ZOSYN SUMMARY
ZOSYN (piperacillin and tazobactam injection) in Galaxy® Containers (PL 2040 Plastic) is a sterile injectable antibacterial combination product consisting of the semisynthetic antibiotic piperacillin sodium and the β-lactamase inhibitor tazobactam sodium for intravenous administration.
Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin.
ZOSYN is indicated for the treatment of patients with moderate to severe infections caused by piperacillin-resistant, piperacillin/tazobactam-susceptible, β-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, β?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, β?lactamase producing strains of Staphylococcus aureus.
Postpartum endometritis or pelvic inflammatory disease caused by piperacillin-resistant, β?lactamase producing strains of Escherichia coli.
Community-acquired pneumonia (moderate severity only) caused by piperacillin-resistant, β?lactamase producing strains of Haemophilus influenzae.
Nosocomial pneumonia (moderate to severe) caused by piperacillin-resistant, β-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.)
ZOSYN 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 ZOSYN 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, β-lactamase producing organisms susceptible to ZOSYN should not require the addition of another antibiotic. (See
DOSAGE AND ADMINISTRATION.)
ZOSYN 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 ZOSYN. 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 ZOSYN (piperacillin and tazobactam) injection and other antibacterial drugs, ZOSYN (piperacillin and tazobactam) 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 Zosyn (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)...
Clinical Trials Related to Zosyn (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.
Trial of Meropenem Versus Piperacillin-Tazobactam on Mortality and Clinial Response [Recruiting]
Infections of the blood are extremely serious and require intravenous antibiotic treatment.
When the infection results from antibiotic resistant bacteria, the choice of antibiotic is
an extremely important decision. Some types of bacteria produce enzymes that may inactivate
essential antibiotics, related to penicillin, called 'beta-lactams'. Furthermore high level
production of these enzymes can occur during therapy and lead to clinical failure, even when
an antibiotic appears effective by laboratory testing. However, this risk of this occurring
in clinical practice has only been well described in a limited range of antibiotic classes
in a type of bacteria called Enterobacter. There is currently uncertainty as to whether a
commonly used, and highly effective antibiotic, called piperacillin-tazobactam is subject to
the same risk of resistance developing while on treatment. Infections caused by Enterobacter
(and other bacteria with similar resistance mechanisms) are often treated with an
alternative drug called meropenem (a carbapenem antibiotic), which is effective but has an
extremely broad-spectrum of activity. Excessive use of carbapenems is driving further
resistance to this antibiotic class - which represent our 'lastline' of antibiotic defence.
As such, we need studies to help us see whether alternatives to meropenem are an effective
and safe choice. No study has ever directly tested whether these two antibiotics have the
same effectiveness for this type of infection. The purpose of this study is to randomly
assign patients with blood infection caused by Enterobacter or related bacteria to either
meropenem or piperacillin/tazobactam in order to test whether these antibiotics have similar
effectiveness.
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.
RCT Meropenem vs Piperacillin-Tazobactam for Definitive Treatment of BSI's Due to Ceftriaxone Non-susceptible Escherichia Coli and Klebsiella Spp. [Recruiting]
No randomized controlled trials (RCTs) have yet been performed comparing different treatment
options for AmpC or ESBL-producing Enterobacteriaceae. During the last 10 years we have seen
an exponentially increasing rate of carbapenem resistance worldwide, including Australia and
New Zealand. The investigators urgently need data from well-designed RCTs to guide
clinicians in the treatment of antibiotic resistant Gram-negative infections. The
investigators face a situation where a commonly used antibiotic for these infections
(meropenem) may be driving carbapenem resistance. For this reason, the investigators are
seeking to compare a carbapenem-sparing regimen with a carbapenem for the treatment of these
infections. Formal evaluation of safety and efficacy of generic antibiotics in the
treatment of infection is of immense clinical and public health importance, and no formal
trial has yet been conducted to address these issues. The international collaboration
between teams of clinician researchers, some of whom are leaders in their field, makes it
highly likely that the outcomes of this trial will have a significant impact on clinical
practice.
The investigators' hypothesis is that piperacillin/tazobactam (a carbapenem-sparing regimen)
is non-inferior to meropenem (a widely used carbapenem) for the definitive treatment of
bloodstream infections due to third-generation cephalosporin non-susceptible E. coli or
Klebsiella species.
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.
Reports of Suspected Zosyn (Piperacillin / Tazobactam) Side Effects
Hepatic Function Abnormal (16),
Pyrexia (14),
Interstitial Lung Disease (14),
Drug Interaction (11),
Renal Failure Acute (11),
Liver Disorder (10),
Rash (10),
Diarrhoea (10),
Renal Impairment (9),
Alopecia (9), more >>
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Page last updated: 2011-12-09
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