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

 
 



SUMMARY

Piperacillin and Tazobactam for Injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibiotic piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration.

Piperacillin and Tazobactam for Injection is indicated for the treatment of patients with moderate to severe infections caused by piperacillin-resistant, piperacillin/tazobactam-susceptible, beta-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, beta-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,ábeta-lactamase producing strains of Staphylococcus aureus.

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

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

Nosocomial pneumonia (moderate to severe) caused by piperacillin-resistant, beta-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, beta-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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NEWS HIGHLIGHTS

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)

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

Piperacillin-Tazobactam Continuous Versus Intermittent Infusion for Pseudomonas Aeruginosa [Recruiting]
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.

Continuous Infusion Piperacillin-tazobactam for the Treatment of Cystic Fibrosis [Recruiting]
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.

Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates [Recruiting]
This is a phase I open label multi-dose study to investigate the pharmacokinetics and safety of piperacillin-tazobactam in infants < 61 days of age with suspected sepsis. There will be four cohorts of 8 infants each:

1. < 32 weeks gestational age and < 14 days postnatal age

2. < 32 weeks gestational age and >=14 days postnatatal age

3. >=32 weeks gestational age and < 14 days postnatal age

4. >=32 weeks gestational age and >=14 days postnatal age. The study requires administration of 6 doses of study drug along with other antimicrobials per standard of care followed by 1 week of safety monitoring. Four 200 ÁL pK samples will be obtained at steady state. The risks are reasonable vs. the benefits and have been minimized appropriately. There may be benefit to the subjects (administration of broad spectrum empirical antimicrobial therapy), and information from the study may benefit a large number of other infants in whom the drug is currently being administered despite the lack of PK data in this population.

Ertapenem Sodium (MK-0826) Versus Piperacillin/Tazobactam Sodium for the Treatment of Diabetic Foot Infections in Chinese Adults (MK-0826-061) [Recruiting]
This study will compare ertapenem sodium to piperacillin/tazobactam sodium for the treatment of moderate to severe diabetic foot infections.

more trials >>

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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