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Composition:


active ingredients: cefoperazone, sulbactam;


FAYTOBACT 1 g: 1 vial contains sulbactam sodium, equivalent to sulbactam 0.5 g, and cefoperazone sodium, equivalent to cefoperazone 0.5 g;


FAYTOBACT 2 g: 1 vial contains sulbactam sodium, equivalent to sulbactam 1 g, and cefoperazone sodium, equivalent to cefoperazone 1 g.


Dosage form. Powder for solution for injection.


Basic physical and chemical properties: crystalline hygroscopic powder from white to almost white in color.


Pharmacotherapeutic group. Antibacterial agents for systemic use. beta-lactam antibiotics. Third-generation cephalosporins. ATX code J01D D62.


Pharmacological properties.


Pharmacodynamics.


The drug contains cefoperazone (a third-generation cephalosporin antibiotic) and sulbactam (an irreversible inhibitor of most major beta-lactamases produced by penicillin-resistant microorganisms).


The antibacterial component of the drug is cefoperazone, which acts on sensitive microorganisms in the stage of active reproduction by inhibiting the biosynthesis of mucopeptide in the cell membrane.


Sulbactam has no pronounced antibacterial activity, except for its action against Neisseriaceae and Acinetobacter. However, biochemical studies on cell-free bacterial systems have shown the ability of sulbactam to permanently inhibit the most important beta-lactamases produced by penicillin-resistant microorganisms.


The potential of sulbactam to prevent the destruction of penicillins and cephalosporins by resistant microorganisms has been confirmed in studies on strains of resistant microorganisms in which sulbactam has demonstrated pronounced synergy with penicillins and cephalosporins. Since sulbactam also binds to some penicillin-binding proteins, sensitive microorganisms become more sensitive to the action of sulbactam/cefoperazone than to the action of cefoperazone alone.


The combination of sulbactam and cefoperazone is active against all microorganisms sensitive to cefoperazone. In addition, when using this combination, there is a synergy of the action of its components against the following microorganisms: Haemophilus influenzae, Bacteroides spp., Acinetobacter calcoaceticus, Enterobacter aerogens, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae, Morganella morganii, Citrobacter freundii, Enterobacter cloacae, Citrobacter diversus.


Sulbactam / cefoperazone is active in vitro against a wide range of clinically significant microorganisms.


Gram-positive microorganisms: Staphylococcus aureus (strains that produce or do not produce penicillinase), Staphylococcus epidermidis, Streptococcus pneumoniae (mainly Diplococcus pneumoniae), Streptococcus pyogenes (β-hemolytic Streptococcus Group A); Streptococcus agalactiae (β-hemolytic Group B Streptococcus), most other types of beta-hemolytic streptococci; most strains of Streptococcus faecalis (enterococci).


Gram-negative microorganisms: Escherichia coli, Klebsiella spp., Enterobacter spp., Citrobacter spp., Haemophilus influenzae, Proteus mirabilis, Proteus vulgaris, Morganella morganii (mainly Proteus morganii), Providencia rettgeri (mainly Proteus rettgeri), Providencia spp., Serratia spp. (including S. marcescens), Salmonella spp.and Shigella spp., Pseudomonas aeruginosa and some species of Pseudomonas, Acinetobacter calcoaceticus, Neisseria gonorrhoeae, Neisseria meningitidis, Bordetella pertussis, Yersinia enterocolitica.


Anaerobic microorganisms: gram-negative bacilli (including Bacteroides fragilis, other Bacteroides species, and Fusobacterium spp.); gram-positive and Gram-negative cocci (including Peptococcus spp., Peptostreptococcus spp. and Veillonella spp.gram-positive bacilli (including Clostridium spp., Eubacterium spp. and Lactobacillus spp.).


For the drug, the following ranges of effective concentrations are established (BMD, mcg/ml according to the concentration of cefoperazone): sensitive – less than 16, intermediate – 17-36, resistant – more than 64.


