Zinnat granules for the preparation of suspension for oral administration 125 mg/5 ml bottle 50 ml in Moscow

Zinnat®

Pills

The standard course of therapy is 7 days (can vary from 5 to 10 days). For optimal absorption, the drug should be taken after meals.

Adults

Children from 3 years old

Oral suspension

The drug Zinnat® in the form of an oral suspension is recommended for use in children from 3 months

. There is no experience with the use of Zinnat® in children under 3 months of age.

If a fixed dose is preferred, then for most infections it is recommended to take 125 mg 2 times a day. Children aged 2 years and older

for
otitis media or more severe infections,
prescribe 250 mg 2 times a day; the maximum daily dose is 500 mg.

When treating infants and children, it may be necessary to calculate the dose depending on body weight and age. For most infections

the dose for
infants and children aged 3 months to 12 years
is 10 mg/kg 2 times a day, but not more than 250 mg/day.
For otitis media and more severe infections,
the recommended dose is 15 mg/kg 2 times a day, but not more than 500 mg/day.

The following tables show doses depending on the age and body weight of the child for dosing Zinnat® suspension 125 mg/5 ml in 5 ml measuring spoons included in the package.

Dose of 10 mg/kg body weight prescribed for most infections

Dose of 15 mg/kg body weight prescribed for otitis media and more severe infections

Step therapy

Cefuroxime is also available as a sodium salt (Zinacef®) for parenteral administration, which allows the same antibiotic to be prescribed sequentially when switching from parenteral to oral therapy is necessary. The drug Zinnat® is effective after parenteral use of the drug Zinacef® for the treatment of pneumonia and exacerbation of chronic bronchitis.

The duration of parenteral and oral courses of treatment is determined by the severity of the infection and the clinical picture.

Pneumonia

The drug Zinacef® (cefuroxime in the form of sodium salt) at a dose of 1.5 g 2-3 times a day (IV or IM) for 48-72 hours, then the drug Zinnat® (cefuroxime axetil) orally at a dose of 500 mg 2 times/day for 7-10 days.

Exacerbation of chronic bronchitis

The drug Zinacef® (cefuroxime in the form of sodium salt) at a dose of 750 mg 2-3 times a day (IV or IM) for 48-72 hours, then a course of treatment with Zinnat® (cefuroxime axetil) orally at a dose 500 mg 2 times/day for 5-10 days.

Zinnat granules for the preparation of suspension for oral administration 125 mg/5 ml bottle 50 ml in Moscow

Pharmacological action: Cefuroxime axetil is a precursor to cefuroxime, which is a second generation cephalosporin antibiotic. Cefuroxime is active against a wide range of pathogens, including strains that produce β-lactamases.

Cefuroxime is resistant to bacterial β-lactamases and is therefore effective against ampicillin-resistant or amoxicillin-resistant strains.

The bactericidal effect of cefuroxime is associated with the suppression of bacterial cell wall synthesis as a result of binding to the main target proteins.

Cefuroxime is generally active in vitro against the following microorganisms.

Gram-negative aerobes: Haemophilus influenzae (including ampicillin-resistant strains), Haemophilus parainfluenzae, Moraxella (Branhamella) catarrhalis, Neisseria gonorrhoeae (including strains that produce and do not produce penicillinase); Escherichia coli, Klebsiella spp., Proteus mirabilis, Providencia spp.

Gram-positive aerobes: Staphylococcus aureus (including penicillinase-producing strains, but excluding methicillin-resistant strains), Staphylococcus epidermidis (including penicillinase-producing strains, but excluding methicillin-resistant strains), Streptococcus pyogenes (and other beta-hemolytic streptococci), Streptococcus pneumoniae, group B streptococci (Streptococcus agalactiae).

Anaerobes: gram-positive and gram-negative cocci (including species of the genera Peptococcus spp. and Peptostreptococcus spp.), gram-positive rods (including species of the genus Clostridium spp., except Clostridium difficile, Propionibacterium spp.), gram-negative rods (including Bacteroides spp. and species of the genus Fusobacterium spp. .), gram-negative spirochetes (including Borrelia spp.).

