Composition, form of production and packaging
Powder for the preparation of a solution for intravenous and / or injections of almost white or yellowish color.
1 f.
cefuroxime (in the form of a sodium salt) 750 mg
Glass bottles (1) - cardboard packs.
Powder for the preparation of a solution for intravenous and / or injections of almost white or yellowish color.
1 f.
cefuroxime (in the form of a sodium salt) 1.5 g
Glass bottles (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2008.
PHARMACHOLOGIC EFFECT
Cephalosporin antibiotic of the second generation. 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, beta-hemolytic streptococci (including Streptococcus pyogenes), Streptococcus pneumoniae, Streptococcus group B (Streptococcus agalactiae), Streptococcus mitis (viridans group), Bordetella pertussis, most Clostridium spp .; Gram-negative microorganisms: Escherichia coli, Klebsiella spp., Proteus mirabilis, Providencia spp., Proteus rettgeri, Haemophilius 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.
PHARMACOKINETICS
Suction
After the / m introduction in a dose of 750 mg C max in the plasma is achieved after 15-60 minutes and is 27 Ојg / ml. With IV administration in doses of 0.75 and 1.5 g C max after 15 minutes is 50 and 100 Ојg / ml, respectively. The therapeutic concentration is maintained for 5.3 and 8 hours, respectively.
Distribution and Metabolism
Binding to plasma proteins is 33-50%.
Therapeutic concentrations are recorded in the pleural fluid, bile, sputum, myocardium, skin and soft tissues. Concentrations of cefuroxime exceeding the minimum inhibitory concentration for most common microorganisms can be achieved in bone tissue, synovial fluid and intraocular fluid. When meningitis penetrates the BBB.Penetrates through the placental barrier, excreted in breast milk.
It is not metabolized in the liver.
Excretion
T 1/2 with iv injection and / m administration of the drug - 1.3-1.5 h, in newborns - 2-2.5 hours.
It is excreted by the kidneys by glomerular filtration and tubular secretion 85-90% unchanged for 8 hours (most of the drug is excreted within the first 6 hours, while creating high concentrations in the urine); after 24 hours it is excreted completely (50% - by tubular secretion, 50% by glomerular filtration).
INDICATIONS
Infectious-inflammatory diseases caused by sensitive microorganisms:
- respiratory tract infections (including bronchitis, pneumonia, lung abscess, pleural empyema);
- infections of the ENT organs (including sinusitis, tonsillitis, pharyngitis, otitis media);
- urinary tract infections (including pyelonephritis, cystitis, asymptomatic bacteriuria, gonorrhea);
- skin and soft tissue infections (including erysipelas, pyoderma, impetigo, furunculosis, phlegmon, erysipeloid);
- wound infection;
- infections of bones and joints (including osteomyelitis, septic arthritis);
- infections of the 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).
DOSING MODE
The drug is administered iv and i / m.
Adults appoint 750 mg 3 times a day; with infections of severe course - the dose is increased to 1.5 g 3-4 times / day (if necessary, the interval between administrations can be reduced to 6 hours). The average daily dose is 3-6 g.
Children are prescribed 30-100 mg / kg / day in 3-4 divided doses. In most infections, the optimal dose is 60 mg / kg / day. Newborns and children under 3 monthsare prescribed 30 mg / kg / day in 2 - 3 doses.
With gonorrhea - in / m in a dose of 1.5 mg once (or as 2 injections of 750 mg with the introduction into different areas, for example, in both gluteal muscles).
With bacterial meningitis - iv 3 g every 8 hours; children younger and older - 150-250 mg / kg / day in 3-4 doses, newborns - 100 mg / kg / day.
In surgeries on the abdominal cavity, pelvic organs and orthopedic operations - iv dose of 1.5 g with induction of anesthesia, then additionally - 750 mg at 8 and 16 h after the operation.
At operations on heart, lungs, an esophagus and vessels - in / in a dose of 1.5 g at an induction of anesthesia, then - in / m on 750 mg 3 times / sut during next 24-48 hours.
When pneumonia - in / m or / in 1.5 g 2-3 times / day for 48-72 h, then go to the inside, 500 mg 2 times a day for 7-10 days.
With an exacerbation of chronic bronchitis , I / m or IV is prescribed 750 mg 2-3 times / day for 48-72 hours, then go to the oral intake of 500 mg 2 times / day for 5-10 days.
When the joint is fully replaced , 1.5 g of the powder is dry mixed with each polymer-methacrylate cement polymer packet before adding the liquid monomer.
In chronic renal failure , correction of the dosing regimen is necessary: ​​with QC from 10 to 20 ml / min , 750 mg / day or 750 mg / day is prescribed for IV, or 750 mg / day for 10 ml / min .
