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ZOSYN®Index Section (piperacillin, tazobactam)

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Intra-abdominal Infections

1.2 Nosocomial Pneumonia

1.3 Skin and Skin Structure Infections

1.4 Female Pelvic Infections

1.5 Community-acquired Pneumonia

1.6 Usage

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

2.2 Dosage in Adult Patients With Indications Other Than Nosocomial Pneumonia

2.3 Dosage in Adult Patients With Nosocomial Pneumonia

2.4 Dosage in Adult Patients With Renal Impairment

2.5 Dosage in Pediatric Patients With Appendicitis/Peritonitis or Nosocomial Pneumonia

2.6 Reconstitution and Dilution of ZOSYN for Injection

2.7 Directions for Use of ZOSYN Injection

2.8 Compatibility with Aminoglycosides

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Adverse Reactions

5.2 Severe Cutaneous Adverse Reactions

5.3 Hematologic Adverse Reactions

5.4 Central Nervous System Adverse Reactions

5.5 Nephrotoxicity in Critically Ill Patients

5.6 Electrolyte Effects

5.7 Clostridioides difficile-Associated Diarrhea

5.8 Development of Drug-Resistant Bacteria

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

6.3 Additional Experience with Piperacillin

7 DRUG INTERACTIONS

7.1 Aminoglycosides

7.2 Probenecid

7.3 Vancomycin

7.4 Anticoagulants

7.5 Vecuronium

7.6 Methotrexate

7.7 Effects on Laboratory Tests

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

8.8 Patients with Cystic Fibrosis

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

12.4 Microbiology

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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