Composition, form of production and packaging
Powder for solution for infusion 1 fl.
cefuroxime 1.5 g
1 g - bottles (1) - packs of cardboard.
1 g - bottles (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2010.
Cephalosporin antibiotic II generation for oral and parenteral use. It acts bactericidal (it breaks the synthesis of the bacterial cell wall). Has a wide spectrum of antimicrobial action.
Highly active against gram-positive microorganisms, including strains resistant to penicillins (with the exception of strains resistant to methicillin): Staphylococcus aureus, Streptococcus pyogenes (and other beta-hemolytic streptococci), Streptococcus pneumoniae, Streptococcus group B (Streptococcus agalactiae), Streptococcus mitis group viridans), most of Clostridium spp .; Gram-negative microorganisms: Escherichia coli, Klebsiella spp., Proteus mirabilis, Providencia spp., Proteus rettgeri, Haemophilus influenzae, including strains resistant to ampicillin; Haemophilus parainfluenzae, including strains resistant to ampicillin; Moraxella catarrhalis, Neisseria gonorrhoeae, including strains producing and not producing penicillinase, Neisseria meningitidis, Salmonella spp., Borrelia burgdorferi; Gram-positive and Gram-negative anaerobes (Peptococcus spp., Peptostreptococcus spp., Fusobacterium spp., Propionibacterium spp.).
Cefuroxime is insensitive: Clostridium difficile, Pseudomonas spp., Campylobacter spp., Acinetobacter calcoaceticus, Listeria monocytogenes, methicillin-resistant strains of Staphylococcus aureus, Staphylococcus epidermidis, Legionella spp., Streptococcus (Enterococcus) faecalis, Morganella morganii, Proteus vulgaris, Enterobacter spp. , Citrobacter spp., Serratia spp., Bacteroides fragilis.
With intravenous administration, 1.5 g of C max is reached after 15 minutes, about 100 Ојg / ml. The therapeutic concentration remains 8 hours. The connection with plasma proteins is 33-50%.
Therapeutic concentrations are created in the pleural fluid, bile, sputum, myocardium; skin and soft tissues. Concentrations of cefuroxime exceeding the minimum inhibitory concentration (MIC) for most microorganisms can be achieved in bone tissue, synovial and intraocular fluid. When meningitis penetrates the blood-brain barrier (BBB). Passes through the placenta and penetrates into breast milk. It is not metabolized in the liver.
T 1/2 - 1.3-1.5 h, in newborns - 2-2.5 hours. 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 within the first 6 hours, creating with high concentrations in the urine): after 24 hours it is excreted completely (50% by tubular secretion, 50% by glomerular filtration).
Infectious-inflammatory diseases caused by microorganisms sensitive to cefuroxime:
- respiratory tract (bronchitis, pneumonia, lung abscess, empyema of the pleura);
- ENT organs (sinusitis, tonsillitis, pharyngitis, otitis media);
- urinary tract (pyelonephritis, cystitis, asymptomatic bacteriuria);
- skin and soft tissues (erysipelas, pyoderma, impetigo, furunculosis, phlegmon, wound infection, erysipelitis);
- bones and joints (osteomyelitis, septic arthritis);
- Small pelvic organs (endometritis, adnexitis, cervicitis);
- sepsis, meningitis, Lyme disease (borreliosis).
Prevention of infectious complications in operations on the chest, abdominal, pelvis, joints (including operations on the lungs, heart, esophagus, vascular surgery with a high risk of infection complications, with orthopedic operations).
Adults appoint 750 mg 3 times a day; with infections of severe course - the dose is increased to 1500 mg 3-4 times / day. The average daily dose is 3-6 g. For bacterial meningitis, intravenously, 3 g every 8 hours. For infections of bones and joints, 1500 mg every 8 hours. For operations on the abdomen, pelvic organs and orthopedic operations, intravenously 1500 mg with the induction of anesthesia, then additionally - intramuscularly 750 mg, 8 and 16 hours after the operation.
In operations on the heart, lungs, esophagus and vessels - intravenously 1500 mg with the induction of anesthesia, then - then go on to intramuscular administration 750 mg 3 times daily for the next 24-48 hours.
For pneumonia, 1,500 mg 2-3 times a day for 48-72 hours, then go on to receive cefuroxime in dosage forms intended for oral administration in appropriate dosages.
With exacerbation of chronic bronchitis, 750 mg 2-3 times a day for 48-72 hours are prescribed, then they are switched to cefuroxime reception in dosage forms intended for oral administration in appropriate dosages. In chronic renal failure (CRF), correction of the dosing regimen is necessary: вЂ‹вЂ‹with creatinine clearance (CK) of more than 20 ml / min, 750-1500 mg every 8 hours is prescribed, with CC 10-20 ml / min prescribed 750 mg every 12 hours, with KK less than 10 ml / min - 750 mg every 24 hours.
