Cefuroxime Cabi, 750 mg 10 pcs

Pharmacotherapeutic group

Cephalosporin antibiotic

ATCode

J01DC02

Pharmacodynamics:

Mechanism of action

Cefuroxime is active against a broad spectrum of pathogens including beta-lactamase-producing strains.

Cefuroxime has good resistance to bacterial beta-lactamases and is accordingly active against a wide range of ampicillin- and amoxicillin-resistant strains.

The bactericidal effect of cefuroxime is associated with suppression of bacterial cell wall synthesis as a result of binding to the main target proteins.

Pharmacodynamic effects

Cefuroxime is a bactericidal antibiotic of cephalosporin group that is resistant to the action of most beta-lactamases and active against a wide range of Gram-positive and Gram-negative microorganisms.

The prevalence of acquired bacterial resistance to cefuroxime varies by region and can be very high in certain types of microorganisms over time. It is preferable to have local sensitivity data especially for therapy of severe infections.

Bacteria generally sensitive to cefuroxime

Gram-positive aerobes

Staphylococcus aureus (methicillin-sensitive strains)*

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Coagulazonegative staphylococci (methicillin-sensitive strains)

Streptococcus pyogenes*

Beta-haemolytic streptococci

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Gram-negative aerobes

Haemophilus influenzae* including ampicillin-resistant strains

Haemophilus parainfluenzae*

Moraxella catarrhalis*

Neisseria gonorrhoeae* including penicillinase-producing and non-penicillinase-producing strains

Neisseria meningitidis

Shigella spp.

Gram-positive anaerobes

Peptostreptococcus spp.

Propionibacterium spp.

Spirochaetes

Borrelia burgdorferi*

Bacteria for which acquired resistance to cefuroxime is likely

Gram-positive aerobes

Streptococcus pneumoniae *

Streptococci Viridians

Gram-negative aerobes

Bordetella pertussis

Citrobacter spp. except C.freundii

Enterobacter spp. except E. aerogenes and E. cloacae

Escherichia coli*

Klebsiella spp. including C. pneumoniae*

Proteus mirabilis

Proteus spp. except P. penneri and P. vulgaris

Providencia spp.

Salmonella spp.

Gram-positive anaerobes

Clostridium spp. other than C.difficile

Gram-negative anaerobes

Bacteroides spp. except B.fragilis

Fusobacterium spp.

Bacteria naturally resistant to cefuroxime

Gram-positive aerobes

Enterococcus spp. including E.faecalis and E.faecium

Listeria monocytogenes

Gram-negative aerobes

Acinetobacter spp.

Burkholderia cepacia

Campylobacter spp.

Citrobacter freundii

Enterobacter aerogenes

Enterobacter cloacae

Morganella morganii

Proteus penneri

Proteus vulgaris

Pseudomonas spp. including P. aeruginosa

Serratia spp.

Stenotrophomonas maltophilia

Gram-positive anaerobes

Clostridium difficile

Gram-negative anaerobes

Bacteroides fragilis

Other

Chlamydia spp.

Mycoplasma spp.

Legionella spp.

* – For these bacteria, the clinical efficacy of cefuroxime has been demonstrated in clinical trials.

Pharmacokinetics:

Absorption

The maximum concentration of cefuroxime in blood plasma after intramuscular administration is observed within 30 to 45 minutes.

Distribution

The drug is 33-50% bound to plasma proteins (depending on the technique used).

Concentrations of cefuroxime exceeding the minimum suppressive concentration for most microorganisms can be achieved in the bone tissue synovial and intraocular fluid. Cefuroxime penetrates the blood-brain barrier in inflammation of the brain membranes.

Metabolism

Cefuroxime is not metabolized and is excreted by glomerular filtration and tubular secretion.

Elimation

The elimination half-life of cefuroxime from serum after intramuscular or intravenous administration is approximately 70 minutes. In newborn children the half-life of cefuroxime may be 3-5 times longer than in adults.

The concomitant administration of probenecid prolongs cefuroxime excretion, which leads to an increase in the maximum concentration of cefuroxime in the serum.

For 24 hours after parenteral administration cefuroxime is excreted almost completely (85-90%) through the kidneys in the unchanged form, the most part of the drug – during the first 6 hours.

The serum concentrations of cefuroxime decrease with dialysis.

Indications

Cefuroxime Kabi is indicated for the treatment of diseases caused by cefuroxime-sensitive bacteria and when the causative agent is not yet identified:

– lower respiratory tract infections such as bacterial pneumonia acute bacterial bronchitis and exacerbation of chronic bronchitis infected bronchiectasis lung abscess postoperative chest infections;

– ENT infections such as otitis media sinusitis tonsillitis pharyngitis;

– urinary tract infections such as acute and chronic pyelonephritis cystitis asymptomatic bacteriuria;

– gonorrhea;

– skin and soft tissue infections such as cellulitis rye and wound infections;

– bone and joint infections such as osteomyelitis and septic arthritis;

– obstetric and gynecological infections such as pelvic inflammatory disease;

– other infections including septicemia meningitis peritonitis;

– prevention of infectious complications during abdominal and pelvic surgeries for orthopedic surgeries on the heart, lungs, esophagus and blood vessels – where there is an increased risk of infectious complications.

