Infections of the upper and lower respiratory tract, urinary tract infections, peritonitis, gallbladder and biliary tract infections and other intra-abdominal infections, sepsis, dermatitis, soft tissues, bones and joints, pelvic inflammation, endometritis, gonorrhea and other genital tract infections. The preparation can be used in combination with other antibiotics.
Composition:
1 vial contains 500 mg or 1 g of cefoperazone in the form of sodium salt and 500 mg or 1 g of sulbactam in the form of the sodium salt (in a 1: 1 ratio), respectively.
Action:
Combination of 3rd generation cephalosporin with a beta-lactamase inhibitor. Cefoperazone in combination with sulbactam has a bactericidal effectStaphylococcus spp. (with the exception of meticillin-resistant strains),Streptococcus spp., Haemophilus influenzae, Neisseria gonorrhoeae andN. meningitidis, chopsticksEnterobacteriaceae (IncludingEscherichia coli, Klebsiella spp., Proteus mirabilis, Enterobacter spp., Salmonella spp., Shigella spp.), Pseudomonas aeruginosa, Acinetobacter calcoaceticus. It also works on anaerobic bacteria (Bacteroides spp. includingBacteroides fragilis, Fusobacterium spp., Peptococcus spp., Peptostreptococcus spp., Veillonella spp., Clostridium spp.Eubacterium spp. It does not work onEnterococcus spp. Cefoperazone binds to plasma proteins in 82-93%. Both cefoperazone and sulbactam penetrate, among others to the bile, skin and its appendages, the fallopian tubes and ovaries, the uterus, as well as the barrier of the placenta and breast milk. Approximately 85% of the dose of sulbactam and 25% of the dose of cefoperazone is excreted in the urine and approximately 70% of cefoperazone - in the bile. T0,5 cefoperazone is 1.7 h; sulbaktam - about 1 hour.
Contraindications:
Hypersensitivity to penicillins, sulbactam, cefoperazone or to other cephalosporins.
Precautions:
In newborns, including premature babies, use after considering the benefit / potential risk ratio. Use cautiously in patients with a history of hypersensitivity to various allergens (including penicillins), severe biliary obstruction, severe liver disease or co-existing renal insufficiency, as well as in patients with a deficient diet, in patients with impaired absorption (m.in. cystic fibrosis) or long-term nutritionally administered (due to the risk of vitamin K deficiency, their prothrombin time should be monitored and, if necessary, vitamin K should be administered). In patients who develop diarrhea following administration, the possibility of pseudomembranous enterocolitis should be considered when establishing a diagnosis - if suspected or confirmed, therapy should be discontinued.
Pregnancy and lactation:
There are no controlled studies on the use of the preparation during pregnancy. Because the risk of harmful effects on the fetus and / or breast-fed children can not be excluded, the preparation should not be used during pregnancy and breast-feeding unless clearly necessary.
Side effects:
Very common: leukopenia, neutropenia, positive Coombs test result, decrease in hemoglobin, hematocrit reduction, thrombocytopenia, increase in ALT, AST in the blood, increase in alkaline phosphatase in the blood. Common: eosinophilia, diarrhea, nausea, vomiting, increased bilirubin in the blood. Uncommon: headache, urticaria, pruritus, fever, phlebitis at the injection site, pain at the injection site, chills. In addition: hypoprotrombinemia, anaphylactoid reaction (including shock), hypersensitivity reactions, vasculitis, hypotension, pseudomembranous enterocolitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, maculopapular rash, hematuria. False positive urine Glucose tests by Benedict or Fehling may occur during treatment.
Dosage:
Intramuscularly or intravenously. Adults: 2-4 g / day in 2 doses every 12 hours; in severe infections up to 8 g / day in 2 doses every 12 h (the recommended maximum daily dose of sulbactam is 4 g or 8 g of Sulperazon).In patients with severe renal impairment, the dose should be adjusted to compensate for the decreased clearance of sulbactam: at a creatinine clearance of 15-30 ml / min. a maximum of 1 g of sulbactam should be administered every 12 h (maximum daily dose of sulbactam is 2 g); at creatinine clearance <15 ml / min. administer 500 mg of sulbactam every 12 hours (maximum daily dose of sulbactam is 1 g); in cases of severe infections, additional administration of cefoperazone may be necessary. The drug should be administered after dialysis. Children: 40-80 mg / kg / day in 2-4 doses every 6 hours to 12 hours. In severe or refractory infections, the dose is increased to 160 mg / kg / day in 2 to 4 doses. In newborns <8 days, the drug is administered every 12 hours (the maximum daily dose of sulbactam in children is 80 mg / kg - if a higher dose is needed, additionally cefoperazone should be given).
(C)
