PIPRACIL SUMMARY
PIPRACIL®
(piperacillin for injection)
For Intravenous and Intramuscular Use
PIPRACIL, sterile piperacillin sodium, is a semisynthetic broad-spectrum penicillin for parenteral use derived from D(-)-α-aminobenzylpenicillin.
Therapeutic: PIPRACIL is indicated for the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below:
Intra-Abdominal Infections including hepatobiliary and surgical infections caused by E. coli, Pseudomonas aeruginosa, enterococci, Clostridium spp., anaerobic cocci, or Bacteroides spp., including B. fragilis.
Urinary Tract Infections caused by E. coli, Klebsiella spp., P. aeruginosa, Proteus spp., including P. mirabilis, or enterococci.
Gynecologic Infections including endometritis, pelvic inflammatory disease, pelvic cellulitis caused by Bacteroides spp., including B. fragilis, anaerobic cocci, Neisseria gonorrhoeae, or enterococci (E. faecalis).
Septicemia including bacteremia caused by E. coli, Klebsiella spp., Enterobacter spp., Serratia spp., P. mirabilis, S. pneumoniae, enterococci, P. aeruginosa, Bacteroides spp., or anaerobic cocci.
Lower Respiratory Tract Infections caused by E. coli, Klebsiella spp., Enterobacter spp., P. aeruginosa , Serratia spp., H. influenzae, Bacteroides spp., or anaerobic cocci. Although improvement has been noted in patients with cystic fibrosis, lasting bacterial eradication may not necessarily be achieved.
Skin and Skin Structure Infections caused by E. coli , Klebsiella spp., Serratia spp., Acinetobacter spp., Enterobacter spp., P. aeruginosa, Morganella morganii, Providencia rettgeri, Proteus vulgaris, P. mirabilis, Bacteroides spp., including B. fragilis, anaerobic cocci, or enterococci.
Bone and Joint Infections caused by P. aeruginosa , enterococci, Bacteroides spp., or anaerobic cocci.
Uncomplicated Gonococcal Urethritis caused by N. gonorrhoeae.
PIPRACIL has also been shown to be clinically effective for the treatment of infections at various sites caused by Streptococcus species including S. pyogenes and S. pneumoniae; however, infections caused by these organisms are ordinarily treated with more narrow spectrum penicillins. Because of its broad spectrum of bactericidal activity against gram-positive and gram-negative aerobic and anaerobic bacteria, PIPRACIL is particularly useful for the treatment of mixed infections and presumptive therapy prior to the identification of the causative organisms.
Also, PIPRACIL may be administered as single drug therapy in some situations where normally two antibiotics might be employed.
Piperacillin has been successfully used with aminoglycosides, especially in patients with impaired host defenses. Both drugs should be used in full therapeutic doses.
Appropriate cultures should be made for susceptibility testing before initiating therapy and therapy adjusted, if appropriate, once the results are known.
Prophylaxis: PIPRACIL is indicated for prophylactic use in surgery including intra-abdominal (gastrointestinal and biliary) procedures, vaginal hysterectomy, abdominal hysterectomy, and cesarean section. Effective prophylactic use depends on the time of administration; PIPRACIL should be given one-half to one hour before the operation so that effective levels can be achieved in the site prior to the procedure.
The prophylactic use of piperacillin should be stopped within 24 hours, since continuing administration of any antibiotic increases the possibility of adverse reactions, but in the majority of surgical procedures, does not reduce the incidence of subsequent infections. If there are signs of infection, specimens for culture and susceptibility testing should be obtained for identification of the causative microorganism so that appropriate therapy can be instituted.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of PIPRACIL and other antibacterial drugs, PIPRACIL should only be used 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 Pipracil (Piperacillin)
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 Pipracil (Piperacillin)
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.
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.
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.
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.
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.
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