Durlobactam / sulbactam Pregnancy and Breastfeeding Warnings

Brand names: Xacduro

Medically reviewed by Drugs.com. Last updated on Dec 21, 2023.

Durlobactam / sulbactam Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy

AU TGA pregnancy category: Not formally assigned to a pregnancy category.
US FDA pregnancy category: Not assigned

Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.
-Durlobactam: No data available on use of this component during pregnancy to inform a drug-related risk.
-Sulbactam: Available published data on use of this component in combination with ampicillin during pregnancy over many decades have not identified a drug-related risk.

Animal studies with durlobactam have revealed evidence of skeletal variations; after administration to pregnant mice and rats during organogenesis, no drug-induced fetal malformations were seen but an increased incidence of skeletal variations was observed in mice at 2 to 4 times the maximum recommended human dose (based on AUC). Animal studies have failed to reveal evidence of fetal harm due to sulbactam (from ampicillin-sulbactam); these studies were performed in mice, rats, and rabbits at doses up to 10 times the human dose. Sulbactam has been reported to cross the human placenta. 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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Durlobactam / sulbactam Breastfeeding Warnings

Use is considered acceptable.

Excreted into human milk: Unknown (durlobactam); Yes (sulbactam [low levels])
Excreted into animal milk: Unknown (durlobactam)

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 adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-Low levels of sulbactam in milk are not expected to cause adverse effects in nursing infants; durlobactam is likely to produce similar levels in milk.
-Disruption of infant's gastrointestinal flora (resulting in diarrhea or thrush) reported occasionally with penicillins; however, such effects have not been adequately evaluated.

Published data report sulbactam in breast milk at an estimated maximum daily infant dose of 560 mcg/kg/day (1% to 2% of adult weight-adjusted dose), assuming mean milk consumption of 200 mL/kg/day.

Milk was collected at random times after doses of sulbactam 0.5 or 1 g infused IV over 20 minutes. Milk levels averaged 0.52 mg/L during the first 8 hours postdose and the highest level was 2.8 mg/L; milk levels varied slightly over that period and there was little difference between the 2 doses. Levels obtained 10.5 to 20.5 hours postdose ranged from 0.12 to 1.2 mg/L.

In a study, postpartum women with endometritis received ampicillin 1 g plus sulbactam 0.5 g or ampicillin 2 g plus sulbactam 1 g infused IV over 20 minutes. Sulbactam milk levels averaged 0.58 mg/L and the highest level was 2.8 mg/L.

See references

Further information

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