pharmacopeia
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PHARMACY BULK PACKAGE-NOT FOR DIRECT INFUSION

Mechanism of action

Sourced from openFDA

Piperacillin and tazobactam is an antibacterial drug [see Microbiology ( 12.4 )] .

Transpeptidase

Indications

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  • Piperacillin and tazobactam for injection, for intravenous use is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a β-lactamase inhibitor indicated for the treatment of: • Intra-abdominal infections in adult and pediatric patients 2 months of age and older ( 1.1 ) • Nosocomial pneumonia in adult and pediatric patients 2 months of age and older ( 1.2 ) • Skin and skin structure infections in adults ( 1.3 ) • Female pelvic infections in adults ( 1.4 ) • Community-acquired pneumonia in adults ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection, USP and other antibacterial drugs, Piperacillin and Tazobactam for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.ICD-10: J18.9

Contraindications

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  • Piperacillin and tazobactam for injection is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or beta-lactamase inhibitors. Patients with a history of allergic reactions to any of the penicillins, cephalosporins, or beta-lactamase inhibitors.contraindicated

Dosage & administration

Sourced from openFDA

• Adult Patients With Indications Other Than Nosocomial Pneumonia: The usual daily dosage of piperacillin and tazobactam for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin and 1.5 g tazobactam) ( 2.1 ) • Adult Patients with Nosocomial Pneumonia: Initial presumptive treatment of patients with nosocomial pneumonia should start with piperacillin and tazobactam at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18.0 g (16.0 g piperacillin and 2.0 g tazobactam). ( 2.2 ) • Adult Patients with Renal Impairment: Dosage in patients with renal impairment (creatinine clearance ≤40 mL/min) and dialysis patients should be reduced, based on the degree of renal impairment. ( 2.3 ) • Pediatric Patients by Indication and Age: See Table below ( 2.4 ) Recommended Dosage of Piperacillin and Tazobactam for Pediatric Patients 2 months of Age and Older, Weighing up to 40 Kg and With Normal Renal Function Age Appendicitis and/or Peritonitis Nosocomial Pneumonia 2 months to 9 months 90 mg/kg (80 mg piperacillin and 10 mg tazobactam) every 8 ( eight ) hours 90 mg/kg (80 mg piperacillin and 10 mg tazobactam) every 6 ( six ) hours Older than 9 months 112.5 mg/kg (100 mg piperacillin and 12.5 mg tazobactam) every 8 ( eight ) hours 112.5 mg/kg (100 mg piperacillin and 12.5 mg tazobactam) every 6 ( six ) hours • Administer piperacillin and tazobactam by intravenous infusion over 30 minutes to both adult and pediatric patients ( 2.1 , 2.2 , 2.3 , 2.4 ) • Piperacillin and tazobactam and aminoglycosides should be reconstituted, diluted, and administered separately.…

Warnings & precautions

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• Serious hypersensitivity reactions (anaphylactic/anaphylactoid) have been reported in patients receiving piperacillin and tazobactam. Discontinue piperacillin and tazobactam if a reaction occurs. ( 5.1 ) • Piperacillin and tazobactam for injection may cause severe cutaneous adverse reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis. Discontinue piperacillin and tazobactam for injection for progressive rashes. ( 5.2 ) • Hemophagocytic lymphohistiocytosis (HLH) has been reported with the use of piperacillin and tazobactam. If HLH is suspected, discontinue piperacillin and tazobactam immediately. ( 5.3 ) • Rhabdomyolysis: If signs or symptoms of rhabdomyolysis are observed, discontinue Piperacillin and tazobactam for injection and initiate appropriate therapy. (5.4) • Hematological effects (including bleeding, leukopenia and neutropenia) have occurred. Monitor hematologic tests during prolonged therapy. ( 5.5 ) • As with other penicillins, piperacillin and tazobactam may cause neuromuscular excitability or seizures. Patients receiving higher doses, especially in the presence of renal impairment may be at greater risk. Closely monitor patients with renal impairment or seizure disorders for signs and symptoms of neuromuscular excitability or seizures.