The following microorganisms are insensitive to cefuroxime.

Clostridium difficile, Pseudomonas spp., Campylobacter spp., Acinetobacter calcoaceticus, Listeria monocytogenes, methicillin-resistant strains of Staphylococcus aureus and Staphylococcus epidermidis, Legionella spp.

Some strains of the following genera are insensitive to cefuroxime.

Enterococcus (Streptococcus) faecalis, Morganella morganii, Proteus vulgaris, Enterobacter spp., Citrobacter spp., Serratia spp., Bacteroides fragilis.

Pharmacokinetics:

Suction:

After oral administration of cefuroxime, axetil is slowly absorbed from the gastrointestinal tract and rapidly hydrolyzed in the mucous membrane of the small intestine and blood to release cefuroxime. Cefuroxime penetrates the blood-brain barrier, the placenta and is excreted in breast milk. Cefuroxime axetil is optimally absorbed when taken immediately after meals.

Additionally for film-coated tablets. Cmax of cefuroxime (2.9 mg/l for a dose of 125 mg and 4.4 mg/l for a dose of 250 mg) are observed after approximately 2.4 hours when taking the drug after meals.

Additionally for granules for the preparation of suspension for oral administration. Cmax of cefuroxime (2-3 mg/l for a dose of 125 mg and 4-6 mg/l for a dose of 250 mg) are observed after approximately 2-3 hours when taking the drug after meals.

Distribution:

The binding to plasma proteins is approximately 33–50%.

Metabolism:

Cefuroxime is not metabolized.

Removal:

T1/2 is 1–1.5 hours. Cefuroxime is excreted by glomerular filtration and tubular secretion. With simultaneous administration of probenecid, the AUC increases by 50%. Serum concentrations of cefuroxime decrease with dialysis.

Indications for use of the drug Zinnat™

Infections caused by microorganisms sensitive to the drug:

• ENT organs (otitis media, sinusitis, tonsillitis, pharyngitis);
• lower respiratory tract (pneumonia, acute bronchitis and exacerbation of chronic bronchitis);
• urinary system (pyelonephritis, cystitis and urethritis);
• skin and soft tissues (furunculosis, pyoderma and impetigo);
• gonorrhea, acute uncomplicated gonococcal urethritis and cervicitis;
• early manifestations of Lyme disease and subsequent prevention of late manifestations of Lyme disease in adults and children over the age of 12 years.

Side effects of the drug Zinnat™

When using cefuroxime axetil, side effects are moderate and are mostly reversible. The following side effects are classified by organs and systems and by frequency of occurrence: very often (≥1/10); often (≥1/100 and ≤1/10); uncommon (≥1/1000 and ≤1/100); rare (≥1/10,000 and ≤1/1000); very rare (≤1/10,000). Infections and infestations Often - overgrowth of Candida . From the blood and lymphatic system Often - eosinophilia. Uncommon: positive Coombs test, thrombocytopenia, leukopenia (sometimes severe). Very rarely - hemolytic anemia. Cephalosporins as a class have the property of being absorbed on the surface of the red blood cell membrane and interacting with antibodies, which can lead to a positive Coombs test (impact on the determination of blood compatibility) and (very rarely) to hemolytic anemia. Immune system Hypersensitivity reactions, including: uncommon - skin rash; rarely - urticaria, itching; very rarely - drug fever, serum sickness, anaphylaxis. From the side of the central nervous system : Often - headache, dizziness. From the gastrointestinal tract Often - gastroenterological disorders, including diarrhea, nausea, abdominal pain. Uncommon: vomiting. Rarely - pseudomembranous colitis. From the hepatobiliary system Often - a transient increase in the level of liver enzymes (ALAT, AST, LDH). Very rarely - jaundice (mostly cholestatic), hepatitis. From the skin and subcutaneous tissues Very rarely - erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (exanthematous necrolysis).

