Sulcef - Instructions For Use, Price, Antibiotic Analogues, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Sulcef

Sulcef: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Sulcef

ATX code: J01DD62

Active ingredient: cefoperazone (Cefoperazone) + sulbactam (Sulbactam)

Manufacturer: Medochemie, Ltd. (Medochemie, Ltd.) (Cyprus)

Description and photo update: 2020-16-01

Prices in pharmacies: from 357 rubles.

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Sulcef is an antibacterial drug, a combination of a third generation cephalosporin and a β-lactamase inhibitor.

Release form and composition

Dosage form - powder for preparation of a solution for intravenous (intravenous) and intramuscular (intramuscular) administration, white or almost white with a yellowish tinge (2.18 g each in colorless glass vials, sealed with rubber stoppers with rolling in aluminum caps; cardboard box 1 bottle and instructions for use Sulcef; for hospitals - in a cardboard box 100 bottles and instructions for use).

1 bottle contains active ingredients (in terms of pure substance):

• cefoperazone sodium (cefoperazone) - 1 g;
• sodium sulbactam (sulbactam) - 1 g.

Pharmacological properties

Pharmacodynamics

Sulcef is a combined antimicrobial drug, the pharmacological activity of which is due to the properties of the active components that make up its composition:

• cefoperazone: an antibiotic of the β-lactam class, cephalosporin of the third generation, acts on microorganisms sensitive to it during their active reproduction by inhibiting the biosynthesis of peptidoglycan (mucopeptide of the cell wall);
• sulbactam: a synthetic preparation with a β-lactam structure similar to that of the antibiotics of the penicillin group; has no clinically significant antibacterial effect (with the exception of activity against Neisseriaceae and Acinetobacter); irreversibly inhibits most of the main β-lactamases, the presence of which provides microflora resistance to β-lactam antibiotics; binds to some PSB (penicillin-binding proteins), as a result of which the combination of sulbactam + cefoperazone is usually more pronounced on sensitive strains, in comparison with the antibacterial effect of cefoperazone alone.

Sulcef's activity is manifested in relation to all microflora susceptible to cefoperazone. In addition, the synergism of the active components of the drug enhances its therapeutic effect against the following microorganisms: Acinetobacter calcoaceticus, Enterobacter cloacae, Escherichia coli, Bacteroides spp., Citrobacter diversus, Citrobacter freundii, Haemophilus influenzae, Staphylococcus spp., Enterobacella morganella, Proteus mirabilis.

In vitro Sulcef is active against a wide range of microorganisms:

• gram-positive: Staphylococcus aureus (producing / non-producing penicillinase), Staphylococcus epidermidis, Streptococcus pyogenes (group A β-hemolytic streptococci), Streptococcus agalactiae (β-hemolytic Streptococcus Streptococcus, β-hemolytic streptococcus group B), many other strains of streptococcus streptococcus
• gram-negative: Bordetella pertussis, Enterobacter spp., Klebsiella spp., Citrobacter spp., Providencia rettgeri, Proteus vulgaris, Providencia spp., Salmonella spp., Serratia spp. (including S. marcescens strain), Shigella spp., Neisseria meningitidis and Neisseria gonorrhoeae, Pseudomonas aeruginosa, Yersinia enterocolitica;
• anaerobic: Bacteroides fragilis, Peptostreptococcus spp., Peptococcus spp., Veillonella spp., Eubacterium spp., Clostridium spp., Lactobacillus spp., Fusobacterium spp.

Pharmacokinetics

Pharmacokinetic characteristics of the active components of Sulcef:

• absorption: after intravenous administration of cefoperazone (1 g) and sulbactam (1 g), their maximum concentrations (C _max) in blood plasma are reached within 5 minutes and, accordingly, average 130.2 μg / ml and 236.8 μg / ml;
• distribution: V _d (volume of distribution) of sulbactam is almost 2 times higher than that of cefoperazone, and is 18-27.6 liters and 10.2-11.3 liters, respectively. Both substances are well distributed in various tissues and fluids, including the appendix, gallbladder, bile, skin, ovaries, uterus, and fallopian grubs. Plasma concentrations are directly proportional to the administered dose of the drug, repeated use does not entail significant changes in the pharmacokinetics of sulbactam and cefoperazone. Injections / infusions of the solution every 8–12 hours lead to the cumulation of cefoperazone and sulbactam;
• excretion: ~ 84% of the sulbactam dose and ~ 25% of the cefoperazone dose are excreted by the kidneys. The remaining amount of cefoperazone is mainly actively excreted in the bile. After parenteral administration of Sulcef, the half-life (T _1/2) for sulbactam is on average 1 hour, for cefoperazone - 1.7 hours.

