Baccefort, 0.5 g+0.5 g 10 ml

Combination drug, broad-spectrum antibiotic.

Cefoperazone – cephalosporin antibiotic of III generation, acts bactericidal, has a broad spectrum of action; highly active against aerobic and anaerobic Gram-positive and Gram-negative microorganisms (including Pseudomonas aeruginosa), resistant to beta-lactamases of Gram-positive and Gram-negative microorganisms.

Sulbactam is an irreversible inhibitor of beta-lactamases that are released by microorganisms resistant to beta-lactam antibiotics; prevents degradation of penicillins and cephalosporins under the action of beta-lactamases of resistant microorganisms; binds to penicillin-binding proteins and shows synergism when used simultaneously with penicillins and cephalosporins.

The combination cefoperazone + sulbactam is active against all microorganisms sensitive to cefoperazone, and shows synergism (reduces up to 4 times the MAC of the combination compared to the values for each component separately) against microorganisms: Haemophilus influenzae, Bacteroides spp, Staphylococcus spp., Acinetobacter calcoaceticus, Enterobacter aerogenes, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae, Morganella morganii, Citrobacter freundii, Enterobacter cloacae, Citrobacter diversus.

It is active in vitro against Gram-positive bacteria – Staphylococcus aureus (including. penicillinase-forming and non-forming strains), Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes (beta-hemolytic strain of group A), Streptococcus agalactiae (beta-hemolytic strain of group B), most strains of beta-hemolytic Streptococcus spp, Enterococcus faecalis; Gram-negative bacteria – Escherichia coli, Klebsiella spp., Enterobacter spp., Citrobacter spp., Haemophilus influenzae, Proteus mirabilis, Morganella morganii, Providencia rettgeri, Providencia spp., Serratia spp. (including Serratia marcescens), Salmonella spp., Shigella spp, Pseudomonas aeruginosa, Acinetobacter calcoaceticus, Neisseria gonorrhoeae, Neisseria meningitidis; Bordetella pertussis, Yersinia enterocolitica; anaerobic bacteria – Bacteroides fragilis, Fusobacterium spp, Peptococcus spp., Peptostreptococcus spp., Veillonella spp., Clostridium spp., Eubacter spp., Lactobacillus spp.

Indications

The treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the cefoperazone+sulbactam combination: pharyngitis, tonsillitis, sinusitis, bronchitis, pneumonia, bronchopneumonia, empyema, lung abscess, pyelonephritis, cystitis, prostatitis, endometritis, gonorrhea, vulvovaginitis; Peritonitis, cholecystitis, cholangitis; acute otitis media, sinusitis, angina; furunculosis, abscess, pyoderma, lymphadenitis, lymphangitis; osteomyelitis, joint infections, sepsis, meningitis.

The prevention of infectious complications after abdominal, gynecological and orthopedic operations, in cardiovascular surgery.

Active ingredient

How to take, the dosage

Integrated by injection in m/m or intra v/v.

The ratio of the components of the combination is 1:1.

In adults, the daily dose of the combination is 2-4 g (cefoperazone 1-2 g + sulbactam 1-2 g). The daily dose should be divided into equal parts and administered every 12 hours.

In severe or refractory infections, the daily dose of the combination may be increased to 8 g (cefoperazone 4 g + sulbactam 4 g).

In children, the daily dose of the combination is 40-80 mg/kg/day (cefoperazone 20-40 mg/kg+sulbactam 20-40 mg/kg). The daily dose should be divided in equal portions and administered every 6-12 hours.

In serious or refractory infections, the daily dose of the combination may be increased to 160 mg/kg.

In newborns during the first week of life, the combination should be administered every 12 h. The maximum daily dose of sulbactam in children should not exceed 80 mg/kg/day.

In patients with significant renal impairment (CKR 15-30 ml/min)the maximum dose of sulbactam is 1 g every 12 hours (maximum daily dose of sulbactam is 2 g) and in patients with CKR less than 15 ml/min the maximum dose of sulbactam is 500 mg every 12 hours (maximum daily dose of sulbactam is 1 g). In severe infections additional administration of cefoperazone may be required. Since in hemodialysis the pharmacokinetics of sulbactam is significantly altered and the T1/2 of cefoperazone from serum is slightly reduced, the administration of this combination should be planned after dialysis.

