Universal reference book for medicines
Product name: BACPERAZONE (BACPERAZONE)

Active substance: cefoperazone, sulbactam

Type: Cephalosporin III generation with beta-lactamase inhibitor

Manufacturer: GEPACH INTERNATIONAL (India)
A typical clinical and pharmacological article
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..

PHARMACHOLOGIC EFFECT
Combined drug.

Cefoperazone - cephalosporin antibiotic III generation, it acts bactericidal, 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 released by microorganisms resistant to beta-lactam antibiotics;
prevents the destruction of penicillins and cephalosporins under the action of beta-lactamases of resistant microorganisms; binding to penicillin-binding proteins, shows a synergism with simultaneous application with penicillins and cephalosporins.
The combination of sulbactam and cefoperazone is active against all microorganisms sensitive to cefoperazone and acts synergistically (up to 4 times the MIC of the combination as compared to the values ​​for each component alone) 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 for a wide range of microorganisms: gram-positive bacteria - Staphylococcus aureus (including strains that form and do not form penicillinases), 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
Infections of the upper and lower respiratory tract:

pharyngitis;

- tonsillitis;

- sinusitis;

- bronchitis;

- pneumonia;

- bronchopneumonia;

- empyema;

- abscess of the lungs.

Urinary tract infections:

- a pyelonephritis;

- Cystitis;

- prostatitis;

- endometritis;

- Gonorrhea;

- vulvovaginitis.

Intra-abdominal infections:

- peritonitis;

- cholecystitis;

- cholangitis.

Infections of ENT organs:

acute otitis media;

- sinusitis;

- angina.

Infections of the skin and soft tissues:

- furunculosis;

- abscess;

- pyoderma;

- lymphadenitis;

- Lymphangitis.

And:

osteomyelitis.

- Infections of joints.

- sepsis;

- Meningitis.

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

DOSING MODE
In / in or / m.
Adults - 2-4 g / day with an interval of 12 hours; with severe, persistent infections - up to 8 g / day. The maximum daily dose is 8 g.
Patients with CRF (QC <30 ml / min) - dose adjustment: QC 15-30 ml / min - the maximum dose of sulbactam is 1 g 2 times / day, CC less than 14 ml / min, respectively - 500 mg 2 times / day.

If the liver function and biliary tract obstruction are disturbed, the maximum daily dose is no more than 2 g.

Children - 40-80 mg / kg / day in 2-4 admission, in newborns during the first week of life - in 2 divided doses;
with severe, long-lasting infections - up to 160 mg / kg / day. The maximum daily dose is 160 mg / kg / day.
If you need more than 80 mg / kg / day, calculated from the activity of cefoperazone, an increase in dose is achieved through the additional administration of cefoperazone.

For IV bolus injection, 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 water. , and injected for 3 minutes;
for intravenous infusion is dissolved as described above, diluted to 20-100 ml and injected for 15-60 minutes; for the / m introduction, sterile water is used for dissolution.
Preparation of the solution using lidocaine: dilution is carried out in 2 stages - with sterile water, then with 2% lidocaine solution to obtain 0.5% lidocaine solution.The total volume of the solvent is 6.7 ml.

SIDE EFFECT
Allergic reactions: urticaria, maculopapular rash, fever, eosinophilia, rarely anaphylactic shock.

Local reactions: with iv injection, phlebitis;
with the / m introduction - soreness in the injection site.
From the digestive system: diarrhea, nausea, vomiting, pseudomembranous colitis.

On the part of the organs of hematopoiesis: anemia, neutropenia, thrombocytopenia, bleeding (vitamin K deficiency).

Laboratory indicators: increased activity of hepatic transaminases and alkaline phosphatase, hypercreatininaemia, hyperbilirubinemia;
hypoprothrombinemia.
CONTRAINDICATIONS
hypersensitivity, incl.
to other beta-lactam antibiotics;
lactation period.

C with caution: renal and / or hepatic insufficiency, colitis (including in the anamnesis), premature neonates, pregnancy.

PREGNANCY AND LACTATION
Contra-indication is the period of lactation.

C with caution: pregnancy.

APPLICATION FOR FUNCTIONS OF THE LIVER
C with caution: kidney failure.

If you need to use the drug in patients with impaired renal function, you should carefully study the instructions.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
C with caution: hepatic insufficiency.

Dose change and control of cefoperazone concentration in blood serum is required with severe biliary obstruction, severe liver failure (maximum daily dose is 2 g).

If you need to use the drug in patients with impaired liver function, you should carefully study the instructions.

APPLICATION FOR CHILDREN
With caution: premature newborns.

If you need to use the drug in children, you should carefully read the instructions.

SPECIAL INSTRUCTIONS
Considering the wide spectrum of activity, it is possible to conduct adequate monotherapy.

With the simultaneous use of aminoglycosides, kidney function should be monitored.

In patients with liver disease and / or biliary tract obstruction, T 1/2 of cefoperazone is increased, excretion by the kidney is increased.
In severe liver function disorders, the concentration of cefoperazone in bile is therapeutic, T 1/2 increases by 2-4 times. Dose change and control of cefoperazone concentration in blood serum is required with severe biliary obstruction, severe liver failure (maximum daily dose is 2 g).
The risk of developing vitamin K deficiency is susceptible to patients who adhere to a defective diet or who have a malnutrition (cystic fibrosis patients, patients who have been on parenteral nutrition for a long time).
Such patients should be monitored for prothrombin time; If necessary, vitamin K is prescribed. The mechanism of vitamin K deficiency development is suppression of the intestinal microflora, which normally synthesizes this vitamin.
With long-term treatment, it is necessary to monitor indicators of kidney function, liver and hematopoietic system.

During the therapy, false-positive results of the determination of glucose in urine with the use of solutions of Benedict or Feling, false-positive Coombs reaction can be observed.

Treatment of premature newborns, pregnant women, during lactation is carried out if the possible benefit exceeds the potential risk.

OVERDOSE
Symptoms: neurological disorders, including convulsions.

Treatment: symptomatic, sedative therapy.
Hemodialysis is effective.
DRUG INTERACTION
Compatible with water d / and, 5% dextrose solution, 0.9% solution of sodium chloride, 5% dextrose solution in 0.225% sodium chloride solution, 5% dextrose solution in 0.9% sodium chloride solution.

Incompatible with Ringer's solution, 2% solution of lidocaine hydrochloride (initial use of water d / and leads to the formation of a compatible mixture);aminoglycosides (if combined therapy is required, it is carried out by sequential fractional intravenous infusion of two drugs using 2 separate IV transfusion systems, the system should be rinsed with a compatible solvent in the interval between doses administration).

The use of ethanol (simultaneously or for the next 5 days after the end of treatment) increases the risk of developing a disulfiram-like reaction ("hot flashes", increased sweating, headache, tachycardia).

TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE
Store in a dry place, protected from light, out of reach of children, at a temperature not excee
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