Axetin powder solution 1.5g vials, 100pcs

Composition

bottle contains the active ingredient-cefuroxime sodium for injection-0.75 g or 1.5 g in terms of cefuroxime.

Pharmacological action

Pharmacotherapeutic group: antibiotic, cephalosporin

ATX code: [J01DA06].

Pharmacological properties

Pharmacodynamics .

Cephalosporin antibiotic of the second generation for parenteral use. Acts bactericidal (disrupts 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 penicillin-resistant strains and with the exception of methicillin-resistant strains, Streptococcus pyogenes, etc. beta-hemolytic streptococci, Streptococcus pneumoniae, Group B Streptococcus (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 ampicillin-resistant strains, Haemophilus parainfluenzae, including ampicillin-resistant strains, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae, including penicillinase-producing and non-producing strains, Neisseria meningitidis, Salmonella spp., Bacteroides spp., Fusobacterium spp., Propionibacterium spp., Borrelia burgdorferi), gram-positive and gram-negative anaerobes (including Peptococcus spp. and Peptostreptococcus spp. ).

They are not sensitive to cefuroxime: 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 use: after intravenous use of 750 mg, the maximum concentration is reached in 15-60 minutes and is 27 mcg / ml. With intravenous use of 750 mg and 1.5 g, the maximum concentration after 15 minutes is 50 and 100 mcg / ml, respectively. The therapeutic concentration is maintained for 5.3 and 8 hours, respectively.

The half-life of intravenous and intramuscular use is 80 minutes, in newborns – 3-5 times longer.

Binding to plasma proteins is 33-50%.

It is not metabolized in the liver.

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

Therapeutic concentrations are recorded in pleural fluid, bile, sputum, myocardium, skin and soft tissues. Cefuroxime concentrations exceeding the minimum suppressive concentration for most common microorganisms can be achieved in bone tissue, synovial fluid, and intraocular fluid. In meningitis, it penetrates through the blood-brain barrier. It passes through the placenta and enters breast milk.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

• respiratory tract infections (including bronchitis, pneumonia, lung abscess, empyema);
• infections of ENT organs (including sinusitis, tonsillitis, pharyngitis);
• urinary tract infections (including pyelonephritis, cystitis, symptomatic bacteriuria, gonorrhea);
• infections of skin and soft tissue (including face);
• infections of bones and joints (including osteomyelitis, septic arthritis);
• infection of the pelvic organs (obstetrics and gynecology);
• septicemia;
• meningitis.

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

Contraindications

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

With caution

Neonatal period, prematurity, chronic renal failure, bleeding and diseases of the gastrointestinal tract (including in the anamnesis, ulcerative colitis), weakened and emaciated patients, pregnancy, lactation.

Side effects

Allergic reactions:  chills, rash, pruritus, 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 oral mucosa, oral candidiasis, glossitis, pseudomembranous enterocolitis, liver dysfunction (increased activity of “liver” enzymes in plasma – aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase; bilirubin), cholestasis.

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

From the side of hematopoietic organs:  reduced 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.

Interaction

Concomitant oral use of loop diuretics slows down channel secretion, reduces renal clearance, increases plasma concentrations, and increases the half-life of cefuroxime.

Concomitant use with 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.

Pharmaceutically compatible with metronidazole, azlocillin, xylitol, with aqueous solutions containing up to 1% lidocaine hydrochloride solution,0.9% sodium chloride solution,5% dextrose solution,0.18% sodium chloride and 4% dextrose solution,5% dextrose and 0.9% sodium chloride solution,5% dextrose and 0.45% sodium chloride,5% dextrose and 0.225% sodium chloride,10% dextrose solution; 10% invert sugar in water for injection, ringer’s solution, a solution of sodium lactate, Hartmann’s solution,0.9% sodium chloride solution,5% dextrose solution and hydrocortisone, heparin (10 u/ml and 50 u/ml) in 0.9% solution of sodium chloride, potassium chloride (10 IEC/l and 40 IEC/l) in 0.9% solution of sodium chloride.

Pharmacologically incompatible with aminoglycosides,2.74% sodium bicarbonate solution.

How to take, course of use and dosage

In / m, in/V. IV and iv adults are prescribed 750 mg 3 times a day; for severe infections, the dose is increased to 1500 mg 3-4 times a day (if necessary, the interval between injections 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 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 in the form of 2 injections of 750 mg with introduction in different areas, for example, in both gluteal muscles).

For bacterial meningitis-iv,3000 mg every 8 hours; for younger and older children-150-250 mg / kg/day in 3-4 doses, for newborns-100 mg / kg/day.

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

For operations on the heart, lungs, esophagus and blood vessels-IV,1500 mg with induction of anesthesia, then-iv,750 mg 3 times a day for the next 24-48 hours.

When the joint is completely replaced,1500 mg of powder is mixed in dry form with each package of methyl methacrylate cement polymer before adding a liquid monomer.

For pneumonia – IV or iv,1500 mg 2-3 times a day for 48-72 hours, then switch to oral use (use dosage forms for oral use) 500 mg 2 times a day for 7-10 days.

In case of exacerbation of chronic bronchitis, they are prescribed IV or iv,750 mg 2-3 times a day for 48-72 hours, then they switch to oral use (use dosage forms for oral use) 500 mg 2 times a day for 5-10 days.

In chronic renal failure, dosage adjustment is necessary: with a creatinine clearance of 10-20 ml/min,750 mg 2 times a day is prescribed intravenously or intramuscularly, with a creatinine clearance of less than 10 ml/min – 750 mg 1 time a day.

Patients undergoing continuous hemodialysis using an arteriovenous shunt or on high-speed hemofiltration in intensive care units are prescribed 750 mg 2 times a day; for patients on low-speed hemofiltration, the recommended doses are prescribed for impaired renal function.

Overdose

Symptoms:  excitement of the central nervous system, convulsions.

Treatment:  prescribing anticonvulsants, providing ventilation and perfusion, monitoring and maintaining vital body functions, hemodialysis and peritoneal dialysis.

Special instructions

Patients with a history of allergic reactions to penicillins may be hypersensitive to cephalosporin antibiotics.During treatment, monitoring of renal function is necessary, especially in patients receiving the drug in high doses. Treatment is recommended to continue for 48-72 hours after symptoms disappear, and in the case of Streptococcus pyogenes infections, it is recommended to continue treatment for at least 10 days.

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

After dilution, it can be stored at room temperature for 7 hours, in the refrigerator for 48 hours. It is allowed to use a solution that has turned yellow during storage.

Do not use ethanol during treatment.

In patients receiving cefuroxime, the use of glucose oxidase or hexokinase tests is recommended when determining blood glucose levels.

During the treatment of meningitis in children, hearing loss may occur.

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

Storage conditions

List B. In a dry place, protected from light, out of reach of children, at a temperature not exceeding 25°C.

Shelf

life is 2 years. Do not use after the expiration date indicated on the package.

Active ingredient

Cefuroxime

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection