Baccefort
Bactsefort: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Bactsefort
ATX code: J01DD62
Active ingredient: cefoperazone (Cefoperazone), sulbactam (Sulbactam)
Manufacturer: PJSC "Kraspharma" (Russia)
Description and photo update: 2019-11-07
Prices in pharmacies: from 169 rubles.
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Baccefort is a combined antibiotic.
Release form and composition
Dosage form - powder for preparation of a solution for intravenous (i / v) and intramuscular (i / m) administration: white or white-yellowish, hygroscopic (0.5 g + 0.5 g, 1 g + 1 g, 1, 5 g + 1.5 g or 2 g + 2 g of active ingredients in colorless glass vials with a volume of 10 and 20 ml, in a cardboard box 1 or 10 bottles and instructions for use of Bakzefort; packing for hospitals - 50 bottles in a cardboard box; complete set with a solvent: dosage 0.5 g + 0.5 g - in a cardboard box 1 blister containing 1 vial with the drug and 1 ampoule with a 5 ml solvent, or separate blisters containing 5 vials with the drug and 5 ampoules with solvent; dosages 1 g + 1 g, 1.5 g + 1.5 g and 2 g + 2 g - in a cardboard box 1 blister strip,containing 1 vial with the drug and 1 ampoule with a solvent of 10 ml or 2 ampoules with a solvent of 5 ml each, or separate blister packs containing 5 vials with the drug and 5 ampoules with a solvent of 10 ml or 10 ampoules with a solvent of 5 ml. An ampoule scarifier or knife is put into a cardboard box. When using ampoules with dots, notches or break rings, the knife / scarifier may be missing).
The content of active substances in 1 bottle: cefoperazone (in the form of sodium salt) - 0.5 / 1 / 1.5 / 2 g and sulbactam (in the form of sodium salt) - 0.5 / 1 / 1.5 / 2 g, respectively.
Pharmacological properties
Pharmacodynamics
Baccefort is a combined antibacterial drug, the mechanism of action of which is due to the properties of the active ingredients:
- cefoperazone is a third generation cephalosporin antibiotic. By inhibiting the biosynthesis of the mucopeptide of the cell wall, it has an effect on sensitive microorganisms during the period of their active reproduction;
- sulbactam - is an irreversible inhibitor of most beta-lactamases, which are produced by microorganisms that are resistant to beta-lactam antibiotics. Its ability to prevent the destruction of cephalosporins and penicillins by resistant bacteria has been confirmed in studies using resistant strains, for which sulbactam has shown pronounced synergism with cephalosporins and penicillins. Possesses independent antibacterial activity against Neisseriaceae and Acinetobacter spp.
The combination of cefoperazone + sulbactam has a more pronounced effect on sensitive strains than cefoperazone alone, since sulbactam also interacts with some penicillin-binding proteins.
Bactsefort is active against all pathogens susceptible to cefoperazone, and also has synergism against various microorganisms, especially Acinetobacter calcoaceticus, Bacteroides spp., Citrobacter diversus, Escherichia coli, Citrobacter freundii, Enterobacter pneumeophonia, Kela influenzae, Enterobacter aerialus Morganella morganii, Proteus mirabilis, Staphylococcus spp.
Under in vitro conditions, the combination of cefoperazone + sulbactam acts on a wide range of clinically significant microorganisms:
- gram-negative bacteria: Enterobacter spp., Acinetobacter calcoaceticus, Citrobacter spp., Bordetella pertussis, Salmonella spp., Haemophilus influenzae, Yersinia enterocolitica, Proteus mirabilis, Shigella spp., Neisseria gonorrrhoei, Escherisis methorrhea, Escherisseria Protein spp. (including Serratia marcescens), Morganella morganii, Klebsiella spp., Providencia spp., Pseudomonas aeruginosa and some others Pseudomonas spp.;
- gram-positive bacteria: many strains of Streptococcus faecalis (enterococci), Streptococcus pyogenes (beta-hemolytic streptococcus group A), Streptococcus pneumonia, Streptococcus agalactiae (beta-hemolytic streptococcus group B) and most other strains of epidermolitis streptococcus beta-hemolytic including producing penicillinase);
- gram-negative anaerobes, including Fusobacterium spp., Bacteroides fragilis and other Bacteroides spp.;
- gram-positive anaerobes, including Eubacterium spp., Clostridium spp., Lactobacillus spp.;
- gram-negative and gram-positive cocci, including Peptostreptococcus spp., Peptococcus spp., Veillonella spp.
