Amoxicillin Sandoz, 12 pcs., 500 mg, film-coated tablets

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Manufacturers: Borshchagovsky Chemical and Pharmaceutical Plant

Active ingredients

• Cefuroxime

Disease class

• Bacterial meningitis, not elsewhere classified
• Pneumonia without specifying the pathogen
• Pyothorax
• Skin abscess, boil and carbuncle
• Peritonitis
• Disease of the digestive system, unspecified
• Urinary tract infection without established localization
• Inflammatory disease of the uterus, other than the cervix

Clinical and pharmacological group

• Not indicated. See instructions

Pharmacological action

• Broad spectrum antibacterial action
• Bactericidal

Pharmacological group

• Cephalosporins

Pharmacological properties of the drug Cefuroxime Sandoz

Pharmacodynamics. Cefuroxime is a cephalosporin antibiotic whose bactericidal effect is due to inhibition of bacterial cell wall synthesis. Has a wide spectrum of antimicrobial action. Highly active against gram-positive microorganisms, including strains resistant to penicillins (except for strains resistant to methicillin): Staphylococcus aureus, Streptococcus pyogenes (and other β-hemolytic streptococci), Streptococcus pneumoniae, Streptococcus group B ( Streptococcus agalactiae ), Streptococcus mitis (group viridans ), 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 ampicillin-resistant strains; Moraxella catarrhalis, Neisseria gonorrhoeae, including penicillinase-producing and non-penicillinase-producing strains, Neisseria meningitidis, Salmonella spp., Borrelia burgdorferi ; – gram-positive and gram-negative anaerobes: Peptococcus spp., Peptostreptococcus spp., Fusobacterium spp., Propionibacterium spp. Insensitive to cefuroxime: Clostridium difficile, Pseudomonas spp., Campylobacter spp., Acinetobacter calcoaceticus, Listeria monocytogenes , methicillin-resistant strains of Staphylococcus aureus, Staphylococcus epidermidis, Legionella spp., Streptococcus (Enterococcus) faecalis, Morganella morganii, Proteus vulgaris, Enterobacter spp. , Citrobacter spp., Serratia spp., Bacteroides fragilis . Pharmacokinetics. After oral administration, cefuroxime axetil is absorbed into the gastrointestinal tract and quickly undergoes hydrolysis in the mucous membrane of the small intestine and blood, releasing the active substance - cefuroxime. Optimal absorption is observed when taking cefuroxime axetil a short time after a meal (50–60%). In this case, the maximum concentration in plasma is achieved after 2–3 hours. After parenteral administration, the maximum concentration in blood plasma is achieved 30–45 minutes after intravenous administration. Widely distributed in tissues and body fluids, including pleural fluid, sputum, bone tissue, synovial and intraocular fluid. Therapeutic concentrations in the CSF are achieved only with meningitis. Plasma protein binding is about 50%. Penetrates through the placenta and into breast milk. Cefuroxime is not metabolized. Most of it is excreted unchanged in the urine. Almost 50% is excreted by glomerular filtration, the rest by renal tubular secretion over 24 hours, with most of the administered dose excreted during the first 6 hours; the drug is present in urine in high concentrations. A small amount is excreted in bile. The half-life is about 70 minutes; in patients with impaired renal function and in newborns, the half-life is prolonged.

Publications

Cefuroxime axetil is a bactericidal betalactam antibiotic belonging to the group of second-generation cephalosporins. its pronounced activity against microorganisms of the family Enterobacteriaceae, Haemophilus influenzae and Moraxella catarrhalis (with comparable activity against gram-positive cocci). This is due to the fact that cefuroxime is highly resistant to beta-lactamases produced by gram-negative pathogens.

A distinctive feature of cefuroxime in comparison with first generation cephalosporins (cefazolin, cephalexin, etc.) is

Thus, cefuroxime is active against most aerobic gram-positive (Staphylococcus aureus, Staphylococcus epidermidis, including strains that produce betalactamase, Streptococcus pneumonae, Streptococcus pyogenes) and gram-negative (Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Neisseria meningitidis , Neisseria gonorrhoeae, Proteus spp., Salmonella spp., Shigella spp., Provdencia spp.) microorganisms, as well as anaerobes (Peptococcus spp., Peptostreptococcus spp., Bacteroides spp., Fusobacterium spp.). Chlamydia, mycoplasma, rickettsia, and legionella are resistant to cefuroxime.

