Cefoperazone & Sulbactam Spenser

• Cephalosporins in combinations

J01DD62 Cefoperazone in combination with a beta-lactamase inhibitor

Cefoperazone

Cefoperazone, Sulbactam

Powder for the preparation of a solution for intravenous and intramuscular administration

Infections of the upper and lower respiratory and urinary tracts, skin and soft tissues, bones and joints, inflammatory diseases of the pelvic organs, genitals (endometritis, gonorrhea, etc.), intra-abdominal infections (peritonitis, cholecystitis, cholangitis, etc.), septicemia, meningitis.

In adults, sulbactam/cefoperazone is recommended for use in the following daily doses (see Table 1):

Table 1

The daily dose should be divided into equal parts and administered every 12 hours.

In severe or refractory infections, the daily dose of sulbactam/cefoperazone can be increased to 8 g at a ratio of the main components of 1:1 (i.e. 4 g of cefoperazone). Patients receiving sulbactam/cefoperazone in a 1:1 ratio may require additional administration of cefoperazone. The dose should be divided into equal parts and administered every 12 hours.

The recommended maximum daily dose of sulbactam is 4 g.

Use in cases of impaired renal function.

In patients with Cl creatinine clearance 15-30 ml/min, the maximum dose of sulbactam is 1 g every 12 hours (maximum daily dose of sulbactam 2 g), and in patients with Cl creatinine less than 15 ml/min, the maximum dose of sulbactam 500 mg every 12 hours (maximum daily dose of sulbactam 1 g). In severe infections, additional administration of cefoperazone may be required.

The pharmacokinetics of sulbactam change significantly with hemodialysis. T_1/2 serum cefoperazone is slightly reduced during hemodialysis. Therefore, the administration of the drug should be planned after dialysis.

Use in children.

In children, sulbactam/cefoperazone is recommended to be used in the following daily doses (see Table 2):

Table 2

The dose should be divided into equal parts and administered every 6-12 hours.

In serious or refractory infections, these dosages can be increased to 160 mg / kg / day at a ratio of the main components of 1:1. The daily dose is divided into 2-4 equal parts.

Use in newborns.

In newborns during the first 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.

Method of preparation of solutions for parenteral use.

In / in the introduction.

For the preparation of the solution for intravenous infusion, a lactated Ringer solution can be used, but it can not be used for initial dissolution, so two-step preparation of the solution is recommended-initially, the powder is dissolved in water for injection, and then diluted with a lactated Ringer solution.

For repeated infusions, the contents of each vial of sulbactam/cefoperazone are dissolved in an adequate volume of 5% dextrose solution in water, 0.9% sodium chloride solution for injection, or sterile water for injection, and then diluted to 20 ml with the same solvent. The infusion is carried out for 15-60 minutes.

For intravenous injection, the contents of each vial should be dissolved as indicated above and administered for a minimum of 3 minutes.

V / m introduction.

To prepare the solution for the/m introduction, you can use 2% lidocaine solution, but you can only apply for the initial dissolution, so it is recommended two-step preparation of the solution — original powder dissolved in water for injection and then diluted with 2% lidocaine hydrochloride.

Preparation of the solution

Table 3

Sulbactam / cefoperazone is compatible with water for injection, 5% dextrose solution, isotonic sodium chloride solution, 5% dextrose solution in saline solution in concentrations from 10 mg / ml of cefoperazone and 10 mg/ml of sulbactam to 250 mg/ml and 250 mg / ml, respectively.

Ringer's laced solution.

To dissolve the powder, use sterile water for injection. The solution is prepared in 2 stages: first, use sterile water for injection (see Table. above), and then the resulting solution is diluted with Ringer's lactated solution to a sulbactam concentration of 5 mg / ml (2 ml of the initial solution is diluted in 50 ml of Ringer's lactated solution or 4 ml in 100 ml of Ringer's lactated solution).

Lidocaine.

To dissolve the powder, use sterile water for injection. A solution containing cefoperazone at a concentration of 250 mg / ml or more is prepared in 2 stages: first, use sterile water for injection (see Table. above), and then diluted with 2% lidocaine solution to obtain a solution containing up to 250 mg / ml of cefoperazone and 250 mg/ml of sulbactam in approximately 0.5% lidocaine hydrochloride solution.

Hypersensitivity, including to penicillins and other cephalosporins.

From the nervous system and sensory organs: headache (0.04%).

From the cardiovascular system and blood (hematopoiesis, hemostasis): hypoprothrombinemia (3.8%), transient eosinophilia (3.5%), decreased hemoglobin (0.9%) and hematocrit (0.9%), thrombocytopenia (0.8%), reversible neutropenia with long-term treatment (0.5%), leukopenia, hypotension, vasculitis.

From the gastrointestinal tract: diarrhea (3.9%), nausea and vomiting (0.6%), pseudomembranous colitis.

Allergic reactions: maculopapular rash (0.6%), urticaria (0.08%), Stevens-Johnson syndrome, anaphylactoid reaction, including shock.

Other: positive Coombs test (5.5%), fever (0.5%), injection pain (0.08%), chills (0.04%), transient increase in ALT (6.2%), AST (5.7%), alkaline phosphatase (2.4%) and bilirubin (1.2%), hematuria, itching.

Local reactions: sometimes-pain at the injection site, phlebitis at the infusion site (0.1%).