Tazilsun Use In Pregnancy & Lactation

Pregnancy: Teratogenic effects: Pregnancy Category B.
Piperacillin/tazobactam: Reproduction studies have been performed in rats and have revealed no evidence of impaired fertility due to piperacillin/tazobactam administered up to a dose which is similar to the maximum recommended human daily dose based on body surface area (mg/m²). Studies in mice and rats have not demonstrated any embryotoxic or teratogenic effects of the piperacillin-tazobactam combination.
Teratology studies have been performed in mice and rats and have revealed no evidence of harm to the fetus due to piperacillin/tazobactam administered up to a dose which is 1 to 2 times and 2 to 3 times the human dose of piperacillin and tazobactam, respectively, based on body surface area (mg/m²).
Piperacillin and tazobactam cross the placenta in humans. Pregnant women should be treated only if the expected benefit outweighs the possible risks to the pregnant woman and fetus.
Piperacillin: Reproduction and teratology studies have been performed in mice and rats and have revealed no evidence of impaired fertility or harm to the fetus due to piperacillin administered up to a dose which is half (mice) or similar (rats) to the maximum recommended human daily dose based on body surface area (mg/m²).
Tazobactam: Reproduction studies have been performed in rats and have revealed no evidence of impaired fertility due to tazobactam administered at doses up to 3 times the maximum recommended human daily dose based on body surface area (mg/m²).
Teratology studies have been performed in mice and rats and have revealed no evidence of harm to the fetus due to tazobactam administered at doses up to 6 and 14 times, respectively, the human dose based on body surface area (mg/m²).
In rats, tazobactam crosses the placenta. Concentrations in the fetus are less than or equal to 10% of those found in maternal plasma.
There are, however, no adequate and well-controlled studies with the piperacillin/tazobactam combination or with piperacillin or tazobactam alone in pregnant women. Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers: Piperacillin is excreted in low concentrations in human milk; tazobactam concentrations in human milk have not been studied. Caution should be exercised when this drug (piperacillin and tazobactam for injection) is administered to a nursing woman. Women who are breast-feeding should be treated only if the expected benefit outweighs the possible risks to the nursing woman and child.