In recent years, there has been an increase in the resistance of pathogens of nosocomial infections to most used antibiotics, including cefuroxime. In particular, according to a multicenter study conducted in Russia (1999), high resistance to cefuroxime was observed in Proteus spp., K. Pneumoniae, and Enterobacter spp. (more than 50% of cases).

Naturally, in accordance with the spectrum of antimicrobial action, the main indications for the use of cefuroxime axetil are infections of the upper and lower respiratory tract (bronchitis, community-acquired pneumonia), ear, throat and nose (otitis, pharyngitis, tonsillitis, sinusitis), urinary tract (urethritis, pyelonephritis , asymptomatic bacteriuria), gonorrhea.

The pharmacodynamics of antimicrobial drugs is determined by the relationship between the concentration of the drug and its clinical effectiveness. The minimum inhibitory concentration (MIC) of the antibiotic is used as one of the surrogate indicators of this interaction. Taking this into account, 2 groups of antibiotics are distinguished: with activity depending on the concentration at the site of infection (aminoglycosides, fluoroquinolones) and with activity depending on exposure at the site of infection. Cephalosporins belong to the 2nd group: for them, it is not so much the concentration that is important, but the duration of interaction with the microorganism. This means that the concentration of cefuroxime, which exceeds the MIC by 2–4 times, should be maintained for about 50% of the time between administrations, and an increase in the MIC, for example, up to 20 times will not be accompanied by an increase in the severity of the clinical effect. A very important conclusion follows from this: the dose is not decisive for the clinical effect of cefuroxime; The duration of interaction between the antibiotic and the microorganism is more important.

Cefuroxime sodium is intended exclusively for parenteral administration (intramuscular or intravenous), since the sodium salt of cefuroxime is practically not absorbed when taken orally. With a half-life of about 80 minutes, the therapeutic concentration of cefuroxime is maintained for 5–8 hours, depending on the dose. This determines the three-fourfold administration of cefuroxime sodium.

Cefuroxime axetil in tablet form, on the contrary, after oral administration is well absorbed and quickly hydrolyzed in the intestinal mucosa and blood into cefuroxime (the bioavailability of cefuroxime axetil increases to 50% when taken with food!). The maximum concentration of the drug is created 2.5–3 hours after administration. As a result of a gradual increase in the concentration of cefuroxime when using cefuroxime axetil, the exposure time of the antibiotic to the microorganism increases, which allows the use of a double dosage regimen of the drug (250–500 mg each).

Side effects when using cefuroxime axetil are typical for all cephalosporins. These are nausea, vomiting, diarrhea, a transient increase in the activity of liver enzymes; cases of the development of pseudomembranous colitis have been described with long-term use (due to increased growth of Clostridium difiсile); leuko- and thrombocytopenia, hemolytic anemia; allergic reactions are possible (in 1–3% of cases, cross reactions with penicillins); headache, drowsiness, etc.

Diuretics and aminoglycosides increase the nephrotoxicity of cefuroxime. Cefuroxime sodium has a sodium concentration of 2.36 mmol/g, which can lead to hypernatremia if renal function is impaired. At the same time, simultaneous use of antacids, proton pump inhibitors and H2 receptor blockers with cefuroxime axetil may lead to a decrease in the bioavailability of the drug.

Thus , cefuroxime axetil is an effective and safe antimicrobial drug for the treatment of most moderate infections. The oral form indicates that the drug has pharmacoeconomically beneficial potential. Cefuroxime axetil can be considered as one of the antibiotics for descalation therapy of infectious diseases (the term means transferring a patient after parenteral administration of an antibiotic to an oral form). This method of antibiotic therapy always has a pharmacoeconomic advantage over standard parenteral antibiotic therapy.

In the Republic of Belarus, cefuroxime axetil is registered by Pharmacar (Palestine) under the trade name Zinex , the release form is 500 mg tablets No. 10 and 250 mg tablets No. 10.

A.V. KHAPALYUK

Pharmaskop No. 2, 2005.

