Zavicefta Use In Pregnancy & Lactation

Pregnancy: There is limited clinical data from the use of ceftazidime-avibactam in pregnant women. Animal embryofetal development studies conducted with ceftazidime or avibactam do not indicate harmful effects at exposures equivalent to therapeutic concentrations. Following administration of avibactam throughout pregnancy and lactation in the rat at maternal exposures greater than or equal to approximately 1.5 times human therapeutic exposures, there were minor changes in the morphology of the kidney and ureters in the rat pups (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Ceftazidime-avibactam should not be used during pregnancy unless clearly necessary and only if the potential benefit outweighs the possible risk.
Lactation: There are no data on human milk excretion of ceftazidime-avibactam. Ceftazidime is excreted in human milk in small quantities. It is unknown whether avibactam is excreted in human milk. Women who are breast-feeding should be treated with ceftazidime-avibactam only if clearly indicated. Interruption of breast-feeding is recommended.
Fertility: The effects of ceftazidime-avibactam on fertility in humans have not been studied. Animal studies with ceftazidime or avibactam do not indicate harmful effects with respect to fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).