Pharmacokinetics. When the drug is administered, approximately 84% of sulbactam and 25% of cefoperazone are excreted by the kidneys. Most of cefoperazone is excreted in the bile. After administration of sulbactam/cefoperazone, the average Half – Life of sulbactam is 1 hour, and cefoperazone is 1.7 hours. Plasma concentrations are proportional to the administered dose. These data correspond to the pharmacokinetic parameters of the components when they are used separately.


The average values of the maximum concentrations of sulbactam and cefoperazone after administration of 2 g of the drug (1 g of sulbactam, 1 g of cefoperazone) intravenously for 5 minutes are 130.2 and 236.8 mcg/mL, respectively. This indicates a larger volume of distribution of sulbactam (Va = 18.0-27.6 L) compared to the distribution of cefoperazone (Va = 10.2-11.3 L). Sulbactam and cefoperazone are intensively distributed in tissues and body fluids, including bile, gallbladder, skin, appendix, fallopian tubes, ovaries, and uterus. In children, the Half – Life of sulbactam is from 0.91 to 1.42 hours, cefoperazone-from 1.44 to 1.88 hours. There are no data on the pharmacokinetic interaction between sulbactam and cefoperazone when used concomitantly in combination.


After repeated administration, no significant changes in the pharmacokinetics of the drug components and any accumulation of them were detected when used every 8-12 hours.


Impaired liver function. See the section "application features".


Impaired renal function. In patients with varying degrees of renal impairment with sulbactam/cefoperazone, the total clearance of sulbactam closely correlates with creatinine clearance. Patients with severe renal impairment have a significant prolongation of the Half-Life of sulbactam (an average of 6.9 and 9.7 hours according to various studies). Hemodialysis significantly affects the Half-Life, total clearance and volume of distribution of sulbactam. There were no significant changes in the pharmacokinetics of cefoperazone in patients with renal insufficiency.


Cefoperazone does not displace bilirubin from binding to serum albumin.


Clinical characteristics.


Indications.


Treatment of infections caused by microorganisms sensitive to the drug:


- infections of the respiratory tract (upper and lower parts);


- urinary tract infections (upper and lower parts);


- peritonitis, cholecystitis, cholangitis and other abdominal infections;


- septicemia;


- meningitis;


- skin and soft tissue infections;


- infections of bones and joints;


- pelvic inflammatory diseases, endometritis, gonorrhea and other genital infections.


Contraindications.


The use of the combined drug is contraindicated in patients with a history of allergy to sulbactam, penicillins or cephalosporins.


Interactions with other drugs and other types of interactions.


Aminoglycosides. Mixing the drug with aminoglycosides in one syringe leads to mutual inactivation; if these groups of antibacterial agents should be used in the same time period, then they should be administered in different places at intervals of 1 hour. The drug increases the risk of developing nephrotoxicity of aminoglycosides, furosemide.


Bacteriostatic drugs (chloramphenicol, erythromycin, sulfonamides, tetracyclines) reduce the activity of the drug.


Probenecid reduces the tubular secretion of sulbactam; the result is an increase in their plasma concentration and Half-Life of drugs and an increased risk of intoxication. Increases the risk of bleeding when used together with nonsteroidal anti-inflammatory drugs.


Alcohol. When drinking alcohol during the course of treatment and for 5 days after treatment with cefoperazone, reactions such as redness of the face, sweating, headache, tachycardia were noted. Similar reactions were observed with the use of other cephalosporins. Patients should be careful when drinking alcoholic beverages when using the drug. When using artificial nutrition (oral or parenteral), solutions containing ethanol should not be used.


Combination therapy. Given the broad spectrum of antibacterial activity of sulbactam/cefoperazone, most infections can be adequately treated with this antibiotic as monotherapy. However, for certain indications, sulbactam/cefoperazone can be used together with other antibiotics. If aminoglycosides are used, it is necessary to monitor renal function throughout the entire course of therapy (also see the section "incompatibilities").


