="text/javascript" src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.boots.min.js"> </script><title>Olsalazine - Drugs and Lactation Database (LactMed®) - NCBI Bookshelf</title>
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<meta name="citation_inbook_title" content="Drugs and Lactation Database (LactMed®) [Internet]">
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<meta name="citation_title" content="Olsalazine">
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<meta name="citation_publisher" content="National Institute of Child Health and Human Development">
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<meta name="citation_date" content="2024/09/15">
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<meta name="citation_keywords" content="Olsalazine">
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<meta name="citation_keywords" content="Olsalazina">
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<meta name="citation_keywords" content="Olsalazinum">
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<meta name="citation_keywords" content="Azodisal">
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<meta name="citation_keywords" content="Rasal">
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<meta name="citation_keywords" content="Dipentium">
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<meta name="citation_keywords" content="Olsalazinum [Latin5,5'-Azobis(salicylic acid)">
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<meta name="citation_keywords" content="UNII-ULS5I8J03O">
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<meta name="citation_keywords" content="ULS5I8J03O">
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<meta name="citation_keywords" content="Salicylic acid, 5,5'-azodi-">
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<meta name="citation_keywords" content="3,3'-Azobis(6-hydroxybenzoic acid)">
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<meta name="citation_keywords" content="Benzoic acid, 3,3'-azobis(6-hydroxy-">
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<meta name="citation_keywords" content="Benzoic acid, 3,3'-azobis(6-hydroxy-, disodium salt">
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<meta name="DC.Title" content="Olsalazine">
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<meta name="description" content="Limited data indicate that olsalazine is poorly excreted into breastmilk. However, olsalazine is a mesalamine prodrug. Rather high levels of the mesalamine metabolite N-acetyl-5-ASA appear in breastmilk and its effects on breastfed infants are unknown. A few cases of diarrhea have been reported in infants exposed to mesalamine, although the rate is not high. Most experts consider mesalamine derivatives to be acceptable during breastfeeding.[1-6] If olsalazine is required by the mother, it is not a reason to discontinue breastfeeding, but carefully observe breastfed infants for diarrhea during maternal use of olsalazine.">
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<meta name="og:description" content="Limited data indicate that olsalazine is poorly excreted into breastmilk. However, olsalazine is a mesalamine prodrug. Rather high levels of the mesalamine metabolite N-acetyl-5-ASA appear in breastmilk and its effects on breastfed infants are unknown. A few cases of diarrhea have been reported in infants exposed to mesalamine, although the rate is not high. Most experts consider mesalamine derivatives to be acceptable during breastfeeding.[1-6] If olsalazine is required by the mother, it is not a reason to discontinue breastfeeding, but carefully observe breastfed infants for diarrhea during maternal use of olsalazine.">
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class="wsprkl btn" title="Jump to next match">▶</a></nav></nav></div><div id="jr-epub-interstitial" class="hidden"></div><div id="jr-content"><article data-type="main"><div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><div class="fm-sec"><h1 id="_NBK501319_"><span class="title" itemprop="name">Olsalazine</span></h1><p class="fm-aai"><a href="#_NBK501319_pubdet_">Publication Details</a></p><p><em>Estimated reading time: 3 minutes</em></p></div></div><div class="jig-ncbiinpagenav body-content whole_rhythm" data-jigconfig="allHeadingLevels: ['h2'],smoothScroll: false" itemprop="text"><p>CASRN: 15722-48-2</p><a href="https://pubchem.ncbi.nlm.nih.gov/substance/135022900" title="View this structure in PubChem" class="img_link" ref="pagearea=body&targetsite=entrez&targetcat=link&targettype=pubchem"><img src="https://pubchem.ncbi.nlm.nih.gov/image/imgsrv.fcgi?t=l&sid=135022900" alt="image 135022900 in the ncbi pubchem database" /></a><div id="LM444.Drug_Levels_and_Effects"><h2 id="_LM444_Drug_Levels_and_Effects_">Drug Levels and Effects</h2><div id="LM444.Summary_of_Use_during_Lactation"><h3>Summary of Use during Lactation</h3><p>Limited data indicate that olsalazine is poorly excreted into breastmilk. However, olsalazine is a mesalamine prodrug. Rather high levels of the mesalamine metabolite N-acetyl-5-ASA appear in breastmilk and its effects on breastfed infants are unknown. A few cases of diarrhea have been reported in infants exposed to mesalamine, although the rate is not high. Most experts consider mesalamine derivatives to be acceptable during breastfeeding.