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The safety of using omeprazole has not been established in pregnant or breastfeeding women.<ref name=Dav2015>{{cite book|title=Davis's Drug Guide for Nurses| vauthors = Vallerand AH, Sanoski CA, Deglin JH |publisher=F.A. Davis Company|year=2015|isbn=978-0-8036-4085-6|edition=14th|pages=924–925|oclc=881473728}}</ref> Epidemiological data do not show an increased risk of major birth defects after maternal use of omeprazole during [[pregnancy]].<ref>{{cite journal | vauthors = Pasternak B, Hviid A | title = Use of proton-pump inhibitors in early pregnancy and the risk of birth defects | journal = The New England Journal of Medicine | volume = 363 | issue = 22 | pages = 2114–2123 | date = November 2010 | pmid = 21105793 | doi = 10.1056/NEJMoa1002689 | s2cid = 10954538 | doi-access = free }}</ref>
 
NoAs of September, 2023, there exist no known [[clinical studies|clinical trials]] that have deeplythoroughly evaluated the potential consequences of the use of omeprazole inwhile [[breastfeeding]]. However, the [[pharmacodynamics]] and [[pharmacokinetics]] of the omeprazole molecule strongly suggest the safety of omeprazoleits use duringwhen breastfeeding:
* Omeprazole has a high [[plasma protein binding]] rate (95%),<ref>{{cite web |url=http://www.pdr.net/drug-summary/prilosec-delayed-release-capsules-and-oral-suspension?druglabelid=1123 |title=Omeprazole drug summary |publisher=PDR.net |access-date=21 October 2018 |url-status=live |archive-url=https://web.archive.org/web/20140303163837/http://www.pdr.net/drug-summary/prilosec-delayed-release-capsules-and-oral-suspension?druglabelid=1123 |archive-date=3 March 2014}}</ref> indicating that a littlesmall amountfraction (i.e. &lt;5%) of the drug ismay be transferred to the [[milk duct]] during [[breast milk]] formation and hence, indirectly to the infant while nursing.
* Omeprazole needs to be administered inas an [[Enteric coating|enteric-coated]] formulation due to its rapid degradation in the acidic conditions of the stomach. This suggests that most of the free molecules ingested by the infant are likely degraded before being absorbed.{{citation needed|date=March 2016}}
 
OmeprazoleConsidering the directly aforementioned points, at normalnormally prescribed doses or when taken as directed if used over-the-counter, omeprazole is likely to be safe duringfor use while breastfeeding.<ref>{{cite web |title=LACTMED: OMEPRAZOLE |url=http://toxnet.nlm.nih.gov/cgi-bin/sis/search2/r?dbs+lactmed:@term+@rel+@rn+73590-58-6 |access-date=21 October 2018 |date=10 March 2015 |url-status=live |archive-url=https://web.archive.org/web/20170908170635/https://toxnet.nlm.nih.gov/cgi-bin/sis/search2/r?dbs+lactmed%253A%2540term+%2540rel+%2540rn+73590-58-6 |archive-date=8 September 2017}}</ref>
 
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