Summary of Use during Lactation

Limited information indicates that ertapenem produces low levels in milk that are not expected to cause adverse effects in breastfed infants. Occasionally disruption of the infant's gastrointestinal flora, resulting in diarrhea or thrush has been reported with beta-lactams, but these effects have not been adequately evaluated. Ertapenem is acceptable in nursing mothers.

Drug Levels

Maternal Levels. Five women who were 5 to 14 days postpartum received ertapenem 1 gram daily for 3 to 10 days for acute pelvic infections. Breastmilk samples were obtained before the first dose and twice during the 24 hours after the last dose as well as daily in the morning for 2 to 5 days after the last dose. Milk concentrations during the first 24 hours of the last dose ranged from <0.125 mg/L to 0.38 mg/L. Milk concentration was <0.125 mg/L by day 3 in 4 of the women and after 5 days in the 5th.[1]

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

Effects in Breastfed Infants

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

Effects on Lactation and Breastmilk

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

References

1.

Research FDA Center for Drug Evaluation and. NDA 21-337. Clinical pharmacology and biopharmaceutics reviews. 2008:37-40. Accessed 09/19/2008. http://www​.fda.gov/cder​/foi/nda/2001/21337_Invanz_biopharmr​.pdf.

Substance Name

Ertapenem

CAS Registry Number

153832-46-3

Drug Class

Breast Feeding

Lactation

Milk, Human

Anti-Infective Agents

Antibacterial Agents

Carbapenems