[<a class="bibr" href="#LM444.REF.1" rid="LM444.REF.1">1</a>-<a class="bibr" href="#LM444.REF.6" rid="LM444.REF.6">6</a>] If olsalazine is required by the mother, it is not a reason to discontinue breastfeeding, but carefully observe breastfed infants for diarrhea during maternal use of olsalazine.</p></div><div id="LM444.Drug_Levels"><h3>Drug Levels</h3><p>Olsalazine is a prodrug that liberates the active drug, mesalamine (5-aminosalicylic acid; 5-ASA), in the gastrointestinal tract. Mesalamine is metabolized to N-acetyl-5-ASA, which is inactive in treating inflammatory bowel disease, but its possible effects on the breastfed infant are unknown.</p><p><i>Maternal Levels.</i> A lactating woman with a long history of Crohn's disease and 2 bowel resections at her terminal ileum was given a single oral dose of olsalazine 500 mg at 4 months postpartum. She was also taking prednisone 17.5 mg daily at the time of the study. Milk samples were taken periodically from 30 minutes to 48 hours after the dose. Olsalazine and its metabolites, olsalazine sulfate and mesalamine were undetectable (<170 mcg/L) in milk at all times during the study. The inactive mesalamine metabolite, N-acetyl-5-ASA, was detectable only at 10, 14 and 24 hours after the dose in concentrations of 170, 183 and 264 mcg/L, respectively.[<a class="bibr" href="#LM444.REF.7" rid="LM444.REF.7">7</a>]</p><p>A woman taking olsalazine capsules 750 mg twice daily collected 5 breastmilk samples over one day at 2 to 4 weeks postpartum. Mesalamine was undetectable (<20 mcg/L) in milk. N-acetyl-5-ASA averaged 2.3 mg/L (range 1.2 to 3.8 mg/L) in the 5 samples. The highest milk level was in the 6 pm sample, but the times of the doses were not stated.[<a class="bibr" href="#LM444.REF.8" rid="LM444.REF.8">8</a>]</p><p><i>Infant Levels.</i> Relevant published information was not found as of the revision date.</p></div><div id="LM444.Effects_in_Breastfed_Infants"><h3>Effects in Breastfed Infants</h3><p>One infant was breastfed during maternal therapy with olsalazine for Crohn's disease. After 2 and 3 weeks of therapy, no rash, wheezing, vomiting or diarrhea were noted in the infant.[<a class="bibr" href="#LM444.REF.7" rid="LM444.REF.7">7</a>]</p><p>The active metabolite of olsalazine, mesalamine, was probably responsible for diarrhea in a 6-week-old whose diarrhea recurred 4 times after rechallenging the mother 4 times during breastfeeding.[<a class="bibr" href="#LM444.REF.9" rid="LM444.REF.9">9</a>]</p><p>In a prospective telephone follow-up study, 8 nursing mothers reported taking mesalamine (dosage and route unspecified). One mother reported diarrhea in her infant. No other adverse reactions were reported in the infants by their mothers.[<a class="bibr" href="#LM444.REF.10" rid="LM444.REF.10">10</a>]</p><p>A case-control study compared the infants of mothers taking mesalamine (n = 117; average dose, 2065 mg daily), olsalazine (n = 2) or sulfasalazine (n = 2) to infants of matched control mothers (n = 121) who were exposed to no treatment known to be harmful to a breastfed infant. Infants were exposed to mesalamine through milk for a mean of 5.3 months (range: 3 days-24 months). Infants were breastfed for an average of about 7.4 months and were followed up at an average age of about 22 months. No difference in the frequency or characteristics of maternally reported adverse events were found between exposed and control infants.[<a class="bibr" href="#LM444.REF.11" rid="LM444.REF.11">11</a>,<a class="bibr" href="#LM444.REF.12" rid="LM444.REF.12">12</a>]</p></div><div id="LM444.Effects_on_Lactation_and_Breastmil"><h3>Effects on Lactation and Breastmilk</h3><p>Relevant published information was not found as of the revision date.</p></div><div id="LM444.Alternate_Drugs_to_Consider"><h3>Alternate Drugs to Consider</h3><p>(Inflammatory Bowel Disease) <a href="/books/n/lactmed/LM513/?report=reader">Adalimumab</a>, <a href="/books/n/lactmed/LM20/?report=reader">Azathioprine</a>, <a href="/books/n/lactmed/LM35/?report=reader">Budesonide</a>, <a href="/books/n/lactmed/LM752/?report=reader">Certolizumab Pegol</a>, <a href="/books/n/lactmed/LM476/?report=reader">Infliximab</a>, <a href="/books/n/lactmed/LM443/?report=reader">Mesalamine</a>, <a href="/books/n/lactmed/LM224/?report=reader">Prednisone</a>, <a href="/books/n/lactmed/LM442/?report=reader">Sulfasalazine</a></p></div><div id="LM444.References"><h3>References</h3><dl class="temp-labeled-list"><dl class="bkr_refwrap"><dt>1.</dt><dd><div class="bk_ref" id="LM444.REF.1">Nielsen
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OH, Maxwell
