Sulcef POR 1g+1g 2.18g vials, 1pc

Composition

>of 1 fl. contains:  Active ingredients:  cefoperazone (in the form of sodium salt) – 1 g; sulbactam (in the form of sodium salt) – 1 g

Pharmacological action

Combined antimicrobial drug.

Cefoperazone is a third-generation cephalosporin that acts on sensitive microorganisms during their active reproduction by inhibiting cell wall mucopeptide biosynthesis. Sulbactam does not have clinically significant antibacterial activity (with the exception of Neisseriaceae and Acinetobacter), it is an irreversible inhibitor of most major beta-lactamases, the presence of which is due to the resistance of microorganisms to beta-lactam antibiotics. Sulbactam also binds to some penicillin-binding proteins, so the combination of sulbactam/cefoperazone often has a more pronounced effect on sensitive strains than cefoperazone alone.

Sulcef is active against all microorganisms sensitive to cefoperazone. In addition, the drug has synergy against various microorganisms, primarily: Haemophilus influenzae, Bacteroides spp., Staphylococcus spp., Acinetobacter colcoaceticus, Enterobacter aerogenes, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae, Morganella morganii, Citrobacter freundii, Enterobacter cloacae, Citrobacter diversus.

The drug is active in vitro against a wide range of clinically significant microorganisms, including gram-positive microorganisms: Staphylococcus aureus (producing and not producing penicillinase), Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes (Group A beta-hemolytic streptococcus), Streptococcus agalactiae (beta-hemolytic streptococcus). group B hemolytic streptococcus), most other strains of beta-hemolytic streptococci, many strains of Streptococcus faecalis (enterococci); gram-negative microorganisms:  Escherichia coli, Klebsiella spp., Enterobacter spp., Citrobacter spp., Haemophilus influenzae, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia rettgeri, Providencia spp., Serratia spp. (including S. marcescens), Salmonella spp., Shigella spp., Pseudomonas aeruginosa, Acinetobacter calcoaceticus, Neisseria gonorrhoeae, Neisseria meningitidis; Bordetella pertussis, Yersinia enterocolitica; anaerobic gram-negative rods, including Bacteroides spp. (including Bacteroides fragilis), 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. ).

Indications

Treatment of infectious and inflammatory diseases caused by drug-sensitive microorganisms: — upper and lower respiratory tract infections— – urinary tract infections;- intraabdominal infections (including cholecystitis, cholangitis);— peritonitis; – septicemia— – meningitis; – skin and soft tissue infections— – bone and joint infections;- pelvic inflammatory diseases (including endometritis);- genital tract infections— – gonorrhea

Recommendations for use

The drug is administered intravenously or intravenously.

Adults are prescribed 2-4 g / day with an interval of 12 hours; for severe, long-term infections-8 g/day. The maximum daily dose is 8 g.

Patients with chronic renal failure (creatinine clearance less than 30 ml / min) dose adjustment is required: with a creatinine clearance of 15-30 ml / min, the drug is prescribed 1 g 2 times / day, with a creatinine clearance of less than 15 ml/min – 500 mg 2 times/day.

In case of severe biliary tract obstruction, severe liver diseases, dose adjustment may be required, the maximum daily dose in such cases is 2 g. In patients with impaired liver function and concomitant renal impairment, it is necessary to monitor the concentration of cefoperazone in blood plasma and adjust the dose of the drug if necessary. If regular monitoring of the concentration of cefoperazone in such cases is not carried out, then the daily dose of the drug should not exceed 2 g.

Children are prescribed the drug at a dose of 40-80 mg / kg / day in 2-4 injections; for severe, long-term infections-160 mg / kg / day. The maximum daily dose is 160 mg / kg / day. If it is necessary to administer more than 80 mg / kg / day (calculated according to the content of cefoperazone), an increase in the dose is achieved by additional use of cefoperazone.

Rules for the preparation and use of solutions

For intravenous use, the contents of the vial are dissolved in an adequate volume of 5% dextrose solution,0.9% sodium chloride solution for injection or sterile water for injection, diluted to 20 ml with the same solution and administered intravenously for 15-60 minutes; intravenously jet for 3 minutes. When administered intravenously, sterile water for injection is used for dissolution. To obtain a cefoperazone concentration of 250 mg/ml or more, dilution is carried out in 2 stages: with sterile water, then with a 2% lidocaine solution to obtain a 0.5% lidocaine solution

Contraindications

-hypersensitivity to the components of the drug—

– hypersensitivity to penicillins and other cephalosporins.

