Is Amoxicillin and Clavulanic Acid safe while breastfeeding?
Here is what NIH LactMed, the U.S. National Library of Medicine's authority on medicines and breastfeeding, reports about Amoxicillin and Clavulanic Acid. This is a summary of that source — not our own verdict.
Effects on the breastfed infant
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 the 14 mothers taking amoxicillin-clavulanate.[ 3 ] A prospective, controlled study asked mothers who called an information service about adverse reactions experience by their breastfed infants. Mothers were taking either amoxicillin or amoxicillin-clavulanic acid. Overall, adverse reactions in the infants were statistically more frequent in the amoxicillin-clavulanic acid group (22.3%) than in the amoxicillin group (7.5%) and the rate of adverse effects was dose-related. Amoxicillin-clavulanate reactions consisted of restlessness (8.9%), diarrhea (5.9%), rash (5.9%), and constipation (1.5%), although no single adverse effect was statistically more frequent than in the amoxicillin group. One infant whose mother was taking 1.5 g daily of amoxicillin-clavulanic acid developed mildly elevated liver enzymes (AST and ALT) during maternal therapy that returned to normal 10 days after discontinuation of the drug.[ 4 ] A 2-month-old infant breastfed since birth. His mother had taken many medications during pregnancy, but she did not recall their identity. She developed mastitis and was treated with amoxicillin-clavulanic acid 1 gram orally every 12 hours and gentamicin 160 mg intramuscularly once daily. The infant was breastfed for 10 minutes starting 15 minutes after the first dose of both drugs. About 20 minutes later, the infant developed a generalized urticaria which disappeared after 30 minutes. A few hours later, the infant breastfed again and the urticaria reappeared after 15 minutes and disappeared after an hour. After switching to formula feeding and no further infant exp
Effects on milk supply
Relevant published information was not found as of the revision date.
Levels in milk
Maternal Levels. After a single 1 gram oral dose of amoxicillin (without clavulanic acid) 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 amoxicillin-clavulanate dose of 500 mg 3 times daily. This amounts to 0.25 to 0.5% of a typical infant amoxicillin dosage. A study involving 25 breastfeeding mothers who had been taking amoxicillin (without clavulanic acid) for at least 2 days, with infants older than 4 weeks had 75 milk samples collected at multiple time points following amoxicillin administration. Pharmacokinetic modeling and Monte Carlo simulations were conducted to estimate the RID based on a maternal dosage of 4 grams daily as a worst-case scenario. The mean RID for amoxicillin was 0.055%, with a maximum value of 0.328% and a 47-fold difference between the highest and lowest RID.[ 2 ] Infant Levels. Relevant published information was not found as of the revision date.
Source: NIH LactMed (National Library of Medicine).
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.