Zinnat, 10 pcs., 250 mg, film-coated tablets

For all dosage forms

Inside

, after meals (tablets)/during meals (suspension). The standard course of therapy is about 7 days (from 5 to 10 days).

Adults:

Additionally for film-coated tablets

Step therapy

Cefuroxime is also available as a sodium salt (Zinacef®) for parenteral administration, which allows the same antibiotic to be prescribed sequentially when switching from parenteral to oral therapy is necessary.

The drug Zinnat® is effective after parenteral use of the drug Zinacef® for the treatment of pneumonia and exacerbation of chronic bronchitis.

The duration of parenteral and oral courses of treatment is determined by the severity of the infection and the clinical picture.

Pneumonia.

The drug Zinacef® at a dose of 1.5 g 2–3 times a day (IV or IM) for 48–72 hours, and then the drug Zinnat® orally at a dose of 500 mg 2 times a day for 7–10 days.

Exacerbation of chronic bronchitis.

Zinacef® at a dose of 750 mg 2–3 times a day (IV or IM) for 48–72 hours, then a course of treatment with Zinnat® orally at a dose of 500 mg 2 times a day for 5–10 days .

Children from 3 years old:

Additionally for granules for the preparation of oral suspension

Special patient groups

Children.

There are no clinical trial data regarding the use of Zinnat® in children under 3 months of age.

If a fixed dose is preferred, then for most infections it is recommended to take 125 mg 2 times a day. Children 2 years of age and older with otitis media or more severe infections are prescribed 250 mg 2 times a day; the maximum daily dose is 500 mg.

When treating infants and children, it may be necessary to calculate the dose depending on body weight and age. For most infections, the dose for infants and children aged 3 months to 12 years is 10 mg/kg 2 times a day, but not more than 250 mg/day. For otitis media and more severe infections, the recommended dose is 15 mg/kg 2 times a day, but not more than 500 mg/day.

The tables below show doses depending on the age and weight of the child for dosing Zinnat® suspension 125 mg/5 ml in 5 ml measuring spoons included in the package.

10 mg/kg dose prescribed for most infections

Dose of 15 mg/kg prescribed for otitis media and more severe infections

Drug interactions Zinnat™

Drugs that reduce gastric acidity may reduce the bioavailability of Zinnat and minimize the effect of accelerating absorption after meals. Like other antibiotics, Zinnat can affect intestinal flora, which leads to decreased estrogen reabsorption and decreased effectiveness of combined oral contraceptives. Since the ferrocyanide test may produce a false-positive result, it is recommended to use the glucose oxidase or hexokinase technique to determine blood glucose levels in patients receiving cefuroxime sodium therapy. Cefuroxime does not affect the results of the alkaline picrate method for determining creatinine levels.

Zinnat 500 mg No. 10 tablet p.o.