Indications for use of the drug Cefuroxime Sandoz

Cefuroxime in tablet form: infections caused by microorganisms sensitive to cefuroxime:

• ENT organs: acute otitis media, sinusitis, tonsillitis, pharyngitis;
• respiratory organs: acute and chronic bronchitis, bacterial pneumonia;
• uncomplicated urinary tract infections: cystitis, acute and chronic pyelonephritis;
• skin and soft tissues: furunculosis, pyoderma, impetigo;
• treatment of early manifestations of Lyme disease (stage I) and prevention of late complications in adults and children over 12 years of age;
• genitourinary system: urethritis, cervicitis, uncomplicated gonorrhea.

Cefuroxime in the form of injections: infections caused by microorganisms sensitive to cefuroxime:

• respiratory tract (acute and chronic bronchitis, pneumonia, bronchiectasis, pulmonary abscess and postoperative infections);
• ENT organs (otitis media, sinusitis, tonsillitis, pharyngitis);
• urinary tract (acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria, gonorrhea);
• skin and soft tissues (erysipelas, wound infections);
• bones and joints (osteomyelitis, septic arthritis);
• in obstetrics and gynecology (inflammatory diseases of the pelvic organs);
• other infections - sepsis, meningitis, Lyme disease (boreliosis).

Prevention of infections during abdominal and orthopedic operations, operations on the pelvic organs, esophagus, lungs, and cardiovascular surgery, when there is an increased risk of infection.

Use of the drug Cefuroxime Sandoz

Cefuroxime Sandoz in tablet form - the dose is set individually depending on the severity of the infection, age, body weight and kidney function of the patient. For the treatment of severe infections, parenteral dosage forms of Cefuroxime Sandoz are recommended. For the treatment of pneumonia and exacerbations of chronic bronchitis, in some cases, the use of cefuroxime axetil (tablet form of cefuroxime) after initial therapy with parenteral cefuroxime sodium solution may be indicated. Recommended dosage regimen for Cefuroxime Sandoz tablets:

For children under 5 years of age, the use of cefuroxime in the form of a suspension is recommended. There is no experience of use in children under 3 months of age. Dosage regimen for patients with impaired renal function, for those on dialysis and the elderly. When using the drug in a dose not exceeding 1 g of cefuroxime axetil per day, no dose adjustment is required. If the creatinine clearance value is ≤20 ml/min, the dose of the drug should be reduced or the interval between doses should be increased. For patients on hemodialysis, an additional dose of cefuroxime axetil is indicated at the end of the hemodialysis session. The average duration of treatment is 7 days (5–10 days). For the treatment of pharyngotonsillitis caused by Streptococcus pyogenes , the duration of treatment is 10 days. The duration of therapy for early manifestations of Lyme disease should be 20 days. Cefuroxime Sandoz tablets are film-coated to reduce the bitter taste. They should be taken after meals, without chewing (tablets should also not be divided or crushed), with sufficient liquid. Cefuroxime Sandoz in injection form - administered intramuscularly or intravenously. Adults are prescribed IV or IM 750 mg 3 times a day. For severe infections - 1.5 g 3 times a day. If necessary, the frequency of use is increased to 4 times a day with a total daily dose of cefuroxime of 3–6 g. Newborns are prescribed a daily dose of 30–100 mg/kg body weight, frequency of administration is 2–3 times a day. In the first weeks of life, the half-life is 3–5 times higher than that for adults. For children of the first year of life and older, the daily dose is 30–100 mg/kg body weight, the frequency of administration is 3–4 times a day. For the treatment of most infections, the daily dose is 60 mg/kg body weight. When treating gonorrhea, 1.5 g of cefuroxime is prescribed once. It can be administered in two injections - 750 mg into the ischial muscle on both sides. Treatment of meningitis. Adults - 3 g of Cefuroxime Sandoz IV every 8 hours. For newborns, the initial daily dose is 100 mg/kg body weight IV. In the future, the dose can be reduced to 50 mg/kg/day. For infants and older, the daily dose is 200–400 mg/kg IV 3–4 times a day. After 3 days of treatment or if the clinical condition improves, the daily dose is reduced to 100 mg/kg/day. To prevent postoperative complications, the dose for adults is 1.5 g IV at the initial stage of anesthesia during abdominal, orthopedic and pelvic surgeries. It is possible to administer an additional injection at a dose of 750 mg IM after 8 and 16 hours. For operations on the heart, lungs, esophagus and blood vessels, a single dose for adults is 1.5 g IV, which is administered at the initial stage of anesthesia; then 750 mg of Cefuroxime Sandoz is administered intramuscularly 3 times a day over the next 24-48 hours. For patients with impaired renal function (creatinine clearance - 10-20 ml/min), it is recommended to administer the drug 750 mg 2 times a day; for more severe disorders (creatinine clearance ≤10 ml/min) - 750 mg 1 time per day. Patients undergoing hemodialysis require an additional dose of 750 mg of cefuroxime at the end of each dialysis procedure. Patients on continuous peritoneal dialysis are usually prescribed 750 mg 2 times a day. Instructions for use Compatible with solutions for IV injections. Cefuroxime remains stable for 2 hours at room temperature and 24 hours at 2–8°C when dissolved:

• in water for injections;
• in 0.9% sodium chloride solution;
• in 5% glucose solution.

Instructions for dilution Cefuroxime Sandoz 750 mg - preparation of solution for intramuscular administration: add 3 ml of water for injection to the bottle with powder to obtain a solution/suspension for injection, shaking gently until a homogeneous suspension is obtained. Cefuroxime Sandoz 1500 mg is not intended for intramuscular administration. Cefuroxime Sandoz 750 mg and 1500 mg - preparation of solution for intravenous administration: dissolve Cefuroxime Sandoz powder in water for injection or 0.9% sodium chloride solution or 5% glucose solution in a volume of at least 6 ml in a bottle of 750 mg and 15 ml - into a bottle of 1500 mg to obtain a solution/suspension for injection, shaking gently until a homogeneous suspension is obtained. When dissolved for intramuscular or intravenous injection, a colorless or yellowish suspension is formed from a white or almost white powder. Before using the finished solution/suspension, it is necessary to check it visually for the presence of undissolved particles or for discoloration. The solution should be used only for 1 injection; the remaining solution/suspension is disposed of.

Powder for the preparation of injection solution Cefuroxim-BHFZ (Cefuroximum-BHFZ)

Instructions for medical use of the drug

Description of pharmacological action

Cefuroxime-BHFZ is a second-generation cephalosporin for parenteral use that has a bactericidal effect. The antimicrobial mechanism of action is associated with inhibition of the activity of the microbial enzyme transpeptidase, leading to disruption of the synthesis of peptidoglycan in the cell wall of microorganisms. The drug has a wide spectrum of action and is stable in the presence of most β-lactamases; acts on strains resistant to ampicillin and amoxicillin.

Indications for use

Cefuroxime-BCPZ is used for the treatment of infectious diseases caused by microorganisms sensitive to the drug, such as: - respiratory tract infections: acute and chronic bronchitis, infected bronchiectasis, bacterial pneumonia, lung abscess, postoperative chest infections; - infections of the ear, throat, nose: sinusitis, tonsillitis, pharyngitis, otitis media; - urinary tract infections: acute and chronic pyelonephritis, cystitis, asymptomatic bacteriuria; - soft tissue infections: erysipelas, wound infections; - infections of bones and joints: osteomyelitis, septic arthritis; - skin infections: furunculosis, pyoderma, impetigo; - sexually transmitted infections: gonorrhea (acute, uncomplicated gonococcal urethritis and cervicitis), especially in cases where penicillin is contraindicated; — obstetrics and gynecology: inflammatory diseases of the pelvic organs; - other infections: septicemia, meningitis, peritonitis; - prevention of postoperative infections: with a high risk of infectious complications after operations on the chest and abdominal cavity, operations on the pelvic organs, during cardiovascular and orthopedic operations. In most cases, monotherapy with Cefuroxime-BCPZ is effective. If necessary, the drug can be used in combination with aminoglycoside antibiotics or with metronidazole (orally, in suppositories or by injection), especially for the prevention of postoperative complications in gastrointestinal and gynecological surgery.

Release form

Powder for the preparation of solution for injection 0.25 g, or 0.75 g, or 1.5 g in bottles No. 5 in a pencil case; 1.5 g in bottles No. 1 in a pack.