Side effects

Allergic reactions:  anaphylactic shock, transient eosinophilia, fever, macular-papular rash, urticaria, pruritus, Stevens-Johnson syndrome. The risk of these reactions is higher in patients with a history of allergic reactions (especially to penicillin). From the digestive system:  diarrhea, nausea, vomiting, pseudomembranous colitis. From the side of laboratory parameters:  increased activity of hepatic transaminases and alkaline phosphatase, hyperbilirubinemia, hypercreatininemia, hypoprothrombinemia. From the hematopoietic system:  reduced neutrophil count, leukopenia and thrombocytopenia, decreased hemoglobin and hematocrit levels; reversible neutropenia is possible with long-term treatment (as with other beta-lactam antibiotics). From the side of the blood coagulation system:  hypoprothrombinemia, bleeding (vitamin K deficiency). Local reactions:  after intravenous injection, transient pain may occur; intravenous use of the drug (as with other cephalosporins and penicillins) using a catheter may develop phlebitis at the infusion site (0.1%); pain during injection is possible. Other services:  headache, fever, chills, hematuria, vasculitis. The drug is well tolerated when administered intravenously

Interaction

Reactions characterized by hot flashes, sweating, headache, and tachycardia have been reported when taking ethanol while using the drug and during the next 5 days after its use ( patients should be warned about the possibility of such reactions when drinking alcohol during treatment). In patients who require artificial nutrition (oral or parenteral), the use of solutions containing ethanol should be avoided.

Pharmaceutical incompatibilities

Solutions of Sulcef and aminoglycosides should not be mixed, given the physical incompatibility between them. If a combination therapy with Sulcef and aminoglycoside is performed, the two drugs are administered by successive infusions using separate secondary catheters, and the primary catheter is washed with an adequate solution between doses of drugs. The interval between the use of Sulcef and aminoglycoside during the day should be as long as possible.

Overdose

Symptoms:  an epileptic seizure.

Treatment:  sedation therapy. With the development of anaphylactic shock – intravenous use of epinephrine, oxygen inhalation, the use of corticosteroids.

Special instructions

Anaphylactic reactions have been reported in patients treated with beta-lactam antibiotics (including cephalosporins). The risk of such reactions is higher if a history of hypersensitivity reactions is indicated. If an allergic reaction occurs, the drug should be discontinued and adequate therapy should be prescribed.

In case of serious anaphylactic reactions, epinephrine should be administered immediately. According to indications, oxygen is prescribed, intravenous corticosteroids are administered and airway patency is ensured, including intubation.

When treated with cefoperazone (as with other antibiotics), vitamin K deficiency develops in rare cases, apparently due to the suppression of the normal intestinal microflora that synthesizes this vitamin. The risk group includes patients who receive poor nutrition, suffer from malabsorption (for example, with cystic fibrosis), and are on IV artificial nutrition for a long time. In such cases, as well as in patients receiving anticoagulants, it is necessary to monitor prothrombin time and, if indicated, prescribe vitamin K.

With long-term treatment with Sulcef (as with other antibiotics), excessive growth of insensitive microorganisms is possible.

During therapy, patients require careful monitoring by a doctor.

With long-term therapy, it is recommended to periodically monitor the function of internal organs (including kidneys, liver) and the hematopoietic system.

Given the wide spectrum of antimicrobial activity, adequate monotherapy can be performed.

With simultaneous use of aminoglycosides, renal function should be monitored.

In case of biliary tract obstruction, severe hepatic insufficiency (the maximum daily dose is 2 g), it is necessary to adjust the dose of Sulcef and control the concentration of cefoperazone in the blood plasma.

During treatment, there may be false positive results of determining glucose in the urine when using Benedict or Fehling solutions, a false positive Coombs reaction.

Use in pediatrics

Treatment of premature newborns is carried out if the expected benefit of therapy exceeds the potential risk. When using the drug in young children, careful monitoring of the functions of internal organs (including kidneys, liver) and the hematopoietic system is required.

Storage conditions

The drug should be stored out of the reach of children, protected from light at a temperature not exceeding 25°C.

Shelf

life is 2 years.

Active ingredient

Cefoperazone, [Sulbactam]

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection and infusion