Composition
1 bottle contains:
Active ingredient:
cefuroxime sodium (in terms of cefuroxime) – 0.75 g
Pharmacological action
Cefuroxime Kabi is a second-generation cephalosporin antibiotic for oral and parenteral use. Acts bactericidal (disrupts the synthesis of the bacterial cell wall). It has a wide spectrum of antimicrobial action.
Highly active against gram-positive microorganisms, including penicillin-resistant strains (with the exception of methicillin-resistant strains): Staphylococcus aureus, Streptococcus pyogenes (and other beta-hemolytic streptococci), Streptococcus pneumoniae, Group B Streptococcus (Streptococcus agalactiae), Streptococcus mitis (viridans group), most Clostridium spp. ; gram-negative microorganisms: Escherichia coli, Klebsiella spp., Proteus mirabilis, Providencia spp., Proteus rettgeri, Haemophilus influenzae, including ampicillin-resistant strains; Haemophilus parainfluenzae, including ampicillin-resistant strains; Moraxella catarrhalis, Neisseria gonorrhoeae, including penicillinase-producing and non-penicillinase-producing strains, Neisseria meningitidis, Salmonella spp., Borrelia burgdorferi; gram-positive and gram-negative anaerobes (Peptococcus spp., Peptostreptococcus spp., Fusobacterium spp., Propionibacterium spp. ).
They are insensitive to cefuroxime: Clostridium difficile, Pseudomonas spp., Campylobacter spp., Acinetobacter calcoaceticus, Listeria monocytogenes, methicillin-resistant strains Staphylococcus aureus, Staphylococcus epidermidis, Legionella spp., Streptococcus (Enterococcus) faecalis, Morganella morganii, Proteus vulgaris, Enterobacter spp., Citrobacter spp., Serratia spp., Bacteroides fragilis.
Pharmacokinetics
With intravenous use of 1.5 g, Cmax is reached in 15 minutes, is about 100 mcg / ml. The therapeutic concentration is maintained for 8 hours. The binding to plasma proteins is 33-50%.
Therapeutic concentrations are created in the pleural fluid, bile, sputum, myocardium; skin and soft tissues. Cefuroxime concentrations exceeding the minimum inhibitory concentration (MPC) for most microorganisms can be achieved in bone tissue, synovial and intraocular fluids. In meningitis, it penetrates the blood-brain barrier (BBB). It passes through the placenta and enters breast milk. It is not metabolized in the liver.
T1/2 – 1.3-1.5 It is excreted by the kidneys by glomerular filtration and tubular secretion of 85-90% unchanged for 8 hours (most of the drug is excreted during the first 6 hours, creating high concentrations in the urine): after 24 hours, it is completely eliminated (50% – by tubular secretion,50% – by glomerular filtration).
Indications
Infectious and inflammatory diseases caused by cefuroxime-sensitive microorganisms:
- respiratory tract infections (bronchitis, pneumonia, lung abscess, pleural empyema);
- ENT organs (sinusitis, tonsillitis, pharyngitis, otitis media);
- urinary tract infections (pyelonephritis, cystitis, asymptomatic bacteriuria);
- skin and soft tissues (erysipelas, pyoderma, impetigo, boils, cellulitis, wound infection, erysipeloid);
- bones and joints (osteomyelitis, septic arthritis);
- pelvic (endometritis, adnexitis, cervicitis);
- sepsis, meningitis, Lyme disease (borreliosis).
Prevention of infectious complications in operations on the chest, abdominal cavity, pelvis, and joints (including operations on the lungs, heart, and esophagus, vascular surgery with a high risk of infectious complications, and orthopedic operations).
Use during pregnancy and lactation
During pregnancy, the drug is used only if the intended benefit to the mother exceeds the potential risk to the fetus, during lactation, when using the drug, breast-feeding should be discontinued.
Contraindications
Hypersensitivity to cefuroxime (including other cephalosporins, penicillins and carbapenems). With caution Neonatal period, prematurity, chronic renal failure, bleeding and diseases of the gastrointestinal tract (including in the anamnesis, ulcerative colitis), weakened and emaciated patients, pregnancy, lactation, simultaneous use with aminoglycosides, “loop” diuretics.
Side effects
Allergic reactions: Â chills, rash, pruritus, urticaria, erythema multiforme (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), bronchospasm, drug fever, serum sickness, anaphylactic shock, cutaneous vasculitis. Local reactions: Â with intramuscular use – pain, irritation and infiltration at the injection site, with intravenous use-phlebitis, thrombophlebitis. Nervous system disorders: Â convulsions. From the genitourinary system: Â itching in the perineum, vaginitis. From the urinary system: Â impaired renal function (with increased creatinine and/or urea nitrogen concentrations and decreased creatinine clearance), dysuria, interstitial nephritis. From the digestive system: Â diarrhea, constipation, flatulence, glossitis, nausea, vomiting, abdominal cramps and pain, ulceration of the oral mucosa, oral candidiasis, cholestasis, pseudomembranous colitis. From the side of hematopoietic organs: Â eosinophilia, leukopenia, neutropenia, thrombocytopenia, agranulocytosis, hemolytic anemia, decreased hemoglobin and hematocrit, hypoprothrombinemia, prolongation of prothrombin time. From the side of the senses: Â hearing loss. Laboratory parameters: Â increased activity of “liver” enzymes (alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, alkaline phosphatase), hyperbilirubinemia, false positive Coombs test.
