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Cefoperazone-Sulbactam

Cephalosporin · Antibiotic

Also known as Cefoperazone/Sulbactam, CPZ/SUL, Cefosul, Cefozon-S, Zosul

CephalosporinAntibioticATC J01DD62
CDSCO approvedSchedule HATC J01DD62
EXCRETION
not curated
INTERACTIONS
none in our sources
PREGNANCY
Category B. Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
FDA category + note

Mechanism

Cefoperazone, a third-generation cephalosporin, inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins, leading to bactericidal action. Sulbactam is a beta-lactamase inhibitor that irreversibly inactivates a broad spectrum of bacterial beta-lactamases, thereby protecting cefoperazone from degradation and extending its antimicrobial spectrum, especially against resistant strains.

Indications

Intra-abdominal infections (e.g., peritonitis, cholecystitis)Pelvic inflammatory diseaseSkin and soft tissue infectionsUrinary tract infections (complicated and uncomplicated)Respiratory tract infections (e.g., pneumonia, bronchitis)SepticemiaMeningitisBone and joint infectionsSurgical prophylaxis

Dosing

Adult
2-4 g (cefoperazone component) IV/IM daily, given in equally divided doses every 12 hours. For severe infections, the dose may be increased up to 8 g/day (cefoperazone component) in 2-4 divided doses.
Pediatric
40-80 mg/kg/day (cefoperazone component) IV/IM, given in 2-4 equally divided doses. For severe infections, up to 160 mg/kg/day (cefoperazone component) may be administered in 2-4 divided doses, not exceeding 8 g/day cefoperazone.
Renal adjustment
CrCl > 30 mL/min: No adjustment. CrCl 15-30 mL/min: Usual dose every 12 hours, but limit sulbactam to 1 g every 12 hours. CrCl < 15 mL/min: Usual dose every 12 hours, but limit sulbactam to 500 mg every 12 hours. Administer after hemodialysis.
Hepatic adjustment
In severe hepatic impairment and/or biliary obstruction, monitor cefoperazone levels; total daily cefoperazone dose should not exceed 4 g due to predominant biliary excretion.
Geriatric
No specific dose adjustment solely based on age. Consider age-related decrease in renal function.
Max dose
Cefoperazone: 8 g/day; Sulbactam: 4 g/day.

Pharmacokinetics

Onset
Rapid (IV)
Peak effect
End of IV infusion
Duration
Dose-dependent, allows for Q12h dosing.
Half-life
Cefoperazone: 1.7-2.4 hours; Sulbactam: Approximately 1 hour.
Bioavailability
100% (IV)
Protein binding
Cefoperazone: 82-93%; Sulbactam: 38%.
Metabolism
Cefoperazone: Minimally metabolized; Sulbactam: Not significantly metabolized.
Excretion
Cefoperazone: Primarily biliary (70-80%), renal (20-30%). Sulbactam: Primarily renal (75-85% as unchanged drug).

Contraindications

  • Hypersensitivity to cefoperazone, sulbactam, other cephalosporins, penicillins, or any component of the formulation.
  • History of severe hypersensitivity reaction to any other beta-lactam antibacterial agent.

Side effects

Common
DiarrheaNauseaVomitingAbdominal painRashPruritusInjection site reactions (pain, phlebitis)Transient elevations in liver function tests
Serious
  • Pseudomembranous colitis (C. difficile infection)
  • Severe hypersensitivity reactions (anaphylaxis)
  • Coagulopathy (vitamin K deficiency, bleeding)
  • Seizures (especially in renal impairment)
  • Neutropenia
  • Thrombocytopenia
  • Hemolytic anemia
  • Cholestatic jaundice

Pregnancy & lactation

Pregnancy

Category B. Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Lactation

Both cefoperazone and sulbactam are excreted in small amounts into breast milk. Generally considered compatible with breastfeeding, but monitor infant for potential adverse effects (e.g., diarrhea, candidiasis, allergic reaction).

Related guidelines

Other Cephalosporin drugs

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