Pharmacodynamics

Cefuroxime-BHFZ is a second-generation cephalosporin for parenteral use that has a bactericidal effect. The antimicrobial mechanism of action is associated with inhibition of the activity of the microbial enzyme transpeptidase, leading to disruption of the synthesis of peptidoglycan in the cell wall of microorganisms. The drug has a wide spectrum of action and is stable in the presence of most β-lactamases; acts on strains resistant to ampicillin and amoxicillin. Active against the following microorganisms: - gram-negative aerobes: Escherichia coli, Klebsiella spp., Proteus rettgeri, Proteus mirabilis, Providencia spp., Haemophilus influenzae (including ampicillin-resistant strains), Haemophilus parainfluenzae (including ampicillin-resistant strains ), Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae (including strains that form penicillinase), Neisseria meningitidis, Salmonella spp (including Salmonella typhi, Salmonella typhimurium); - gram-positive aerobes: Staphylococcus aureus, Staphylococcus epidermidis (including strains that form penicillinase, but excluding methicillin-resistant strains), Streptococcus pyogenes (as well as other β-hemolytic streptococci), Streptococcus pneumoniae, Streptococcus spp. group B (Streptococcus agalactiae), Streptococcus mitis (viridans group), Bordetella pertussis; — anaerobes: Peptococcus and Peptostreptococcus species, gram-positive bacteria (including Clostridium spp.) and gram-negative bacteria (including Bacteroides spp. and Fusobacterium spp.), Propionibacterium spp. Partially resistant to the drug: Proteus morganii, Proteus vulgaris; microorganisms insensitive to Cefuroxime-BCPZ: Clostridium difficile, Pseudomonas spp., Campylobacter spp., Acinetobacter calcoaceticus, Legionella spp., Listeria monocytogenes, some strains of Serratia spp.;

Pharmacokinetics

Cefuroxime-BHFZ is used only parenterally, as it is quickly destroyed by gastric juice. When the drug is administered intramuscularly at a dose of 0.75 g, the maximum concentration is formed after 45 - 60 minutes and is about 27 - 30 mcg/ml. When administered intravenously at a dose of 0.75 g and 1.5 g, the therapeutic concentration in the blood plasma is observed after 15 minutes and is 50 mcg/ml and 100 mcg/ml, respectively. The degree of binding to plasma proteins is about 50%. The drug forms therapeutic concentrations in pleural and synovial fluids, bile, sputum, bone and soft tissues, myocardium, and skin. In case of inflammation of the meninges, Cefuroxime-BCPZ penetrates well through the blood-brain barrier. The drug passes through the placental barrier and can be excreted in human milk. The half-life (T1/2) of the drug when administered intramuscularly and intravenously is about 1.5 hours (in newborns and infants, T1/2 is increased and ranges from 4 to 6.5 hours). More than 80% of the administered drug is eliminated unchanged by the kidneys: about 50% by glomerular filtration and about 50% by tubular secretion over 8 hours, forming an effective concentration in the urine and urinary tract. After 24 hours, the drug is no longer detectable in the body.

Use during pregnancy

Use caution during pregnancy (especially in the early stages) and during breastfeeding.

Contraindications for use

Hypersensitivity to cephalosporin antibiotics, diseases that are accompanied by bleeding from the gastrointestinal tract; history of diseases of the digestive canal, especially ulcerative colitis or enteritis, first trimester of pregnancy, lactation.

Side effects

When using the drug, side effects occur relatively rarely, are moderate and reversible. The use of the drug may cause the following adverse reactions: - from the gastrointestinal tract: diarrhea, nausea, vomiting, oral candidiasis, occasionally - pseudomembranous colitis, stomatitis, glossitis, anorexia, increased activity of blood transaminases, bilirubin, cholestasis, intestinal dysbiosis; - from the hematopoietic system: anemia, eosinophilia, leukopenia, neutropenia, thrombocytopenia, hemolysis of erythrocytes, hypoprothrombinemia; - allergic reactions: rash, itching, urticaria, fever, rarely - anaphylactic shock; - local reactions: pain or infiltration at the injection site, after intravenous administration in some cases - phlebitis; - others: sometimes there is a transient increase in the level of liver enzymes, especially in patients with liver pathology, but there is no data on the direct adverse effect of the drug on the functional state of the liver. Headache, drowsiness, dysuria, interstitial nephritis.

