| Cefol S 1.5G | |
|---|---|
| Each vial contains: | |
| Cefoperazone | 1000mg |
| Sulbactam | 500 mg |
| Cefol S 3.0G | |
| Each vial contains: | |
| Cefoperazone | 2000mg |
| Sulbactam | 1000 mg |
Cefol s Injection is indicated for the treatment of the following infections when caused by susceptible organisms:
a. Respiratory tract infections (upper and lower)
b. Urinary tract infections (upper and lower)
c. Peritonitis, cholecystitis, cholangitis, and other intra-abdominal infections
d. Septicemia
e. Meningitis
f. Skin and soft tissue infections
g. Bone and joint infections
h. Pelvic inflammatory disease, endometritis, gonorrhea, and other infections of the genital tract
Because of the broad spectrum of activity of sulbactam/cefoperazone, most infections can be treated adequately with this antibiotic combination alone. However, sulbactam/cefoperazone may also be used concomitantly with other antibiotics if such combinations are indicated. If an aminoglycoside is used, renal function should be monitored during the course of therapy.
1) Diabetes mellitus
2) Pre-diabetes
3) Metabolic syndrome
3) Insulin Resistance.
| Daily dosage recommendations for sulbactam/cefoperazone in adults are as follows: | |||
|---|---|---|---|
| Ratio | Sulbactam/Cefoperazone (g) | Sulbactam Activity (g) | Cefoperazone Activity (g) |
| 1:1 | 2.0 to 4.0 | 1.0 to 2.0 | 1.0 to 2.0 |
| 1:2 | 3.0 to 6.0 | 1.0 to 2.0 | 2.0 to 4.0 |
Doses should be administered every 12 hours in equally divided doses.
In severe or refractory infections, the daily dosage of sulbactam/cefoperazone may be increased up to 8 g of the 1:1 ratio (i.e. 4 g of cefoperazone activity) or 12 g of the 1:2 ratio (i.e. 8 g of cefoperazone activity). Patients receiving the 1:1 ratio may require additional cefoperazone administered separately. Doses should be administered every 12 hours in equally divided doses.
The recommended maximum daily dosage of sulbactam is 4 g. In febrile neutropenia, the total daily dose can be administered twice or thrice a day in equally divided doses.
Dosage regimens of sulbactam/Cefoperazone 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). 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.
Cefoperazone is extensively excreted through the bile. The serum half-life of cefoperazone is usually prolonged and urinary excretion of the drug increased in patients with hepatic disease 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 such cases, dosage should not exceed 2 g/day of cefoperazone without close monitoring of serum concentrations.
| Daily dosage recommendations for sulbactam/cefoperazone in children are as follows: | |||
|---|---|---|---|
| Ratio | Sulbactam/Cefoperazone (g) | Sulbactam Activity (g) | Cefoperazone Activity (g) |
| 1:1 | 40 to 80 | 20 to 40 | 20 to 40 |
| 1:2 | 60 to 120 | 20 to 40 | 40 to 80 |
Doses should be administered every 12 hours in equally divided doses.
In serious or refractory infections, these dosages may be increased up to 160 mg/kg/day or 240 mg/kg/day of the 1:2 ratio (160 mg/kg/day cefoperazone activity).
Doses should be administered in two to four equally divided doses.
For neonates in the first week of life, the drug should be given every 12 hours. The maximum daily dosage of sulbactam in pediatric patients should not exceed 80 mg/kg/day. If more than 80 mg/kg/day of cefoperazone activity is necessary, additional cefoperazone should be administered separately.
For intravenous 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, then further diluted to 20mL with the same solution, and followed by the administration over 15 to 60 minutes. Lactated ringer solution is a suitable vehicle for intravenous infusion, but it is not, however, for initial reconstitution.
For intravenous injection, each vial should be reconstituted as above and administered over a minimum of 3 minutes.
Sulbactam/cefoperazone is compatible with water for injection, 5% dextrose, normal saline, 5% dextrose in 0.225% saline, and 5% dextrose in normal saline at concentrations of 10mg cefoperazone and 5mg sulbactam per mL and up to 250mg cefoperazone and 125mg sulbactam per mL.
Cefol S injection is contraindicated in patients with a known allergy to penicillins, sulbactam, cefoperazone, or any of the cephalosporins.