The sensitivity of bacteria to cefuroxime varies by region and over time. Where possible, local sensitivity data should be taken into account (see subsection “Pharmacodynamics”).

Active ingredient

Composition

1 vial contains:

the active substance:

cefuroxime sodium (in conversion to cefuroxime) – 0.75 g.

How to take, the dosage

Cefuroxime is intended for intravenous and/or intramuscular administration.

In intramuscular administration, no more than 750 mg of Cefuroxime Kabi should be administered at one injection site.

General recommendations

– Adults

The recommended dose for most infections is 750 mg 3 times daily intramuscularly or intravenously.

In more severe infections, the drug is administered intravenously at a dose of 15 g 3 times a day. If necessary, Cefuroxime Kabi can be given every 6 hours and the daily dose can be 3 to 6 g.

– Children

The recommended dose is 30-100 mg/kg/day divided into 3 to 4 injections.

For most infections, the optimal dose is 60 mg/kg/day.

– Infants

The recommended dose is 30-100 mg/kg/day divided into 2-3 injections (see Pharmacokinetics subsection)

Gonorrhea

– Adults

The recommended dose is 15 g once (as two doses of 750 mg intramuscularly to different injection sites such as both buttocks).

Meningitis

The drug Cefuroxime Kabi is recommended as basic therapy for bacterial meningitis caused by susceptible strains.

– Adults

The recommended dose is 3 g intravenously every 8 hours.

– Children

The recommended dose is 150-250 mg/kg/day intravenously divided into 3-4 injections.

– Infants

The recommended dose is 100 mg/kg/day intravenously.

Prevention of postoperative complications

– Adults

In operations on pelvic abdominal organs and orthopedic interventions, Cefuroxime Kabi in a dose of 15 g is administered intravenously during introductory anesthesia. After surgery, an additional 750 mg of Cefuroxime Kabi may be administered intramuscularly after 8 hours and 750 mg of Cefuroxime Kabi after 16 hours.

Patients on hemodialysis should receive an additional 750 mg of Cefuroxime Kabi intravenously or intramuscularly at the end of each hemodialysis session.

In addition to parenteral administration, Cefuroxime Kabi may be added to the peritoneal dialysis solution (usually 250 mg for every 2 liters of dialysis solution).

Patients with renal failure who are in the intensive care unit on continuous hemodialysis using an arterio-venous shunt or on high-speed hemofiltration are recommended a dose of 750 mg twice daily. If low rate hemofiltration is used, doses recommended for patients with impaired renal function, depending on creatinine clearance values, are used.

In patients undergoing cardiac, esophageal and cardiovascular surgery during anesthetic insertion, Cefuroxime Kabi is given at a dose of 15 g intravenously and then 750 mg 3 times daily by intramuscular injection for 24-48 hours.

In joint arthroplasty, Cefuroxime Kabi 15 g as cefuroxime dry powder can be mixed with the contents of each of the methyl methacrylate cement polymer packets before adding the liquid monomer.

Patients with impaired renal function

As with all similar antibiotics that are excreted by the kidneys when renal impairment is severe, reduction of the dose of Cefuroxime Kabi is recommended to compensate for delayed excretion of the drug (see table “Dose Adjustment of Cefuroxime Kabi in adult patients with impaired renal function”).

There is no need to reduce the standard dose of the drug (750 mg – 15 g 3 times daily) in patients with a creatinine clearance of 20 mL/min or higher.

Interaction

Simultaneous administration with loop diuretics (furosemide) and aminoglycosides slows down tubular secretion, decreases renal clearance, increases plasma concentrations and prolongs the half-life of cefuroxime, which increases the risk of nephrotoxic effects.

Cefuroxime Kabi in combination with aminoglycosides acts additively but sometimes synergism may be observed. Cefuroxime Kabi should not be mixed in the same syringe with aminoglycosides.

In common with other antibiotics, Cefuroxime Kabi can inhibit intestinal flora that can lead to decreased estrogen reabsorption and decreased efficacy of oral hormonal contraceptives.

Solution compatibility

. It is pharmaceutically compatible with aqueous solutions containing up to 1% lidocaine hydrochloride 09% sodium chloride 5 and 10% dextrose solution 018% sodium chloride solution and 4% dextrose solution 5% dextrose and 09% sodium chloride solution Ringer’s solution Hartmann’s solution Sodium lactate heparin solution (10 U/ml and 50 U/ml) in 09% sodium chloride solution.

Pharmaceutically incompatible with aminoglycosides with 274% sodium hydrocarbonate solution.

