Expiration date: 08/2025

Form of issue and composition:

Powder for solution for in / and / m introduction of white or white with a yellowish tinge.

1 flask:

cefuroxime (in the form of sodium salt) 750 mg

750 mg-bottles of 10 ml (1) - packs cardboard.

Powder for solution for in / and / m introduction of white or white with a yellowish tinge.

1 flask:

cefuroxime (in the form of sodium salt) 1.5 g

1.5 g-bottles of 20 ml (1) - packs cardboard.

Pharmacological action:

Cephalosporin antibiotic II generation for parenteral use. Acts bactericidal (violates the synthesis of the bacterial cell wall). It has a wide range of antimicrobial action.

Highly active against gram-positive microorganisms: Staphycccus aureus, Staphycccus epidermidis (including strains resistant to penicillins and with the exception of strains resistant to methicillin), Streptcccus pygenes, Streptcccus pneumniae, Streptcccus groups B (including Streptcccus agaactiae), Streptcccus mitis group of viridans gram-negative microorganisms: Escherichia ci, Kebsiea spp., Prteus mirabiis, Prvidencia spp., Prteus rettgeri, Haemphius infuenae (including strains resistant to ampicillin), Haemphius parainfuenae (including strains resistant to ampicillin), Mraxea (Branhamea) catarrhais, Neisseria gnrrheae (including strains producing and not producing penicillinase), Neisseria meningitis, meningitis Samnea., Brdetea pertussis, Brreia burgdrferi anaerobic: Peptcccus spp., Peptstreptcccus spp., Bacterides spp., Fusbacterium spp., Prpinibacterium spp., Cstridium spp. (most strains).

To the cxm insensitive Cstridium difficie, Pseudmnas spp., Campybacter spp., Acinetbacter cacaceticus, Listeria mncytgenes, methicillin-resistant strains of Staphycccus aureus, methicillin-resistant strains of Staphycccus epidermidis, Leginea spp., Streptcccus (Entercccus) faecais, Mrganea mrganii, Prteus vugaris, Enterbacter spp., Citrbacter spp., Serratia spp., Bacterides fragiis.

Pharmacokinetics:

Suction

After I/m administration of the drug at a dose of 750 mg Cmax achieved through 15-60 minutes and is 27 ug/ml.When I/V administration of the drug at doses of 750 mg and 1.5 g Cmax achieved through 15 minutes and is 50 ug/ml and 100 ug / ml, respectively. Therapeutic concentration is maintained 5.3 and 8 h, respectively.

Distribution and metabolism

Not metabolized in the liver.

The plasma protein binding is 33-50%. Therapeutic concentrations are achieved in pleural fluid, bile, sputum, myocardium, skin and soft tissues. Cefuroxime concentrations exceeding the minimum inhibitory concentration for most common microorganisms can be achieved in bone tissue, synovial fluid and intraocular fluid. In meningitis permeates through GEB. Passes through the placental barrier and is excreted in breast milk.

Breeding

T1/2 at/in and/m introduction - 80 min, in newborns T1 / 2 increases by 3-5 times.

85-90% is excreted by glomerular filtration and tubular secretion unchanged for 8 h (most of the drug is excreted during the first 6 h, while creating high concentrations in the urine) after 24 h is excreted completely (50% - by tubular secretion, 50% - by glomerular filtration).

Indications:

Bacterial infections caused by sensitive microorganisms:

• respiratory tract infections (bronchitis, pneumonia, lung abscess, pleural empyema)
  
• infections of ENT organs (sinusitis, tonsillitis, pharyngitis)
  
• urinary tract infections (pyelonephritis, cystitis, symptomatic bacteriuria, gonorrhoea)
  
• skin and soft tissue infections (erysipelas, pyoderma, impetigo, furuncles, cellulite, wound infection, erysipeloid)
  
• bone and joint infections (osteomyelitis, septic arthritis)
  
• infection of the pelvic organs (in obstetrics and gynecology)
  
• septicaemia
  
• meningitis.
  

Prevention of infectious complications in operations on the chest organs (including during operations on the lungs, heart, esophagus), abdomen, pelvis, joints, in vascular surgery with a high risk of infectious complications in orthopedic surgery.

Dosage regimen:

The drug is prescribed in / m,/in (jet or drip).

In/in and / m adults appoint 750 mg 3 times/day in severe infections dose 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 of 3-6 grams per day

Children older than 3 months appoint 30-100 mg/kg / day in 3-4 introduction. For most infections, the optimal dose is 60 mg/kg / day.

Newborns and children up to 3 months appoint 30 mg/kg/day in 2-3 introduction.

With gonorrhea-in / m 1.5 g once (or in the form of 2 injections of 750 mg with an introduction to different areas, for example, in both gluteal muscles).

In bacterial meningitis-in / in 3 g every 8 h for children of younger and older age - 150-250 mg/kg/day in 3-4 introduction, newborn - 100 mg/kg/day.

At operations on an abdominal cavity, pelvic organs and at orthopedic operations - in/in 1.5 g at induction of anesthesia, then in addition - in/m on 750 mg in 8 and 16 h after operation.

