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AI-Generated response:

Is pregnancy a contraindication to the administration of zosyn?

Answer generated on June 10, 2024

The AI-generated responses are for illustration purposes only and should not be used for medical purposes.

Pregnancy is not a contraindication to the administration of Zosyn (piperacillin and tazobactam), but caution is advised due to insufficient data on drug-associated risks for major birth defects and miscarriage.

  • Piperacillin and tazobactam cross the placenta in humans, but there are insufficient data to inform a drug-associated risk for major birth defects and miscarriage in human pregnancy.[1-2]

  • Animal studies have shown no fetal structural abnormalities in rats or mice when Zosyn was administered intravenously at doses up to 3 times the human dose based on body surface area.[1-2]

  • Fetotoxicity, such as increased stillbirths and pup mortality, was observed in the presence of maternal toxicity in rats at doses less than the maximum recommended human daily dose.[1-2]

  • The background risk of major birth defects and miscarriage in the general U.S. population is estimated to be 2-4% and 15-20%, respectively.[2]

  • Zosyn is excreted in human milk, and patients should be counseled about this during pregnancy and lactation.[2-3]

Additional info

When considering the use of Zosyn in pregnant patients, it is important to weigh the potential benefits against the possible risks. The lack of comprehensive human data necessitates a cautious approach, although animal studies suggest a relatively low risk of teratogenic effects at clinically relevant doses. The decision to use Zosyn during pregnancy should be made based on the clinical condition of the patient and the perceived benefit of the treatment. Always consider alternative antibiotics if the safety profile during pregnancy is better understood. Additionally, monitoring for adverse effects in both the mother and the fetus might be prudent if Zosyn is used during pregnancy.

References

Reference 1

1.

Elsevier ClinicalKey Drug Monograph

Content last updated: May 6, 2024.

Contraindications And Precautions Piperacillin and tazobactam cross the placenta in humans. However, there are insufficient data with piperacillin and/or tazobactam in human pregnancy to inform a drug-associated risk for major birth defects and miscarriage. No fetal structural abnormalities were observed in rats or mice when zosyn powder was given intravenously at doses 1 to 2 times and 2 to 3 times the human doses of piperacillin and tazobactam, respectively, based on body surface area. Fetotoxicity (i.e., increased stillbirths, increased pup mortality) in the presence of maternal toxicity was observed in peri/postnatal studies in rats given zosyn powder by intraperitoneal administration prior to mating and throughout gestation or from gestation day 17 through lactation day 21 at doses less than the maximum recommended human daily dose based on body surface area.

Pregnancy Piperacillin and tazobactam cross the placenta in humans. However, there are insufficient data with piperacillin and/or tazobactam in human pregnancy to inform a drug-associated risk for major birth defects and miscarriage. No fetal structural abnormalities were observed in rats or mice when zosyn was given intravenously at doses 1 to 2 times and 2 to 3 times the human doses of piperacillin and tazobactam, respectively, based on body surface area. Fetotoxicity (i.e., increased stillbirths, increased pup mortality) in the presence of maternal toxicity was observed in peri/postnatal studies in rats given zosyn by intraperitoneal administration prior to mating and throughout gestation or from gestation day 17 through lactation day 21 at doses less than the maximum recommended human daily dose based on body surface area.

Reference 2

2.

Food and Drug Administration (DailyMed).

Publish date: May 3, 2024.

Pregnancy 8.1 Pregnancy Risk Summary Piperacillin and tazobactam cross the placenta in humans. However, there are insufficient data with piperacillin and/or tazobactam in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. No fetal structural abnormalities were observed in rats or mice when piperacillin and tazobactam was administered intravenously during organogenesis at doses 1 to 2 times and 2 to 3 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area (mg/m 2 ). However, fetotoxicity in the presence of maternal toxicity was observed in developmental toxicity and peri/postnatal studies conducted in rats (intraperitoneal administration prior to mating and throughout gestation or from gestation day 17 through lactation day 21) at doses less than the maximum recommended human daily dose based on body-surface area (mg/m 2 ) ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In embryo-fetal development studies in mice and rats, pregnant animals received intravenous doses of piperacillin and tazobactam up to 3000/750 mg/kg/day during the period of organogenesis. There was no evidence of teratogenicity up to the highest dose evaluated, which is 1 to 2 times and 2 to 3 times the human dose of piperacillin and tazobactam, in mice and rats respectively, based on body-surface area (mg/m 2 ). Fetal body weights were reduced in rats at maternally toxic doses at or above 500/62.5 mg/kg/day, minimally representing 0.4 times the human dose of both piperacillin and tazobactam based on body-surface area (mg/m 2 ).

Information For Patients Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Zosyn (piperacillin sodium and tazobactam sodium) or other antibacterial drugs in the future. Pregnancy and Lactation Patients should be counseled that Zosyn (piperacillin sodium and tazobactam sodium) can cross the placenta in humans and is excreted in human milk [see Use in Specific Populations (8.1, 8.2) ]. Baxter Healthcare Corporation Deerfield, IL 60015 USA Made in USA Baxter, Galaxy and Zosyn (piperacillin sodium and tazobactam sodium) are trademarks of Baxter International Inc. or its subsidiaries. Clinitest is a registered trademark of Siemens Healthcare Diagnostics Inc. 07-19-07-565

Reference 3

3.

Food and Drug Administration (DailyMed).

Publish date: March 3, 2023.

Information For Patients Pregnancy and Lactation Patients should be counseled that ZOSYN can cross the placenta in humans and is excreted in human milk [see Use in Specific Populations (8.1, 8.2) ]. This product's labeling may have been updated. For the most recent prescribing information, please visit http://www.pfizer.com. CLINITEST ® is a registered trademark of Siemens Healthcare Diagnostics Inc. GALAXY is a registered trademark of Baxter International Inc. LAB-1527-1.0 Figure Figure Logo

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