Cefurozine - instructions for use, dose, side effects, contraindications

Cephalosporin antibiotic II generation for 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 (Staphylococcus aureus, Staphylococcus epidermidis, including strains resistant to penicillins and with the exception of strains resistant to methicillin, Streptococcus pyogenes, etc. beta-hemolytic streptococci, 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, Haemophilus influenzae, including strains resistant to ampicillin, Haemophilus parainfluenzae,including strains resistant to ampicillin, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae, including strains producing and not producing penicillinase, Neisseria meningitidis, Salmonella spp., Bacteroides spp., Fusobacterium spp., Propionibacterium spp., Borrelia burgdorferi), gram-positive and Gram-negative anaerobes (including Peptococcus spp. and Peptostreptococcus spp.).

By cefuroxime not sensitive: Clostridium difficile, Pseudomonas spp, Campylobacter spp, Acinetobacter calcoaceticus, Listeria monocytogenes, methicillin-resistant strains of Staphylococcus aureus, methicillin-resistant strains of Staphylococcus epidermidis, Legionella spp, Streptococcus (Enterococcus) faecalis, Morganella morganii, Proteus... vulgaris, Enterobacter spp., Citrobacter spp., Serratia spp., Bacteroides fragilis.

Pharmacokinetics:

Parenteral administration: after the / m administration of 750 mg, the maximum concentration is reached after 15-60 minutes and is 27 μg / ml. With IV administration of 750 mg and 1.5 g, the maximum concentration after 15 minutes is 50 and 100 μg / ml, respectively. The therapeutic concentration remains 5.3 and 8 hours, respectively.

The half-life for IV and / or injection is 80 minutes, for newborns 3-5 times longer.

The connection with plasma proteins is 33-50%. It is not metabolized in the liver.

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 completely removed (50% by tubular secretion, 50% by glomerular filtration).

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 blood-brain barrier. Passes through the placenta and penetrates into breast milk.

Indications:Bacterial infections caused by sensitive microorganisms: infectious diseases of the respiratory tract (bronchitis, pneumonia, abscess of the lungs, pleural empyema, etc.), LOP-organs (sinusitis, tonsillitis, pharyngitis, etc.), urinary tract (pyelonephritis, cystitis, symptomatic bacteriuria, gonorrhea, etc.), skin and soft tissues (erysipelas, pyoderma, impetigo, furunculosis, cellulitis, wound infection, erysipelitis, etc.), bones and joints (osteomyelitis, septic arthritis, etc.), pelvic organs (in obstetrics and gynecology), septicemia, meningitis, pro lacticus of infectious complications in operations on the organs of the thorax, abdominal cavity, pelvis, joints, (incl.at operations on lungs, heart, an esophagus, in vascular surgery at a high degree of risk of infectious complications, at orthopedic operations).

Contraindications:

Hypersensitivity (including to other cephalosporins, penicillins and carbapenems).

Carefully:neonatal period prematurity, chronic renal failure, bleeding and gastrointestinal tract diseases (including history, ulcerative colitis), weakened and emaciated patients, pregnancy, lactation.

Dosing and Administration:

In / m, in / in. In / in and / m adults are prescribed 750 mg 3 times a day; for infections of severe course, the dose is increased to 1500 mg 3-4 times a day (if necessary, the interval between administrations can be reduced to 6 hours). The average daily dose is 3000-6000 mg.

Children are prescribed 30-100 mg / kg / day in 3-4 divided doses. 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 doses.

With gonorrhea - in / m, 1500 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, 3000 mg every 8 hours; children of younger and older age -150-250 mg / kg / day in 3-4 doses, newborns - 100 mg / kg / day.

In surgeries on the abdominal cavity, pelvic organs and in orthopedic operations - IV, 1500 mg with the induction of anesthesia, then additionally - in / m 750 mg, 8 and 16 hours after the operation.

At operations on heart, lungs, an esophagus and vessels - in / in, 1500 mg at an induction of anesthesia, then - in / m, on 750 mg 3 times a day during the subsequent 24-48 ch.

When the joint is fully replaced, 1500 mg of the powder is dry mixed with each polymer methyl methacrylate cement pack before adding the liquid monomer.

