Pfizer Corporation Hong Kong Limited 美國輝瑞科研製藥

Indications¹

Sulperazon™ is indicated for the treatment of respiratory tract infections (upper and lower), urinary tract infections (upper and lower), peritonitis, cholecystitis, cholangitis and other intra-abdominal infections, septicemia, meningitis, skin and soft tissue infections, bone and joint infections, pelvic inflammatory disease, endometritis, gonorrhea, and other infections of the genital tract caused by susceptible organisms.

Clinical Evidence

Role of Sulperazon™ in febrile neutropenia
Winston DJ, et al compared Sulperazon™ with imipenem as empirical monotherapy for febrile, granulocytopenic patients in a prospective, randomized, controlled trial. In this trial, 101 patients received cefoperazone/sulbactam (4 g/2 g bid) while 102 patients received imipenem (500 mg qid).²
The results of the study showed an overall favorable clinical response rate in 91 of 103 patients (88%) receiving Sulperazon™ and 84 of 104 patients (81%) receiving imipenem.²

Role of Sulperazon™ in lower respiratory tract infections
Li J, et al compared the efficacy and safety of intravenous Sulperazon™ with imipenem/cilastatin in the treatment of lower respiratory tract infections.³ A total of 61 and 63 patients, respectively, were evaluated for efficacy and safety. Drugs were administered twice a day for 7–14 days at a daily dose of either 2.0–4.0 g of Sulperazon™ or 2.0–4.0 g imipenem.
The overall clinical efficacy rates of Sulperazon™ and imipenem were 93.5% and 93.3%, respectively.

Role of Sulperazon™ in intra-abdominal infections
The Multicentre Amoxicillin Short Course Therapy (MASCOT) study group compared Sulperazon™ with combined third-generation cephalosporin, metronidazole and aminoglycoside for treatment of intra-abdominal infections in a randomized, open-label and multicenter study. ⁴ In this study, 154 subjects received Sulperazon™ 2–8 g/day and 152 subjects received a combination of ceftazidime (2–6 g/day), amikacin 15 mg/kg/day and metronidazole 500 mg tid. Non-inferiority of Sulperazon™ (91.9%) compared with the ceftazidime-amikacin-metronidizole combination (81.8%) was demonstrated, with continued resolution of clinical signs and symptoms at the 30-day follow-up.
Empirical Sulperazon™ monotherapy could be a useful adjunct to surgical intervention for intra-abdominal infections.

Role of Sulperazon™ in Acinetobacter infections
Acinetobacter baumannii has emerged as an important nosocomial pathogen, and its multiple antibiotic resistance threatens the successful treatment of A. baumannii infections worldwide. Antibiotic therapy with sulbactam against the genus Acinetobacter is receiving renewed attention. A retrospective study compared the efficacy of Sulperazon™ (35 patients) and imipenem/cilastatin (12 patients) in the treatment of Acinetobacter infections.
Overall clinical response of Sulperazon™ was found to be comparable to imipenem/cilastatin for treating patients with Acinetobacter infections.⁵

Safety Profile¹

CONTRAINDICATIONS: Hypersensitivity to penicillins, sulbactam, cefoperazone, or any of the cephalosporins.

SAFETY PRECAUTIONS: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam or cephalosporin therapy. Dose modification may be necessary in cases of severe biliary obstruction, severe hepatic disease or in cases of renal dysfunction coexistent with either of those conditions. Vitamin K deficiency has occurred in a few patients treated with cefoperazone; prothrombin time should be monitored in these patients and patients receiving anticoagulant therapy – exogenous vitamin K is administered as indicated. It is advisable to check periodically for organ system dysfunction during extended therapy. Clostridium difficile-associated diarrhea (CDAD) has been reported, ranging in severity from mild diarrhea to fatal colitis.

SIDE EFFECTS: Diarrhea/loose stools, positive direct Coombs test, transient eosinophilia, hypo-prothrombinemia and transient elevations of liver function tests (eg, SGOT, SGPT, alkaline phosphatase and bilirubin).

POST-MARKETING UNDESIRABLE EFFECTS: Anaphylactoid reaction, hypotension, pseudomembranous colitis, leucopenia, pruritus, Stevens-Johnson syndrome, hematuria and vasculitis.

INTERACTIONS: Alcohol.

PREGNANCY and LACTATION: Pregnancy Category B – Sulperazon™ has teratogenic effects; it should only be used during pregnancy if clearly needed. Only small quantities of sulbactam and cefoperazone are excreted in human milk; caution should be exercised when sulbactam/cefoperazone is administered to a nursing mother.

Dosages¹

Adults: 2.0–4.0 g of the 1:1 ratio and 1.5–3.0 g of the 1:2 ratio per day in equally divided doses 12 hourly; for severe or refractory infections, 8 g of the 1:1 ratio or 12 g of the 1:2 ratio per day in equally divided doses 12 hourly; maximum sulbactam dosage: 4 g/day.

Children: 40–80 mg/kg/day of the 1:1 ratio and 30–60 mg/kg/day of the 1:2 ratio in equally divided doses 6 to 12 hourly; for serious or refractory infections, 160 mg/kg/day of the 1:1 ratio or 240 mg/kg/day of the 1:2 ratio in 2 to 4 equally divided doses.

Neonates: Given every 12 hours; maximum sulbactam dosage: 80 mg/kg/day; 1:2 product ratio must be used if more than 80 mg/kg/day cefoperazone activity is required; dose adjustment is required in patients with renal insufficiency.

Strengths¹

Sulperazon™ 1:1 ratio: 500 mg sulbactam + 500 mg cefoperazone
Sulperazon™ 1:2 ratio: 500 mg sulbactam + 1000 mg cefoperazone

Packing¹

Sulperazon™ 1:1 ratio: 500 mg sulbactam + 500 mg cefoperazone (10 vials/ box)
Sulperazon™ 1:2 ratio: 500mg sulbactam + 1000 mg cefoperazone (1 vial)

Please refer to the full prescribing information for more safety information.

References

1. Sulperazon™ (sulbactam/cefoperazone) [package insert]. Hong Kong: Pfizer Pharmaceuticals Inc.; October 2007.

2. Winston DJ, Bartoni K, Bruckner DA, Schiller GJ, Territo MC. Randomized comparison of sulbactam/cefoperazone with imipenem as empirical monotherapy for febrile granulocytopenic patients. Clin Infect Dis 1998;26:576-583.

3. Li J, Zhu Y, Hu W. A randomized clinical study of sulperazon versus tienam in the treatment of LRTIS. Chin J Intern Med 1996;35:819-823.

4. Chandra A, Dhar P, Dharap S, Goel A, et al. Cefoperazone-sulbactam for treatment of intra-abdominal infections: results from a randomized, parallel group study in India. Surg Infect (Larchmt) 2008;9:367-376.

5. Choi JY, Kim CO, Park YS, et al. Comparison of efficacy of cefoperazone/sulbactam and imipenem/cilastatin for treatment of Acinetobacter bacteremia. Yonsei Med J 2006;47:63-69.

Please review the full product information or package insert before prescribing.

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