Cefosulbin
Therapy and medicine

Cefosulbin

Cefosulbin is an antibacterial two-component powder for injection, systemic use. It is recommended for the treatment of infectious diseases in the respiratory and urinary tracts, on the skin, in soft tissues, bones and joints, as well as in peritonitis, meningitis, cholecystitis, and inflammation of the pelvic organs. Read more about the drug, dosage, application in the instructions.

Information
Indications for use (instruction)

Treatment of infections caused by drug-sensitive microorganisms:

  • respiratory tract infections (upper and lower parts);
  • urinary tract infections (upper and lower divisions);
  • peritonitis, cholecystitis, cholangitis and other infections of the abdominal cavity;
  • septicemia;
  • meningitis;
  • infections of the skin and soft tissues;
  • bone and joint infections;
  • pelvic inflammatory diseases, endometritis, gonorrhea and other genital infections.
How to use

The drug solution can be administered intravenously and intramuscularly.

The combination of sodium sulbactam/cefoperazone sodium is presented as a dry powder for reduction in the ratio of 1:1 in terms of free sulbactam and cefoperazone. The 1:1 powder vials contain the equivalent of 500 mg + 500 mg and 1000 mg + 1000 mg of sulbactam and cefoperazone, respectively.

Adults. The usual dose of Cefosulbin® for adults is 2–4 g per day (ie, 1 to 2 g of cefoperazone per day) intravenously or intramuscularly in evenly distributed doses every 12 hours.

Ratio

Sulbactam /

cefoperazone (g)

Sulbactam 

dose (g)

Cefoperazone

dose (g)

1 : 1

2–4

1–2

1–2

In severe or refractory infections, the daily dose of Cefosulbin® can be increased to 8 g (that is, the dose of cefoperazone - 4 g) intravenously in evenly distributed doses every 12 hours. The recommended maximum daily dose of sulbactam is 4 g (8 g of the drug Cefosulbin).

Use in patients with impaired renal function. The dosage regimen when using the drug to treat patients with a significant decrease in renal function (creatinine clearance less than 30 ml / min) is subject to correction in order to compensate for the reduced clearance of sulbactam. For patients with creatinine clearance of 15–30 ml/min, sulbactam is prescribed in a maximum dose of 1 g, which is administered every 12 hours (maximum daily dose of 2 g of sulbactam), and for patients with creatinine clearance less than 15 ml/min, sulbactam is prescribed in a maximum dose of 500 mg every 12 hours (maximum daily dose of 1 g of sulbactam). In severe infections, it may be necessary to additionally administer cefoperazone.

The pharmacokinetic profile of sulbactam is significantly impaired by hemodialysis. The half-life of cefoperazone in blood plasma during hemodialysis is slightly reduced. Thus, the dosage regimen for dialysis should be adjusted.

Combination therapy. Given the wide range of antibacterial activity of sulbactam/cefoperazone, most infections are effectively treated with monotherapy with this drug. However, in some cases, sulbactam/cefoperazone can be used in combination with other antibiotics. In the case of the simultaneous use of aminoglycosides, it is necessary to monitor renal and hepatic function throughout the course of treatment.

Use in patients with impaired liver function. Dose adjustment may be required in cases of severe obstructive jaundice and severe liver disease, or when a similar pathology is accompanied by impaired renal function. Patients with impaired liver function and concomitant impaired renal function need to control the concentration of cefoperazone in blood plasma and, if necessary, appropriate dose adjustment. In cases of lack of careful monitoring of the concentration of the drug in blood plasma, the dose of cefoperazone should not exceed 2 g per day.

Children. The usual dose of Cefosulbin® for children is from 40 to 80 mg/kg/day (i.e. 20–40 mg of cefoperazone/kg/day), evenly distributed in 2–4 doses.

Ratio

Sulbactam /

cefoperazone

(mg / kg body weight / day)

Sulbactam 

dose

(mg / kg body weight / day)

Cefoperazone

dose

(mg / kg body weight / day)

1 : 1

40–80

20–40

20–40

In severe or refractory infections, this dose can be increased to 160 mg/kg/day (80 mg of cefoperazone / kg / day), evenly dividing it into 2–4 doses.

Newborns. For newborns of the 1st week of life, the drug should be administered every 12 hours. The maximum daily dose of sulbactam in children should not exceed 80 mg/kg/day (160 mg/kg/day of the drug Cefosulbin®). In cases where a dose of cefoperazone is required, which exceeds 80 mg/kg/day, an additional dose of cefoperazone should be used separately.

Introduction

For a drop infusion, the contents of each vial of Cefosulbin® should be restored in an appropriate amount of 5% aqueous glucose solution, 0.9% sodium chloride solution for injection or water for injection, and then diluted in 20 ml with the same solution, followed by administration for 15–60 minutes

Recovery.

Total dose

(g)

Equivalent dose

sulbactam + cefoperazone (g)

Solvent

volume

Maximum end

concentration (mg/ml)

1

0,5+0,5

3,4

125+125

2

1+1

6,7

125+125

Ringer's Lactate Solution is an acceptable solvent for infusion, but not for primary reconstitution.

For injection, the contents of each vial should be diluted as described above and administered for at least 3 minutes.

Intravenous administration.

A 2% solution of lidocaine hydrochloride is an acceptable solvent for the preparation of a solution for intramuscular administration, but not for primary dilution.

It was found that Cefosulbin® is compatible with water for injection, 5% glucose solution, 0.9% sodium chloride solution, 5% glucose solution in 0.225% sodium chloride solution and 5% dextrose in 0.9% sodium chloride solution in concentrations from 10 mg of cefoperazone and 5 mg of sulbactam per 1 ml and up to 250 mg of cefoperazone and 125 mg of sulbactam per 1 ml.

Ringer's lactate solution. For recovery, sterile water for injection should be used. A two-stage dilution is necessary using sterile water for injection (see the table above), then the resulting solution should be diluted with Ringer's lactate solution to obtain a concentration of sulbactam of 5 mg/ml (up to 2 ml or 4 ml of the initially diluted solution, add 50 ml or 100 ml of lactate solution Ringer respectively).

Lidocaine. For recovery, sterile water for injection should be used.

Dispose of any unused product or waste in accordance with local regulations.

Children. The drug can be used in children (see above).

Contraindications

The use of the combination drug is contraindicated in patients with a sensibility to sulbactam, penicillin or cephalosporin.

Composition

Active ingredients: sodium sulbactam, sodium cefoperazone;

1 vial contains sodium sulbactam equivalent to 0.5 g or 1 g of sulbactam, sodium cefoperazone equivalent to 0.5 g or 1 g of cefoperazone.

Release form

1 or 5 vials in a carton.

Storage conditions

Store in the original package at a temperature not exceeding 25 °C. Keep out of the reach of children.

Manufacturer

Haupt Pharma Latina S.r.l., Borgo San Michele S.S 156 km. 47, 600 – 04100 Latina (LT), Italy.

Sanitary and hygienic conclusion

№ 1186 dated 05/28/2019
Registration Certificates
UA/9805/01/01
UA/9805/01/02