Cefurosin powder for solution for injection 750mg, No. 1

Infectious and 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);

• infections of the skin and soft tissues (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 during operations on the organs of the chest, abdominal cavity, pelvis, joints (including during operations on the lungs, heart, esophagus, in vascular surgery with a high risk of infectious complications, during orthopedic operations).

The drug is administered intravenously and intramuscularly.

Adults are prescribed 750 mg 3 times / day; for severe infections - the dose is increased to 1.5 g 3-4 times / day (if necessary, the interval between injections 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 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 - intramuscularly at a dose of 1.5 mg once (or in the form of 2 injections of 750 mg with the introduction in different areas, for example, in both gluteal muscles).

With bacterial meningitis - IV, 3 g every 8 hours; children of younger and older age - 150-250 mg / kg / day in 3-4 doses, for newborns - 100 mg / kg / day.

For operations on the abdominal cavity, pelvic organs and for orthopedic operations - intravenous in a dose of 1.5 g with induction of anesthesia, then additionally - intramuscularly at 750 mg 8 and 16 hours after the operation.

For operations on the heart, lungs, esophagus and blood vessels - i / v at a dose of 1.5 g with induction of anesthesia, then i / m 750 mg 3 times / day for the next 24-48 hours.

With pneumonia - i / m or i / v 1.5 g 2-3 times / day for 48-72 hours, then switch to oral administration, 500 mg 2 times a day for 7-10 days.

With an exacerbation of chronic bronchitis, it is prescribed intramuscularly or intravenously, 750 mg 2-3 times / day for 48-72 hours, then switch to oral administration of 500 mg 2 times / day for 5-10 days.

For complete joint replacement - 1.5 g of powder is dry mixed with each package of methyl methacrylate cement polymer before adding liquid monomer.

In chronic renal failure, correction of the dosage regimen is necessary: ??with CC from 10 to 20 ml / min, 750 mg intravenous or intramuscularly is prescribed 2 times / day, with CC <10 ml / min - 750 mg 1 time / day.

Patients on continuous hemodialysis using an arterio-venous shunt or high speed hemofiltration in the ICU are prescribed 750 mg 2 times / day; for patients on low speed hemofiltration, the recommended doses are prescribed for impaired renal function.

Preparation of solution for injection

Solution for intramuscular injection: add 3 ml of water for injection to 750 mg of the drug. Shake gently until a suspension forms. Cefuroxime is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.

Solution for intravenous injection: 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 minutes): 1.5 g of the drug is dissolved in 50 ml of water for injection. These solutions can be injected directly into a vein or into an infusion tube.

Powder for the preparation of a solution for intravenous and intramuscular administration of an almost white or yellowish color.

1 fl.

cefuroxime (in the form of sodium salt) 750 mg

Hypersensitivity to the drug and other cephalosporins, penicillins and carbapenems.

The drug should be used with caution in newborns and premature infants, with chronic renal failure, bleeding and gastrointestinal diseases (including a history of NUC), during pregnancy and lactation, in debilitated and malnourished patients.

pharmachologic effect

II generation cephalosporin antibiotic. Acts bactericidal (disrupts the synthesis of the bacterial cell wall). Possesses 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 group B (Streptococcus pneumoniae) Streptococcus mitis (viridans group), Bordetella pertussis, most of Clostridium spp .; gram-negative microorganisms: Escherichia coli, Klebsiella spp., Proteus mirabilis, Providencia spp., Proteus rettgeri, Haemophilius influenzae (including ampicillin resistant strains); Haemophilus parainfluenzae, including ampicillin resistant strains; 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.

To cefuroxime are insensitive: Clostridium difficile, Pseudomonas spp., Campylobacter spp., Acinetobacter calcoaceticus, Listeria monocytogenes, methicillin-resistant strains of Staphylococcus aureus, Staphylococcus, Enterococcus epidermidis, Legioncoella spp. , Citrobacter spp., Serratia spp., Bacteroides fragilis.

Pharmacokinetics

Suction

After intramuscular administration in a dose of 750 mg, Cmax in plasma is reached after 15-60 minutes and is 27 ?g / ml. When administered intravenously in doses of 0.75 and 1.5 g, Cmax after 15 minutes is 50 and 100 ?g / ml, respectively. The therapeutic concentration is maintained for 5.3 and 8 hours, respectively.

Distribution and metabolism

Plasma protein binding is 33-50%.

Therapeutic concentrations are recorded in pleural fluid, bile, sputum, myocardium, skin and soft tissues. Cefuroxime concentrations in excess of the minimum inhibitory concentration for most common organisms can be achieved in bone, synovial fluid, and intraocular fluid. With meningitis, it penetrates the BBB. Penetrates through the placental barrier, excreted in breast milk.

Not metabolized in the liver.

Withdrawal

T1 / 2 with i / v and i / m administration of the drug - 1.3-1.5 hours, in newborns - 2-2.5 hours.

It is excreted by the kidneys by glomerular filtration and tubular secretion 85 -90% unchanged within 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).

Side effect

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

From the digestive system: diarrhea, nausea, vomiting or constipation, flatulence, abdominal cramps and pain, ulceration of the oral mucosa, oral candidiasis, glossitis, pseudomembranous enterocolitis, liver dysfunction (increased activity of AST, ALT, ALP, LDH, bilirubin), cholestasis.

From the urinary system: impaired renal function, dysuria.

From the reproductive system: itching in the perineum, vaginitis.

From the side of the central nervous system: convulsions.

From the senses: hearing loss.

From the hematopoietic 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.

Application during pregnancy and lactation

The use of the drug during pregnancy is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use cefuroxime during lactation, the question of stopping breastfeeding should be resolved.

Application for impaired renal function

In chronic renal failure, correction of the dosing regimen is necessary: ??with CC 10-20 ml / min, intravenous or intramuscularly administered 750 mg 2 times / day, with CC less than 10 ml / min - 750 mg 1 time / day.

Patients on continuous hemodialysis using an arterio-venous shunt or high speed hemofiltration in the ICU are prescribed 750 mg 2 times / day; for patients on low speed hemofiltration, the recommended doses are prescribed for impaired renal function.

special instructions

Patients with a history of allergic reactions to penicillins may have hypersensitivity to cephalosporin antibiotics.

In the course of treatment, it is necessary to monitor kidney function, especially in patients receiving the drug in high doses.

Treatment is continued for 48-72 hours after the symptoms disappear; in the case of infections caused by Streptococcus pyogenes, 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.

The ready-to-use solution can be stored at room temperature for 7 hours, in the refrigerator - within 48 hours. It is allowed to use the solution that has turned yellow during storage.

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

When switching from parenteral administration to oral administration, the severity of the infection, the sensitivity of microorganisms and the general condition of the patient should be taken into account. If no improvement is noted 72 hours after ingestion of cefuroxime, parenteral administration should be continued.

Overdose

Symptoms: CNS excitement, convulsions.

Treatment: prescribing antiepileptic drugs, monitoring and maintaining vital body functions, hemodialysis and peritoneal dialysis.

Drug interactions

Concomitant oral administration of loop diuretics slows down tubular secretion, decreases renal clearance, increases plasma concentration and increases T1 / 2 of cefuroxime.

With simultaneous use with aminoglycosides and diuretics, the risk of nephrotoxic effects increases.

Pharmaceutical interactions

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's 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 0.9% sodium chloride solution.