Ceftobiprole medocaril Pregnancy and Breastfeeding Warnings

Brand names: Zevtera

Medically reviewed by Drugs.com. Last updated on May 12, 2025.

Ceftobiprole medocaril Pregnancy Warnings

According to some authorities: Use is not recommended unless clearly needed.

US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.
-Available data over several decades on the use of cephalosporins in pregnant women have not established drug-related risks; the absence of risk has not been definitely determined.

Animal studies have failed to reveal evidence of fetal harm; however, the abortion rate was slightly increased at maternotoxic doses. After IV administration to pregnant rats and pregnant cynomolgus monkeys during organogenesis, no adverse fetal developmental outcomes were observed at doses up to 360 mg/kg/day (about 1.4 times the maximum recommended human dose [MRHD] based on total body surface area [BSA]-normalized comparisons) and 120 mg/kg/day (about 0.9 times the MRHD based on BSA comparison), respectively. Slight decreases in maternal body weight gain and food intake were observed at 360 mg/kg/day (rats) and 120 mg/kg/day (monkeys); a slight increase in abortion rate (about 10% above historical controls) was associated with 120 mg/kg/day in monkeys. There are no controlled data in human pregnancy.

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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Ceftobiprole medocaril Breastfeeding Warnings

According to some experts, use is considered acceptable.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding for the child.

Excreted into human milk: Unknown
Excreted into animal milk: Yes (low levels)

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-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 adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
---The possibility of sensitization should be considered.
-No serious adverse effects have been reported for other cephalosporins during breastfeeding.
---Disruption of the infant's gastrointestinal flora (resulting in diarrhea or thrush) has been reported occasionally with cephalosporins; such effects have not been adequately evaluated and cannot be excluded with this drug.

See references

Further information

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