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

/p>

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 bacteria sensitive to cefuroxime and also in cases where the pathogen has not yet been identified:

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

– infections of the ENT organs, such as otitis media, sinusitis, tonsillitis, pharyngitis;

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

– gonorrhea;

– infections of the skin and soft tissues such as cellulitis, erysipelas and wound infections;

– infections of bones and joints such as osteomyelitis and septic arthritis;

– obstetric and gynecological infections such as inflammatory diseases of the pelvic organs;

– other infections including septicemia, meningitis, peritonitis;

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

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

Pharmacological effect

Pharmacotherapeutic group

Antibiotic-cephalosporin

ATX code

J01DC02

Pharmacodynamics:

Mechanism of action

Cefuroxime is active against a wide range 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 the suppression of bacterial cell wall synthesis as a result of binding to the main target proteins.

Pharmacodynamic effects

Cefuroxime is a bactericidal antibiotic of the cephalosporin group, 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, over time, resistance can be very high in certain types of microorganisms. It is preferable to have local susceptibility data, especially when treating severe infections.

Bacteria are usually sensitive to cefuroxime

Gram-positive aerobes

Staphylococcus aureus (strains sensitive to methicillin)*

Coagulase-negative staphylococci (strains sensitive to methicillin)

Streptococcus pyogenes*

Beta-hemolytic streptococci

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.

Spirochetes

Borrelia burgdorferi*

Bacteria for which acquired resistance to cefuroxime is likely

Gram-positive aerobes

Streptococcus pneumoniae*

Streptococci of the Viridians group

Gram-negative aerobes

Bordetella pertussis

Citrobacter spp. except C.freundii

Enterobacter spp. except E. aerogenes and E. cloacae

Escherichia coli*

Klebsiella spp. including K. pneumoniae*

Proteus mirabilis

Proteus spp. except P. penneri and P. vulgaris

Providencia spp.

Salmonella spp.

Gram-positive anaerobes

Clostridium spp. except C. difficile

Gram-negative anaerobes

Bacteroides spp. except B.fragilis

Fusobacterium spp.

Bacteria that are 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

Others

Chlamydia spp.

Mycoplasma spp.

Legionella spp.

* – for these bacteria, the clinical effectiveness of cefuroxime has been demonstrated in clinical studies.

Pharmacokinetics:

Suction

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

Distribution

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

Concentrations of cefuroxime exceeding the minimum inhibitory concentration for most microorganisms can be achieved in bone tissue, synovial and intraocular fluids. Cefuroxime penetrates the blood-brain barrier during inflammation of the meninges.

Metabolism

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

Removal

The serum half-life of cefuroxime after intramuscular or intravenous administration is approximately 70 minutes. In newborns, the half-life of cefuroxime can be 3-5 times longer than in adults.

Concomitant administration of probenecid prolongs the excretion of cefuroxime, resulting in an increase in the maximum serum concentration of cefuroxime.

Within 24 hours after parenteral administration, cefuroxime is almost completely (85-90%) excreted unchanged through the kidneys, with most of the drug being eliminated in the first 6 hours.

Serum concentrations of cefuroxime decrease with dialysis.

Special instructions

Antibiotics of the cephalosporin group in high doses should be prescribed with caution to patients receiving concomitant therapy with strong diuretics such as furosemide or aminoglycosides since the risk of renal failure increases. As a result, it is necessary to monitor renal function when using this combination of drugs, especially in elderly patients and in patients with a history of kidney disease (see section “Dosage and Administration”).

As with other therapeutic regimens for the treatment of meningitis with cefuroxime, some children experienced mild to moderate hearing loss.

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

As with the use of other antibiotics, when using the drug Cefuroxime Kabi, the growth of fungi of the genus Candida may be observed.

Long-term therapy with the drug may lead to excessive growth of other non-susceptible microorganisms (for example, enterococci and Clostridium difficile), and it may be necessary to discontinue the course of treatment with the drug.