Directions for use and doses

Cefuroxime-BCPZ is administered only intramuscularly or intravenously. To prepare a solution for intramuscular administration, add 1 - 2 ml of water for injection or 1 - 2.5 ml of isotonic (0.9%) sodium chloride solution to 0.25 g of the drug; to 0.75 g of the drug - 3 - 6 ml of water for injection or 3 - 7.5 ml of isotonic (0.9%) sodium chloride solution, shake until a suspension or solution is formed. Depending on the volume of solvent, the drug may take the form of an opaque milky suspension or a yellowish solution. To prepare a solution for intravenous jet administration, 0.25 g of the drug is dissolved in no less than 3 ml of water for injection; 0.75 g of the drug - not less than 9 ml of water for injection; 1.5 g of the drug in at least 15 ml of water for injection. The prepared solution can be colored from pale yellow to light amber. Different color intensities do not affect the therapeutic effectiveness and safety of the drug. Inject slowly - over 3 - 5 minutes. For short-term intravenous infusions (up to 30 minutes), 1.5 g of the drug is dissolved in 50 ml of solvent, which can be isotonic (0.9%) sodium chloride solution, water for injection or 5% glucose solution. Adults are prescribed 0.75 g (for infections caused by gram-positive microorganisms) and 1.5 g (for infections caused by gram-negative microorganisms) 3 times a day intramuscularly or intravenously. If necessary, the interval between administrations can be reduced to 6 hours. The daily dose of Cefuroxime-BCPZ averages 3.0 - 6.0 g. For gonorrhea, the drug is administered in a dose of 1.5 g once or divided into 2 doses into both sciatic muscles. Children under 14 years of age and infants over 2 months of age are prescribed the drug intramuscularly or intravenously at a dose of 30–100 mg/kg body weight per day, divided into 3–4 administrations. For most infectious diseases, the effective dose is 60 mg/kg. Newborns and children under 2 months are prescribed a dose of 30 - 100 mg/kg/day, divided into 2 - 3 injections, but it must be borne in mind that T1/2 of cefuroxime in the first weeks of a child’s life can be 3 - 5 times more than in adults. The drug is used as monotherapy for meningitis if it is caused by sensitive strains: adults are prescribed 3.0 g intravenously every 8 hours; Infants after 2 months and children under 14 years of age are prescribed 200 - 240 mg/kg/day intravenously, divided into 3-4 doses. If a therapeutic effect is achieved after 3 days, the dose can be reduced to 100 mg/kg per day. For newborns and infants up to 2 months, the daily dose should not exceed 100 mg/kg/day intravenously, which should be divided into 3 or 4 doses. When a therapeutic effect is achieved, the dose is reduced to 50 mg/kg body weight per day intravenously. To prevent postoperative complications, the dose is 1.5 g intravenously at the stage of induction of anesthesia during abdominal, pelvic or orthopedic operations. It is possible to administer an additional injection at a dose of 0.75 g intramuscularly after 8 and 16 hours. For operations on the heart, lungs, esophagus and blood vessels, a single dose of the drug is 1.5 g intravenously, which is administered at the stage of induction of anesthesia; then 0.75 g of Cefuroxime-BCPZ is administered intramuscularly 3 times a day over the next 24 to 48 hours. Patients with impaired renal function (creatinine clearance 10 - 20 ml/min) are recommended to administer Cefuroxime-BCPZ 0.75 g 2 times a day; in more severe cases (creatinine clearance less than 10 ml/min) – 0.75 g once a day. The duration of treatment with Cefuroxime-BCPZ depends on the nature and severity of the pathological process and is determined, in addition, by bacteriological testing data. Treatment usually lasts from 5 to 10 days (average 7). For most infectious diseases, treatment continues for at least another 24 hours after the symptoms of the disease disappear and the effect of treatment is confirmed by the results of bacteriological analysis.

Overdose

Unreasonably high doses of the drug can cause stimulation of the central nervous system, which is expressed in the form of seizures. There is no specific antidote. Cefuroxime-BCPZ plasma levels can be reduced by hemodialysis or peritoneal dialysis.