Instructions for medical use of the drug Zinnat® Trade name Zinnat® International nonproprietary name Cefuroxime Dosage form Film-coated tablets, 500 mg Composition One tablet contains the active substance - cefuroxime axetil 601.44 mg (corresponding to cefuroxime) (500.00), excipients: cellulose microcrystalline, croscarmellose sodium, type A; sodium lauryl sulfate, hydrogenated vegetable oil, anhydrous colloidal silicon dioxide, shell composition: hypromellose, propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), white Opasprey M-1-7120J, white Opasprey composition: hypromellose 5cP or 6cP, titanium dioxide (E171 ), sodium benzoate, denatured alcohol (74 OR), purified water. Description Capsule-shaped, film-coated tablets, white or off-white, with a biconvex surface, marked “GX EG2” on one side and smooth on the other. Pharmacotherapeutic group Antibacterial drugs for systemic use. Other beta-lactam antibacterial drugs. Second generation cephalosporins. Cefuroxime. ATC code J01DC02 Pharmacological properties Pharmacokinetics Absorption After oral administration, cefuroxime axetil is absorbed from the gastrointestinal tract and is rapidly hydrolyzed in the intestinal mucosa and blood, releasing cefuroxime into the systemic circulation. Optimal absorption is achieved when taking the tablets after meals. After taking cefuroxime with food, its maximum concentration (2.9 mg/l for 125 mg, 4.4 mg/l for 250 mg, 7.7 mg/l for 500 mg and 13.6 mg/l for 1 g) in the blood plasma is determined after 2.4 hours. Distribution The degree of binding of cefuroxime to plasma proteins ranges from 33% to 50%, depending on the route of administration. Metabolism Cefuroxime is not metabolized in the body. Elimination The half-life of cefuroxime is 1-1.5 hours. Cefuroxime is excreted unchanged by the kidneys by glomerular filtration and tubular secretion. Competitive administration of probenecid increased AUC by 50%. Renal impairment The pharmacokinetics of cefuroxime have not been studied in patients with varying degrees of renal dysfunction. The half-life of cefuroxime increases with declining renal function, which is the main guide for dose selection in these patients. In patients undergoing hemodialysis, at least 60% of the total dose of cefuroxime is present in the body at the time of initiation of dialysis, which is eliminated within 4 hours of the dialysis procedure. Thus, such patients require an additional dose of cefuroxime upon completion of the hemodialysis procedure. Pharmacodynamics Zinnat® is a second generation cephalosporin antibiotic. Has a wide spectrum of action. It is resistant to the action of most β-lactamases, therefore it is active against ampicillin-resistant or amoxicillin-resistant strains. It has a bactericidal effect, disrupts the synthesis of bacterial cell walls as a result of binding to the main target proteins. The resistance of strains depends on geographic location and time. Use local resistance data to treat severe infections. Cefuroxime is effective against the following microorganisms Aerobic gram-positive bacteria: Streptococcus pyogenes* Beta-hemolytic streptococci Aerobic gram-negative bacteria: Haemophilus influenzae* (including ampicillin-resistant strains) Haemophilus parainfluenzae* Moraxella catarrhalis* Neisseria gonorrhoea* (including strains producing and non-producing penicillinase-inducing) Anaerobic gram-positive bacteria: Peptostreptococcus spp. Propionibacterium spp. Spirochetes Borrelia burgdorferi* Organisms with possible resistance to cefuroxime Aerobic gram-positive bacteria: Staphylococcus spp., including S. aureus (methicillin-susceptible isolates only)* Streptococcus pneumoniae* Aerobic gram-negative bacteria: Citrobacter spp., not including C. freundii Enterobacter spp., excluding E. aerogenes and E. cloacae Escherichia coli* Klebsiella spp., including Klebsiella pneumoniae* Proteus mirabilis Proteus spp., excluding P. penneri and P. vulgaris Providencia spp. Anaerobic Gram-positive bacteria: Clostridium spp., not including C. Difficile Anaerobic Gram-negative bacteria: Bacteroides spp., not including B. fragilis Fusobacterium spp. Enterococcus spp. are resistant to cefuroxime, including E. faecalis and E. faecium Listeria monocytogenes Acinetobacter spp. Burkholderia cepacia Campylobacter spp. Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Morganella morganii Proteus penneri Proteus vulgaris Pseudomonas spp., including Pseudomonas aeruginosa Serratia spp. Stenotrophomonas maltophilia Clostridium difficile Chlamydia species Mycoplasma species Legionella species Bacteroides fragilis *Clinical efficacy has not been confirmed in clinical studies Indications for use Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug: - infections of the upper respiratory tract, ENT organs (including acute mild otitis, sinusitis, tonsillitis and pharyngitis) - lower respiratory tract infections, for example, pneumonia, acute bronchitis, exacerbation of chronic bronchitis - infections of the genitourinary system (including pyelonephritis, cystitis, urethritis) - gonorrhea, acute uncomplicated gonococcal urethritis, cervicitis - skin infections and soft tissues, for example, furunculosis, pyoderma, impetigo - Lyme disease at an early stage and subsequent prevention of late stages of this disease in adults and children over 12 years of age. The sensitivity of strains may vary depending on geographical location and time. Use local susceptibility data whenever possible. Method of administration and dosage The duration of use of the drug is on average 7 days (from 5 to 10 days). For optimal absorption, the drug should be taken after meals. Adults Severe lower respiratory tract infections or if pneumonia is suspected, 500 mg 2 times a day. Lyme disease in adults and children over 12 years old, 500 mg 2 times a day for 20 days. Stepped therapy The duration of therapy depends on the severity of the disease and the clinical condition of the patient . Pneumonia Zinacef® at a dose of 1.5 g 2-3 times a day (IV or IM) for 48-72 hours, and then Zinnat® at a dose of 500 mg 2 times a day for 7-10 days. Exacerbation of chronic bronchitis Zinacef® at a dose of 750 mg 2-3 times a day (IV or IM) for 48-72 hours, and then Zinnat® at a dose of 500 mg 2 times a day for 5-10 days . Children Zinnat® tablets cannot be broken, so children under 18 years of age are recommended to use the drug in the form of a