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Avibactam / ceftazidime Pregnancy and Breastfeeding Warnings

Avibactam / ceftazidime is also known as: Avycaz

Avibactam / ceftazidime Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed. US FDA pregnancy category: B

Animal studies have failed to reveal evidence of fetal harm with ceftazidime. Animal studies have failed to reveal evidence of teratogenicity or embryofetal toxicity with avibactam at doses up to 11 and 2 times the human exposure (based on AUC) in rats and rabbits, respectively; increased post-implantation loss, reduced fetal weights, delayed ossification of several bones, and other anomalies were seen with higher doses in rabbits. There are no controlled data in human pregnancy. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Avibactam / ceftazidime Breastfeeding Warnings

Use of ceftazidime (alone) during breastfeeding is considered acceptable. According to limited data, single maternal doses (up to 2 g) produce low levels in milk that are not expected to cause harmful effects in the nursing infant. Ceftazidime (2 g IV every 8 hours for 5 days) was used in 11 women. The trough milk levels averaged 3.8, 5.2, and 4.5 mg/L before the next dose, 1 hour after the dose, and 3 hours after the dose, respectively; not statistically significant. Drug milk levels averaged 3.9 mg/L for samples before the 7th dose and 4.9 mg/L in samples after the 7th dose; not statistically significant.

Caution is recommended. Excreted into human milk: Unknown (avibactam); Yes (ceftazidime [low levels]) Excreted into animal milk: Yes (avibactam [dose-dependent]) Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Avycaz (avibactam-cefTAZidime)." Forest Pharmaceuticals, St. Louis, MO.

References for breastfeeding information

  1. "Product Information. Avycaz (avibactam-cefTAZidime)." Forest Pharmaceuticals, St. Louis, MO.

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