The minimum inhibitory concentration (MIC) of cefoperazone for sensitive microorganisms is ≤ 16 μg / ml, for organisms with intermediate sensitivity - 17–63 μg / ml, for resistant microorganisms -> 64 μg / ml.
Pharmacokinetics
After intravenous administration of 2 g of Bakcefort (1 g of sulbactam and cefoperazone), the maximum concentrations (C max) for 5 minutes averaged: sulbactam - 130.2 μg / ml, cefoperazone - 236.8 μg / ml. The volume of distribution (V d) of sulbactam is 18 - 27.6 liters, cefoperazone - 10.2 - 11.3 liters.
After i / m administration of 1.5 g of Bakcefort (0.5 g of sulbactam and 1 g of cefoperazone), Cmax of sulbactam and cefoperazone in serum are 19 and 64.2 μg / ml, respectively, observed in the period from 15 minutes to 2 hours.
Both active components of Baccefort are well distributed in tissues and body fluids, including the gallbladder, bile, appendix, skin, uterus, ovaries, fallopian tubes, etc.
Approximately 84% of the dose of sulbactam and 25% of the dose of cefoperazone after administration of Bakcefort is excreted by the kidneys. Most of the remaining dose of cefoperazone is excreted in the bile. Cefoperazone does not displace bilirubin from plasma protein binding. The serum concentration of the drug is proportional to the administered dose.
The half-life (T ½) of sulbactam is about 1 hour, cefoperazone is 1.7 hours.
When the drug was administered 2–3 times a day (every 8–12 h), no cumulation was observed. There are no data on any pharmacokinetic interactions between cefoperazone and sulbactam when using Bakcefort. With repeated administration of the drug, significant changes in the pharmacokinetics of both components were not observed.
In patients with liver disease and / or biliary obstruction, T ½ of cefoperazone is usually increased, and renal excretion of the drug is enhanced. Even with severe impairment of hepatic function, the therapeutic concentration of cefoperazone in the bile is achieved, but T ½ increases by 2–4 times.
When renal function is impaired, there is a high correlation between the total clearance of sulbactam from the body and the calculated creatinine clearance (CC). In patients with end-stage renal failure, T ½ sulbactam is lengthened to 6.9–9.7 hours. Hemodialysis, according to studies, causes significant changes in V d, total clearance and T ½ sulbactam.
The pharmacokinetic characteristics of Baccefort were studied in elderly patients with impaired liver function and renal failure. Revealed a lengthening of the period T ½, an increase in V d and a decrease in the clearance of both active substances of the drug (compared with healthy volunteers). Pharmacokinetics of cefoperazone correlated with the degree of liver dysfunction, and sulbactam - with the degree of renal dysfunction.
In studies of the use of the combination of sulbactam + cefoperazone in children, no significant changes in pharmacokinetic parameters were found in comparison with those in adults. T ½ of sulbactam was 0.9‒1.42 h, cefoperazone - 1.44‒1.88 h.
Indications for use
Baccefort is used in the treatment of infectious and inflammatory diseases caused by sensitive pathogens:
- inflammatory diseases of the pelvic organs and infections of the genital tract, including pelvioperitonitis, endometritis, gonorrhea;
- meningitis;
- kidney and urinary tract infections;
- sepsis;
- infections of the skin and soft tissues, bones and joints;
- cholangitis, cholecystitis, peritonitis and other abdominal infections;
- upper and lower respiratory tract infections.
Contraindications
The use of the antibiotic Baccefort is contraindicated in case of hypersensitivity to sulbactam, cefoperazone, penicillins or other cephalosporins.
Baccefort should be used with caution in the treatment of newborns (including premature babies), patients with severe renal and hepatic insufficiency, as well as pregnant and lactating women.