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C, Hendel
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J. IBD medications during pregnancy and lactation.
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Nat Rev Gastroenterol Hepatol
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2014;11:116-27.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/23897285" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 23897285</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>2.</dt><dd><div class="bk_ref" id="LM444.REF.2">Mahadevan
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U, Matro
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R. Care of the pregnant patient with inflammatory bowel disease.
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Obstet Gynecol
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2015;126:401-12.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/26241432" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26241432</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>3.</dt><dd><div class="bk_ref" id="LM444.REF.3">Nguyen
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GC, Seow
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CH, Maxwell
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C, et al.
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The Toronto Consensus Statements for the Management of IBD in Pregnancy.
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Gastroenterology
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2016;150:734-57.e1.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/26688268" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26688268</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>4.</dt><dd><div class="bk_ref" id="LM444.REF.4">van der Woude
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CJ, Ardizzone
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S, Bengtson
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MB, et al.
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The second European evidenced-based consensus on reproduction and pregnancy in inflammatory bowel disease.
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J Crohns Colitis
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2015;9:107-24.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/25602023" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25602023</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>5.</dt><dd><div class="bk_ref" id="LM444.REF.5">Torres
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J, Chaparro
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M, Julsgaard
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M, et al.
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European Crohn's and Colitis Guidelines on Sexuality, Fertility, Pregnancy, and Lactation.
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J Crohns Colitis
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2023;17:1-27.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/36005814" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 36005814</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>6.</dt><dd><div class="bk_ref" id="LM444.REF.6">Russell
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MD, Dey
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M, Flint
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J, et al.
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British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: Immunomodulatory anti-rheumatic drugs and corticosteroids.
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Rheumatology (Oxford)
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2023;62:e48-e88.
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[<a href="/pmc/articles/PMC10070073/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC10070073</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/36318966" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 36318966</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>7.</dt><dd><div class="bk_ref" id="LM444.REF.7">Miller
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LG, Hopkinson
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JM, Motil
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KJ, et al.
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Disposition of olsalazine and metabolites in breast milk.
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J Clin Pharmacol
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1993;33:703-6.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/8408729" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 8408729</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>8.</dt><dd><div class="bk_ref" id="LM444.REF.8">Ambrosius Christensen
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L., Rasmussen
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SN, Hansen
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SH, et al.
