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Piperacillin and Tazobactam (Piperacillin Sodium / Tazobactam Sodium) - Summary







The PHARMACY BULK VIAL 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.

Piperacillin and tazobactam for injection is indicated for the treatment of patients with moderate to severe infections caused by piperacillin-resistant, piperacillin/tazobactam-susceptible, ß-lactamase producing strains of the designated microorganisms in the specified conditions listed below:

Appendicitis (complicated by rupture or abscess) and peritonitis caused by piperacillin-resistant, ß-lactamase producing strains of Escherichia coli or the following members of the Bacteroides fragilis group:  B. fragilis , B. ovatus , B. thetaiotaomicron , or B. vulgatus .  The individual members of this group were studied in less than 10 cases.

Uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections caused by piperacillin-resistant, ß-lactamase producing strains of Staphylococcus aureus .

Postpartum endometritis or pelvic inflammatory disease caused by piperacillin-resistant, ß-lactamase producing strains of Escherichia coli .

Community-acquired pneumonia (moderate severity only) caused by piperacillin-resistant, ß-lactamase producing strains of Haemophilus influenzae .

Nosocomial pneumonia (moderate to severe) caused by piperacillin-resistant, ß-lactamase producing strains of Staphylococcus aureus and by piperacillin/tazobactam-susceptible Acinetobacter baumanii , Haemophilus influenzae , Klebsiella pneumoniae , and Pseudomonas aeruginosa (Nosocomial pneumonia caused by P. aeruginosa should be treated in combination with an aminoglycoside) (see DOSAGE AND ADMINISTRATION ).

Piperacillin and tazobactam for injection is indicated only for the specified conditions listed above.  Infections caused by piperacillin-susceptible organisms, for which piperacillin has been shown to be effective, are also amenable to piperacillin and tazobactam for injection treatment due to its piperacillin content.  The tazobactam component of this combination product does not decrease the activity of the piperacillin component against piperacillin-susceptible organisms.  Therefore, the treatment of mixed infections caused by piperacillin-susceptible organisms and piperacillin-resistant, ß-lactamase producing organisms susceptible to piperacillin and tazobactam for injection should not require the addition of another antibiotic (see DOSAGE AND ADMINISTRATION ).

Piperacillin and tazobactam for injection is useful as presumptive therapy in the indicated conditions prior to the identification of causative organisms because of its broad spectrum of bactericidal activity against gram-positive and gram-negative aerobic and anaerobic organisms.

Appropriate cultures should usually be performed before initiating antimicrobial treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to piperacillin and tazobactam for injection.  Antimicrobial therapy should be adjusted, if appropriate, once the results of culture(s) and antimicrobial susceptibility testing are known.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of piperacillin and tazobactam for injection and other antibacterial drugs, piperacillin and tazobactam for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.  When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.  In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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Published Studies Related to Piperacillin and Tazobactam (Piperacillin / Tazobactam)

Piperacillin/tazobactam monotherapy versus piperacillin/tazobactam plus amikacin as initial empirical therapy for febrile neutropenia in children with acute leukemia. [2011.05]
The purpose of this study is to compare the efficacy and safety of piperacillin/tazobactam (PIP/TAZO) versus PIP/TAZO plus amikacin in febrile neutropenic children with acute leukemia (AL). Children with AL who had febrile neutropenic episodes were randomized to treatment with PIP/TAZO versus PIP/TAZO plus amikacin...

Microbiological equivalence of bacteriostatic and bactericidal activities of the sera from healthy volunteers receiving generic piperacillin/tazobactam (Pipertaz) and original piperacillin/tazobactam (Tazocin). [2011.02]
CONCLUSION: The sera from healthy volunteers receiving Pipertaz contain bacteriostatic and bactericidal activities not significantly different from those receiving Tazocin.

Piperacillin-tazobactam versus carbapenem therapy with and without amikacin as empirical treatment of febrile neutropenia in cancer patients: results of an open randomized trial at a university hospital. [2010.08]
OBJECTIVE: Empirical beta-lactam monotherapy has become the standard therapy in febrile neutropenia. The aim of this study was to compare the efficacy and safety of piperacillin-tazobactam versus carbapenem therapy with or without amikacin in adult patients with febrile neutropenia... CONCLUSIONS: The effect of empirical regimen of piperacillin-tazobactam regimen is equivalent to carbapenem in adult febrile neutropenic patients.

Piperacillin/tazobactam versus imipenem/cilastatin for severe diabetic foot infections: a prospective, randomized clinical trial in a university hospital. [2010.08]
In this prospective, randomized, open-label clinical trial, we compared the efficacy and safety of two antibiotic regimens for severe diabetic foot infections (DFI). Sixty-two in-patients with DFI received either piperacillin/tazobactam (Pip-Tazo, n = 30) (4.5 g intravenously every 8h) or imipenem/cilastatin (IMP, n = 32) (0.5 g intravenously every 6h)...

Low-dose beta-lactam plus amikacin in febrile neutropenia: cefepime vs. piperacillin/tazobactam, a randomized trial. [2010.04]
Patients with fever and granulocytopenia are at risk of developing severe infection. We performed a prospective, randomized trial to evaluate the efficacy of low-dose cefepime plus amikacin (C-A) compared to low-dose piperacillin/tazobactam plus amikacin (PT-A)...

