Sulzontsef
Sulzontsef: 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: Sulzoncef
ATX code: J01DD62
Active ingredient: cefoperazone (Cefoperazone), sulbactam (Sulbactam)
Manufacturer: SINTEZ, JSC (Russia)
Description and photo update: 2019-05-07
Prices in pharmacies: from 229 rubles.
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Sulzontsef is a combined antibacterial drug.
Release form and composition
It is produced in the form of a powder for the preparation of a solution for intravenous (i / v) and intramuscular (i / m) administration: white or white with a yellowish tinge [2 g each in 20 ml vials, in a cardboard box of 1, 5 or 10 vials, 10 bottles in a cardboard box; 2 g in 20 ml vials, 5 vials in a blister contour package, 1-2 packs in a cardboard box; 2 g in vials with a volume of 20 ml, in a blister contour package 1 bottle complete with 1 or 2 ampoules of solvent (water for injection) 5 ml each, in a cardboard box 1 package; 2 g in 20 ml vials, 5 vials in a blister contour packaging complete with 5 ampoules of 5 ml solvent, in a cardboard box 1-2 packs. Each pack also contains instructions for the use of Sulzontsef].
Active substances in 1 bottle:
- cefoperazone (in the form of sodium salt) - 1 g;
- sulbactam (in the form of sodium salt) - 1 g
Pharmacological properties
Pharmacodynamics
Sulzontsef is a combined broad-spectrum antibacterial agent. Its effectiveness is explained by the properties of the active ingredients:
- Cefoperazone is an antimicrobial agent of the III generation cephalosporin class with a broad spectrum of activity, which has bactericidal activity against gram-negative and gram-positive aerobic and anaerobic microorganisms (including Pseudomonas aeruginosa). Shows resistance to β-lactamases of gram-negative and gram-positive bacteria;
- sulbactam is an irreversible inhibitor of β-lactamases, which are secreted by bacteria resistant to beta-lactam antibiotics. Prevents the destruction of cephalosporins and penicillins under the influence of β-lactamases of resistant organisms. Due to its binding to penicillin-binding proteins, it exhibits synergism when used simultaneously with cephalosporins and penicillins. Shows activity only against Acinetobacter spp. and Neisseria spp.
Thanks to the combination of cefoperazone + sulbactam, Sulzontsef is effective in all diseases caused by microorganisms sensitive to cefoperazone, since it acts synergistically: it reduces the minimum inhibitory concentration (MIC) up to 4 times compared to the MIC for each of the components separately.
Sulzoncef is effective against Acinetobacter calcoaceticus, Bacteroides spp., Citrobacter diversus, Citrobacter freundii, Escherichia coli, Enterobacter aerogenes, Enterobacter cloacae, Haemophilus influenzae, Klebsiella pneumoniae, Morganella morganii, Proteapus spp.
In vitro, Sulzontsef has demonstrated activity against the following microorganisms:
- gram-negative aerobic bacteria: Acinetobacter calcoaceticus, Bordetella pertussis, Citrobacter spp., Enterobacter spp., Escherichia coli, Haemophilus influenzae, Klebsiella spp., Morganella morganii, Neisseria meningia aerrabitis, Neisseria gonorrrrrrrrh (including Providencia rettgeri), Shigella spp., Salmonella spp., Serratia spp. (including Serratia marcescens), Yersinia enterocolitica;
- gram-positive aerobic bacteria: Enterococcus faecalis, Streptococcus pyogenes (beta-hemolytic strain of group A), Staphylococcus aureus (including strains that form penicillinase), Streptococcus agalactiae (beta-hemolytic strains of group B), pneumoniae (beta-hemolytic strain of group B) most strains of beta-hemolytic Streptococcus spp.;
- anaerobic bacteria: Eubacterium spp., Clostridium spp., Bacteroides spp. (including Bacteroides fragilis), Fusobacterium spp., Lactobacillus spp., Peptostreptococcus spp., Peptococcus spp., Veillonella spp.
For sensitivity testing, it is recommended to use discs containing 75 µg cefoperazone and 30 µg sulbactam [Kirby-Bauer Disk Diffusion Test].
Pharmacokinetics
After intravenous administration of Sulzontsef for 5 minutes at a dose of 2 g (1 g of cefoperazone and sulbactam each), the maximum concentration (Cmax) of drugs averaged 130.2 μg / ml and 236.8 μg / ml, respectively. The volume of distribution (Vd) can vary within: sulbactam - 8-27.6 liters; cefoperazone - 10.2-11.3 liters. The serum concentration of the drug is proportional to the administered dose.
Both active substances of Sulzontsef are well distributed in tissues and body fluids, including the gallbladder, bile, appendix, skin, uterus, ovaries, fallopian tubes.