Special Instructions

High-dose cephalosporin antibiotics should be used with caution in patients receiving concomitant therapy with strong diuretics such as furosemide or aminoglycosides because of the increased risk of renal failure. Due to this, renal function should be monitored when using such a combination of drugs, especially in elderly patients and patients with a history of renal disease (see section “Dosage and administration”).

As with other therapeutic regimens, mild to moderate hearing loss has been noted in some children with treatment of meningitis with cefuroxime.

Persistence of Haemophilus influenzae in the cerebrospinal fluid was noted 18-36 hours after injection. Similar phenomena have also been observed with other antibiotics, but their clinical significance is not known.

As with other antibiotics, growth of Candida fungi may be observed with Cefuroxime Kabi.

Long-term therapy with the drug may lead to overgrowth of other insensitive microorganisms (e.g., enterococci and Clostridium difficile) and discontinuation of treatment with the drug may be necessary.

Pseudomembranous colitis has been described in cases of pseudomembranous colitis when taking antibiotics, the severity of which may vary from mild to life-threatening. Therefore, it is important to consider the possibility of pseudomembranous colitis in patients with diarrhea during or after antibiotic use. If the diarrhea is prolonged or severe or if the patient experiences abdominal cramps, treatment should be stopped immediately and the patient should be examined. Drugs that inhibit intestinal peristalsis should not be used.

The drug Cefuroxime Kabi does not affect the results of determination of glucose in urine by enzymatic methods.

In the use of other methods (Benedicta fiedinga Clinitest) there may be interactions that do not lead to false positives as observed with some other cephalosporins.

In patients receiving Cefuroxime Kabi, it is recommended to use the glucose oxidase or hexokinase method to determine blood/plasma glucose levels.

The drug Cefuroxime Kabi does not affect the quantitative determination of creatinine by the alkaline-PCR method.

The use of cefuroxime does not affect the ability to operate vehicles and other machinery.

Contraindications

Hypersensitivity to cephalosporin antibiotics penicillins and carbapenems in the history.

Must be used with caution in renal insufficiency gastrointestinal diseases (including history and nonspecific ulcerative colitis) when combined with loop diuretics and aminoglycosides in early pregnancy and lactation and in infants (especially premature infants).

Side effects

The undesired reactions presented below are listed according to organ and system involvement and frequency of occurrence.

The incidence is defined as follows: very common (≥1/10) common (≥1/100 and < 1/10) infrequent (≥1/1000 and < 1/100) rare (≥1/10 000 < 1/1000) and very rare (< 1/10 000 including isolated cases).

Frequency of adverse reactions

Infectious and parasitic diseases

Rare: candidiasis of the oral cavity and mucous membranes.

Disorders of the blood and lymphatic system

Often: eosinophilia neutropenia.

Infrequent: leukopenia decreased hemoglobin level positive Coombs test.

Rare: thrombocytopenia.

Very rare: hemolytic anemia.

The cephalosporins as a class tend to be absorbed onto the surface of red blood cell membranes and interact with antibodies to the drug leading to a positive Coombs test (which can affect cross compatibility) and very rarely, hemolytic anemia.

Immune system disorders

Hypersensitivity reactions including:

Infrequent: skin rash urticaria and itching.

Rarely: drug-induced fever.

Very rare: interstitial nephritis anaphylaxis cutaneous vasculitis.

Also see. “Skin and subcutaneous tissue disorders” and “Renal and urinary tract disorders.”

Gastrointestinal tract disorders

Infrequent: gastrointestinal disorder.

Very rare: pseudomembranous colitis (see section “Special indications”).

Liver and biliary tract disorders

Often: transient increase of “liver” enzymes activity.

Infrequent: transient increase of bilirubin concentration.

These adverse reactions occur particularly in patients with a history of liver disease but no symptoms of liver damage have been reported.

Skin and subcutaneous tissue disorders

Very rare: erythema multiforme toxic epidermal necrolysis and Stevens-Johnson syndrome.

Also see. “Immune system disorders.”

Renal and urinary tract disorders

Very rare: increased serum creatinine concentration increased residual nitrogen in the blood and decreased creatinine clearance (see section “Special indications”).

Also see. “Immune system disorders.

Hearing and labyrinth disorders

Very rare: mild to moderate hearing loss in children during treatment of meningitis.

General disorders and disorders at the injection site

Often: reactions at the injection site which may include soreness and thrombophlebitis. Soreness at the site of intramuscular injection is more likely with higher doses; however, this is usually not a reason to withdraw the drug.

Overdose

Symptoms: increased cortical excitability with the development of seizures.

Treatment: symptomatic hemodialysis peritoneal dialysis.

Pregnancy use

The drug Cefurcosim Kabi should be used if the potential benefit to the mother is greater than the potential risk to the fetus and child.

Pregnancy

There is no experimental evidence of embryopathic or teratogenic effects of cefuroxime, but as with other drugs, caution should be exercised when prescribing it in early pregnancy.

Breast-feeding

Cautious use of cefuroxime should be made with nursing mothers because the drug is excreted with the breast milk.

Similarities