suspension or tablets of 125 mg or 250 mg (with the exception of treatment of Lyme disease in children over 12 years of age). Renal failure Cefuroxime is excreted primarily by the kidneys. In patients with impaired renal function, a dose reduction is recommended to correct excretion. Creatinine clearance T1/2 (hours) Recommended dose ≥30 ml/min 1.4 - 2.4 No dose adjustment required (standard dose 125 - 500 mg twice daily) 10-29 ml/min 4.6 Standard individual dose every 24 hours <10 ml/ min 16.8 Standard individual dose every 48 hours During the hemodialysis procedure 2 - 4 Additional single individual dose at the end of the dialysis procedure Side effects Adverse reactions to cefuroxime are usually transient and mild. The frequency of occurrence is determined as follows: very often (≥1/10), often (≥1/100 - <1/10), infrequently (≥1/1,000 - <1/100), rarely (≥1/10,000 - <1/1,000), very rare (<1/10,000, including isolated cases), unknown (frequency cannot be estimated). Often - increased growth of resistant microorganisms of the genus Candida - eosinophilia - headache, dizziness - gastrointestinal disorders, including diarrhea, nausea, abdominal pain - temporary increase in the activity of liver enzymes (ALT, AST, LDH), Uncommon - positive Coombs test, thrombocytopenia, leukopenia (sometimes pronounced) - skin rash - vomiting Rarely - urticaria, itching - pseudomembranous colitis Very rarely - hemolytic anemia - fever of drug etiology, serum sickness, anaphylaxis - jaundice (mainly cholestatic), hepatitis - erythema multiforme, Stevens syndrome - Johnson, toxic epidermal necrolysis (exanthematous necrolysis) Contraindications - hypersensitivity to cephalosporin antibiotics, penicillins and carbapenes or to any component of the drug - children and adolescents under 18 years of age (exception - treatment of Lyme disease in children over 12 years of age) With caution: - first trimester of pregnancy Drug interactions Drugs that reduce gastric acidity may reduce the bioavailability of Zinnat® and minimize the effect of accelerating absorption after meals. Like other antibiotics, Zinnat® can affect the intestinal flora, thereby leading to a decrease in estrogen reabsorption and a decrease in the effectiveness of combined oral contraceptives. Since the ferrocyanide test may produce a false-positive result, it is recommended to use the glucose oxidase or hexokinase technique to determine blood glucose levels in patients receiving cefuroxime sodium therapy. Zinnat® does not affect the results of the alkali picrate method for determining creatinine levels. Simultaneous administration with probenecid leads to an increase in the AUC of Zinnat® by 50%. Special instructions The drug Zinnat® is prescribed with extreme caution to patients who have a history of allergic reactions to penicillins or other beta-lactam antibiotics with a history of hypersensitivity to pecicillin antibiotics and other beta-lactamases. As with other antibiotics, long-term treatment with the drug may result in increased growth of resistant microorganisms (Candida, Enterococci, Clostridium difficile), which may require discontinuation of treatment. When diarrhea occurs during the use of antibiotics, including the drug Zinnat®, one should keep in mind the possibility of developing pseudomembranous colitis, the severity of which can vary from minor to life-threatening. Thus, it is important to consider the possibility of this pathology in patients with diarrhea that occurs during treatment or after cessation of therapy. If the patient has prolonged or severe diarrhea or if abdominal cramps are present, treatment should be stopped immediately and the patient should be referred for further investigation. When treating Lyme disease with Zinnat®, a Jarisch-Gersheimer reaction is sometimes observed. This reaction is a direct consequence of the bactericidal effect of Zinnat® on the causative agent of the disease - the spirochete Borrelia burgdorferi - and is a frequent and usually spontaneous consequence of treatment. It is necessary to explain to patients that this is a common consequence of antibiotic therapy for Lyme disease and does not require special therapy. With step therapy, the time to switch to oral therapy is determined by the severity of the infection, the clinical condition of the patients and the sensitivity of the pathogen. If there is no clinical improvement within 72 hours, parenteral therapy should be continued. Read the instructions for use of the drug Zinacef if prescribed. Pregnancy and lactation period Use in the second and third trimesters of pregnancy, as well as during lactation, is possible in cases where the expected benefit of therapy for the mother outweighs the potential risk for the fetus. Lactation Cefuroxime passes into breast milk, and therefore the use of the drug during feeding should be considered with caution. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms Since cases of dizziness may occur when taking the drug Zinnat®, care must be taken when driving vehicles and other mechanisms. Overdose Symptoms: disturbances on the part of the central nervous system, which are manifested by agitation and convulsions. Treatment: carry out symptomatic therapy. Zinnat® is eliminated by hemodialysis or peritoneal dialysis. Release form and packaging Film-coated tablets, 500 mg. 10 tablets are placed in a blister pack made of polyvinyl chloride film and aluminum foil. 1 blister pack together with instructions for medical use in the state and Russian languages ​​are placed in a cardboard pack. Storage conditions Store at a temperature not exceeding 30 °C. Keep out of the reach of children! Shelf life: 3 years Do not use after expiration date. Conditions for dispensing from pharmacies By prescription Manufacturer/packer Glaxo Operations Great Britain Limited, Great Britain (Harmire Road, Barnard Castle, Durham, DL12 8DT, United Kingdom) Name and country of the holder of the registration certificate Glaxo Operations Great Britain Ltd. Glaxo Wellcome Operations, UK (Glaxo Wellcome House, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom) Address of the organization that accepts claims from consumers regarding the quality of products (products) in the Republic of Kazakhstan Representative office of GlaxoSmithKline Export Ltd in Kazakhstan 050059, Almaty, Furmanov St., 273 Phone number: +7 701 9908566, +7 727 259 09 96 Fax number: + Email address