Patients on continuous hemodialysis using an arteriovenous shunt or on high-speed haemofiltration in intensive care units are prescribed 750 mg 2 times / day; for patients on low-speed haemofiltration, doses recommended for renal dysfunction are prescribed.
Use in children
Newborns and children under 3 months are prescribed 30 mg / kg / day in 2-3 injections: for bacterial meningitis - 100 mg / kg / day.
Children over 3 months are prescribed 30-100 mg / kg / day in 3-4 injections. In most infections, the optimal dose is 60 mg / kg / day. In severe and life-threatening infections, doses of 100 mg / kg / day (but not exceeding the dose in adults) can be used. In the case of bacterial meningitis, high doses of 200-240 mg / kg / day IV are used, divided into equal doses, which are administered every 6-8 hours.
With infection of bones and joints - 150 mg / kg / day, divided into equal doses, which are administered every 8 hours.
If the renal function is impaired, the frequency of administration should correspond to the frequency of application of the drug in adults with concomitant renal failure.
For intravenous infusion, 1500 mg is dissolved in 50 ml of water for injection, 0.9% solution of sodium chloride or 5% glucose solution.
Allergic reactions: chills, rash, itching, urticaria, multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis, bronchospasm, interstitial nephritis, angioedema, anaphylactic shock.
On the part of the reproductive system: itching in the perineum, vaginitis.
On the part of the urinary system: a violation of kidney function, dysuria. Increase in the concentration of creatinine and urea nitrogen in plasma, decrease in creatinine clearance.
From the central nervous system (CNS): convulsions.
On the part of the digestive system: diarrhea, nausea, vomiting, cramps and abdominal pain, ulceration of the oral mucosa, candidiasis of the oral cavity, pseudomembranous colitis.
From the senses: a decrease in hearing.
From the hemopoiesis: a decrease in hemoglobin and hematocrit, eosinophilia, transient neutropenia, leukopenia, hemolytic anemia.
Laboratory indicators: increased activity of "liver" enzymes, including alkaline phosphatase (APF), lactate dehydrogenase (LDH). Hyperbilirubinemia, decreased triglycerides, false-positive Coombs test.
Local reactions: irritation, infiltration and pain at the injection site, phlebitis.
- hypersensitivity (including other cephalosporins, penicillin and carbapenems).
With caution: the period of newborns, prematurity, chronic renal failure, bleeding and gastrointestinal diseases (including in history, ulcerative colitis), weakened and emaciated patients.
PREGNANCY AND LACTATION
In pregnancy, the drug is used only if the intended benefit to the mother exceeds the potential risk to the fetus, during lactation with the drug, breast-feeding should be discontinued.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution: chronic renal failure.
APPLICATION FOR CHILDREN
With caution: the period of newborns, prematurity.
Patients who had a history of allergic reactions to penicillins, may have a hypersensitivity to cephalosporin antibiotics. In the process of treatment, control of kidney function is necessary, especially in patients receiving the drug in high doses. Treatment continues for 48-72 hours after the disappearance of symptoms, in the case of infections caused by Streptococcus pyogenes, treatment course - at least 7-10 days.
During treatment, a false positive test of Coombs and a false positive urine reaction to glucose are possible.
In patients receiving cefuroxime, glucose oxidase or hexokinase tests are recommended when determining blood glucose concentrations. When switching from parenteral administration to the administration of cefuroxime in oral dosage forms, the severity of the infection, the sensitivity of the microorganisms and the general condition of the patient should be considered. If 72 hours after taking cefuroxime inside, there is no improvement, it is necessary to continue parenteral administration.
Impact on the ability to drive vehicles and manage mechanisms
Patients taking cefuroxn, should be careful when driving a car and taking other potentially dangerous activities that require increased attention and speed of psychomotor reactions, due to the possibility of side effects from the central nervous system.
Treatment: the appointment of anticonvulsants, monitoring and maintenance of vital body functions, hemodialysis and peritoneal dialysis.
Simultaneous oral administration of "loop" diuretics slows tubular secretion, reduces renal clearance, increases plasma concentration, and increases the half-life of cefuroxime.
When used simultaneously with aminoglycosides and diuretics, the risk of nephrotoxic effects increases.
It is pharmaceutically compatible with 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, Hartman solution, sodium lactate solution, heparin (10 U / ml and 50 U / ml) in a 0.9% solution of sodium chloride.
Pharmaceutically incompatible with aminoglycosides, sodium bicarbonate solution 2.74%.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
At a temperature of no higher than 25 В° C in a dark place. Keep out of the reach of children. Shelf life - 2 years.