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ZOSYN in the Galaxy® Frozen Bag—Compliance, Convenience, Efficiency, and Safety

Compliance

  • In accordance with USP <797> Pharmaceutical Compounding—Sterile Preparations52*
  • Compliant with JCAHO Medication Management Standard MM.4.4053†

Convenience and Efficiency

  • Reduces drug preparation and administration time and steps for pharmacy and nursing staff54
  • Reduces the need for medical supplies necessary for compounding54
  • Reduces waste from unused or improperly mixed medications54,55

Safety

  • Eliminates calculations and reduces chance of contamination when reconstituting54,55

* USP <797> contains the procedures and requirements for compounding sterile preparations.52

† The Joint Commission on Accreditation of Healthcare Organizations, Critical Access Hospital 2006 Medication Management, includes a section on the Element of Performance that states, "Prescription medications are dispensed in the most ready-to-administer forms available from the manufacturer..."53


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ZOSYN in the Galaxy Frozen Bag

ZOSYN in the Galaxy Frozen Bag


STORAGE

Store in a freezer capable of maintaining a temperature of -20°C (-4°F).

THAWING OF PLASTIC CONTAINER

Thaw frozen container at room temperature (20°C to 25°C; 68°F to 77°F) or under refrigeration (2°C to 8°C; 36°F to 46°F). DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION.

STABILITY OF THAWED SOLUTION

The thawed solution is stable for 14 days under refrigeration (2°C to 8°C; 36°F to 46°F) or 24 hours at room temperature (20°C to 25°C; 68°F to 77°F). DO NOT REFREEZE THAWED ANTIBIOTICS. UNUSED PORTIONS OF ZOSYN SHOULD BE DISCARDED. DO NOT ADD SUPPLEMENTARY MEDICATION.

Galaxy is a registered trademark of Baxter International Inc.

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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.

 

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