Baksefort, instructions for use: method and dosage
A solution prepared from Bakcefort powder is administered intravenously (drip or stream) or intramuscularly. If a single dose exceeds 2 g, intravenous administration is preferred.
The doses indicated below are presented as the sum of cefoperazone and sulbactam in a 1: 1 ratio.
The recommended daily dose of Baccefort for adults is 2-4 g (i.e., 1-2 g of sulbactam and 1-2 g of cefoperazone), it is divided into two equal parts and administered every 12 hours.
In severe and refractory infectious diseases, it is possible to increase the daily dose to a maximum of 8 g (4 g of sulbactam and cefoperazone each). Do not exceed the recommended highest dose. If necessary, additional administration of a drug containing only cefoperazone should be prescribed.
In case of renal failure with a CC <30 ml / min, the dose of Bakcefort is calculated according to sulbactam:
- CC 15-30 ml / min - 1 g every 12 hours;
- CC <15 ml / min - 0.5 g every 12 hours.
In cases of severe infections, patients with renal impairment may require additional cefoperazone. Since T ½ of cefoperazone from serum decreases during hemodialysis, Baccefort should be administered after dialysis.
A change in the dose of Baccefort may be required in the presence of severe liver disease and severe obstruction of the biliary tract, as well as in renal failure, combined with one of the indicated conditions. In patients with hepatic and concomitant renal failure, receiving cefoperazone in a daily dose of more than 2 g, it is necessary to control its concentration in the blood serum and, if necessary, adjust the dosage regimen of the drug.
For children, Bakcefort is prescribed in a daily dose of 0.04–0.08 g / kg (sulbactam and cefoperazone in a 1: 1 ratio, i.e. 0.02–0.04 g / kg of sulbactam and the same amount of cefoperazone). The daily dose is divided into equal parts and injected at intervals of 6-12 hours. In severe or refractory infectious processes, the daily dose may be increased to 0.16 g / kg (the ratio of active substances is also 1: 1), in this case it is divided by 2 4 introductions in equal parts.
For newborns before the seventh day of life, Baccefort is administered at intervals of 12 hours. The daily dose of sulbactam should not exceed 0.08 g / kg.
Preparation and administration of injection solution
With intravenous administration of Bakzefort, water for injection, sodium chloride solution 0.9%, dextrose solution 5%, dextrose solution 5% in sodium chloride solution 0.225% or dextrose solution 5% in sodium chloride solution 0.9 can be used as a solvent %. The amount of solvent required depends on the dose of the drug (cefoperazone + sulbactam):
- 0.5 g + 0.5 g - 3.4 ml;
- 1 g + 1 g - 6.8 ml;
- 1.5 g + 1.5 g - 10.2 ml;
- 2 g + 2 g - 13.6 ml.
The maximum final concentration is 0.125 g + 0.125 g.
Intravenous administration:
- IV jet injection: the contents of the vial are dissolved in the above amount of the solvent, the drug is injected for at least 3 minutes;
- intravenous drip injection: the powder is diluted as indicated above, after which the resulting solution is diluted with the same solvent that was used for the initial dissolution to a volume of 20 - 100 ml. Injected over 15-60 minutes.
For intramuscular administration, water for injection and a 2% lidocaine solution can be used as a solvent, however, lidocaine cannot be used for the initial dilution of Bakcefort powder due to their pharmaceutical incompatibility. Compatibility can be achieved using a two-step solution preparation. For primary dilution, use water for injection in the following dose-dependent volumes (cefoperazone + sulbactam):
- 0.5 g + 0.5 g - 2.6 ml;
- 1 g + 1 g - 5 ml.
Next, the resulting solution is diluted with 2% lidocaine solution in the following volume, depending on the dose (cefoperazone + sulbactam):
- 0.5 g + 0.5 g - 0.8 ml;
- 1 g + 1 g - 1.7 ml.
Thus, an antibiotic solution is obtained in a 0.5% lidocaine solution.
Bactsefort is injected deep into areas with a pronounced muscle layer (for example, in the upper-outer quadrant of the buttock).
After dilution of the powder, solutions for intramuscular and intravenous administration can be stored for no more than 24 hours at room temperature (~ 25 ° C) or for 48 hours at a temperature of 2‒8 ° C (in a refrigerator).