Pharmacokinetics in special clinical situations:

• patients with liver disease and / or obstruction of the biliary tract: usually T _{1/2 of} cefoperazone increases and the volume of excretion of the drug in urine increases. Despite this, in severe hepatic impairment, the level of cefoperazone in the bile reaches a therapeutic concentration, and T _1/2 increases 2–4 times;
• patients with impaired renal function of varying severity: a high degree of correlation was established between the total clearance of sulbactam and the calculated CC (creatinine clearance). Patients with end-stage renal failure showed a significant increase in T _1/2 - from 6.9 to 9.7 hours. During hemodialysis, significant changes in T _1/2, V _d and total clearance of sulbactam are observed;
• elderly patients with impaired renal and / or liver function: both sulbactam and cefoperazone have an increase in V _d and T _1/2, as well as a decrease in clearance. Pharmacokinetic characteristics of sulbactam depend on the degree of impairment of renal function, and cefoperazone - on the degree of impairment of hepatic function;
• pediatric patients: no significant differences in the pharmacokinetic parameters of cefoperazone and sulbactam were observed in comparison with adult patients. The average T _{1/2 of} sulbactam in children varies in the range of 0.91-1.42 hours, cefoperazone - 1.44-1.88 hours.

Indications for use

Sulcef is recommended for the treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the combination of sulbactam + cefoperazone, of the following localization:

• upper and lower respiratory tract (tonsillitis, pharyngitis, sinusitis, bronchitis, bronchopneumonia, pneumonia, empyema, lung abscess);
• genitourinary tract (pyelonephritis, prostatitis, gonorrhea, vulvovaginitis, cystitis, endometritis);
• the gastrointestinal tract and other, usually sterile, areas of the abdominal cavity (intra-abdominal infection, including cholecystitis, cholangitis, peritonitis);
• the lining of the brain (meningitis);
• skin and subcutaneous fat (abscess, furunculosis, pyoderma, lymphangitis, lymphadenitis);
• bones and joints (osteomyelitis).

Sulcef is also prescribed for the treatment of septicemia, a bacterial infection of unspecified localization.

Contraindications

Antibiotic Sulcef is contraindicated for use in case of hypersensitivity to penicillins, cefoperazone (and other β-lactam antibiotics) and sulbactam.

The drug is prescribed with caution to patients with severe impairment of renal and / or liver function, colitis (including data in history), pregnant and lactating women, as well as newborns born prematurely.

Sulcef, instructions for use: method and dosage

The solution prepared from Sulcef powder is administered parenterally (intravenously or intramuscularly).

Recommended daily dosage for adult patients: 2-4 g, divided into 2 injections with an interval of 12 hours; for the treatment of severe, long-term infections - 8 g each, observing the specified interval between injections at 12 hours. The maximum daily dose is 8 g.

Correction of the daily dose in chronic renal failure, depending on the CC, subject to the introduction of the solution 2 times a day:

• CC 15-30 ml / min - 1 g;
• CC <15 ml / min - 0.5 g each

Patients with severe obstruction of the biliary tract and / or severe liver disease may need to adjust the dosage regimen. The maximum daily dose of Sulcef for such patients is 2 g.

In case of impaired hepatic function with concomitant impairment of renal function, it is necessary to monitor the plasma content of cefoperazone and adjust its dose, if necessary. In the absence of constant monitoring of the level of cefoperazone, its daily dose should not exceed 2 g.