Interaction with substances used in laboratory tests. A false positive reaction to glucose in the urine can be detected when using a solution of Benedict or Fehling.


Application features.


Hypersensitivity. Severe and sometimes fatal anaphylactic reactions have been reported in patients treated with beta-lactam or cephalosporins. Such reactions are more likely to occur in individuals with a known history of hypersensitivity to many allergens. If allergic reactions develop, the drug should be discontinued immediately and appropriate treatment should be prescribed. Severe anaphylactic reactions require immediate use of emergency therapy, in particular the introduction of epinephrine. According to indications, it is possible to use oxygen therapy, intravenous administration of corticosteroids, ensuring airway patency, including intubation.

General warnings. As with other antibiotics, treatment with cefoperazone in some patients can lead to the development of vitamin K deficiency. the mechanism of this phenomenon is probably associated with the suppression of intestinal microflora, which normally synthesizes this vitamin. Thus, the risk group includes patients with limited nutrition, malabsorption (for example, with gallbladder fibrosis) and people who are on parenteral (intravenous) nutrition for a long time. In such patients, prothrombin time should be monitored. Similar monitoring should be performed for patients receiving anticoagulant therapy. In these cases, exogenous vitamin K should be prescribed.


As with other antibiotics, long-term treatment with the drug can lead to increased growth of resistant microflora. During treatment, it is necessary to carefully monitor the condition of patients. You should be prepared for periodic manifestations of disorders of the kidneys, liver and hematopoietic system, as with the use of other systemic agents. This is especially true for newborns, especially premature babies, as well as other infants.


It is necessary to periodically check whether any manifestations of organ system disorders, including kidney, liver, and hematopoietic system disorders, have occurred during long-term treatment.


Clostridium difficile-related diarrhea (CDAD) has been reported with almost all antibacterial agents, including sulbactam sodium/ cefoperazone sodium. The severity of symptoms can range from moderate diarrhea to fatal colitis. Treatment with antibacterial agents suppresses the normal flora of the colon, which leads to increased growth of C. difficile. 


C. difficile produces toxins A and B, which are important in the development of CDAD. Hypertoxin produced by C. difficile strains causes an increase in morbidity and mortality rates, since these microorganisms may be immune to antimicrobial therapy, which may lead to the need for colectomy.  CDAD should be considered in all patients who have developed diarrhea after taking antibiotics. It is necessary to carefully collect a medical history of the disease, since the occurrence of CDAD was reported 2 months after the appointment of antibacterial agents.


If superinfection occurs, appropriate treatment should be prescribed.


This medicine contains sodium: the drug may not be suitable for use in patients who are on a diet with controlled sodium content.


Use in patients with impaired renal function. In patients with impaired renal function of varying degrees when using the drug, the total clearance of sulbactam closely correlates with a certain creatinine clearance. In patients with severe renal impairment, there is a significant increase in the Half-Life of sulbactam. Hemodialysis significantly affects the Half-Life, total clearance, and volume of distribution of sulbactam. No changes in the pharmacokinetics of cefoperazone were found in patients with renal insufficiency.


Use in patients with impaired liver function. Cefoperazone is largely excreted in the bile. In patients with liver disease and/or biliary tract obstruction, the plasma half-life of cefoperazone is usually prolonged and urinary excretion increases. Even with severe hepatic impairment, therapeutic concentrations of cefoperazone are detected in the bile, and the Half-Life in blood plasma increases by 2-4 times.


In cases of severe biliary tract obstruction, severe liver disease, or concomitant renal impairment, dose adjustment may be necessary.


Use in elderly and senile patients. When using both sulbactam and cefoperazone, there was an increase in the Half-Life, a decrease in total clearance, and an increase in the volume of distribution compared to data for young volunteers. The pharmacokinetics of sulbactam directly correlated with the level of renal function, and the pharmacokinetics of cefoperazone correlated well with impaired liver function.


