Bacperazone: Instructions for use: Description of the drug: Price on EUROLAB

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Manufacturers: Gepach International

Active ingredients

Sulbactam
Cefoperazone

Disease class

Cholera
Typhoid and paratyphoid
Other salmonella infections
Leprosy [Hansen's disease]
Other septicemia
Bacterial infection of unspecified localization
Other and unspecified infectious diseases

Clinical and pharmacological group

Not indicated. See instructions

Pharmacological action

Antibacterial
Bactericidal

Pharmacological group

Cephalosporins in combinations

Powder for the preparation of injection solution Bacperazone (Bacperazone)

Instructions for medical use of the drug

Description of pharmacological action

Combined drug. Cefoperazone is a third-generation cephalosporin antibiotic that is bactericidal and has a wide 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, which are secreted by microorganisms resistant to beta-lactam antibiotics; prevents the destruction of penicillins and cephalosporins under the influence of beta-lactamases of resistant microorganisms; binding to penicillin-binding proteins, it exhibits synergism when used simultaneously with penicillins and cephalosporins. The combination of sulbactam and cefoperazone is active against all microorganisms sensitive to cefoperazone and acts synergistically (reduces the MIC of the combination by up to 4 times 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. Active in vitro against a wide range of microorganisms: gram-positive bacteria - Staphylococcus aureus (including strains that form and do not form penicillinase), 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 for use

Infections of the upper and lower respiratory tract: -pharyngitis; -tonsillitis; -sinusitis; -bronchitis; -pneumonia; -bronchopneumonia; -empyema; -lung abscess. Urinary tract infections: -pyelonephritis; -cystitis; -prostatitis; - endometritis; -gonorrhea; -vulvovaginitis. Intra-abdominal infections: -peritonitis; -cholecystitis; -cholangitis. Infections of ENT organs: - acute otitis media; -sinusitis; -angina. Skin and soft tissue infections: -furunculosis; -abscess; - pyoderma; - lymphadenitis; -lymphangitis. And also: -osteomyelitis. - joint infections. -sepsis; -meningitis. Prevention of infectious complications after abdominal, gynecological and orthopedic operations, in cardiovascular surgery.

Release form

powder for preparing a solution for intravenous and intramuscular administration 0.25 g + 0.25 g; bottle (bottle) cardboard pack 1 powder for preparing a solution for intravenous and intramuscular administration 0.5 g + 0.5 g; bottle (bottle) cardboard pack 1 powder for preparing a solution for intravenous and intramuscular administration 1 g + 1 g; bottle (bottle) cardboard pack 1

Pharmacodynamics

Combined drug. Cefoperazone is a third-generation cephalosporin antibiotic that is bactericidal and has a wide 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, which are secreted by microorganisms resistant to beta-lactam antibiotics; prevents the destruction of penicillins and cephalosporins under the influence of beta-lactamases of resistant microorganisms; binding to penicillin-binding proteins, it exhibits synergism when used simultaneously with penicillins and cephalosporins. The combination of sulbactam and cefoperazone is active against all microorganisms sensitive to cefoperazone and acts synergistically (reduces the MIC of the combination by up to 4 times compared to the values for each component separately) against microorganisms: Haemophilias influenzae, Bacteroides spp., Staphylococcus spp., Acinetobacter calcoaceticus, Enterobacter aerogenes, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae, Morganella morganii, Citrobacter freundii, Enterobacter cloacae, Citrobacter diversus. Active in vitro against a wide range of microorganisms: gram-positive bacteria - Staphylococcus aureus (including strains that form and do not form penicillinase), 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 gonorrhpeae, 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: Infections of the upper and lower respiratory tract: pharyngitis, tonsillitis, sinusitis, bronchitis, pneumonia, bronchopneumonia, empyema, lung abscess; urinary tract infections: pyelonephritis, cystitis, prostatitis, endometritis, gonorrhea, vulvovaginitis; intraperitoneal infections: peritonitis, cholecystitis, cholangitis; ENT infections: acute otitis media, sinusitis, tonsillitis; infections of the skin and soft tissues: furunculosis, abscess, pyoderma, lymphadenitis, lymphangitis; osteomyelitis, joint infections; sepsis; meningitis. Prevention of infectious complications after abdominal, gynecological and orthopedic operations, in cardiovascular surgery.

Pharmacokinetics

Cefoperazone - binding to plasma proteins is 82-93%. Distributed in tissues and body fluids, reaching Cmax in bile after 1-2 hours. It penetrates poorly through the blood-brain barrier, penetrates the placental barrier, and is excreted in breast milk. Excreted in bile. Up to 30% of the dose is excreted unchanged in the urine within 12-24 hours. Sulbactam - after IM and IV administration, high concentrations of sulbactam in the blood are achieved. Penetrates well into tissues and biological fluids of the body, passes through the placental barrier, and is excreted in breast milk. With inflamed meningeal membranes, the penetration of the drug into the cerebrospinal fluid increases sharply. Sulbactam undergoes almost no metabolic transformations. T1/2 of sulbactam is approximately 1 hour, excreted mainly unchanged in the urine (70-80%), as well as in bile. Approximately 25% of the drug is excreted as metabolites.

