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Zifam CS1/CS2 is available in 1 g and 2 g strength vials.
The total dosage of 1 g has an equivalent dosage of 0.5 g of sulbactam and 0.5 g of cefoperazone. The total volume of reconstituted solution is 4 mL and the maximum final concentration is 125 mg/mL of sulbactam and 125 mg/mL of cefoperazone.
The total dosage of 2 g has an equivalent dosage of 1 g of sulbactam and 1 g of cefoperazone. The total volume of reconstituted solution is 8 mL and the maximum final concentration is 125 mg/mL of sulbactam and 125 mg/mL of cefoperazone.
Adults: Usual Dose: 2-4 g/day. Doses should be administered IV or IM every 12 hrs in equally divided doses. In severe or refractory infections, the daily dosage may be increased up to 8 g (ie, 4-g cefoperazone activity).
Patients receiving the 1:1 ratio may require additional cefoperazone administered separately. Doses should be administered every 12 hrs in equally divided doses. The recommended maximum daily dosage of sulbactam is 4 g.
Dosage regimen of sulbactam/cefoperazone should be adjusted in patients with marked decrease in renal function (creatinine clearance of <30 mL/min) to compensate for the reduced clearance of sulbactam. Patients with creatinine clearance between 15 and 30 mL/min should receive a maximum of 1 g of sulbactam administered every 12 hrs (maximum daily dosage of 2-g sulbactam), while patients with creatinine clearance of <15 mL/min should receive a maximum of 500 mg of sulbactam every 12 hrs (maximum daily dosage of 1-g sulbactam). In severe infections, it may be necessary to administer additional cefoperazone.
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.
Children: Usual Daily Dose: 40-80 mg/kg/day (ie, 20-40 mg/kg/day cefoperazone activity) in 2-4 equally divided doses. In serious or refractory infections, the dosage may be increased up to 160 mg/kg/day (ie, 80 mg/kg/day cefoperazone activity) in 2-4 equally divided doses. For neonates in the 1st week of life, the drug should be given every 12 hrs. The maximum daily dosage of sulbactam in pediatrics should not exceed 80 mg/kg/day. In cases where doses above 80 mg/kg/day cefoperazone activity are necessary, additional cefoperazone should be administered.
IV Administration: For intermittent infusion, each vial of sulbactam/cefoperazone 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 administration over 15-60 mins.
For IV injection, each vial should be reconstituted as previously mentioned and administered over a minimum of 3 mins.
IM Administration: Sterile water for injection should be used for reconstitution. For a concentration of cefoperazone of ≥250 mg/mL, a 2-step dilution is required using sterile water for injection further diluted with 2% lidocaine to yield solutions containing up to 250 mg cefoperazone and sulbactam 125 mg/mL in approximately 0.5% lidocaine HCl solution.
Incompatibilities: Aminoglycosides: Solution of sulbactam/cefoperazone and aminoglycosides should not be directly mixed, since there is a physical incompatibility between them. If combination therapy with sulbactam/cefoperazone and an aminoglycoside is contemplated, this can be accomplished by sequential intermittent IV infusion provided that separate secondary IV tubing is used and that the primary IV tubing is adequately irrigated with an approved diluent between doses. It is also suggested that doses of sulbactam/cefoperazone be administered throughout the day at times as far removed from administration of the aminoglycoside as possible.
Lactated Ringer's Solution: Initial reconstitution with Lactated Ringer's solution should be avoided since this mixture has been shown to be incompatible. However, a 2-step dilution process involving initial reconstitution in water for injection will result in a compatible mixture when further diluted with Lactated Ringer's solution.
Lidocaine: Initial reconstitution with 2% lidocaine HCl solution should be avoided since these mixtures have been shown to be incompatible. However, a 2-step dilution process involving initial reconstitution in water for injection will result in a compatible mixture when further diluted with 2% lidocaine HCl solution.