There is no information about any pharmacokinetic interaction of cefoperazone with sulbactam. With repeated use of the drug, significant changes in the pharmacokinetics of both active ingredients are not observed.
Excretion of cefoperazone: 25% of the dose - by the kidneys, the rest - with bile. Sulbactam is excreted mainly (84%) by the kidneys.
The half-life (T 1/2) of cefoperazone is 1.7 hours, sulbactam is an average of 1 hour.
Pharmacokinetics in special cases:
- impaired renal function: in patients receiving Sulzontsef, there was a relationship between the total clearance of sulbactam from the body and the calculated creatinine clearance. With end- stage renal failure, its T 1/2 increases significantly (up to 6.9-9.7 hours); in patients undergoing hemodialysis, Vd, total body clearance and T 1/2 of sulbactam change significantly;
- liver dysfunction and / or obstruction of the biliary tract: in patients, T 1/2 of cefoperazone is lengthened and the excretion of the drug by the kidneys increases. Even with severe violations of hepatic function in the bile, the therapeutic concentration of the drug is achieved, and T 1/2 increases by 2-4 times;
- children's age: there were no significant changes in the pharmacokinetic parameters of both components of Sulzontsef compared with those in adults. Average T 1/2 is: cefoperazone - 1.44-1.88 hours; sulbactam - 0.91-1.42 hours;
- elderly age (in patients with renal insufficiency and functional disorders of the liver): in comparison with healthy patients, a decrease in clearance, an increase in Vd and T 1/2 of both sulbactam and cefoperazone were revealed. The pharmacokinetics of cefoperazone correlates with the degree of liver dysfunction, the pharmacokinetics of sulbactam - with the degree of renal dysfunction.
Indications for use
Sulzontsef is indicated for the treatment of the following bacterial infections caused by susceptible microorganisms:
- meningitis;
- sepsis;
- osteomyelitis, joint infections;
- infections of the skin and soft tissues (lymphangitis, lymphadenitis, abscess, furunculosis, pyoderma);
- infections of the ENT organs (sinusitis, acute otitis media, tonsillitis);
- infections of the upper and lower respiratory tract (sinusitis, tonsillitis, pharyngitis, empyema, bronchitis, pneumonia, bronchopneumonia, lung abscess);
- urinary tract infections (cystitis, pyelonephritis, vulvovaginitis, endometritis, gonorrhea, prostatitis);
- intra-abdominal infections (cholangitis, cholecystitis, peritonitis).
Sulzontsef is also used for prophylactic purposes to prevent infectious complications after abdominal, orthopedic and gynecological operations, as well as in cardiovascular surgery.
Contraindications
Absolute:
- lactation period;
- hypersensitivity to any component of the drug or other beta-lactam antibiotics.
Relative (the antibiotic Sulzontsef can be used, but after assessing the benefits and risks):
- colitis (current or history);
- renal / hepatic impairment;
- period of pregnancy;
- premature newborns.
Sulzontsef, instructions for use: method and dosage
Sulzontsef is administered intramuscularly, intravenously drip or stream.
Doses of the drug are indicated as the sum of cefoperazone and sulbactam in a ratio of 1 ÷ 1.
The daily dose for adults is 2-4 g, Sulzontsef is administered at intervals of 12 hours. In severe, persistent infections, the dose may be increased to 8 g per day (4 g of cefoperazone and sulbactam).
In chronic renal failure [creatinine clearance (CC) <30 ml / min], dose adjustment is required. The maximum dose of sulbactam for patients with CC 15-30 ml / min is 1 g 2 times a day, with CC <14 ml / min - 500 mg 2 times a day.
In case of impaired liver function and obstruction of the biliary tract, the daily dose of cefoperazone should not exceed 2 g.
For children, Sulzontsef is prescribed in a daily dose of 40–80 mg / kg in 2–4 injections, for newborns during the first week of life, the daily dose is divided into 2 injections. In the case of severe, long-term infections, the daily dose may be increased to 160 mg / kg. If it becomes necessary to use a higher dose, the increase is made due to the additional administration of cefoperazone alone.
Preparation and administration rules:
- IV bolus administration: the powder contained in 1 vial is dissolved with an adequate amount of sterile water for injection, dextrose (glucose) solution 5%, sodium chloride solution 0.9%, dextrose (glucose) solution 5% in sodium chloride solution 0, 9% or 5% dextrose (glucose) solution in 0.225% sodium chloride solution. Duration of administration - 3 minutes;
- IV infusion (drip) introduction: the powder is dissolved according to the method described above, then diluted to a volume of 20-100 ml. Enter within 15-60 minutes;
- i / m introduction: the powder is dissolved with sterile water for injection. If necessary, further add a solution of lidocaine 2% to obtain a 0.5% solution. The total volume of the solvent is 6.7 ml.
