TSEFURUS

Active material: Cefuroxime
When ATH: J01DC02
CCF: Cephalosporin II generation
ICD-10 codes (testimony): A39, A40, A41, A46, A54, G00, H66, J01, J02, J03, J04, J15, J20, J31, J32, J35.0, J37, J42, J85, J86, J90, L01, L02, L03, L08.0, M00, M86, N10, N11, N30, N34, N41, N70, N71, N72, N73.0, T79.3, Z29.2
When CSF: 06.02.02
Manufacturer: Synthesis of (Russia)

Pharmaceutical form, composition and packaging

Powder for solution for I / O, and the / m white or white with a yellowish tint.

750 mg – vials 10 ml (1) – packs cardboard.

Powder for solution for I / O, and the / m white or white with a yellowish tint.

1.5 g – vials 20 ml (1) – packs cardboard.

Pharmacological action

II generation cephalosporin antibiotic for parenteral administration. Effective bactericidal (violates the synthesis of the bacterial cell wall). It has a wide spectrum of antimicrobial action.

Highly active against gram-positive microorganisms: Staphylococcus aureus, Staphylococcus epidermidis (including strains, penicillin-resistant strains, and except, resistant to methicillin), Streptococcus pyogenes, Streptococcus pneumoniae, Group B Streptococcus (incl. Streptococcus agalactiae), Streptococcus mitis group viridans; Gram-negative microorganisms: Escherichia coli, Klebsiella spp., Proteus is wonderful, Providencia spp., Proteus rettgeri, Haemophilus influenzae (including strains, Ampicillin resistant), Haemophilus parainfluenzae (including strains, Ampicillin resistant), Moraxella (Branham) catarrhalis, Neisseria gonorrhoeae (including strains, producing and not producing penicillinase), Neisseria meningitidis, Salmonella spp., Bordetella pertussis, Borrelia burgdorferi; anaerobes: Peptococcus spp., Peptostreptococcus spp., Bacteroides spp., Fusobacterium spp., Propionibacterium spp., Clostridium spp. (most strains).

To cefuroxime insensitive 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

Absorption

After the / m injection at a dose of 750 mg C_max achieved through 15-60 and m is 27 ug / ml. The on / in the introduction of the drug in doses 750 mg 1.5 г C_max achieved through through 15 and m is 50 ug / ml 100 ug / ml, respectively. Therapeutic concentration is maintained 5.3 and 8 h, respectively.

Distribution and metabolism

Do not metabolized in the liver.

Plasma protein binding – 33-50%. Therapeutic concentrations are achieved in pleural fluid, bile, mokrote, miokarde, skin and soft tissue. Concentrations of cefuroxime, exceeding the minimum inhibitory concentrations for most common microorganisms, It can be achieved in bone, synovial fluid and aqueous humor. When meningitis penetrate the BBB. It passes through the placental barrier and is excreted in breast milk.

Deduction

T_1/2 when in / and / m introduction – 80 m, T in newborns_1/2 increases 3-5 time.

85-90% displayed by glomerular filtration and tubular secretion as unchanged for 8 no (most of the drug is excreted within the first 6 no, creating a high concentration in urine); through 24 h displayed completely (50% – by tubular secretion, 50% – by glomerular filtration).

Testimony

Bacterial infections, caused by susceptible microorganisms:

- Respiratory tract infections (bronchitis, pneumonia, lung abscess, empyema);

- Infections of upper respiratory tract (sinusitis, tonsillitis, pharyngitis);

- Urinary tract infections (pyelonephritis, cystitis, symptomatic bacteriuria, gonorrhea);

- Infections of the skin and soft tissues (mug, pyoderma, impetigo, furunculosis, cellulitis, wound infection, erysipeloid);

- Bone and joint infections (osteomyelitis, septicheskiy arthritis);

- Pelvic infection (in obstetrics and gynecology);

- Septicemia;

- Meningitis.

Prevention of infectious complications in surgery of the chest (incl. in lung surgery, heart, esophagus), abdomen, clean, joints, in vascular surgery at high risk of infectious complications, orthopedic surgery.

Dosage regimen

The drug is prescribed in / m, I / (bolus or infusion).

V / a and / m adult appoint 750 mg 3 times / day; at severe infections increase the dose to 1.5 g 3-4 times / day (if necessary, the interval between administrations may be reduced to 6 no). Average daily dose – 3-6 g.

Babies senior 3 Months appoint 30-100 mg / kg / day 3-4 introduction. For most infections the optimal dose is 60 mg / kg / day.

Infants and children up to 3 Months appointed 30 mg / kg / day 2-3 introduction.

At gonorrhea – / m 1.5 g once (or as 2 injections 750 mg introduction into different areas, eg, both gluteal muscles).

At bacterial meningitis – in / on 3 g every 8 no; children younger and older – 150-250 mg / kg / day 3-4 introduction, newborn – 100 mg / kg / day.

At abdominal surgery, pelvic and orthopedic surgery – I / 1.5 g at ​​induction of anesthesia, then further – w / m 750 mg after 8 and 16 hours after surgery.

At heart surgery, light, esophagus and blood vessels – I / 1.5 g at ​​induction of anesthesia, then – w / m 750 mg 3 times / day for the next 24-48 no.

At total joint replacement – 1.5 g powder are mixed in dry form with each packet a methyl methacrylate polymer cement prior to adding the liquid monomer.