Cases of pseudomembranous colitis have been described when taking antibiotics, the severity of which can vary from mild to life-threatening. Therefore, it is important to consider the possibility of developing pseudomembranous colitis in patients with diarrhea during or after antibiotic use. If diarrhea is prolonged or severe or the patient experiences abdominal cramps, treatment should be stopped immediately and the patient should be examined. You should not use medications that inhibit intestinal motility.

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

When using other methods (Benedikta Fedinga Clinitest), an interaction may be observed which, however, does not lead to false-positive results, which was observed with some other cephalosporins.

In patients receiving the drug 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 picrate method.

Impact on the ability to drive vehicles. Wed and fur.:

The use of cefuroxime does not affect the ability to drive vehicles and other mechanisms.

Active ingredient

Cefuroxime

Composition

1 bottle contains:

active ingredient:

Cefuroxime sodium (in terms of cefuroxime) – 0.75 g.

Pregnancy

Cefurcosim Kabi should be used if the potential benefit to the mother outweighs 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 must be exercised when prescribing it in early pregnancy.

Breastfeeding period

Caution must be exercised when prescribing cefuroxime to nursing mothers since the drug is excreted in breast milk.

Contraindications

History of hypersensitivity to cephalosporin antibiotics, penicillins and carbapenems.

With caution:

It should be used with caution in case of renal failure, diseases of the gastrointestinal tract (including a history of nonspecific ulcerative colitis), if combined use with loop diuretics and aminoglycosides is necessary in early pregnancy and lactation, as well as in newborns (especially premature infants).

Side Effects

The undesirable reactions presented below are listed in accordance with the damage to organs and organ systems and the frequency of occurrence.

The frequency of occurrence is determined as follows: very common (≥1/10) common (≥1/100 and <1/10) uncommon (≥1/1000 and <1/100) rare (≥1/10,000 <1/1000) and very rare (<1/10,000 including isolated cases).

Frequency of occurrence of adverse reactions

Infectious and parasitic diseases

Rarely: candidiasis of the oral cavity and mucous membranes.

Blood and lymphatic system disorders

Common: neutropenia, eosinophilia.

Uncommon: leukopenia, decreased hemoglobin level, positive Coombs test.

Rarely: thrombocytopenia.

Very rare: hemolytic anemia.

Cephalosporins as a class tend to be absorbed onto the surface of the red blood cell membrane and interact with anti-drug antibodies, resulting in a positive Coombs test (which may interfere with cross-compatibility) and very rarely, hemolytic anemia.

Immune system disorders

Hypersensitivity reactions including:

Uncommon: skin rash, urticaria and itching.

Rare: drug fever.

Very rare: interstitial nephritis, anaphylaxis, cutaneous vasculitis.

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

Gastrointestinal disorders

Uncommon: gastrointestinal upset.

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

Disorders of the liver and biliary tract

Often: transient increase in the activity of liver enzymes.

Uncommon: transient increase in bilirubin concentration.

These adverse reactions occur particularly in patients with a history of liver disease; however, no symptoms of liver damage were observed.

Skin and subcutaneous tissue disorders

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

See also: Immune system disorders.

Renal and urinary tract disorders

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

See also: Immune system disorders.

Hearing and labyrinth disorders

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

General and administration site disorders

Common: injection site reactions which may include pain and thrombophlebitis. Pain at the site of intramuscular injection is more likely when high doses are administered; however, this is not usually a reason to discontinue the drug.

Interaction

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

The drug Cefuroxime Kabi in combination with aminoglycosides acts additively, but sometimes synergistic action can be observed. The drug Cefuroxime Kabi cannot be mixed in the same syringe with aminoglycosides.

Like other antibiotics, Cefuroxime Kabi can inhibit intestinal flora, which can lead to decreased estrogen reabsorption and decreased effectiveness of oral hormonal contraceptives.

Solution compatibility

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

Pharmaceutically incompatible with aminoglycosides with sodium bicarbonate solution 274%.

Overdose

Symptoms: increased excitability of the cerebral cortex with the development of seizures.

Treatment: symptomatic hemodialysis, peritoneal dialysis.

Storage conditions

In a place protected from light, at a temperature not exceeding 25 °C

Shelf life

2 years

Manufacturer

Labesfal Laboratorios Almiro S.A, Portugal