Index of drugs

Treatment of the following infections in adults and children over 3 months of age: acute streptococcal tonsillitis and pharyngitis; acute bacterial sinusitis; acute otitis media; exacerbation of chronic bronchitis; cystitis; pyelonephritis; uncomplicated skin and soft tissue infections; early form of Lyme disease (borreliosis). National recommendations on the proper use of antibacterial agents should be taken into account.

1 tabl it contains 125 mg, 250 mg or 500 mg of cefuroxime in the form of axetil (and respectively 0.2 mg, 0.3 mg or 0.4 mg of aspartame - E951).

Β-lactam antibiotic, second generation cephalosporin. Species usually sensitive: aerobic Gram-positive bacteria -Staphylococcus aureus (sensitive to methicillin),Streptococcus pyogenes, Streptococcus agalactiae; aerobic Gram-negative bacteria -Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis; spirochetes -Borrelia burgdorferi. Species among which there is a problem of acquired resistance: Gram-positive aerobic bacteria -Streptococcus pneumoniae; aerobic Gram-negative bacteria -Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus spp. (different thanP.vulgaris), Providencia spp.; Anaerobic Gram-positive bacteria -Peptostreptococcus spp, Propionibacterium spp; Anaerobic Gram-negative bacteria -Fusobacterium spp., Bacteroides spp. Microbes with innate resistance: Gram-positive aerobic bacteria -Enterococcus faecalis, Enterococcus faecium; aerobic Gram-negative bacteria -Acinetobacter spp, Campylobacter spp, Morganella morganii, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens; Anaerobic Gram-negative bacteria -Bacteroides fragilis; other -Chlamydia spp, Mycoplasma spp, Legionella spp. After oral administration, the drug is absorbed from the gastrointestinal tract and is quickly hydrolyzed in the intestinal mucosa and in the blood, which releases the active substance, cefuroxime, into the bloodstream. Absorption is optimal when the drug is taken soon after a meal. Maximum serum concentration occurs after approx. 2.4 hours. Binding to proteins is 33-50%. Cefuroxime may reach concentrations above the minimum inhibitory concentrations for the most common palatine tonsils, sinus tissues, bronchi mucosa, bones, pleural fluid, synovial fluid, synovial fluid, interstitial fluid, bile, sputum and aqueous humor. Cefuroxime crosses the blood-brain barrier in meningitis. Cefuroxime is not metabolised. T_0,5 in the serum is 1-1.5 hours. Cefuroxime is eliminated by glomerular filtration and tubular secretion.

Hypersensitivity to cefuroxime or to any of the excipients. Previously known hypersensitivity to cephalosporin antibiotics. Severe hypersensitivity (eg, anaphylactic reaction) to any other β-lactam antibiotic (penicillins, monobactams and carbapenems) in history.

Special care should be taken in patients who have an allergic reaction to penicillins or other β-lactam antibiotics due to the risk of cross-sensitivity. If severe hypersensitivity reactions occur after taking the medicine, the preparation should be discontinued immediately and appropriate emergency procedures instituted. Before starting treatment, it should be determined whether the patient has had a severe allergic reaction to cefuroxime, other cephalosporins or any other β-lactam antibiotic in the past. Caution should be exercised when cefuroxime is used in patients who have experienced a moderate allergic reaction to other β-lactam antibiotics in the past. A Jarisch-Herxheimer reaction has been observed after using cefuroxime axetil for the treatment of Lyme disease (Lyme disease) - patients should be informed about this common and usually spontaneous reaction. The use of the drug may cause excessive growth of yeasts.Prolonged treatment may also be the cause of excessive growth of other non-susceptible microorganisms (e.g. enterococci andClostridium difficile), which may require discontinuation of treatment. Patients who develop diarrhea during or after treatment with cefuroxime should consider the possibility of colitis (from mild to life threatening). Discontinuation of cefuroxime should be considered and special treatment of infection should be consideredClostridium difficile. Do not administer drugs that inhibit intestinal peristalsis. There is no experience in the use of the preparation in children under 3 months of age. The preparation contains aspartame - special care should be taken in patients with phenylketonuria.

During pregnancy, use only if the expected benefit outweighs the potential risk to the fetus (animal studies did not show adverse effects on pregnancy, embryonal / fetal development, birth or neonatal development, data on use in pregnant women are limited). Cefuroxime is excreted in small amounts in breast milk. The drug can be used in women who are breastfeeding only after careful assessment of the benefit / risk ratio. In a breast-fed infant, you may experience diarrhea, fungal infection of the mucous membranes, hypersensitivity reactions, and you may need to stop your baby from breast.

Common: excessive growthCandida spp., eosinophilia, headache, dizziness, diarrhea, nausea, abdominal pain, transient elevation of liver enzymes. Uncommon: positive Coombs' reaction, thrombocytopenia, leukopenia (sometimes severe), vomiting, skin rash. Frequency unknown: excessive growthClostridium difficile, hemolytic anemia, drug-induced fever, serum sickness syndrome, anaphylactic reaction, Jarisch-Herxheimer reaction, pseudomembranous colitis, jaundice (mainly congestive), hepatitis, urticaria, pruritus, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis , angioneurotic edema.

Orally.Adults and children (≥40 kg) - acute tonsillitis, pharyngitis, acute rhinosinusitis: 250 mg twice daily; acute otitis media: 500 mg twice daily; exacerbation of chronic bronchitis: 500 mg twice daily; cystitis: 250 mg twice daily; pyelonephritis: 250 mg twice daily; uncomplicated skin and soft tissue infections: 250 mg twice daily; Lyme disease: 500 mg twice daily.Children about the month of <40 kg - acute tonsillitis and pharyngitis, acute rhinosinusitis: 10 mg / kg 2 times a day (up to 125 mg 2 times a day); otitis media or, if appropriate, more severe infections in children ≥ 2 years old: 15 mg / kg Twice daily (maximum 250 mg 2 times a day); cystitis: 15 mg / kg Twice daily (maximum 250 mg 2 times a day); pyelonephritis: 15 mg / kg Twice daily (maximum 250 mg 2 times a day); uncomplicated skin and soft tissue infections: 15 mg / kg Twice daily (maximum 250 mg 2 times a day); Lyme disease: 15 mg / kg 2 times a day (up to 250 mg 2 times a day). There is no experience with administering the drug to children aged <3 months.Time of treatment. Treatment of most infections lasts 7 days (may last from 5 to 10 days); treatment of Lyme disease lasts for 14 days (in the range of 10 to 21 days).Special groups of patients. In patients with renal insufficiency, the dosage should be adjusted for creatinine clearance - CCr ≥ 30 ml / min: no change in dosage is necessary; 10-29 ml / min: a typical dose administered every 24 hours; CCr <10 ml / min: a typical dose administered every 48 hours; hemodialysis patients: an additional single standard dose given at the end of each dialysis. The occurrence of hepatic impairment has no effect on the pharmacokinetics of cefuroxime.Way of giving. The drug should be taken after a meal in order to ensure optimal absorption. The tablets should not be crushed (therefore they are not suitable for patients who can not swallow tablets). In children, cefuroxime axetil can be used in the form of an oral suspension (tablets and granules for oral suspension containing cefuroxime axetil, are not bioequivalent and can not be substituted for each other on the basis of conversion of milligrams per milligrams).