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Hypersensitivity: Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients receiving therapy with beta-lactams. Before initiating therapy with sulbactam/cefoperazone, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, carbapenems or other beta-lactam agents. If an allergic reaction occurs, sulbactam/cefoperazone must be discontinued immediately and appropriate alternative therapy instituted.
General: Serious haemorrhage cases, including fatalities, have been reported with sulbactam/cefoperazone. As with other antibiotics, Vitamin K deficiency resulting in coagulopathy has occurred in patients treated with sulbactam/cefoperazone. The mechanism is most probably related to the suppression of gut flora which normally synthesize this vitamin. Those at risk include patients with poor diet, malabsorption states (e.g., cystic fibrosis) and patients on prolonged intravenous alimentation regimens. Prothrombin time should be monitored in these patients, and patients receiving anticoagulant therapy, and exogenous vitamin K administered as indicated. Discontinue sulbactam/cefoperazone if there is persistent bleeding and no alternative explanations are identified.
As with other antibiotics, overgrowth of non-susceptible organisms may occur during prolonged use of sulbactam/cefoperazone. Patients should be observed carefully during treatment. As with any potent systemic agent, it is advisable to check periodically for organ system dysfunction during extended therapy; this includes renal, hepatic, and hematopoietic systems. This is particularly important in neonates, especially when premature, and other infants.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including sulbactam sodium/cefoperazone sodium, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
Effects on Ability to Drive and Use Machines: Clinical experience with sulbactam/cefoperazone indicates that it is unlikely to impair a patient's ability to drive or use machinery.
Use in Hepatic Dysfunction: Cefoperazone is extensively excreted in bile. The serum half-life of cefoperazone is usually prolonged and urinary excretion of the drug increased in patients with hepatic diseases and/or biliary obstruction. Even with severe hepatic dysfunction, therapeutic concentrations of cefoperazone are obtained in bile and only a 2- to 4-fold increase in half-life is seen.
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.
In patients with hepatic dysfunction and concomitant renal impairment, cefoperazone serum concentrations should be monitored and dosage adjusted as necessary. In these cases dosage should not exceed 2 g/day of cefoperazone without close monitoring of serum concentrations.
Use in Infancy: Sulbactam/cefoperazone has been effectively used in infants. It has not been extensively studied in premature infants or neonates. Therefore, in treating premature infants and neonates potential benefits and possible risks involved should be considered before instituting therapy (see Pharmacology: Toxicology: Preclinical Safety Data - Use in Pediatrics under Actions).
Cefoperazone does not displace bilirubin from plasma protein binding sites.
