Amoxicillin Pregnancy and Breastfeeding Warnings
Amoxicillin Pregnancy Warnings
Amoxicillin has been assigned to pregnancy category B by the FDA. Animal studies using 10 times the human dose have failed to reveal any evidence of teratogenicity. Although no controlled data in human pregnancy are available, literature reports of adverse fetal effects are lacking. Amoxicillin is only recommended during pregnancy when benefit outweighs risk.
In the Collaborative Perinatal Project involving 50,282 mother-child pairs, there were 3,546 mother-child pairs exposed to penicillin derivatives in the first trimester. As a group, there was no significant increase in the risk of malformations. In the Michigan Medicaid Birth Defects Study involving 229,101 pregnancies from 1985 to 1992, there were 8,538 first trimester exposures to amoxicillin. Overall, 317 cases of birth defects were observed (363 expected). There was no evidence of an association between first trimester use of amoxicillin and major groups of malformations. A Danish study of 401 women exposed to amoxicillin during pregnancy from 1991 to 2000 did not find an increased risk of birth defects or adverse outcomes compared to women who had taken no medication. Transient decreases in total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol plasma concentrations have been reported in pregnant women who received ampicillin and this may also occur with amoxicillin.
Amoxicillin Breastfeeding Warnings
In one study, six women were administered a single 1000 mg dose of amoxicillin on the third postpartum day. Amoxicillin milk concentrations ranged from 0.10 to 0.81 mcg/mL, with a peak concentration measured at 5 hours post-dose. The milk to maternal serum concentration ratio ranged from 0.013 to 0.043.
Amoxicillin is excreted into human milk in small amounts. Sensitization of the infant may occur. The American Academy of Pediatrics considers the use of amoxicillin to be compatible with breast-feeding. The manufacturer recommends that caution be used when administering amoxicillin to nursing women.
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