Use during pregnancy

Contraindication: lactation period. Caution: pregnancy.

Use for renal impairment

Caution: renal failure. If it is necessary to use the drug in patients with impaired renal function, you should carefully study the instructions.

Other special occasions at reception

Caution in case of liver failure. If it is necessary to use the drug in patients with impaired liver function, you should carefully study the instructions.

Contraindications for use

Hypersensitivity.

Side effects

Allergic reactions: urticaria, maculopapular rash, fever, eosinophilia, rarely - anaphylactic shock. Local reactions: with intravenous administration - phlebitis; with intramuscular injection - pain at the injection site. From the digestive system: diarrhea, nausea, vomiting. From the hematopoietic organs: anemia, neutropenia, thrombocytopenia, bleeding (vitamin K deficiency). Laboratory indicators: increased activity of “liver” transaminases and alkaline phosphatase, hypercreatininemia, hyperbilirubinemia; hypoprothrombinemia.

Directions for use and doses

IV or IM. Adults - 2-4 g/day. at intervals of 12 hours; for severe, persistent infections - 8 g/day. The maximum daily dose is 8g. For patients with chronic renal failure (creatinine clearance less than 30 ml/min) - dose adjustment: creatinine clearance 15-30 ml/min - 1 g 2 times a day, creatinine clearance less than 14 ml/min - 500 mg 2 times a day. Children - 40-80 mg/kg/day. in 2-4 doses; for severe, long-term infections - 160 mg/kg/day. The maximum daily dose is 160 mg/kg/day. If it is necessary to administer more than 80 mg/kg/day, calculated from the activity of cefoperazone, an increase in the dose is achieved through additional administration of cefoperazone. For intravenous infusion, the contents of the bottle are dissolved in an adequate volume of 5% dextrose solution, 0.9% NaCl solution for injection or sterile water for injection, diluted to 20 ml with the same solution and administered over 15-60 minutes; for intravenous bolus administration, dissolve as indicated above and administer within 3 minutes; For intramuscular administration, sterile water for injection is used for dissolution. To obtain a cefoperazone concentration of 250 mg/ml or more, dilution is carried out in 2 stages: with sterile water, then with a 2% lidocaine solution to obtain a 0.5% lidocaine solution.

Overdose

Symptoms: epileptic seizure. Treatment: sedative therapy. With the development of anaphylactic shock - intravenous administration of epinephrine, oxygen inhalation, corticosteroids.

Interactions with other drugs

Compatible with water for injection, 5% dextrose solution, 0.9% NaCl solution, 5% dextrose solution in 0.25% NaCl solution, 5% dextrose solution in 0.9% NaCl solution. Incompatible with Hartmann's solution, 2% lidocaine hydrochloride solution (initial use of water for injection results in a compatible mixture); aminoglycosides (if combination therapy is necessary, it is carried out by sequential fractional intravenous infusion of 2 drugs, using 2 separate systems for intravenous transfusion; in the interval between doses, the system should be washed with a compatible solvent). Use with ethanol (simultaneously or within the next 5 days after completion of treatment) increases the risk of side effects (hot flashes, increased sweating, headache, tachycardia).

Special instructions for use

Given the wide spectrum of activity, adequate monotherapy can be carried out. When using aminoglycosides concomitantly, it is necessary to monitor renal function. In patients with liver diseases and/or biliary obstruction, T1/2 of cefoperazone increases, and renal excretion is increased. In severe liver dysfunction, the concentration of cefoperazone in bile is therapeutic, T1/2 increases by 2-4 times. Changing the dose and monitoring the concentration of cefoperazone in the blood serum is required for severe obstruction of the biliary tract, severe liver failure (maximum daily dose - 2 g). Patients who adhere to an inadequate diet or have malabsorption of food (patients with cystic fibrosis; patients on parenteral nutrition for a long time) are at risk of developing vitamin K deficiency. In such patients, prothrombin time should be monitored; if necessary, vitamin K is prescribed. The mechanism for the development of vitamin K deficiency is the suppression of the intestinal microflora, which normally synthesizes this vitamin. With long-term treatment, it is necessary to monitor indicators of kidney, liver and hematopoietic system function. During therapy, false-positive results of determining glucose in urine may be observed when using Benedict's or Fehling's solutions, or a false-positive Coombs reaction. Treatment of premature newborns, pregnant women, and lactation is carried out if the possible benefit outweighs the potential risk.