Patients on continuous hemodialysis using an arteriovenous shunt or high-velocity haemofiltration in the ICU are prescribed 750 mg 2 times / day; for patients on low-velocity haemofiltration, doses recommended for renal impairment are prescribed.
Preparation of injection solution
Solution for IM injections : add 3 ml of water for injection to 750 mg of the drug. Gently shake until a slurry forms. Cefuroxime is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.
Solution for intravenous injections : dissolve 750 mg of the drug in 6 or more ml of water for injection, and 1.5 g in 15 or more ml of water for injection.
For short-term intravenous infusions (up to 30 min): 1.5 g of the drug is dissolved in 50 ml of water for injection. These solutions can be injected directly into the vein or into the tube of the infusion system.
SIDE EFFECT
Allergic reactions: chills, rash, itching, urticaria, rarely - multiforme exudative erythema, bronchospasm, malignant exudative erythema (Stevens-Johnson syndrome), anaphylactic shock.
On the part of the digestive system: diarrhea, nausea, vomiting or constipation, flatulence, cramps and abdominal pain, ulceration of the oral mucosa, candidiasis of the oral cavity, glossitis, pseudomembranous enterocolitis, impaired liver function (increased activity of AST, ALT, ALP, LDG, bilirubin), cholestasis.
On the part of the urinary system: a violation of kidney function, dysuria.
On the part of the reproductive system: itching in the perineum, vaginitis.
From the side of the central nervous system: convulsions.
From the senses: a decrease in hearing.
On the part of the hemopoietic system: a decrease in the concentration of hemoglobin and hematocrit, anemia (aplastic or hemolytic), eosinophilia, neutropenia, leukopenia, agranulocytosis, thrombocytopenia, hypoprothrombinemia, prolongation of prothrombin time.
Local reactions: irritation, infiltration and pain at the injection site, phlebitis.
CONTRAINDICATIONS
- Hypersensitivity to the drug and other cephalosporins, penicillins and carbapenems.
With caution should be used in newborns and premature infants, chronic renal failure, bleeding and gastrointestinal diseases (including NJA in the anamnesis), during pregnancy and lactation, in weakened and depleted patients.
PREGNANCY AND LACTATION
The use of the drug in pregnancy is possible only in those cases when the intended use for the mother exceeds the potential risk to the fetus.
If you need to use cefuroxime during lactation, you should decide whether to stop breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
In chronic renal failure , correction of the dosing regimen is necessary: with a CC of 10-20 ml / min , 750 mg / day or 750 mg / day is prescribed for IV, or 750 mg / day for SC less than 10 ml / min .
Patients on continuous hemodialysis using an arteriovenous shunt or high-velocity haemofiltration in the ICU are prescribed 750 mg 2 times / day; for patients on low-speed haemofiltration, doses recommended for renal dysfunction are prescribed.
SPECIAL INSTRUCTIONS
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 the symptoms; In the case of infections caused by Streptococcus pyogenes, the course of treatment is at least 7-10 days.
During treatment, a false positive Coombs reaction and a false positive urine reaction to glucose are possible.
The 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 yellow solution during storage.
In patients receiving cefuroxime, glucose oxidase or hexokinase tests are recommended when determining blood glucose concentrations.
When switching from parenteral to ingestion, 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.
OVERDOSE
Symptoms: CNS excitement, convulsions.
Treatment: the appointment of antiepileptic drugs, control and maintenance of vital body functions, hemodialysis and peritoneal dialysis.
DRUG INTERACTION
Simultaneous oral administration of "loop" diuretics slows tubular secretion, reduces renal clearance, increases plasma concentration and increases T 1/2 cefuroxime.
When used simultaneously with aminoglycosides and diuretics, the risk of nephrotoxic effects increases.
Pharmaceutical interaction
Pharmaceutically compatible with aminoglycosides, sodium bicarbonate solution 2.74%, as well as with metronidazole, azlocillin, xylitol, aqueous solutions containing up to 1% lidocaine hydrochloride, 0.9% sodium chloride solution, 5% dextrose solution, 0.18% sodium chloride solution and 4% solution dextrose, 5% dextrose solution and 0.9% sodium chloride solution, 5% dextrose solution and 0.45% sodium chloride solution, 5% dextrose solution and 0.225% sodium chloride solution, 10% dextrose solution; 10% inverted sugar in water for injection, Ringer's solution, sodium lactate solution, Hartman solution, 0.9% sodium chloride solution, 5% dextrose solution and hydrocortisone, heparin (10 U / ml and 50 U / ml) in 0.9% sodium chloride solution , potassium chloride (10 meq / L and 40 meq / L) in a 0.9% solution of sodium chloride.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored out of reach of children dry, protected from light at a temperature of no higher than 25 В° C. Shelf life - 2 years.