Interactions with other drugs

1.5 g of Cefuroxime-BCPZ dissolved in 15 ml of water for injection can be used together with metronidazole (500 mg/100 ml), and both drugs remain active for 24 hours at temperatures up to 25°C. The drug is compatible with a sterile 1% solution of lidocaine hydrochloride and with most other common solvents used for the preparation of solutions for parenteral administration. The drug retains its pharmacological properties for 24 hours at room temperature in the following solvents: - 0.9% sodium chloride solution for injection; — 5% glucose solution (dextrose) for injection; — 10% solution of invert glucose in water for injection. Cefuroxime-BCPZ should not be mixed in the same syringe with aminoglycoside antibiotics. Sodium bicarbonate solution for injection at a concentration of 2.74% significantly affects the coloring of the drug after dissolution, so it is not recommended for use for diluting the drug. When used simultaneously with nephrotoxic antibiotics (aminoglycosides) and potent diuretics (furosemide), polymexide, the risk of kidney damage increases; when used simultaneously with erythromycin, the activity of both antibiotics may decrease; when combined with phenylbutazone and probenecid, the clearance of Cefuroxime-BCPZ decreases and its concentration in the blood increases. When using Cefuroxime-BCPZ, intestinal microflora may be inhibited, which leads to a decrease in the synthesis of vitamin K and other phyloquinones. With the simultaneous use of drugs that reduce platelet aggregation (NSAIDs, salicylates), the risk of bleeding increases. When used together with anticoagulants, an increase in anticoagulant effect was noted. When administered simultaneously with potentially nephrotoxic drugs (aminoglycosides, polymyxin B) and powerful diuretics (ethacrynic acid, furosemide), the risk of developing renal failure increases. The simultaneous use of the drug with probenecid and phenylbutazone reduces the rate of elimination of Cefuroxime-BCPZ from the patient’s body and increases its concentration in the blood plasma. The combined use of the drug with erythromycin reduces the effectiveness of both antibiotics. The drug solution should not be mixed or administered in the same syringe or dropper with aminoglycosides due to pharmaceutical incompatibility.

Special instructions for use

Intramuscular injections into the upper outer quadrant of the sciatic major muscle should be deep. Before administering the drug solution, you must make sure that the needle is outside the vessels. To prevent the development of phlebitis, the Cefuroxime-BCPZ solution must be administered intravenously slowly over 2 to 4 minutes. In case of renal and liver failure, the dose of the drug is reduced. For renal patients (creatinine clearance less than 10 ml/min), the daily dose of the antibiotic should not exceed 0.75 g. In cases of treatment of patients with renal and liver failure, as well as when treatment is carried out with hemodialysis, it is necessary to adjust the dose of Cefuroxime-BCPZ and monitor its concentration in blood plasma. With long-term use of the drug, it is necessary to conduct bacteriological studies to determine the development of dysbacteriosis. Prescribe with caution to children and adults prone to allergic reactions. Elderly and debilitated patients are recommended to take simultaneous administration of vitamin K preparations. It should be taken into account that in newborns the excretion of the drug is 3-5 times lower than in adults. As with the use of other antibiotics, long-term, uncontrolled use of Cefuroxime-BCPZ may contribute to the development of drug-resistant microorganisms. There is no experimental data on the embryotoxic or teratogenic effects of the drug, but it should not be used in the first months of pregnancy. Cefuroxime-BCPZ is excreted in human milk, so when using the drug it is necessary to stop feeding the baby. It is advisable to monitor (with long-term use) the cellular composition of peripheral blood, liver and kidney function. A positive reaction to sugar in the urine may occur. Use with caution for vehicle drivers.

Storage conditions

Store in a dry place, protected from light and out of reach of children, at a temperature of 2 to 25°C.

Best before date

24 months

ATX classification:

J Antimicrobials for systemic use

J01 Antimicrobials for systemic use

J01D Other beta-lactam antibiotics

J01DC Second generation cephalosporins

J01DC02 Cefuroxime

Side effects of the drug Cefuroxime Sandoz

from the blood and lymphatic system: rarely - decreased hemoglobin levels, eosinophilia, leukopenia, neutropenia and thrombocytopenia; very rarely - hemolytic anemia. From the gastrointestinal tract: rarely - nausea, vomiting, diarrhea; Cases of pseudomembranous colitis have been described. From the hepatobiliary system: in isolated cases - increased activity of liver transaminases and bilirubin in the blood plasma, jaundice. From the kidneys and urinary tract: increased levels of creatinine and urea in the blood plasma, especially in patients with renal failure; rarely - acute interstitial nephritis. Allergic reactions: rash, urticaria, itching; very rarely - erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. From the immune system: rarely - serum sickness; very rarely - anaphylaxis. From the central nervous system: headache, dizziness; very rarely - agitation, irritability, confusion. From the ENT organs: very rarely - mild to moderate hearing loss in children after treatment of meningitis. Other: effects due to chemotherapy: prolonged use of the drug can lead to the development of secondary superinfections caused by resistant microorganisms, such as Candida, Enterococci and Clostridium difficile. General and local reactions: phlebitis (with intravenous administration), pain at the injection site (with intramuscular administration); with rapid intravenous administration of cefuroxime, a feeling of fever or nausea may occur; rarely - drug fever. Laboratory indicators: pseudo-positive Coombs test, which may affect the results of blood compatibility tests; false positive reaction of the glucosuric test.

