This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Animal studies have revealed evidence of slightly decreased fetal weight and effects on vertebral ossification. While no maternal or embryofetal effects were observed in pregnant rats administered IV doses up to 700 mg/kg/day (about 1.2 times the maximum recommended human dose [MRHD] based on AUC) during organogenesis, slight decreases in average fetal weight and an associated decrease in the average number of ossified sacrocaudal vertebrae were observed in pregnant mice administered IV doses up to 700 mg/kg/day (about 3 times the MRHD based on body surface area comparison) during organogenesis. This drug crossed the placental barrier in rats. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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At 5 to 14 days postpartum, 5 women received 1 g IV once a day for 3 to 10 days for acute pelvic infections. Samples of breast milk were collected before the first dose, twice during the 24 hours after the last dose, and each morning for 2 to 5 days after the last dose. Milk levels ranged from less than 0.125 (lower limit of quantitation) to 0.38 mcg/mL within 24 hours of the last dose and were less than 0.125 mcg/mL by the third (4 women) and fifth (1 woman) days after the last dose.

LactMed and other experts: Use is considered acceptable.
-According to some authorities: Breastfeeding is not recommended during use of this drug.
-According to some authorities: This drug should not be used unless the benefit to the mother outweighs the risk to the infant.

Excreted into human milk: Yes (in small amounts)

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-According to limited data, low levels in milk are not expected to cause harmful effects in the nursing infant.
-Disruption of infant's gastrointestinal flora (resulting in diarrhea or thrush) reported occasionally with beta-lactams, but such effects have not been adequately evaluated.

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