Use for the treatment of children. Studies in the pediatric population did not reveal any changes in the pharmacokinetics of the drug components, and there are no significant differences compared to adults.


Use for the treatment of infants. The drug can be effectively used in infants. However, comprehensive studies on the use of premature infants or newborns have not been conducted. Therefore, the potential benefits and possible risks of therapy should be carefully evaluated before starting treatment for premature infants or newborns. Cefoperazone does not displace bilirubin from plasma protein binding sites.

Use during pregnancy or lactation.


The drug penetrates the placental barrier. Prescribe the drug to pregnant women should only be when the possible benefit to the mother outweighs the potential risk to the fetus.


Only a small fraction of the administered dose of sulbactam and cefoperazone passes into breast milk. Although both components of the drug penetrate in small amounts into breast milk, the drug should be prescribed with caution to women who are breast-feeding.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


The impact is unlikely.


Dosage and administration.


The solution of the drug can be administered intravenously and intramuscularly.


Before starting therapy, it is necessary to exclude the presence of hypersensitivity to Faytobact in the patient (make an intradermal test for antibiotic tolerance).


Adults should use in an average daily dose of 2-4 G (administered every 12 hours). In severe cases of infections, the dose can be increased to 8 g per day with a ratio of active substances of 1:1 (i.e., the content of cefoperazone is 4 g). Patients receiving sulbactam and cefoperazone in a ratio of 1:1 may need additional separate administration of cefoperazone. In this case, it should be administered every 12 hours in equal doses. The recommended maximum daily dose of sulbactam is 4 g.


Use in patients with impaired renal function. The dose regimen when using the drug for the treatment of patients with a significant decrease in renal function (creatinine clearance less than 30 mL/min) is subject to correction in order to compensate for the reduced clearance of sulbactam. Patients with a creatinine clearance of 15-30 mL/min should be prescribed sulbactam at a maximum dose of 1 g, which is administered every 12 hours (the maximum daily dose is 2 g of sulbactam), and patients with a creatinine clearance of less than 15 mL/min should be prescribed sulbactam at a maximum dose of 500 mg, which is administered every 12 hours (the maximum daily dose is 1 g of sulbactam). In severe infections, additional administration of cefoperazone may be necessary.


The pharmacokinetic profile of sulbactam is significantly impaired with hemodialysis. The Half-Life of cefoperazone in blood plasma during hemodialysis is slightly reduced. Thus, the dose regimen for dialysis should be subject to correction.


Combination therapy. Given the wide spectrum of antibacterial activity of sulbactam/cefoperazone, most infections are effectively treated with monotherapy with this drug. However, in some cases, sulbactam/cefoperazone can be used in combination with other antibiotics. In the case of concomitant use of aminoglycosides, it is necessary to monitor the function of the kidneys and liver throughout the entire course of treatment.


Use in patients with impaired liver function. Dose adjustment may be necessary in cases of severe obstructive jaundice and severe liver diseases, or when both pathologies are accompanied by impaired renal function. Patients with impaired liver function and concomitant renal impairment should monitor the concentration of cefoperazone in blood plasma and, if necessary, adjust the dose accordingly. In the absence of careful monitoring of the concentration of the drug in blood plasma, the dose of cefoperazone should not exceed 2 g per day.


For children, the dose of the drug is 40-80 mg/kg per day. The drug should be administered every 6-12 hours in evenly distributed doses.


In the case of severe infections, these doses can be increased to 160 mg/kg per day with a ratio of sulbactam and cefoperazone of 1:1. the dose should be administered, dividing it into 2-4 equal parts.


Treatment of infants. In infants of the 1st week of life, the drug should be administered every 12 hours.


The maximum daily dose of sulbactam for children should not exceed 80 mg/kg per day. If the required dose of cefoperazone exceeds 80 mg/kg/day, cefoperazone should be prescribed separately.

Children.