Storage conditions

Store in a dry place, protected from light, out of reach of children, at a temperature not exceeding 25°C.

Best before date

36 months

ATX classification:

J Antimicrobials for systemic use

J01 Antimicrobials for systemic use

J01D Other beta-lactam antibiotics

J01DD Third generation cephalosporins

J01DD62 Cefoperazone in combination with other drugs

Bacperazone

Composition: Cefoperazone + Sulbactam

wide spectrum of antibacterial action
effective monotherapy for severe infections
single inhibitor protected cephalosporin
highly resistant to beta-lactamases

Properties:

Bacperazone is a cephalosporin antibiotic for parenteral use, which is a combination of cefoperazone (3rd generation cephalosporin) and a beta-lactamase inhibitor (sulbactam) in a 1:1 ratio. This combination increases the spectrum of antimicrobial action of cefoperazone and significantly increases its clinical effectiveness. Bakperazone has pronounced bactericidal activity against a wide range of clinically significant strains of gram-positive and gram-negative aerobes, incl. nosocomial, resistant to other antibiotics (enterobacteriaceae producing broad and extended spectrum beta-lactamases, P. aeruginosa, Acinetobacter spp.). Good bactericidal activity against anaerobic bacteria was noted. Primary resistance to the drug is possessed by: methicillin-resistant staphylococci, listeria, E. faecium, E.faecalis, C. difficile, Chlamydia spp., Mycoplasma spp. Secondary resistance of microorganisms to the drug Bacperazone develops slowly (high resistance to the action of beta-lactamases). Bakperazone penetrates well and accumulates in various fluids and tissues of the body (including penetrates the placenta and is found in amniotic fluid). It has a double mechanism of excretion from the body: with bile (75-80%) and with urine. The half-life is 2 hours. It has an Antabuse-like effect, which persists for 48 hours after discontinuation of the drug.

Indications:

Bacperazone is a drug for monotherapy for the following diseases:

severe bacterial infections of the upper and lower respiratory tract, including those with ineffective previous therapy (hospital pneumonia, destructive pneumonia, pleural empyema, lung abscesses),
severe infections of the ENT organs, incl. caused by P. aeruginosae (acute sinusitis, severe otitis media);
intra-abdominal infections (including peritonitis of various locations, including postoperative, liver abscesses),
biliary tract infections (cholangitis, cholecystitis),
gynecological infections (pelvioperitonitis, endometritis),
complicated kidney and urinary tract infections,
infections of soft tissues, bones and joints caused by multidrug-resistant or mixed anaerobic-aerobic microflora (including diabetic foot and postoperative purulent complications after operations on the abdominal and pelvic organs);
sepsis,
infections due to neutropenia,
prevention of infectious complications in oncohematology.

Release form:

Bacperazone (cefoperazone + sulbactam), powder for the preparation of a solution for intravenous and intramuscular administration, 250 mg + 250 mg each; 500 mg+500 mg; 1.0 g + 1.0 g. In glass bottles with a capacity of 10 ml and 20 ml. The solvent used is “Water for injection” in 5 ml ampoules.

One bottle with the drug and instructions for use in a cardboard pack.

Shelf life – 3 years.

Dosage:

Adults and children over 12 years of age: 1-2 g Bacperazone (0.5-1 g cefoperazone and 0.5-1 g sulbactam, respectively) every 12 hours. For severe, life-threatening infections - 4 g (2 g cefoperazone and 2 g sulbactam) IV every 12 hours. The maximum daily dose of sulbactam should not exceed 4 g. Patients receiving the drug in a 1:1 ratio may require additional administration of cefoperazone.

In patients with severe renal failure, dose adjustment is required. When creatinine clearance is 15-30 ml/min, 1 g is administered every 12 hours; if creatinine clearance is less than Bakperazone 15 ml/min - 0.5 g every 12 hours. For severe infections, additional administration of cefoperazone may be required. In patients undergoing hemodialysis, Sulperacef is administered immediately after the end of the dialysis session.

A dose change in case of impaired liver function may be required only in cases of severe obstruction of the biliary tract and severe liver disease, as well as in patients with a combination of hepatic and renal failure. In these cases, it is recommended to monitor the serum concentration of cefoperazone and adjust its dose if necessary. If regular monitoring of the serum concentration of cefoperazone is not possible, then its daily dose should not exceed 2 g.

In children from 1 month to 12 years, the daily dose of the drug is 40-80 mg/kg, which is divided into 2-4 administrations with Bakperazone at intervals of 6-12 hours. For the treatment of severe infections, the dose is increased to 160 mg/kg per day.

In newborns, the maximum daily dose of sulbactam should not exceed 80 mg/kg/day;
During the first week of life, the drug should be administered every 12 hours. THERE ARE CONTRAINDICATIONS, CONSULT WITH A SPECIALIST BEFORE USE

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