Generic Name
Tazobactam
Brand Names
Piperacillin, Zosyn, Zerbaxa
FDA approval date: March 01, 1998
Classification: beta Lactamase Inhibitor
Form: Injection
What is Piperacillin (Tazobactam)?
Piperacillin and tazobactam for injection, USP is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: Intra-abdominal infections in adult and pediatric patients 2 months of age and older.
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Brand Information
Piperacillin and Tazobactam (Piperacillin and Tazobactam)
1DOSAGE FORMS AND STRENGTHS
Piperacillin and Tazobactam for Injection, USP is supplied as a white to off-white lyophilized powder in bottles of the following size:
Each Piperacillin and Tazobactam for Injection, USP 40.5 gram pharmacy bulk bottle contains piperacillin sodium equivalent to 36 grams of piperacillin and tazobactam sodium equivalent to 4.5 grams tazobactam.
2CONTRAINDICATIONS
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.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Hypersensitivity Adverse Reactions
- Severe Cutaneous Adverse Reactions
- Hemophagocytic Lymphohistiocytosis
- Rhabdomyolysis [
- Hematologic Adverse Reactions
- Central Nervous System Adverse Reactions
- Nephrotoxicity in Critically Ill Patients
- Clostridioides difficile-Associated Diarrhea [see Warnings and Precautions (5.9)]
3.1Clinical 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. However, in 3.2% of the patients treated worldwide, piperacillin and tazobactam was discontinued because of adverse events primarily involving the skin (1.3%), including rash and pruritus; the gastrointestinal system (0.9%), including diarrhea, nausea, and vomiting; and allergic reactions (0.5%).
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. However, in 3.2% of the patients treated worldwide, piperacillin and tazobactam was discontinued because of adverse events primarily involving the skin (1.3%), including rash and pruritus; the gastrointestinal system (0.9%), including diarrhea, nausea, and vomiting; and allergic reactions (0.5%).
Nosocomial Pneumonia Trials
Two trials of nosocomial lower respiratory tract infections were conducted. In one study, 222 patients were treated with piperacillin and tazobactam for injection in a dosing regimen of 4.5 g every 6 hours in combination with an aminoglycoside and 215 patients were treated with imipenem/cilastatin (500 mg/500 mg every 6 hours) in combination with an aminoglycoside. In this trial, treatment-emergent adverse events were reported by 402 patients, 204 (91.9%) in the piperacillin and tazobactam group and 198 (92.1%) in the imipenem/cilastatin group. Twenty-five (11.0%) patients in the piperacillin and tazobactam group and 14 (6.5%) in the imipenem/cilastatin group (p > 0.05) discontinued treatment due to an adverse event.
The second trial used a dosing regimen of 3.375 g given every 4 hours with an aminoglycoside.
Other Trials - Nephrotoxicity
In a randomized, multicenter, controlled trial in 1200 adult critically ill patients, piperacillin and tazobactam was found to be a risk factor for renal failure (odds ratio 1.7, 95% CI 1.18 to 2.43), and associated with delayed recovery of renal function as compared to other beta-lactam antibacterial drugs1
Adverse Laboratory Changes (Seen During Clinical Trials)
Of the trials reported, including that of nosocomial lower respiratory tract infections in which a higher dose of piperacillin and tazobactam was used in combination with an aminoglycoside, changes in laboratory parameters include:
Hematologic—decreases in hemoglobin and hematocrit, thrombocytopenia, increases in platelet count, eosinophilia, leukopenia, neutropenia. These patients were withdrawn from therapy; some had accompanying systemic symptoms (e.g., fever, rigors, chills).
Coagulation—positive direct Coombs' test, prolonged prothrombin time, prolonged partial thromboplastin time
Hepatic—transient elevations of AST (SGOT), ALT (SGPT), alkaline phosphatase, bilirubin
Renal—increases in serum creatinine, blood urea nitrogen
Additional laboratory events include abnormalities in electrolytes (i.e., increases and decreases in sodium, potassium, and calcium), hyperglycemia, decreases in total protein or albumin, blood glucose decreased, gamma-glutamyltransferase increased, hypokalemia, and bleeding time prolonged.
Clinical Trials in Pediatric Patients
Clinical studies of piperacillin and tazobactam in pediatric patients suggest a similar safety profile to that seen in adults.
In a prospective, randomized, comparative, open-label clinical trial of pediatric patients, 2 to 12 years of age, with intra-abdominal infections (including appendicitis and/or peritonitis), 273 patients were treated with piperacillin and tazobactam for injection 112.5 mg/kg given IV every 8 hours and 269 patients were treated with cefotaxime (50 mg/kg) plus metronidazole (7.5 mg/kg) every 8 hours. In this trial, treatment-emergent adverse events were reported by 146 patients, 73 (26.7%) in the piperacillin and tazobactam for injection group and 73 (27.1%) in the cefotaxime/metronidazole group. Six patients (2.2%) in the piperacillin and tazobactam for injection group and 5 patients (1.9%) in the cefotaxime/metronidazole group discontinued due to an adverse event.