At pneumonia – / m or / by 1.5 g 2-3 times / day for 48-72 no, then move on ingestion (using dosage forms of cefuroxime axetil for oral administration) by 500 mg 2 times / day for 7-10 days.

At exacerbation of chronic bronchitis appoint / m or / by 750 mg 2-3 times / day for 48-72 no, then move on ingestion (using dosage forms of cefuroxime axetil for oral administration) by 500 mg 2 times / day for 5-10 days.

At chronic renal failure necessary correction mode. At CC 10-20 ml / min administered in / in or / m 750 mg 2 times / day, at CC less than 10 ml / min – by 750 mg 1 time / day.

Patients, We are on continuous hemodialysis using arteriovenous shunt or hemofiltration high speed ICU, appointed 750 mg 2 times / day; to patients, located on low speed hemofiltration, prescribed dose, recommended in case of violation of renal function.

Preparation of suspensions and solutions for parenteral administration

For the preparation of suspensions for the / m to 750 mg (vial 10 ml) add 3 ml water for injection, to 1.5 g (vial 20 ml) – 6 ml water for injection.

To prepare the solution for I / O to the introduction of the jet 750 mg (vial 10 ml) add 9 ml water for injection or a; to 1.5 g (vial 20 ml) – 14 ml or more of water for injections.

In the case of short-term / in infusions (eg, to 30 m) 1.5 g is dissolved in 50 ml water for injection. These solutions can be administered directly into a vein or into an infusion system, If the patient parenterally administered fluid.

Side effect

Allergic reactions: chills, rash, itch, hives; rarely – erythema multiforme, bronchospasm, Stevens-Johnson syndrome, anaphylactic shock.

From the digestive system: diarrhea, nausea, vomiting or constipation, flatulence, cramping and abdominal pain, ulceration of the oral mucosa, oral candidiasis, glossitis, pseudomembranous enterocolitis, abnormal liver function (increased activity of AST, GOLD, Alkaline phosphatase, LDH, bilirubin), cholestasis.

With the genitourinary system: impairment of renal function (a decrease in creatinine clearance, elevation of creatinine and BUN in blood), dizurija, itching in the perineum, vaginitis.

From the side of hematopoiesis: decrease in hemoglobin and hematocrit, anemia (aplastic or hemolytic), eozinofilija, neutropenia, leukopenia, agranulocytosis, thrombocytopenia, gipoprotrombinemii, prolonged prothrombin time.

Local reactions: irritation, infiltration and pain at the injection site, phlebitis.

Contraindications

- Hypersensitivity (incl. to other cephalosporins, penicillin and carbapenems).

FROM caution should be prescribed to newborn (incl. premature), in chronic renal failure, bleeding and gastrointestinal diseases (incl. history, nespetsificheskiy yazvennыy colitis), weakened and depleted patients, Pregnancy, lactation (breast-feeding).

Pregnancy and lactation

Caution should be used Tsefurus^® Pregnancy and lactation.

Cautions

Patients, with a history of allergic reaction to penicillin, may have a hypersensitivity to cephalosporin antibiotics.

During treatment requires monitoring of renal function, especially in patients, receiving the drug at high doses.

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

During treatment, possible false-positive direct Coombs' test and false positive reaction to urinary glucose.

During treatment can not use ethanol.

Patients, receiving cefuroxime, the determination of blood glucose levels are recommended tests with glucose oxidase or hexokinase.

The treatment of meningitis in children may reduce hearing.

In the transition from parenteral to receive inward to consider the severity of infection, the sensitivity of micro-organisms and the general condition of the patient. If after 72 hours after administration of cefuroxime into not marked clinical improvement, We need to continue parenteral administration.

Overdose

Symptoms: CNS excitation, convulsions.

Treatment: appointment of anticonvulsants, ensure ventilation and perfusion, monitoring and maintenance of vital body functions, e pyeritonyealinyi dialysis and hemodialysis.

Drug Interactions

Simultaneous oral administration “loop” diuretics slows tubular secretion, reduces renal clearance, It increases the concentration in plasma and increases the half-life of cefuroxime.

While the use of aminoglycosides and diuretics increased risk of nephrotoxic effects.

Preparations, lowering gastric acidity, reduce the absorption and bioavailability of cefuroxime.

Pharmaceutical interaction

Pharmaceutically compatible with aqueous solutions, containing up to 1% Lidocaine hydrochloride, 0.9% sodium chloride solution, 5% dextrose (Glucose), 0.18% sodium chloride solution and 4% dextrose (Glucose), 5% dextrose (Glucose) and 0.9% sodium chloride solution, 5% dextrose (Glucose) and 0.45% sodium chloride solution, 5% dextrose (Glucose) and 0.225% sodium chloride solution, 10% dextrose (Glucose); 10% inverted sugar in water for injection, Ringer, solution of sodium lactate, Hartmann's solution, geparinom (10 IU / ml 50 U / ml) in 0.9% sodium chloride solution, potassium chloride (10 mEq / L 40 mEq / L) in 0.9% sodium chloride solution.

Pharmaceutical incompatible with aminoglycosides, solution of sodium bicarbonate 2.74%.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored in a dry, protected from light, reach of children, at a temperature no higher than 25 ° C. Shelf life – 2 year.

After dilution can be stored at room temperature for 7 no, in a refrigerator – during 48 no. Allowed to use yellowed during storage solution.