Cefotetan Pregnancy and Breastfeeding Warnings

Brand names: Cefotan

Medically reviewed by Drugs.com. Last updated on Aug 2, 2023.

Cefotetan Pregnancy Warnings

Cefotetan has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Cefotetan should only be given during pregnancy when need has been clearly established.

There are no reports of congenital defects associated with cefotetan. Japanese data have shown that cefotetan crosses the human placenta. In one study, 20 pregnant women were given cefotetan 1 gram intravenously between one and four hours prior to Cesarean section.

The highest umbilical cord and amniotic fluid drug levels were in the patients who had received cefotetan four hours before surgery, averaging 12.5 and 8.1 mcg per mL, respectively. Other Japanese studies have shown cord and amniotic fluid levels double these values, or 24.7 and 20.0 mcg per mL, respectively, one hour after a 1 gram intravenous dose of cefotetan.

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Cefotetan Breastfeeding Warnings

Cefotetan is excreted into human milk in small amounts. Adverse effects in the nursing infant are unlikely. Other cephalosporins have been classified as compatible with breast-feeding by the American Academy of Pediatrics.

The average milk to maternal serum ratio from one study of six lactating women was 0.05 10 hours after the first dose and 0.07 10 hours after the fifth dose of cefotetan 1 gram intravenously every 12 hours. The milk drug levels ranged from 0.29 to 0.59 mcg per mL 4 to 10 hours after a dose. These amounts represent a miniscule amount of drug to the nursing infant, such that adverse effects are unlikely.

While cefotetan is poorly absorbed from the gastrointestinal tract of adults, its oral bioavailability in neonates is not known. Some experts warn of the unknown direct effects on the nursing infant, modification of neonatal bowel flora, and interference with the interpretation of culture results in the case of an evaluation of a suspected infection.

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Further information

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