Adverse reactions

Sourced from openFDA

The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Adverse Reactions [see Warnings and Precautions ( 5.1 )] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.2 )] • Hemophagocytic Lymphohistiocytosis [see Warnings and Precautions ( 5.3 )] • Rhabdomyolysis [ see Warnings and Precautions (5.4) ] • Hematologic Adverse Reactions [see Warnings and Precautions ( 5.5 )] • Central Nervous System Adverse Reactions [see Warnings and Precautions ( 5.6 )] • Nephrotoxicity in Critically Ill Patients [see Warnings and Precautions ( 5.7 )] • Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions ( 5.9 )] The most common adverse reactions (incidence >5%) are diarrhea, constipation, nausea, headache and insomnia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact WG Critical Care, LLC at 1-866-562-4708 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials in Adult Patients During the initial clinical investigations, 2621 patients worldwide were treated with piperacillin and tazobactam in phase 3 trials. In the key North American monotherapy clinical trials (n=830 patients), 90% of the adverse events reported were mild to moderate in severity and transient in nature.

Use in specific populations

Sourced from openFDA

Dosage in patients with renal impairment (creatinine clearance ≤40 mL/min) should be reduced based on the degree of renal impairment. ( 2.3 , 8.6 ) 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/m2). 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/m2) [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 to 4% and 15 to 20%, respectively.

Pharmacokinetics

Sourced from openFDA
Metabolism
The mean and coefficients of variation (CV%) for the pharmacokinetic parameters of piperacillin and tazobactam after multiple intravenous doses are summarized in Table 8. Table 8.

Overdosage

Sourced from openFDA

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 recommended dosages. Patients may experience neuromuscular excitability or seizures if higher than recommended doses are given intravenously (particularly in the presence of renal failure) [see Warnings and Precautions ( 5.5 )] . Treatment should be supportive and symptomatic according to the patient's clinical presentation. Excessive serum concentrations of either piperacillin or tazobactam may be reduced by hemodialysis. Following a single 3.375 g dose of piperacillin and tazobactam, the percentage of the piperacillin and tazobactam dose removed by hemodialysis was approximately 31% and 39%, respectively [see Clinical Pharmacology ( 12 )] .

Approval history

Sourced from openFDA
  • Feb 24, 1998NDANDA050750Baxter Hlthcare Corp
  • Oct 21, 2010ANDAANDA065362Sandoz
  • May 23, 2011ANDAANDA065498Eugia Pharma Speclts
  • May 31, 2011ANDAANDA090498Istituto Bio Ita Spa
  • May 31, 2011ANDAANDA065523Istituto Bio Ita Spa
  • Aug 15, 2014ANDAANDA065458Onesource Specialty
  • Oct 29, 2014ANDAANDA203557Sandoz
  • Apr 3, 2025NDANDA206056B Braun Medical

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
32,661 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective3,0729.4%
  2. 2Off Label Use2,7438.4%
  3. 3Acute Kidney Injury2,3157.1%
  4. 4Pyrexia2,2436.9%
  5. 5Pneumonia1,5014.6%
  6. 6Diarrhoea1,4274.4%
  7. 7Thrombocytopenia1,2633.9%
  8. 8Sepsis1,2403.8%
  9. 9Condition Aggravated1,2013.7%
  10. 10Neutropenia1,1183.4%
  11. 11Febrile Neutropenia1,1133.4%
  12. 12Dyspnoea1,0933.3%
  13. 13Rash1,0843.3%
  14. 14Hypotension1,0163.1%
  15. 15Nausea9923.0%

Literature

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Recent PubMed references pinned to Piperacillin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 219 ClinicalTrials.gov registrations naming Piperacillin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Piperacillin work?
Piperacillin and tazobactam is an antibacterial drug [see Microbiology ( 12.4 )] .
What is Piperacillin used for?
According to FDA labeling, Piperacillin carries indications including: Piperacillin and tazobactam for injection, for intravenous use is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a β-lactamase inhibitor indicated for the treatment of: • Intra-abdominal infections in adult and pediatric patients 2 months of age and older ( 1.1 ) • Nosocomial pneumonia in adult and pediatric patients 2 months of age and older ( 1.2 ) • Skin and skin structure infections in adults ( 1.3 ) • Female pelvic infections in adults ( 1.4 ) • Community-acquired pneumonia in adults ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection, USP and other antibacterial drugs, Piperacillin and Tazobactam for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Piperacillin?
Piperacillin is classified as Penicillins with extended spectrum, Transpeptidase Inhibitors, Decreased Cell Wall Synthesis & Repair.
What are the brand names for Piperacillin?
Piperacillin is marketed under brand names including Zosyn.
What are the contraindications for Piperacillin?
Piperacillin labeling lists contraindications including: Piperacillin and tazobactam for injection is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or beta-lactamase inhibitors. Patients with a history of allergic reactions to any of the penicillins, cephalosporins, or beta-lactamase inhibitors.. Always consult the full prescribing information and a clinician.
Note. Data for piperacillin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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