Instructions for use ZINNAT™ tablets

Suction

After oral administration of cefuroxime, axetil is absorbed from the gastrointestinal tract and is rapidly hydrolyzed in the intestinal mucosa and blood, releasing cefuroxime into the bloodstream. Cefuroxime axetil is optimally absorbed when taken immediately after meals.

After dosing of cefuroxime axetil tablets, Cmax in serum (2.1 mcg/ml for a dose of 125 mg, 4.1 mcg/ml for a dose of 250 mg, 7.0 mcg/ml for a dose of 500 mg and 13.6 mcg/ml for a dose of 1000 mg) is achieved in approximately 2- 3 hours after taking the dose with food. The extent of absorption of cefuroxime from suspension is reduced compared to tablets, resulting in later and lower peak serum levels and reduced systemic bioavailability (4–17% less). Cefuroxime axetil oral suspension was not bioequivalent to cefuroxime axetil tablets in studies in healthy volunteers and is therefore not interchangeable on a milligram-for-milligram basis (see Dosage Regimen).

Distribution

Protein binding ranges from 33 to 50%, depending on the methodology used. After taking a single dose of cefuroxime axetil in the form of a 500 mg tablet by 12 healthy volunteers, Vd was 50 l. Concentrations of cefuroxime exceeding the minimum inhibitory concentrations for common pathogens can be achieved in the tonsils, sinus tissue, bronchial mucosa, pleural fluid, intraarticular fluid, synovial fluid, interstitial fluid, bile, sputum and intraocular fluid. Cefuroxime penetrates the BBB during inflammation of the meninges.