Special instructions for the use of the drug Cefuroxime Sandoz

It is necessary to prescribe the drug with extreme caution to patients who have had an allergic reaction to penicillin or any other β-lactam drug. The drug is prescribed with extreme caution to patients with impaired liver function. For patients with renal failure, dose selection is carried out individually. The use of cefuroxime axetil is not recommended for patients with severe bowel dysfunction accompanied by vomiting and diarrhea, as this leads to a decrease in the level of absorption of the drug. In such cases, it is advisable to prescribe parenteral forms of cefuroxime. The occurrence of severe diarrhea during treatment with the drug may be a consequence of the development of pseudomembranous colitis. In these cases, the use of the drug must be stopped and appropriate examination must be carried out. In patients receiving cefuroxime axetil, it is recommended that blood glucose concentrations be determined using glucose oxidase or hexokinase methods. Cefuroxime does not affect the determination of creatinine when tested with alkaline picrate. During pregnancy and breastfeeding. Cefuroxime penetrates the placental barrier. Limited evidence suggests no side effects. However, due to insufficient experience with use during treatment of pregnant women, the drug is prescribed during this period only after a thorough analysis of the risk/benefit ratio. In breastfed children, when the nurse uses the drug, sensitization, diarrhea and colonization of the mucous membrane by yeast-like fungi may occur. It is better to stop breastfeeding during treatment with the drug. Impact on the ability to drive vehicles and work with complex mechanisms. Sometimes the use of cefuroxime is accompanied by a side effect such as dizziness, which can affect the ability to drive vehicles and operate complex machinery.

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• Pancef Oral tablets
• Nifuroxazide (Nifuroxazide) Oral tablets
• Cifran OD Oral tablets
• Pancef Granules for the preparation of suspension for oral administration
• Augmentin ES Powder for oral solution

** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use the drug Cefuroxime-BHFZ, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.

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** Attention! The information presented in this medication guide is intended for medical professionals and should not be used as a basis for self-medication. The description of the drug Cefuroxime-BCPZ is provided for informational purposes only and is not intended for prescribing treatment without the participation of a physician. Patients need to consult a specialist!

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Drug interactions Cefuroxime Sandoz

It is recommended to avoid the combination of oral cefuroxime axetil with antacids due to increased gastric pH, which may affect the absorption of cefuroxime. Concomitant use of cefuroxime in high doses with diuretics (ethacrynic acid, furosemide), aminoglycosides, amphotericin, colistin and polymyxin increases the risk of developing renal failure. When used simultaneously with phenylbuzatone or probenecid, the renal clearance of cefuroxime and its concentration in the blood plasma may decrease. When administered intravenously, other drugs should not be added to the solution. Cefuroxime Sandoz and aminoglycosides and other antibiotics should not be mixed in a syringe. When used in combination with erythromycin, the effectiveness of both antibiotics may be reduced. It is recommended to avoid the simultaneous use of cefuroxime with tetracyclines, macrolides or chloramphenicol. Cefuroxime, by suppressing the intestinal flora, prevents the synthesis of vitamin K. When used simultaneously with drugs that reduce platelet aggregation (NSAIDs, salicylates, sulfinpyrazone), the risk of bleeding increases. For the same reason, when used simultaneously with anticoagulants, an increase in the anticoagulant effect is observed. The pH value of 2.74% sodium bicarbonate solution for injection affects the color of the finished solution of the drug. Therefore, it is not recommended to use sodium bicarbonate solution for diluting cefuroxime. If necessary, for patients undergoing infusion of sodium bicarbonate solution, cefuroxime solution with water for injection is injected into the tube supplied from the infusion device.