If regular monitoring of serum cefoperazone concentrations is not performed, the minimum daily dose should not exceed 2 g.

If more than 80 mg/kg/day, calculated by cefoperazone activity, the dose increase is achieved by additional administration of cefoperazone.

For intravenous bolus administration the contents of the vial are dissolved in an adequate volume of 5% dextrose solution, 0.9% sodium chloride solution, 5% dextrose solution in 0.225% sodium chloride solution, 5% dextrose solution in 0.9% sodium chloride solution or sterile d/i water, and administered for 3 min; for intravenous infusion it is dissolved as indicated above, diluted to 20-100 ml and administered for 15-60 min; for intravenous infusion sterile d/i water is used for dissolution.

Preparing the solution using lidocaine: dilute in 2 steps – with sterile water, then with 2% lidocaine solution to obtain 0.5% lidocaine solution. The total volume of solvent is 6.7 ml.

Interaction

Compatible with d/i water, 5% dextrose solution, 0.9% sodium chloride solution, 5% dextrose solution in 0.225% sodium chloride solution, 5% dextrose solution in 0.9% sodium chloride solution.

Incompatible with Ringer’s solution, 2% lidocaine hydrochloride solution (initial use of d/i water results in a compatible mixture); aminoglycosides (if combined therapy is necessary, it is performed by sequential fractional IV infusions of the two drugs, using 2 separate IV transfusion systems; in the interval between doses the system should be flushed with a compatible solvent).

The use of ethanol (concomitantly or within the next 5 days after treatment completion) increases the risk of a disulfiram-like reaction (“hot flashes”, increased sweating, headache, tachycardia).

Special Instructions

When concomitant use of aminoglycosides, renal function should be monitored.

In patients with liver disease and/or with biliary obstruction the T1/2 of cefoperazone is increased and renal excretion is increased. In severe hepatic impairment, the concentration of cefoperazone in bile is therapeutic, T1/2 increases 2-4 times. Dose modification and control of cefoperazone serum concentration is required in severe biliary obstruction, severe hepatic insufficiency (maximum daily dose is 2 g).

Patients on an incomplete diet or with impaired absorption of food (cystic fibrosis patients; patients on parenteral nutrition for a long time) are at risk of vitamin K deficiency. In such patients should be monitored prothrombin time, if necessary prescribe vitamin K. The mechanism of vitamin K deficiency is the suppression of intestinal microflora, which normally synthesize this vitamin.

With long-term treatment it is necessary to monitor indicators of renal function, liver function and the hematopoietic system.

False positives in the urine glucose determination with Benedict or Fehling solutions and false positive Coombs reaction may be observed during treatment.

The treatment of premature infants, pregnant women, during lactation is carried out if the possible benefit exceeds the potential risk.

Contraindications

Hypersensitivity to cefoperazone, sulbactam, penicillins, other cephalosporins.

With caution: renal and/or hepatic failure, colitis (including anamnesis), premature infants, pregnancy.

Side effects

Allergic reactions: anaphylactic shock.

Digestive system disorders: diarrhea, nausea, vomiting, pseudomembranous colitis; transient increase of liver function parameters – AST, ALT, ALF, serum bilirubin.

Allergic reactions: maculopapular rash, pruritus, urticaria, Stevens-Johnson syndrome (the risk of these reactions is higher in patients with a history of allergic reactions).

Hematopoietic system disorders: decrease of neutrophil number, reversible neutropenia (during long-term treatment), decrease of hemoglobin and hematocrit level, transient eosinophilia, leukopenia, thrombocytopenia, hypoprotrombinemia; in single cases – positive Coombs’ test. A false-positive reaction to glucose in the urine may be observed when using Benedict’s or Fehling’s solution.

Urinary system disorders: hematuria.

Local reactions: sometimes after an intravenous injection there is transient pain, burning at the injection site. When administered intravenously with a catheter phlebitis may develop at the site of infusion.

Others: headache, fever, chills, vasculitis.

Similarities