FDA approves use of Zosyn in a more convenient regimen
MADISON, N.J., April 29, 2003 -- Wyeth Pharmaceuticals announced that the use of Zosyn (piperacillin/tazobactam) in a dosing regimen of four times a day for patients with hospital-acquired (nosocomial) pneumonia has been approved by the FDA. Nosocomial pneumonia is a serious infection, representing approximately 15 percent of all hospital-associated infections, and remains an important cause of morbidity and mortality among hospitalized patients.
Prior to this approval, Zosyn was dosed six times per day for nosocomial pneumonia. This new regimen eliminates two doses per patient per day, which provides added convenience and potential savings for hospitals.
"Two fewer doses means that less time will be spent in the pharmacy on preparation, less nursing time will be spent on administration, and the need for two infusion sets will be eliminated," says Victoria Kusiak, M.D., Vice President, Global Medical Affairs and North American Medical Director, Wyeth Pharmaceuticals.
Zosyn, which was first approved by the FDA in 1993, is an injectable antibiotic consisting of a beta-lactamase inhibitor, tazobactam, in combination with an extended-spectrum penicillin, piperacillin, which is a broad-spectrum, beta-lactam antibiotic.
In addition to nosocomial pneumonia, Zosyn is indicated as monotherapy for intra-abdominal infections (specifically appendicitis and peritonitis); skin and skin structure infections including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections; gynecologic infections (postpartum endometritis and pelvic inflammatory disease); and community-acquired pneumonia in hospitalized patients.
Clinical study support
In support of a new dosing regimen, Zosyn was evaluated in 437 patients with serious nosocomial pneumonia in a randomized, double-blind registration trial in the United States and Canada. In this trial, Zosyn was dosed at 4.5 grams every six hours versus Primaxin (imipenem/cilastatin), which was dosed at 500 mg every six hours. Both drugs were started initially with an aminoglycoside. The aminoglycoside was discontinued if Pseudomonas aeruginosa was not identified as the causative pathogen. In this trial, Zosyn and Primaxin were found comparable in terms of clinical efficacy and bacterial eradication regardless of whether or not the patient was on mechanical ventilation (breathing machine).
The most commonly reported adverse events in this clinical trial of Zosyn (4.5 g every six hours) plus an aminoglycoside, irrespective of relationship to therapy, included diarrhea (17.6%), fever (2.7%), urinary tract infection (2.7%), and rash (2.3%).
Zosyn (piperacillin/tazobactam) 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:
- 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 baumannii, Haemophilus influenzae, Klebsiella pneumoniae, and Pseudomonas aeruginosa (nosocomial pneumonia caused by P. aeruginosa should be treated in combination with an aminoglycoside).
- 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, beta-lactamase producing strains of Staphylococcus aureus.
- Postpartum endometritis or pelvic inflammatory disease caused by piperacillin-resistant, beta-lactamase producing strains of Escherichia coli.
Important safety information
Careful inquiry should be made concerning previous hypersensitivity reaction, as serious and occasionally fatal anaphylactic/anaphylactoid reactions (including shock) have been reported in patients receiving therapy with penicillins including Zosyn. Zosyn is contraindicated in patients with a history of these reactions to any of the penicillins, cephalosporins, or beta-lactamase inhibitors.
While Zosyn possesses the characteristic low toxicity of the penicillin group of antibiotics, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, during prolonged therapy is advisable.
During clinical trials, pseudomembranous colitis has been rarely reported (<1%).
The most commonly reported adverse events in clinical trials, irrespective of relationship to therapy, included diarrhea (11.3%), headache (7.7%), constipation (7.7%), nausea (6.9%), and insomnia (6.6%).
Source: Wyeth Pharmaceuticals
Posted: April 2003