Side effects
- from the immune system: fever, maculopapular rash, urticaria, eosinophilia; rarely - anaphylactic shock;
- on the part of the hematopoietic organs: bleeding (due to vitamin K deficiency), neutropenia, anemia, thrombocytopenia;
- from the digestive system: nausea, vomiting, diarrhea, pseudomembranous colitis, hyperbilirubinemia, increased alkaline phosphatase and hepatic transaminase activity;
- laboratory parameters: hypoprothrombinemia, hypercreatininemia;
- local reactions: with intramuscular injection - soreness; with intravenous administration - phlebitis.
Overdose
In the case of an excessive dose of Sulzontsef, neurological disorders, including convulsions, are possible.
It is shown that symptomatic therapy is carried out, including the appointment of sedatives. Hemodialysis is effective.
special instructions
The antibiotic Sulzontsef has a wide spectrum of action, therefore it can be used as a drug for monotherapy.
In the case of the combined use of aminoglycoside antibiotics, careful monitoring of renal function is indicated.
With prolonged treatment with Sulzontsef, it is necessary to regularly check the indicators of the hematopoietic system, liver and kidney function.
During therapy in patients with impaired absorption of food (in the case of parenteral nutrition or cystic fibrosis) and receiving malnutrition, the risk of developing vitamin K deficiency is increased due to the suppression of the intestinal microflora by the antibiotic, which synthesizes this vitamin. Such patients require monitoring of prothrombin time. If necessary, prescribe vitamin K preparations.
Against the background of the use of Sulzontsef, it is possible to obtain a false-positive Coombs reaction, as well as false-positive results for glucose in urine when using Benedict's reagent or Fehling's liquid.
Application during pregnancy and lactation
Pregnant Sulzontsef is prescribed only in situations where the expected benefit from therapy is higher than the potential risks.
If treatment is required during lactation, it is recommended to stop breastfeeding.
Pediatric use
In pediatric practice, Sulzontsef is used as directed by a specialist in compliance with the recommended dosage regimen.
With caution and only after assessing the benefits and risks, the drug is prescribed to premature newborns.
With impaired renal function
Sulzoncef should be used with caution in patients with renal impairment.
In chronic renal failure, dose adjustment is required. The maximum dose of sulbactam for patients with CC 15-30 ml / min is 1 g 2 times a day, with CC <14 ml / min - 500 mg 2 times a day.
For violations of liver function
Observance of precautions is required when treating patients with hepatic impairment.
Use in the elderly
In elderly patients, the likelihood of age-related decline in kidney and liver function should be considered.
Drug interactions
Sulzontsef is compatible with water for injection and the following solutions: dextrose (glucose) 5%; sodium chloride 0.9%; dextrose (glucose) 5% + sodium chloride 0.9%; dextrose (glucose) 5% + sodium chloride 0.225%.
Sulzontsef is incompatible with Ringer's solution, as well as with 2% lidocaine hydrochloride solution. A compatible mixture with lidocaine is achieved by the initial use of water for injection (i.e., Sulzontsef is diluted with injection water and only then lidocaine is added).
As a result of the simultaneous use with aminoglycoside antibiotics, there is a synergism of antibacterial action, therefore Sulzontsef cannot be mixed with aminoglycosides. If combination therapy is needed, the two drugs are given in sequential fractional IV infusions using two separate IV systems. It is imperative that the system is flushed with a compatible solvent between doses.
When ethanol is used (during the period of Sulzontsef's use or within 5 days after its cancellation), the likelihood of a disulfiram-like reaction, manifested by increased sweating, hot flashes, headache, and tachycardia, increases.
Analogs
Sulzontsef's analogues are Bakperazon, Broadsef-S, Zavicefta, Claruktam, Paktocef, Sulperazon, Sulmover, Sulcef, Sulperazon, Tsebanex, Cefpar SV and others.
Terms and conditions of storage
Store at a temperature not exceeding 25 ° C, out of reach of children, protected from light, in a dry place.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Sulzontzef
The opinion of medical specialists about Sulzontzef is positive. An antibiotic is often prescribed for the treatment of infectious diseases, including as part of complex therapy, since it demonstrates high efficiency against a large number of pathogens, has no age restrictions and multiple contraindications.
Patients also leave positive reviews about Sulzontsef, noting an improvement in the condition already on the second day after the start of treatment and good tolerance of the drug.
Price for Sulzontsef in pharmacies
The price for Sulzontsef is on average 200 rubles. for 1 bottle containing 2 g of powder for preparing a solution for intravenous and intramuscular administration.
Sulzontsef: prices in online pharmacies
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Drug name Price Pharmacy |
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Sulzoncef 1 g + 1 g powder for preparation of solution for intravenous and intramuscular administration 1 pc. 229 r 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!