Interaction
Concomitant use of loop diuretics slows down tubular secretion, reduces renal clearance, increases plasma concentrations, and increases the half-life of cefuroxime. Concomitant use with aminoglycosides and diuretics increases the risk of nephrotoxic effects Pharmacologically compatible with aqueous solutions containing up to 1% lidocaine hydrochloride,0.9% sodium chloride solution,5 and 10% dextrose solution,0.18% sodium chloride solution and 4% dextrose solution,5% dextrose solution and 0.9% sodium chloride solution, Ringer’s solution, Hartmann’s solution, sodium lactate solution, heparin (10 U / ml and 50 U/ml) in 0.9% sodium chloride solution Pharmacologically incompatible with aminoglycosides, sodium bicarbonate solution 2.74%.
How to take, course of use and dosage
Intramuscularly, intravenously, adults are prescribed 0.75 g 3 times a day; for severe infections, the dose is increased to 1.5 g 3-4 times a day (if necessary, the interval between injections can be reduced to 6 hours). The average daily dose is 3-6 g. Children older than 3 months are prescribed 30-100 mg / kg / day in 3-4 injections. For most infections, the optimal dose is 60 mg / kg / day. Newborns and children under 3 months are prescribed 30 mg / kg / day in 2-3 injections. With gonorrhea-intramuscularly, adults 1.5 g once (in the form of 2 injections of 0.75 g each with injection in different areas, for example, in both gluteal muscles). For bacterial meningitis-intravenously, adults – 3 g every 8 hours; young and older children-150-250 mg / kg / day in 3-4 injections, newborns-100 mg / kg/day in 2-3 injections.
For the prevention of postoperative complications: – for operations on the heart, lungs, esophagus and blood vessels-intravenously,1.5 g 0.5-1 h before the operation and 0.75 g intravenously or intramuscularly every 8 hours for prolonged operations for the next 24-48 hours (for open heart operations, the total dose is up to 6 g); – for operations on the abdominal cavity, pelvic organs and orthopedic operations-intravenously,1.5 g for induction of anesthesia, then additionally-intramuscularly,0.75 g,8 and 16 hours after the operation;-when the joint is completely replaced – 1.5 g of powder is mixed in dry form with each package of methyl methacrylate cement polymer before adding a liquid monomer. For pneumonia-intramuscularly or intravenously,1.5 g 2-3 times a day for 48-72 hours, then switch to oral use (use dosage forms for oral use) 0.5 g 2 times a day for 7-10 days. In case of exacerbation of chronic bronchitis, they are prescribed intramuscularly or intravenously,0.75 g 2-3 times a day for 48-72 hours, then they switch to oral use (use dosage forms for oral use) 0.5 g 2 times a day for 5-10 days.
In chronic renal failure, it is necessary to adjust the dosage regimen in adults: with a creatinine clearance of 10-20 ml / min,0.75 g is administered intravenously or intramuscularly 2 times a day, with a creatinine clearance of less than 10 ml/min – 0.75 g 1 time a day. In case of chronic renal failure in children, the dosage regimen should be changed in accordance with the recommendations for adults. Patients on continuous hemodialysis using an arteriovenous shunt or on high-speed hemofiltration in intensive care units are prescribed 0.75 g 2 times a day; for patients on low-speed hemofiltration, the recommended doses for impaired renal function are prescribed.
Overdose
Symptoms: agitation of the central nervous system, convulsions. Treatment: symptomatic, hemodialysis, peritoneal dialysis.
Special instructions
Patients with a history of allergic reactions to penicillins may be hypersensitive to cephalosporin antibiotics. During treatment, it is necessary to monitor renal function, especially in patients receiving the drug in high doses, in elderly patients with a history of kidney disease, when used simultaneously with aminoglycosides and loop diuretics. Treatment is continued for 48-72 hours after symptoms disappear; in the case of Streptococcus pyogenes infections, the course of treatment is at least 7-10 days. During treatment, a false positive direct Coombs reaction and a false positive urine glucose reaction are possible. In patients receiving cefuroxime, when determining the concentration of glucose in the blood, it is recommended to use tests with glucose oxidase or hexokinase.
Pseudomembranous colitis occurs when a wide range of antibiotics are used, and the possibility of its occurrence should be borne in mind in patients with severe diarrhea that occurred during or after a course of antibiotic treatment. Do not use ethanol during treatment. During the treatment of meningitis in children, hearing loss may occur. When switching from parenteral use to oral use, the severity of the infection, the sensitivity of microorganisms and the general condition of the patient should be taken into account. If there is no clinical effect 72 hours after the start of treatment, parenteral therapy should be continued.
Ready-to-use solution can be stored at room temperature for 7 hours, in the refrigerator-for 48 hours. It is allowed to use a solution that has turned yellow during storage. Influence on the ability to drive motor vehicles and control mechanisms During treatment, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.
Form of production
Powder for preparation of solution for infusions
Storage conditions
In a dark place, at a temperature not exceeding 25 °C
Shelf life
2 years
Active ingredient
Cefuroxime
Conditions of release from pharmacies
By prescription
Dosage form
solution for injection
Indications
Sinusitis, Gastrointestinal Infections, Sepsis, Pharyngitis, Vaginal Infections, Skin Infections
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Side effects of Cefuroxime Cabi, 750mg vials, 10pcs.
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