With pneumonia - in / m or / in, 1,500 mg 2-3 times a day for 48-72 hours, then go to the inside (use medicinal forms for oral administration) 500 mg 2 times a day for 7 -10 days.

When exacerbation of chronic bronchitis is prescribed in / m or / in, 750 mg 2-3 times a day for 48-72 hours, then go to the inside (use medicinal forms for oral administration) of 500 mg twice a day in for 5-10 days.

In chronic renal failure, correction of the dosing regimen is necessary: with creatinine clearance of 10-20 ml / min, IV or IV is given 750 mg twice daily, with creatinine clearance less than 10 ml / min 750 mg once a day .

Patients on continuous hemodialysis using an arteriovenous shunt or high-velocity haemofiltration inIntensive care units, 750 mg are administered twice a day; for patients on low-velocity haemofiltration, doses recommended for renal impairment are prescribed.

Side effects:

Allergic reactions: chills, rash, itching, urticaria, rarely - erythema multiforme, bronchospasm, Stevens-Johnson syndrome, anaphylactic shock.

On the part of the digestive system: diarrhea, nausea, vomiting or constipation, flatulence, spasms and abdominal pain, ulceration of the oral mucosa, oral candidiasis, glossitis, pseudomembranous enterocolitis, impaired liver function (increased activity of "liver" enzymes in plasma - aspartate aminotransferase , alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase, bilirubin), cholestasis.

On the part of the genitourinary system: impaired renal function (decreased creatinine clearance, increased creatinine and residual urea nitrogen in the blood), dysuria, itching in the perineum, vaginitis.

On the part of the organs of hematopoiesis: a decrease in Hb 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.

Overdose:

Symptoms: CNS excitement, convulsions. Treatment: the appointment of anticonvulsants, ventilation and perfusion, control and maintenance of vital body functions, hemodialysis and peritoneal dialysis.

Interaction:

Simultaneous oral administration of "loop" diuretics slows down the channel 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.

Drugs that reduce the acidity of gastric juice, reduce the absorption of cefuroxime and its bioavailability.

Pharmaceutically compatible with metronidazole, azlocillin, xylitol, with aqueous solutions containing up to 1% lidocaine hydrochloride, 0.9% sodium chloride solution, 5% dextrose solution, 0.18% sodium chloride solution and 4% dextrose solution, 5% dextrose solution and 0.9% solution sodium chloride, 5% dextrose solution and 0.45% sodium chloride solution, 5% dextrose solution and 0.225% sodium chloride solution,10% solution of dextrose; 10% inverted sugar in water for injection, Ringer's solution, sodium lactate solution, Hartmann 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.

Pharmaceutically incompatible with aminoglycosides, sodium bicarbonate solution 2.74%.

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 is recommended to continue for 48-72 hours after the disappearance of symptoms, in the case of infections caused by Streptococcus pyogenes, it is recommended to continue treatment for at least 10 days.

During treatment, a false positive Coombs reaction and a false positive urine reaction to glucose are possible.

After dilution, it can be stored at room temperature for 7 hours, in the refrigerator for 48 hours. Yellow solution may be used during storage.

During treatment can not be used ethanol.

In patients receiving cefuroxime, when determining the level of glucose in the blood, it is recommended to use tests with glucose oxidase or hexokinase.

Against the background of treatment of meningitis in children, hearing loss is possible.

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 receiving cefuroxime inside there is no clinical improvement, it is necessary to continue parenteral administration.

Form release / dosage:Powder for the preparation of solution for injection in vials of 750 mg.

Packaging:Powder for the preparation of solution for injection in vials of 750 mg, one bottle in a pack of cardboard.

Storage conditions:

In a place protected from light, inaccessible to children, at a temperature of no higher than 25 ° C.

Shelf life:3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N014926 / 01

Date of registration:27.01.2009

The owner of the registration certificate:SPC ELFA, CJSC SPC ELFA, CJSC Russia

Manufacturer: & nbsp

PROTECH BIOSYSTEMS, PVT. Ltd. India

Information update date: & nbsp29.11.2015

Illustrated instructions

Instructions

Cefurozin® (Cefurozine®)