Adults: The usual adult dose of the combination is 2 to 4 g/day (i.e., 1-2 g/day each of Cefoperazone + Sulbactam) given IV or IM in equally divided doses every 12 hours. In severe or refractory infections the daily dosage may be increased to 8 g (i.e., 4 g/day each of Cefoperazone + Sulbactam) given IV or IM in equally divided doses every 12 hours. The recommended maximum daily dosage of Sulbactam is 4 g (8 g of the combination).
Children: The usual dosage in children is 40-80 mg/kg/day (20 to 40 mg/kg/day each of Cefoperazone and Sulbactam) every six to twelve hours. In serious or refractory infections, these dosages may be increased up to 240 mg/kg/day (160 mg/kg/day cefoperazone activity). Doses should be administered in two to four equally divided doses.
Use in Neonates: For neonates in the first week of life, the drug should be given every 12 hours. The maximum daily dosage of sulbactam in pediatrics should not exceed 80 mg/kg/day.
Renal Impairment: Dosage regimens of Cefoperazone + Sulbactam should be adjusted in patients with a marked decrease in renal function (creatinine clearance of less than 30 mL/min) to compensate for the reduced clearance of sulbactam. Patients with creatinine clearances between 15 and 30 mL/min should receive a maximum of 1 g of sulbactam every 12 hours (maximum daily dosage of 2 g sulbactam), while patients with creatinine clearances of less than 15 mL/min should receive a maximum of 500 mg of sulbactam every 12 hours (maximum daily dosage of 1 g sulbactam).
The pharmacokinetic profile of sulbactam is significantly altered by hemodialysis. The serum half-life of cefoperazone is reduced slightly during hemodialysis. Thus, dosing should be scheduled to follow a dialysis period.
Hepatic Impairment: Cefoperazone is extensively excreted through the bile. 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 such cases, dosage should not exceed 2 g/day of cefoperazone without close monitoring of serum concentrations.
Method of Administration: Intravenous Administration: For intermittent infusion, each vial of Cefoperazone + Sulbactam should be reconstituted with the appropriate amount of 5% Dextrose in Water, 0.9% Sodium Chloride Injection or Sterile Water for Injection and then diluted to 20 mL with the same solution followed by the administration over 15 to 60 minutes.
Lactated Ringer's Solution is a suitable vehicle for intravenous infusion, however, not for initial reconstitution.
For intravenous injection, each vial should be reconstituted as previously mentioned and administered over a minimum of 3 minutes.
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