Amoxicillin

Drug Levels and Effects:




Summary of Use during Lactation:


Amoxicillin is acceptable to use during breastfeeding. Limited information indicates that single maternal doses of amoxicillin 1 gram produce low levels in milk that are not expected to cause adverse effects in breastfed infants. Occasionally, rash and disruption of the infant's gastrointestinal flora, resulting in diarrhea or thrush, have been reported, but these effects have not been adequately evaluated.


Drug Levels:


Maternal Levels.

After a single 1 gram oral dose of amoxicillin in 6 women, peak milk amoxicillin levels occurred 4 to 5 hours after the dose. Average milk levels were 0.69 mg/L (range 0.46 to 0.88 mg/L) at 4 hours and 0.81 mg/L (range 0.39 to 1.3 mg/L) at 5 hours after the dose.[1] Using these data, an exclusively breastfed infant would be expected to receive a maximum of about 0.1 mg/kg daily of amoxicillin with a maternal dose of 500 mg 3 times daily. This amounts to 0.25 to 0.5% of a typical infant amoxicillin dosage.

Infant Levels.

Relevant published information was not found as of the revision date.


Effects in Breastfed Infants:


In a telephone follow-up study, 25 nursing mothers reported taking amoxicillin (dosage unspecified). Three mothers reported diarrhea in their infants. No rashes or candidiasis were reported among the exposed infants.[2]

In contrast, a small, controlled, prospective study had mothers monitor their infants for signs of adverse effects (furring of the tongue, feeding difficulties, changes in stool frequency and consistency, diaper rash, and skin rash). Weight change and the development of jaundice were also recorded. No statistical differences in these parameters were found between the infants of the control mothers and those of mothers taking the related antibiotics, ampicillin or ampicillin-clavulanate.[3]

A prospective, controlled study asked mothers who called an information service about adverse reactions experienced by their breastfed infants. Of 40 infants exposed to amoxicillin in breastmilk, 2 developed diarrhea and 1 developed a rash.[4]

A study compared the breastfed infants of mothers taking amoxicillin to those taking a macrolide antibiotic. Adverse reactions occurred in 8.3% of the infants exposed to amoxicillin which was similar to the rate in macrolide-exposed infants. Reactions included rash and somnolence.[5]


Possible Effects on Lactation:


Relevant published information was not found as of the revision date.


References:


1. Kafetzis DA, Siafas CA, Georgakopoulos PA et al. Passage of cephalosporins and amoxicillin into the breast milk. Acta Paediatr Scand. 1981;70:285-8. PMID:7246123
2. Ito S, Blajchman A, Stephenson M et al. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168:1393-9. PMID:8498418
3. Campbell AC, McElnay JC, Passmore CM. The excretion of ampicillin in breast milk and its effect on the suckling infant. Br J Clin Pharmacol. 1991;31:230p. Abstract.
4. Benyamini L, Merlob P, Stahl B et al. The safety of amoxicillin/clavulanic acid and cefuroxime during lactation. Ther Drug Monit. 2005;27:499-502. PMID:16044108
5. Goldstein LH, Berlin M, Tsur L et al. The safety of macrolides during lactation. Breastfeed Med. 2009;4:197-200. PMID:19366316



Substance Identification:




Substance Name:

Amoxicillin

CAS Registry Number:

26787-78-0

Drug Class:


  • Antiinfective Agents

  • Antibacterial Agents

  • Penicillins


  • Administrative Information:




    LactMed Record Number:


    13


    Last Revision Date:


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