If it is necessary to use Ringer's lactate, Bakcefort powder must first be dissolved with water for injection (in volumes recommended for intravenous administration), and only then diluted with Ringer's lactate solution to a sulbactam concentration of 5 mg / ml (25 ml for each 1 ml of primary solution).
Side effects
Baccefort is generally well tolerated. Most of the reported side effects were mild or moderate and persisted until the end of the course of therapy.
Possible adverse reactions:
- blood and lymphatic system: very often (≥ 1/10) - neutropenia 1, leukopenia 1, positive direct Coombs' reaction 1, thrombocytopenia 1, decreased hematocrit and hemoglobin 1; often (from ≥ 1/100 to <1/10) - eosinophilia 1, coagulopathy 2; the frequency is unknown (the available data do not allow to accurately estimate the incidence of the side effect) - hypoprothrombinemia 2;
- nervous system: infrequently (from ≥ 1/1000 to <1/100) - headache;
- immune system: frequency unknown - anaphylactic shock 1.3, anaphylactic reaction 1.3, anaphylactoid reaction 3 (including shock) 2, hypersensitivity reactions 2.3;
- vessels: frequency unknown - vasculitis 2, bleeding 2.3, arterial hypotension 2;
- gastrointestinal tract: often - nausea, diarrhea, vomiting; frequency unknown - pseudomembranous colitis 2;
- liver and biliary tract: very often - an increase in the activity of aspartate aminotransferase 1, alanine aminotransferase 1 and alkaline phosphatase 1 in the blood; often - an increase in the concentration of bilirubin in the blood 1; frequency unknown - jaundice 2;
- kidneys and urinary tract: frequency unknown - hematuria 2;
- skin and subcutaneous tissue: infrequently - itchy skin, urticaria; frequency unknown - maculopapular rash 2, exfoliative dermatitis 2.3, Stevens-Johnson syndrome 2.3, toxic epidermal necrolysis 2.3;
- others: infrequently - chills, fever, burning, pain at the injection site, phlebitis at the infusion site.
1 When calculating the frequency of such side effects as abnormal laboratory test results, all available data were taken into account, including in patients who had abnormalities before starting drug treatment. This approach was used because the baseline data did not allow to separate the subset of patients with baseline abnormalities in test results, who had significant changes after the start of treatment, and the subset of patients with baseline abnormalities in test results, who did not have significant changes after the start of treatment. changes in laboratory results. As for the number of platelets, neutrophils, leukocytes, hematocrit and hemoglobin, only abnormalities are reported in the reports, and there was no indication of this decrease or increase in indicators.
2 Side effects recorded during the post-registration use of Bakcefort.
3 Fatal cases have been reported.
Overdose
Information on the acute toxicity of both active substances of the drug is limited.
In the case of an excessive dose of Baccefort, the development of adverse reactions noted during treatment with the drug can be expected. A high concentration of sulbactam in the cerebrospinal fluid can cause neurological damage, including seizures.
Overdose treatment is symptomatic. To remove the drug from the body, hemodialysis can be prescribed, especially in patients with impaired renal function.
special instructions
During treatment, patients should be under close medical supervision. With long-term therapy, it is recommended to periodically check the indicators of the functions of internal organs (including the hematopoietic system, kidneys and liver), especially in newborns (including premature babies) and young children.
Antibacterial agents disrupt the normal intestinal microflora, which is why there is an overgrowth of Clostridium difficile. With virtually all antibiotics, cases of Clostridium difficile-associated diarrhea have been reported. Its severity can range from mild to severe (pseudomembranous colitis), which can be fatal. The likelihood of such a complication should be considered in all patients with diarrhea during or after antibiotic withdrawal. In this regard, if you suspect the development of pseudomembranous colitis, Baccefort is canceled and appropriate treatment is prescribed (vancomycin or metronidazole orally, enterosorbents, infusion therapy). If necessary, colectomy is performed. Patients who have had diarrhea associated with Clostridium difficile during antibiotic therapy,over the next two months, close medical supervision is required.