At operations on heart, lungs, esophagus and vessels-in / in 1.5 g at induction of anesthesia, then-in / m on 750 mg 3 times / day during the next 24-48 h.

With a full joint replacement - 1.5 g of powder is mixed dry with each pack of methyl methacrylate cement polymer before adding the liquid monomer.

With pneumonia-in / m or/in 1.5 g 2-3 times/day for 48-72 hours, then go to the reception inside (use dosage forms of cefuroxime axetil for oral administration) for 500 mg 2 times / day for 7-10 days.

In case of exacerbation of chronic bronchitis appoint / m or / 750 mg 2-3 times / day for 48-72 hours, then go to the reception inside (use dosage forms of cefuroxime axetil for oral administration) 500 mg 2 times/day for 5-10 days.

In chronic renal failure requires correction dosing regimen. When CC 10-20 ml/min appoint/V or V/m 750 mg 2 times/day for CC less than 10 ml/min - 750 mg 1 time/day.

Patients who are on continuous hemodialysis using arterio-venous shunt or high-speed hemofiltration in intensive care units are prescribed 750 mg 2 times / day for patients who are on low-speed hemofiltration, doses recommended for renal dysfunction are prescribed.

Preparation of suspension and solution for parenteral administration

For the preparation of the suspension for the / m introduction to 750 mg (a bottle of 10 ml) add 3 ml of water for injection, to 1.5 g (a bottle of 20 ml) - 6 ml of water for injection.

To prepare the solution for the on/in the introduction of the jet to 750 mg (bottle volume 10 ml) was added 9 ml water for injection or more to 1.5 g (bottle volume 20 ml) - 14 ml or more water for injection.

In the case of short-term in/in injections (eg, 30 min) 1.5 g dissolved in 50 ml of water for injection. These solutions can be injected directly into the vein or into the infusion system, if the patient is parenterally injected liquids.

Side effect:

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

From the digestive system: diarrhea, nausea, vomiting or constipation, flatulence, cramps and abdominal pain, ulceration of the mucous membrane of the oral cavity, oral candidiasis, glossitis, pseudomembranous enterocolitis, abnormal liver function (increased activity of AST, ALT, alkaline phosphatase, LDH, bilirubin), cholestasis.

From the urogenital system: violation of kidney function (decrease in creatinine clearance, increase in the content of residual creatinine and urea nitrogen in the blood), dysuria, itching in the crotch, vaginitis.

From the hematopoietic organs: reduction of hemoglobin and hematocrit, anemia (aplastic or hemolytic), eosinophilia, neutropenia, leukopenia, agranulocytosis, thrombocytopenia, hypoprothrombinemia, prothrombin time prolongation.

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

Contraindications:

• hypersensitivity (including to other cephalosporins, penicillins and carbapenems).
  

Caution should be prescribed to newborns (including premature), chronic renal failure, bleeding and gastrointestinal diseases (including history, ulcerative colitis), weakened and exhausted patients, pregnancy, lactation (breastfeeding).

Pregnancy and lactation:

Caution should be used Zephyrus® during pregnancy and breastfeeding.

Special instruction:

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

In the course of treatment requires control of kidney function, especially in patients receiving the drug in high doses.

Treatment is recommended to continue for 48-72 hours after the disappearance of symptoms. In case of infections caused by Streptcccus pygenes, it is recommended to continue treatment for at least 10 days.

During treatment possible false-positive direct Coombs test and a false-positive reaction for urine glucose.

Ethanol should not be used during treatment.

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

With the treatment of meningitis in children may decrease hearing.

In the transition from parenteral to oral administration should take into account the severity of infection, sensitivity of microorganisms and the General condition of the patient. If 72 hours after administration of cefuroxime inside there is no clinical improvement, it is necessary to continue parenteral administration.

Overdose:

Symptoms: Central nervous system excitation, convulsions.

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

Drug interaction:

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

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

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

Pharmaceutical interaction

Farmatsevticeski compatible with aqueous solutions containing up to 1% lidocaine hydrochloride, 0.9% solution of sodium chloride, 5% solution of dextrose (glucose), 0.18% sodium chloride and 4% dextrose solution (glucose) 5% solution of dextrose (glucose) and 0.9% sodium chloride solution, 5% solution of dextrose (glucose) and 0.45% sodium chloride solution, 5% solution of dextrose (glucose) and 0.225% solution of sodium chloride, 10% solution of dextrose (glucose) 10% invert sugar in water for injection, a ringer solution, a solution of sodium lactate, Hartman's solution, heparin (10 U / ml and 50 U/ml) in 0.9% sodium chloride solution, potassium chloride (10 MEK/l and 40 MEK / l) in 0.9% sodium chloride solution.

Farmatsevticeski incompatible with aminoglikozidami, solution of sodium bicarbonate 2.74%.

Storage terms and conditions:

List B. the Drug should be stored in a dry, protected from light, out of reach of children, at a temperature not exceeding 25°C. shelf life - 2 years.

After reconstitution can be stored at room temperature for 7 hours, in the refrigerator for 48 h allowed the use yellowed during storage of the solution.