In a retrospective, cohort study, 140 pediatric patients 2 months to less than 18 years of age with nosocomial pneumonia were treated with piperacillin and tazobactam and 267 patients were treated with comparators (which included ticarcillin-clavulanate, carbapenems, ceftazidime, cefepime, or ciprofloxacin). The rates of serious adverse reactions were generally similar between the piperacillin and tazobactam and comparator groups, including patients aged 2 months to 9 months treated with piperacillin and tazobactam 90 mg/kg IV every 6 hours and patients older than 9 months and less than 18 years of age treated with piperacillin and tazobactam 112.5 mg/kg IV every 6 hours.
3.2Postmarketing Experience
In addition to the adverse drug reactions identified in clinical trials in Table 6 and Table 7, the following adverse reactions have been identified during post-approval use of piperacillin and tazobactam. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hepatobiliary—hepatitis, jaundice
Hematologic—hemolytic anemia, agranulocytosis, pancytopenia
Immune—hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock), hemophagocytic lymphohistiocytosis (HLH), acute myocardial ischemia with or without myocardial infarction may occur as part of an allergic reaction
Renal—interstitial nephritis
Nervous system disorders - seizures
Psychiatric disorders—delirium
Respiratory—eosinophilic pneumonia
Skin and Appendages—erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), dermatitis exfoliative, and linear IgA bullous dermatosis
Musculoskeletal—rhabdomyolysis
Postmarketing experience with piperacillin and tazobactam in pediatric patients suggests a similar safety profile to that seen in adults.
3.3Additional Experience with Piperacillin
The following adverse reaction has also been reported for piperacillin for injection:
4OVERDOSAGE
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)
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
5DESCRIPTION
Piperacillin and Tazobactam for Injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration.
Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2
Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2
The chemical structure of tazobactam sodium is:
Piperacillin and tazobactam contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product.
Piperacillin and tazobactam is a white to off-white sterile, lyophilized powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass bottles. This product does not contain excipients or preservatives.
The pharmacy bulk package bottle is a container of sterile preparation which contains many single doses for parenteral use. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion.
Each Piperacillin and Tazobactam for Injection, USP 40.5 gram pharmacy bulk package bottle contains piperacillin sodium equivalent to 36 grams of piperacillin and tazobactam sodium equivalent to 4.5 grams of tazobactam sufficient for delivery of multiple doses.
Meets USP Organic Impurities Test 3.
6REFERENCES
1. Jensen J-US, Hein L, Lundgren B, et al. BMJ Open 2012;
2:e000635. doi:10.1136.
7HOW SUPPLIED/STORAGE AND HANDLING
Piperacillin and Tazobactam for Injection, USP is supplied as follows:
44567-804-01 40.5 grams per 1 bottle per carton
- Pharmacy Bulk Bottle
- Each pharmacy bulk package bottle provides piperacillin sodium equivalent to 36 grams of piperacillin and tazobactam sodium equivalent to 4.5 grams of tazobactam. Each pharmacy bulk package bottle contains 84.6 mEq (1,945 mg) of sodium.
Storage Conditions
Prior to Reconstitution: Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.]
Sterile, Preservative-free.
The container closure is not made with natural rubber latex.
8PATIENT COUNSELING INFORMATION
Serious Hypersensitivity Reactions
Advise patients, their families, or caregivers that serious hypersensitivity reactions, including serious allergic cutaneous reactions, could occur with use of piperacillin and tazobactam that require immediate treatment. Ask them about any previous hypersensitivity reactions to piperacillin and tazobactam, other beta-lactams (including cephalosporins), or other allergens [see
Hemophagocytic Lymphohistiocytosis
Prior to initiation of treatment with piperacillin and tazobactam, inform patients that excessive immune activation may occur with piperacillin and tazobactam and that they should report signs or symptoms such as fever, rash, or lymphadenopathy to a healthcare provider immediately
Diarrhea
Advise patients, their families, or caregivers that diarrhea is a common problem caused by antibacterial drugs, including piperacillin and tazobactam, which usually ends when the drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the drug. If this occurs, patients should contact their physician as soon as possible
Antibacterial Resistance
Patients should be counseled that antibacterial drugs including piperacillin and tazobactam should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When piperacillin and tazobactam is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. 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 piperacillin and tazobactam or other antibacterial drugs in the future.
Pregnancy and Lactation
Patients should be counseled that piperacillin and tazobactam for injection can cross the placenta in humans and is excreted in human milk
CLINITEST® is a registered trademark of Siemens Healthcare Diagnostics Inc.
Manufactured for:
WG Critical Care, LLC
Paramus, NJ 07652
Made in Italy
9PRINCIPAL DISPLAY PANEL
NDC 44567-804-01
PIPERACILLIN AND TAZOBACTAM
Pharmacy Bulk Package-
Rx only
PIPERACILLIN AND TAZOBACTAM
Pharmacy Bulk Package-
Rx only