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Clinical Trials Related to Piperacillin and Tazobactam (Piperacillin / Tazobactam)

Safety and Pharmacokinetics of Piperacillin-tazobactam Extended Infusion in Infants and Children (PIP-TAZO) [Not yet recruiting]
Severe infection is one of the main causes of disease in hospitalized children and can be deadly. With the lack of novel antibiotics approved in children and the emergence of drug resistant bacteria, there is a critical need to optimize dosing of existing antibiotics. Piperacillin-tazobactam is an antibiotic frequently used for treatment of severe infection in children in Canadian hospitals. To optimize this antibiotic's efficacy despite the rise of antibiotic resistance, alternative dosing strategy is commonly used in adults, which consists of prolonging the time during which the drug is infused (4 hours instead of 30 min). Children clear piperacillin-tazobactam from their bodies at a slower rate than adults, consequently extended-infusion strategy cannot be directly extrapolated from adult to children. We believe that younger children need piperacillin-tazobactam infusions that are shorter compared to adults to achieve appropriate concentrations.

Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa [Completed]
The main objective is to verify that the administration of piperacillin / tazobactam administered by continuous infusion to treat complicated infections or with known or suspected nosocomial isolation of Pseudomonas aeruginosa is superior in efficacy to a 30% higher dose administered in conventional short infusion. The secondary objectives were compared between the following variables:

- Microbiological response at 3 days of starting treatment

- Time to microbiological cure

- Clinical response at 3 days of starting treatment

- Time to achieve defervescence

- To examine the relationship between pharmacokinetic variables and parameters of

efficacy and safety

- To test the hypothesis that continuous infusion maintains adequate plasma drug levels

compared with levels achieved with intermittent administration.

- Cost-effectiveness analysis

- Occurrence of adverse effects

To this end, we designed a multicenter, randomized, controlled, double blind, comparing both forms of administration in patients with complicated or nosocomial infection with or without isolation of Pseudomonas aeruginosa. Patients who are candidates for inclusion are classified according to APACHE II and to have or not isolation of Pseudomonas aeruginosa. Subsequently be randomized to receive piperacillin-tazobactam by continuous infusion or short. Primary endpoint was measured as the ultimate effectiveness of treatment and other variables such as high efficiency, safety, pharmacokinetic and pharmacoeconomic.

PK/PD of High Dose Pip/Tazo in Obese Patients [Recruiting]
Worldwide rates of obesity have doubled in the last 30 years, and obesity has been associated as a risk factor for hospital-acquired infections and increased occurrence of death in critically-ill patients. Piperacillin/tazobactam is a commonly prescribed antibiotic for critically ill patients with an infection, however, limited information exists for dosing this drug in obese patients. In these limited reports, standard doses of piperacillin/tazobactam given to the small number of obese patients resulted in lower blood concentrations, which could lead to inadequate killing of bacteria. The purpose of this study is to compare blood concentrations from standard piperacillin/tazobactam dosing compared to higher dosing regimens in obese patients. This study will also include information on the safety and tolerability of the higher dose regimens. The study investigators believe that the higher dosing regimen will produce adequate blood levels in obese patients and will not add any more risk of harm to obese patients receiving this higher dose.

Pharmacokinetics of Piperacillin/Tazobactam in Patients Treated by Continuous Renal Replacement Therapy [Completed]
The pharmacokinetics of piperacillin/tazobactam will be evaluated in twenty septic patients with renal failure undergoing continuous veno-venous hemodiafiltration.

Continuous Infusion Piperacillin-tazobactam for the Treatment of Cystic Fibrosis [Terminated]
Cystic fibrosis is an inherited disorder leading to chronic pulmonary inflammation and infection. A majority of people with cystic fibrosis have large quantities of bacteria residing in their lungs. One of the most common and harmful bacteria is called Pseudomonas aeruginosa. Patients with cystic fibrosis require frequent therapy with intravenous (I. V.) antibiotics to treat lung infections thought to be caused by Pseudomonas aeruginosa. One of the antibiotics frequently used to treat this bacteria is piperacillin-tazobactam. Piperacillin-tazobactam is thought to be the most effective when there is a constant level of drug in the body. The standard way to administer piperacillin-tazobactam is to give several grams 4 times each day as a 30 minute infusion. An alternative way to give piperacillin-tazobactam is by a continuous infusion; a continuous infusion will make it more likely that drug will remain at a constant level in the body. The objective of this study is to determine if administering piperacillin-tazobactam as a continuous infusion is more effective at treating people having a pulmonary exacerbation of cystic fibrosis than a standard 30 minute infusion, 4 times a day.

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Reports of Suspected Piperacillin and Tazobactam (Piperacillin / Tazobactam) Side Effects

Renal Failure Acute (36)Pruritus (35)Rash Erythematous (34)Paraesthesia (33)Rash Maculo-Papular (31)Skin Warm (23)Product Contamination Microbial (20)Thrombocytopenia (20)Death (18)Cytolytic Hepatitis (18)more >>

Page last updated: 2011-12-09

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