ZOSYN Then and Today

The addition of edetate disodium dihydrate (EDTA) and sodium citrate to ZOSYN resulted in expanded compatibility with the aminoglycosides amikacin or gentamicin, via Y-site infusion at specific doses and specific concentrations, and with certain diluents.⁴

Compatibility Information for ZOSYN in Standard and Pharmacy Bulk Vials and Galaxy^® Bags

ZOSYN containing EDTA is compatible for simultaneous coadministration via Y-site infusion with only the following aminoglycosides under the following conditions.

Galaxy is a registered trademark of Baxter International Inc.

*The concentration ranges in this table are based on administration of the aminoglycoside in divided doses
(10-15 mg/kg/day in 2 daily doses for amikacin and 3-5 mg/kg/day in 3 daily doses for gentamicin). Administration of amikacin or gentamicin in a single daily dose or in doses exceeding those stated above via Y-site with ZOSYN containing EDTA has not been evaluated. See full Prescribing Information for each aminoglycoside for complete dosage and administration instructions.

^†ZOSYN 3.375 g per 50 mL Galaxy Bags are NOT compatible with gentamicin for coadministration via a Y-site due to higher concentrations of piperacillin and tazobactam. ZOSYN is not compatible with tobramycin for simultaneous coadministration via Y-site infusion.

Compatibility of ZOSYN with other aminoglycosides has not been established. Only the concentration and diluents for amikacin or gentamicin with the dosages of ZOSYN listed herein have been established as compatible for coadministration via Y-site infusion. Simultaneous coadministration via Y-site infusion in any manner other than listed herein may result in inactivation of the aminoglycoside by ZOSYN.

Indications

• Nosocomial pneumonia (moderate to severe) caused by piperacillin-resistant, β-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.)
• Community-acquired pneumonia (moderate severity only) caused by piperacillin-resistant, β-lactamase producing strains of Haemophilus influenzae
• 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
• 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
• 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. However, before prescribing, please consult the full Prescribing Information
• Postpartum endometritis or pelvic inflammatory disease caused by piperacillin-resistant, β-lactamase producing strains of Escherichia coli

Important Safety Information

• ZOSYN is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or β-lactamase inhibitors
• 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
• 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
• Clostridium difficile–associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including ZOSYN, and may range in severity from mild diarrhea to fatal colitis
• The most commonly reported adverse events in clinical trials of ZOSYN (4.5 g every 6 hours) plus an aminoglycoside included diarrhea (17.6%), fever (2.7%), vomiting (2.7%), urinary tract infection (2.7%), and rash (2.3%)
• 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%)
• Like all β-lactams, ZOSYN is not a suitable agent for strains of methicillin-resistant Staphylococcus. If MRSA or MRSE is suspected, the addition of an appropriate agent such as vancomycin may be warranted
• To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZOSYN and other antibacterial drugs, ZOSYN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria
• Initial presumptive treatment of patients with nosocomial pneumonia should start with ZOSYN at a dosage of 4.5 g every 6 hours plus an aminoglycoside. If P. aeruginosa is not isolated, the aminoglycoside may be discontinued at the discretion of the treating physician

Please see full Prescribing Information.