Fight Act can be used for children. However, comprehensive studies on the use of the drug in premature infants or newborns have not been conducted. Therefore, the potential benefits and possible risks of therapy should be carefully evaluated before starting treatment for premature infants or newborns.


Overdose.


Overdose of the drug can cause manifestations that represent increased side effects. It should be taken into account that high concentrations of beta-lactam antibiotics in the cerebrospinal fluid can cause neurological reactions, in particular seizures. Since cefoperazone and sulbactam are isolated from the circulatory system by hemodialysis, this procedure may increase the elimination of the drug from the body in case of overdose in patients with impaired renal function.


Adverse reactions.


The drug is usually well tolerated. Most of the side effects are mild or moderate and do not require discontinuation of the drug.


When used, the following side effects were detected.


From the digestive system. The most common side effects of the drug, as well as other antibiotics, were manifestations of the digestive system, including diarrhea, nausea and vomiting, pseudomembranous colitis, superinfections, hyperesthesia of the oral mucosa.


From the skin and subcutaneous tissues. As with all penicillins and cephalosporins, hypersensitivity may include maculopapular rash and urticaria, erythema, exfoliative dermatitis, toxic epidermal necrolysis, pruritus, and Stevens-Johnson syndrome. The development of these reactions is more likely in patients with a history of allergies, in particular to penicillins.


From the side of the blood and lymphatic system. There were cases of a slight decrease in the number of neutrophils. As with other beta-lactam antibiotics, reversible neutropenia may develop with prolonged use. Some individuals may have a positive direct Coombs test during treatment. There may be a decrease in the level of hemoglobin or hematocrit, cases of eosinophilia, thrombocytopenia and hypoprothrombinemia, leukopenia, anemia.


From the central nervous system. Cefoperazone can significantly reduce the reserve of albumin concentration, and in the treatment of newborns with jaundice, it increases the risk of developing bilirubin encephalopathy.


From the cardiovascular system. Hypotension, vasculitis, bradycardia/tachycardia, cardiogenic shock, cardiac arrest.


From the immune system. Hypersensitivity reactions, anaphylactoid and anaphylactic reactions (including anaphylactic shock).


Other manifestations. Headache, drug-induced fever, chills, pain and changes at the injection site, muscle twitching, anxiety.


From the side of the kidneys and urinary system. Hematuria.


From the side of the hepatobiliary system. Jaundice.


From the respiratory system. Infrequently laryngospasm, bronchospasm in patients with a history of bronchial asthma and chronic obstructive airway diseases. Rare: allergic rhinitis, dyspnoea.


Changes in laboratory parameters. There was a variable increase in the indicators of functional liver tests ASAT, Alt, the level of alkaline phosphatase, bilirubin, prolongation of prothrombin time, pseudo-positive results in determining the glucose content in the urine by nonenzymatic methods.


Local reactions. The drug is well tolerated when administered intramuscularly. Occasionally, there may be pain at the injection site. As with other cephalosporins and penicillins, when the drug is administered through an intravenous catheter, some patients may develop phlebitis at the infusion site.


Infections and infestations: superinfections.


Expiration date. 2 years.


Storage conditions.


Store in the original packaging, at a temperature not exceeding 25 °C OUT of the reach of children.


Incompatibility. Faytobact and aminoglycosides should not be directly mixed, as there is a physical incompatibility between them. If combination therapy with the drug and aminoglycosides is necessary, their sequential separate drip infusion should be used using a separate secondary intravenous tube system, while the primary intravenous tube system should be thoroughly rinsed with the appropriate solution in between infusions of these drugs. It is also advisable that during the day the intervals between the administration of the drug and aminoglycosides should be as long as possible.


Primary dilution with ringer's lactate solution is not recommended, as this mixture is incompatible with the drug (see the section "dosage and administration").


Primary dilution with 2% lidocaine solution is not recommended, as this mixture is incompatible (see the section "dosage and administration").


Cefoperazone is physically incompatible with perfinazine, promethazine.

Tags: Sulbactam, Cefoperazone