The pharmacokinetics of cefuroxime when taken orally is linear in the dose range from 125 mg to 1000 mg. After repeated oral administration of the drug in doses from 250 mg to 500 mg, no accumulation of cefuroxime occurs.

Metabolism and excretion

Cefuroxime is not metabolized.

T1/2 from serum is from 1 to 1.5 hours. Cefuroxime is eliminated through glomerular filtration and tubular secretion. Renal clearance ranges from 125 to 148 ml/min/1.73 m2.

Pharmacokinetics in special groups of patients

There were no differences in the pharmacokinetics of cefuroxime between men and women.

No special precautions are required in elderly patients with normal renal function when using the drug in doses up to 1 g/day. Elderly patients are more likely to have decreased renal function, so the dose in elderly patients should be adjusted according to renal function (see Dosage Regimen).

In children over 3 months of age, the pharmacokinetics of cefuroxime are similar to those in adults. There are no data from clinical studies on the use of cefuroxime axetil in children under 3 months of age.

The safety and effectiveness of cefuroxime axetil in patients with renal impairment have not been established. Cefuroxime is excreted primarily by the kidneys. Accordingly, as with all such antibiotics, in patients with significant impairment of renal function (i.e., creatinine clearance <30 ml/min), it is recommended to reduce the dose of cefuroxime to compensate for its slower elimination (see Dosage Regimen). Cefuroxime is effectively eliminated by dialysis.

There are no data in patients with impaired liver function. Because Cefuroxime is excreted primarily by the kidneys; impaired liver function is not expected to affect the pharmacokinetics of cefuroxime.

Relationship between pharmacokinetics and pharmacodynamics

For cephalosporins, the most important pharmacokinetic-pharmacodynamic index that correlates with in vivo efficacy has been demonstrated to be the dosing interval (%T) during which unbound drug concentrations remain above the minimum inhibitory concentration (MIC) of cefuroxime for individual species ( i.e. %T>MPC).

Special instructions for the use of Zinnat™

The drug is prescribed with extreme caution to patients with a history of allergic reactions to penicillins or other β-lactam antibiotics. The use of cefuroxime axetil (as well as other antibiotics) can lead to overgrowth of Candida . Long-term use may also lead to overgrowth of other nonsusceptible microorganisms (eg, Enterococci, Clostridium difficile ), which may require discontinuation of treatment. When using broad-spectrum antibiotics, pseudomembranous colitis may develop. This should be taken into account if patients experience severe diarrhea during or after treatment. The composition of the drug in the form of a suspension includes sucrose, which must be taken into account when prescribing the drug to patients with diabetes mellitus. The suspension also contains aspartame, which is a source of phenylalanine, so this form of the drug is used with caution to treat patients with phenylketonuria. During treatment with Zinnat in patients with Lyme disease, the development of the Yarisch-Gersheimer reaction is possible. This reaction occurred directly as a result of the bactericidal effect of Zinnat on the microorganism that causes Lyme disease, the spirochete Borrelia burgdorferi. It is necessary to explain to patients that this is a common consequence of antibiotic therapy for Lyme disease and does not require special therapy. When carrying out sequential therapy, the time of transition from parenteral administration of the drug to oral administration is determined by the severity of the infection, the clinical condition of the patient and the sensitivity of the infectious agent. If there is no clinical improvement within 72 hours, parenteral therapy should be continued. During pregnancy and breastfeeding . There is no experimental data on the embryotoxic or teratogenic effects of cefuroxime axetil, but it should be prescribed with caution in the first months of pregnancy. Cefuroxime is excreted in breast milk, so the drug is used with caution during breastfeeding. Children . There is no experience with the use of Zinnat for the treatment of children under 3 months of age. Impact on the ability to drive vehicles and operate machinery . Since the drug may cause dizziness, the patient should be warned that driving vehicles and operating machinery should be done with caution.