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ZOSYN®(piperacillin, tazobactam)

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ZOSYN® Quick Finder

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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1 INDICATIONS AND USAGE

1.1 Intra-abdominal Infections

ZOSYN is indicated in adults and pediatric patients (2 months of age and older) for the treatment of...

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2 DOSAGE AND ADMINISTRATION

    

2.1 Dosage in Adult Patients With Indications Other Than Nosocomial Pneumonia

The usual total daily dosage of...

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3 DOSAGE FORMS AND STRENGTHS

ZOSYN (piperacillin and tazobactam) for Injection is a white to off-white powder in vials [all strengths of ZOSYN (piperacillin and tazobactam) for Injection are not currently being marketed]:...

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4 CONTRAINDICATIONS

ZOSYN is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or beta-lactamase inhibitors.

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5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Adverse Reactions

Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions (including...

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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

•
Hypersensitivity Adverse Reactions [see Warnings...
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7 DRUG INTERACTIONS

7.1 Aminoglycosides

Piperacillin may inactivate aminoglycosides by converting them to microbiologically inert amides.

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Piperacillin and...

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10 OVERDOSAGE

There have been postmarketing reports of overdose with piperacillin and tazobactam. The majority of those events experienced, including nausea, vomiting, and diarrhea, have also been reported with the usual...

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11 DESCRIPTION

ZOSYN (piperacillin and tazobactam) for Injection is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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15 REFERENCES

1.
Jensen J-US, Hein L, Lundgren B, et al. BMJ Open 2012; 2:e000635. doi:10.1136.
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16 HOW SUPPLIED/STORAGE AND HANDLING

ZOSYN (piperacillin and tazobactam) for Injection was supplied as single-dose vials and pharmacy bulk vials in the following sizes; however all strengths of ZOSYN (piperacillin and...

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17 PATIENT COUNSELING INFORMATION

Serious Hypersensitivity Reactions

Advise patients, their families, or caregivers that serious...

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Figure

This product's labeling may have been updated. For the most recent prescribing information, please visit http://www.pfizer.com.

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Call (800) 438-1985

Contact Pfizer Medical Information to speak with a professional regarding your medical question on a Pfizer prescription product: (800) 438-1985

Report Adverse Event
Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.
FDA Medwatch
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.