Recommended daily dosage for children (based on 1 kg of the child's body weight): 40–80 mg / kg, divided into 2–4 injections; treatment of severe, long-term infections - 160 mg / kg. The maximum daily dose is 160 mg / kg. If it is necessary to administer Sulcef in an amount of more than 80 mg / kg (calculated by the dose of cefoperazone), an increase is provided due to the additional administration of cefoperazone.

In newborns of the first week of life, the interval between Sulcef doses is 12 hours.

Rules for the preparation and administration of solutions:

• injection of the solution into a vein: an adequate volume of 5% dextrose solution, or 0.9% sodium chloride solution for injection, or sterile water for injection is added to the contents of the vial; the volume is brought up to 20 ml with the same solution and injected into a vein: drip - for 15-60 minutes or jet - 3 minutes;
• injection of the solution into the muscle: sterile water for injection is added to the contents of the vial. In order to obtain a concentration of cefoperazone ≥ 250 mg / ml, the dilution is carried out in two stages: the first - with sterile water, the second - with 2% lidocaine solution to obtain a 0.5% lidocaine solution.

Side effects

Possible negative reactions from systems and organs with parenteral administration of Sulcef:

• immune system: transient eosinophilia, anaphylactic shock, fever, maculopapular rash, pruritus, urticaria, Stevens-Johnson syndrome (the likelihood of these reactions is higher in patients with a history of hypersensitivity reactions, especially to penicillin);
• digestive system: nausea, vomiting, diarrhea, pseudomembranous colitis;
• laboratory data: hyperbilirubinemia, hypoprothrombinemia, hypercreatininemia, increased activity of hepatic aminotransferases and alkaline phosphatase;
• hematopoietic system: a decrease in the number of neutrophils, leukopenia, thrombocytopenia, a decrease in the concentration of hemoglobin and the level of hematocrit; as a result of prolonged therapy, as with the use of other β-lactam antibiotics, the development of reversible neutropenia is possible;
• hemostasis system: bleeding (lack of vitamin K), hypoprothrombinemia;
• local reactions: i / m injection - transient pain; intravenous injection (as with the introduction of other cephalosporins or penicillins using a catheter) - phlebitis at the infusion site (0.1%), pain during administration is possible;
• other reactions: fever, headache, chills, vasculitis, hematuria.

When administered intramuscularly, Sulcef is well tolerated.

Overdose

A symptom of Sulcef's overdose is an epileptic seizure.

In case of intoxication, sedation is recommended. If anaphylactic shock develops, epinephrine is administered intravenously, the patient is supplied with oxygen inhalation, and glucocorticosteroids (GCS) are prescribed.

special instructions

In patients receiving β-lactam antibiotics (including cephalosporin groups), episodes of anaphylactic reactions were observed, the likelihood of which is higher in patients with a history of hypersensitivity reactions. If such reactions develop, the use of Sulcef is immediately discontinued and adequate treatment is provided. The serious development of anaphylactic reactions requires the urgent administration of epinephrine. According to indications, oxygen is prescribed, airway patency is ensured, including if necessary, intubation is performed, intravenous corticosteroids are administered.

Cefoperazone, like other antibiotics, in rare cases can cause the development of vitamin K hypovitaminosis. This is probably due to the suppression of the normal intestinal microflora that synthesizes this vitamin. At risk of vitamin K deficiency are those who are malnourished, malabsorbed (cystic fibrosis), and have been on parenteral artificial nutrition for a long time. These patients, as well as patients receiving anticoagulants, should be under the control of prothrombin time. If indicated, they should be given vitamin K.

Long-term use of Sulcef, like other antibiotics, can cause overgrowth of resistant microorganisms.

It is important to provide patients with close medical supervision during treatment.

With a long course of therapy, it is necessary to periodically monitor the indicators of the function of internal organs (including the kidneys and liver), as well as the hematopoietic system.

Since Sulcef has a wide spectrum of antimicrobial activity, it can be used for adequate monotherapy.

Concomitant use with aminoglycosides is carried out under the control of renal function.

With obstruction of the biliary tract and severe hepatic failure, patients need to adjust the dose of Sulcef and control the plasma content of cefoperazone in the blood.

