Cefpar SB

Cefpar SB Dosage/Direction for Use

cefoperazone + sulbactam

Manufacturer:

KAPL

Distributor:

Averroes Pharma
Full Prescribing Info
Dosage/Direction for Use
Adults: Daily dosage recommendations for sulbactam/cefoperazone in adults are as follows: (See Table 1.)

Click on icon to see table/diagram/image

Doses should be administered every 12 hrs in equally divided doses.
In severe or refractory infections the daily dosage of sulbactam/cefoperazone may be increased up to 8 g (ie, 4 g cefoperazone activity). Patients 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.
Renal Dysfunction: Dosage regimens 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 clearances 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 clearances 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: Daily dosage recommendations for sulbactam/cefoperazone in children are as follows: (See Table 2.)

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Doses should be administered every 6 to 12 hours in equally divided doses. In serious or refractory infections, these dosages may be increased up to 160 mg/kg/day. Doses should be administered in 2-4 equally divided doses.
Neonates: 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. For doses of sulbactam/cefoperazone requiring >80 mg/kg/day cefoperazone activity, additional cefoperazone should be administered separately.
Administration: Intravenous: For intermittent infusion, each vial of sulbactam/cefoperazone should be reconstituted with the appropriate amount (see Reconstitutions as follows) 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 min.
Lactated Ringer's Solution is a suitable vehicle for intravenous infusion, however, not for initial reconstitution (see Reconstitutions as follows and Incompatibilities under Cautions for Usage).
For intravenous injection, each vial should be reconstituted as described previously and administered over a minimum of 3 min.
Intramuscular: Lidocaine HCl 2% is a suitable vehicle for intramuscular administration, however, not for initial reconstitution (see Reconstitutions as follows and Incompatibilities under Cautions for Usage).
Reconstitution: Cefoperazone/Sulbactam is available in 1.0g strength vial. (See Table 3.)

Click on icon to see table/diagram/image

Cefoperazone/Sulbactam has been shown to be compatible with water for injections. 5% dextrose, normal saline, 5% dextrose in 0.225% saline, and 5% dextrose in normal saline at concentration of 10 mg cefoperazone and 5 mg sulbactam per ml and up to 250 mg cefoperazone and 125 mg sulbactam per ml.
Lactated Ringer's Solution: Sterile water for injection should be used for reconstitution (see Incompatibilities under Cautions for Usage). A two step dilution is required using Sterile Water for Injection (shown in table previously) further diluted with Lactated Ringer's Solution to a sulbactam concentration of 5 mg/ml (use 2 ml initial dilution in 50 ml or 4 ml initial dilution in 100 ml Lactated Ringer's Solution).
Lidocaine: Sterile Water for Injection should be used for reconstitution. For a concentration of cefoperazone of 250 mg/l or larger, a two step dilution is required using Sterile Water for Injection (shown in table previously) further diluted with 2% Lidocaine to yield solutions containing up to 250 mg cefoperazone and 125 mg sulbactam per ml in approximately a 0.5% Lidocaine HCl solution.
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