There are known cases of hypersensitivity reactions, including fatal ones, in patients treated with cephalosporins and beta-lactam antibiotics, including the combination of cefoperazone + sulbactam. The risk of hypersensitivity reactions is higher in individuals with a history of various allergic reactions. If such a complication develops, Bakcefort is canceled and appropriate treatment will be prescribed. Severe anaphylactic reactions require urgent administration of epinephrine and glucocorticosteroids, as well as ensuring airway patency (if necessary, intubation).
During the period of therapy, it is recommended to refrain from drinking alcohol, since when combined with ethanol, cefoperazone can cause the development of disulfiram-like effects.
In rare cases, Baccefort causes a deficiency of vitamin K. This is probably due to the suppression of the normal intestinal microflora that synthesizes this vitamin. Risk factors include malnutrition, prolonged intravenous artificial nutrition, and malabsorption syndrome (eg, in cystic fibrosis). In these cases, and with the simultaneous use of anticoagulants, prothrombin time should be monitored. Vitamin K supplementation may be required.
With prolonged use of Bakcefort, like any other antibiotic, excessive growth of insensitive microorganisms is possible.
Influence on the ability to drive vehicles and complex mechanisms
Special clinical studies have not been carried out, however, the experience of clinical use indicates that the negative effect of Bakzefort on the reaction rate and the ability to concentrate is unlikely.
Application during pregnancy and lactation
Adequate controlled studies have not been conducted. It is known that both active components of Baccefort penetrate the placental barrier and into breast milk. In this regard, for pregnant and breastfeeding women, the drug is prescribed only if the intended benefits of antibiotic therapy definitely outweigh the potential risks to the fetus / infant.
Pediatric use
Antibiotic Baccefort is used in children according to indications. However, before starting treatment for newborns (including premature babies), it is recommended to assess the balance of benefits and possible risks, since the experience of using the drug in patients of this age group is limited.
With impaired renal function
Baccefort in renal failure should be used with caution.
For violations of liver function
Baccefort should be used with caution in severe liver disease.
Use in the elderly
In elderly patients, a possible decrease in renal and / or liver function should be considered.
Drug interactions
Baccefort is pharmaceutically incompatible with aminoglycosides. In combination therapy, both drugs should be administered by successive infusions at the greatest possible intervals. It is recommended to use separate secondary catheters; in case of one venous access, it is necessary to flush the primary catheter well between injections of drugs.
The use of Fehling's solution or Benedict's solution during antibiotic therapy may cause a false positive reaction to glucose in the urine.
Taking ethanol during the period of cefoperazone application and within 5 days after its cancellation can cause the development of disulfiram-like reactions (sweating, hot flashes, headache, tachycardia). It is recommended to avoid the use of solutions containing ethanol.
Analogs
Analogs of Bakzefort are: Broadsef-S, Bakperazon, Zavicefta, Zerbaxa, Claruktam, Paktocef, Sulzontsef, Sulmover, Sulperacef, Sulcef, Sulperazon, Cefoperazon + Sulbactam, Cefpar SV, Cebanex, etc.
Terms and conditions of storage
Shelf life is 2 years.
Store in a place protected from light and out of reach of children with a temperature not exceeding 25 ° C.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Bakzefort
On the forums and specialized medical sites, there are no reviews about Bakcefort, on the basis of which it is possible to assess the effectiveness of the drug and its tolerance.
Price for Baksefort in pharmacies
The price of Bakcefort depends on the dosage, the region of sale and the pharmacy chain selling the drug. The approximate cost of 1 bottle in a dose of 0.5 g + 0.5 g is 156 rubles, 1 g + 1 g - 300-350 rubles, in a dose of 2 g + 2 g - 594 rubles.
Bakcefort: prices in online pharmacies
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Drug name Price Pharmacy |
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Bactsefort 0.5 g + 0.5 g powder for preparation of solution for intravenous and intramuscular administration 1 pc. 169 RUB Buy |
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Bactsefort 1000 mg + 1000 mg powder for preparation of solution for intravenous and intramuscular administration 1 pc. 334 r Buy |
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Bakcefort 2.0 + 2.0 powder for preparation of solution for intravenous and intramuscular administration 1 pc. 629 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