During Sulcef therapy, when glucose is oxidized with Benedict-Fehling's reagent to determine its concentration in urine, false positive results may occur. A direct Coombs' test can also give a false positive result.

Influence on the ability to drive vehicles and complex mechanisms

The antibiotic Sulcef does not negatively affect human cognitive functions.

Application during pregnancy and lactation

Women during gestation or lactation use Sulcef only if the expected benefit to the mother exceeds the potential risk to the development and growth of the fetus or child.

Pediatric use

Premature newborns are treated with Sulcef only if the expected benefit exceeds the potential risk.

When treating young children, it is necessary to ensure careful monitoring of the functions of internal organs (including the kidneys and liver) and the hematopoietic system.

With impaired renal function

It is necessary to adjust the dose of Sulcef for chronic renal failure (chronic renal failure) with CC less than 30 ml / min.

Patients with impaired renal function and concomitant hepatic insufficiency require monitoring of the level of cefoperazone in the blood plasma and appropriate dose adjustment. If it is impossible to provide such control, the maximum daily dose of Sulcef for patients in this group is 2 g.

For violations of liver function

Dose adjustment may be required in patients with severe biliary obstruction and severe liver disease.

Patients with impaired liver function and concomitant renal failure require monitoring of the level of cefoperazone in blood plasma and appropriate dose adjustment. If it is impossible to provide such control, the maximum daily dose of Sulcef for patients in this group is 2 g.

Use in the elderly

In elderly patients with impaired renal / hepatic function, there is a change in the main pharmacokinetic parameters of both cefoperazone and sulbactam: an increase in T _1/2 and V _d, a decrease in CC. At the same time, the pharmacokinetics of sulbactam correlates with the level of impaired renal function, and the pharmacokinetics of cefoperazone - with the level of impaired hepatic function.

Drug interactions

In patients using Sulcef, when taking alcohol during therapy and within five days after administration of the solution, the risk of a disulfiram-like reaction is increased, the symptoms of which are hot flashes, hyperhidrosis, headache and tachycardia. The doctor is obliged to warn about the possibility of developing such symptoms when consumed during antibiotic therapy, drinks and medicines containing ethanol.

Do not mix Sulcef with aminoglycoside solutions, since the drugs are pharmaceutically incompatible. If such a combined treatment is required, the two drug solutions are administered by successive fractional IV infusions using separate secondary catheters. Flush the primary catheter between drug administrations with a compatible solvent. During the day, the intervals between the administration of the antibacterial drug and the aminoglycoside should be as long as possible.

The simultaneous use of Sulcef with loop diuretics can contribute to the development of their nephrotoxic effect.

Sulcef solution is compatible with 5% dextrose solution; 0.9% NaCl solution; 5% dextrose solution in 0.225% NaCl solution; 5% dextrose solution in 0.9% NaCl solution; sterile water for injection.

The drug is incompatible with Ringer's solution, as well as 2% lidocaine solution. However, the initial dilution of Sulcef with sterile water for injection results in a mixture compatible with lidocaine.

Analogs

Sulcef's analogues are Bakperazon, Broadsef-S, Bakcefort, Paktocef, Sulzontsef, Sulmover, Sulperacef, Cebanex, Cefoperazone and Sulbactam Jodas, Cefoperazone and Sulbactam Spencer, Cefpar SV, Cefoperazon and others Sulbactam.

Terms and conditions of storage

Store in a place protected from light at temperatures up to 25 ° C. Keep out of the reach of children.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Sulcef

On specialized sites and medical portals, reviews of Sulcef from patients are very rare. Perhaps this is due to the specificity of the drug's use: it is mainly prescribed for the treatment of severe infectious lesions and is administered in a hospital setting. Patients who were prescribed Sulcef note that it quickly and very effectively helps with complex infections.

The price of Sulcef in pharmacies

On average, in pharmacies, the price of Sulcef, a powder for preparing a solution for intravenous and intramuscular administration, 1 g + 1 g, for 1 bottle 2.18 g is 385–409 rubles.

Sulcef: prices in online pharmacies

Drug name Price Pharmacy

Sulcef 1g + 1g powder for preparation of solution for intravenous and intramuscular administration 1 pc. 357 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!