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Salazosulfapyridine and metabolites in fetal and maternal body fluids with special reference to 5-aminosalicylic acid.
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Acta Obstet Gynecol Scand
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1987;66:433-5.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/2892343" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 2892343</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>9.</dt><dd><div class="bk_ref" id="LM444.REF.9">Nelis
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GF. Diarrhoea due to 5-aminosalicylic acid in breast milk.
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Lancet
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1989;333:383.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/2563532" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 2563532</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>10.</dt><dd><div class="bk_ref" id="LM444.REF.10">Ito
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S, Blajchman
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A, Stephenson
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M, et al.
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Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication.
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Am J Obstet Gynecol
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1993;168:1393-9.
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[<a href="https://pubmed.ncbi.nlm.nih.gov/8498418" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 8498418</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>11.</dt><dd><div class="bk_ref" id="LM444.REF.11">Moretti
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ME, Spiczynski
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Y, Hashemi
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G, et al.
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Prospective follow-up of infants exposed to 5-aminosalicylic acid containing drugs through maternal milk.
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J Clin Pharmacol
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1998;38:867. doi:10.1177/009127009803800901 [<a href="http://dx.crossref.org/10.1177/009127009803800901" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">CrossRef</a>]</div></dd></dl><dl class="bkr_refwrap"><dt>12.</dt><dd><div class="bk_ref" id="LM444.REF.12">Moretti ME. Prospective follow-up of infants exposed to 5-aminosalicylic acid containing drugs through maternal milk. Theses Canada 1998. <a href="https://library-archives.canada.ca/eng/services/services-libraries/theses/Pages/item.aspx?idNumber=51446896" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https:<wbr style="display:inline-block"></wbr>​//library-archives<wbr style="display:inline-block"></wbr>​.canada.ca/eng/services<wbr style="display:inline-block"></wbr>​/services-libraries<wbr style="display:inline-block"></wbr>​/theses/Pages/item<wbr style="display:inline-block"></wbr>​.aspx?idNumber=51446896</a></div></dd></dl></dl></div></div><div id="LM444.Substance_Identification"><h2 id="_LM444_Substance_Identification_">Substance Identification</h2><div id="LM444.Substance_Name"><h3>Substance Name</h3><p>Olsalazine</p></div><div id="LM444.CAS_Registry_Number"><h3>CAS Registry Number</h3><p>15722-48-2</p></div><div id="LM444.Drug_Class"><h3>Drug Class</h3><p>Breast Feeding</p><p>Lactation</p><p>Milk, Human</p><p>Gastrointestinal Agents</p><p>Anti-Inflammatory Agents, Non-Steroidal</p></div></div><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_top_margin"><p><b>Disclaimer: </b>Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.</p></p></div></dd></dl></dl></div><div id="bk_toc_contnr"></div></div></div><div class="fm-sec"><h2 id="_NBK501319_pubdet_">Publication Details</h2><h3>Publication History</h3><p class="small">Last Revision: <span itemprop="dateModified">September 15, 2024</span>.</p><h3>Copyright</h3><div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright Notice</a><p class="small"><b>Attribution Statement:</b> LactMed is a registered trademark of the U.S. Department of Health and Human Services.</p></div></div><h3>Publisher</h3><p><a href="https://www.nlm.nih.gov/" ref="pagearea=page-banner&targetsite=external&targetcat=link&targettype=publisher">National Institute of Child Health and Human Development</a>, Bethesda (MD)</p><h3>NLM Citation</h3><p>Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-. Olsalazine. [Updated 2024 Sep 15].<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/lactmed/LM627/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M75,30 c-80,60 -80,0 0,60 c-30,-60 -30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Prev</text></svg></a></div><div class="small-screen-next"><a href="/books/n/lactmed/olutasidenib/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M25,30c80,60 80,0 0,60 c30,-60 30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Next</text></svg></a></div></article></div><div id="jr-scripts"><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/libs.min.js"> </script><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.min.js"> </script></div></div>
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