Zinnat 125 mg/5 ml 50 ml gran.d/susp. for oral administration

Zinnat®

The standard course of therapy is about 7 days (from 5 to 10 days). For optimal absorption, Zinnat® suspension should be taken with food.

Adults

Special patient groups

Children

There are no data from clinical studies regarding the use of Zinnat® in children under 3 months of age. If a fixed dose is preferred, 125 mg twice daily is recommended for most infections. Children aged two years and older with otitis media or more severe infections are prescribed 250 mg twice a day; the maximum daily dose is 500 mg. When treating children, it may be necessary to calculate the dose depending on body weight and age. For most infections, the dose for children aged 3 months to 12 years is 10 mg/kg twice a day, but not more than 250 mg per day. For otitis media and more severe infections, the recommended dose is 15 mg/kg twice a day, but not more than 500 mg per day.

The following tables show doses depending on the age and body weight of the child for dosing Zinnat® suspension 125 mg/5 ml with a 5 ml measuring spoon 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

Cefuroxime is also available in the form of a sodium salt (Zinacef®) for parenteral administration. This allows switching from parenteral cefuroxime to oral administration if clinically indicated.

Patients with impaired renal function

Cefuroxime is excreted primarily by the kidneys.

It is recommended to reduce the dose of cefuroxime in patients with severe renal impairment to compensate for delayed elimination (see table below).

Method of preparing the suspension

- Shake the bottle of granules several times.

— Pour 20 ml of water into a measuring glass up to the mark (this amount of water is sufficient to prepare a 50 ml suspension).

— Pour the measured amount of water into the bottle and close the bottle with a lid.

— Turn the bottle over and shake it vigorously (about 1.5 minutes) to mix the drug well.

Turn the bottle over to its original position and shake vigorously. Before each use of the drug, shake the bottle of suspension vigorously.

When taking the drug, you can add cold fruit juice or milk to each portion of the suspension, and this portion of the suspension should be used immediately. Do not dilute the entire volume of suspension with juice or milk at once.

Zinnat 125 mg/5 ml 50 ml gran.d/susp. for oral administration

Instructions for medical use of the drug Zinnat® Trade name Zinnat® International nonproprietary name Cefuroxime Dosage form Granules for the preparation of suspension for oral administration, 125 mg/5 ml Composition 5 ml of suspension contain the active substance - cefuroxime axetil 150.0 mg (corresponding to cefuroxime 125 mg), excipients : stearic acid, sucrose, flavor “Tutti Frutti” 51.880/AR 05:51, acesulfame potassium, aspartame, povidone K30, xantham gum. Description Granules in the form of grains of irregular shape, of various sizes, but not more than 3 mm, white or almost white. When diluted with water, a white to light yellow suspension with a characteristic fruity odor is formed. 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 the suspension is taken with food. When taking a suspension, the rate of absorption (Cmax) of cefuroxime axetil is lower than when taking tablets, (Cmax) of which is determined after 2-4 hours, as a result of which the maximum concentration decreases, the time to reach it increases and systemic bioavailability decreases (by 4-17%). 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 with food. Adults Most infections 250 mg twice daily Genitourinary tract infections 125 mg twice daily Pyelonephritis 250 mg twice daily Mild to moderate lower respiratory tract infections, such as bronchitis 250 mg twice daily Severe infections lower respiratory tract or suspected pneumonia 500 mg 2 times a day Uncomplicated gonorrhea single dose 1 g Lyme disease in adults and children over 12 years old 500 mg 2 times a day for 20 days Stepped therapy Duration of therapy depends on the severity of the disease and clinical patient's condition. 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 . Pediatric use If a fixed dose is preferred, the average dose for most infections is 125 mg twice daily. In infants and children under 12 years of age with acute otitis media or other severe infections, it is recommended to prescribe the drug at a dose of 250 mg twice a day, with a maximum daily dose of 500 mg. There are no clinical studies on the use of the drug in children under 3 months of age. In infants and children from 3 months to 12 years, it is recommended to calculate the dose of the drug according to the child’s weight at the rate of 10 mg/kg body weight 2 times a day (for most infections), but not more than 250 mg per day. Otitis media and severe infectious diseases in children 15 mg/kg body weight 2 times a day, but not more than 500 mg per day. The following 2 tables are divided according to age and weight using a measuring spoon (5ml) for 125 mg/5 ml or 250 mg/5 ml suspension. Dose at the rate of 10 mg/kg prescribed for most infections: Age Approximate weight (kg) 2 times a day (mg) Measuring spoon (5 ml) 125 mg 250 mg from 3 to 6 months 4 - 6 40 - 60 - from 6 months up to 2 years 6 - 12 60 - 120 - 1 - from 2 to 12 years from 12 to >20 125 1 Dose at the rate of 15 mg/kg, prescribed for otitis media and severe infections: Age Approximate weight (kg) 2 times a day (mg) Scoop (5 ml) 125 mg 250 mg from 3 to 6 months 4 - 6 60 - 90 - from 6 months to 2 years 6 - 12 90 -180 1 - 1 from 2 to 12 years from 12 to >20 180 -250 1 - 2 - 1 For accurate dosing in very young children, a dosing syringe can be used, however, a measuring spoon is the most optimal method of dosing the drug in children who are able to take the suspension from a spoon. Renal failure Cefuroxime is excreted primarily by the kidneys. In patients with impaired renal function, a dose reduction is recommended to correct delayed 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 Preparation of the suspension Shake the bottle several times (within 1 minute). Remove the cover and protective membrane. If the membrane has been damaged, do not use the product. Fill a measuring cup with 20 ml of water up to the mark. Pour the measured amount of water into the bottle and close the lid. Invert the bottle and shake it vigorously (at least 15 seconds) to completely mix the drug. Turn the bottle over to its original position and shake vigorously again. If you do not plan to use the suspension immediately after dilution, immediately place the bottle in the refrigerator (from 2º C to 8º C). When taking the drug, you can add cold fruit juice or milk to each serving of the suspension. The suspension, further diluted in this way, should be consumed immediately. Do not dilute the entire volume of suspension with juice or milk at once. 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 under 3 months of age With caution: - first trimester of pregnancy Drug interactions Drugs that reduce the acidity of gastric juice 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. As with other antibiotics, with long-term treatment with the drug, increased growth of insensitive microorganisms (Candida, Enterococci, Clostridium difficile) is possible, 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. In step therapy, the timing of switching 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. Patients with diabetes mellitus should take into account the presence of sucrose in the suspension. When prescribing Zinnat® to patients with phenylketonuria, the presence of aspartame in the composition of the drug, which may be a source of phenylalanine, should be taken into account. Use in pediatrics There is no experience in treating children under 3 months of age. Pregnancy and lactation Teratogenic and embryotoxic effects are not observed, but, as with other drugs, the drug should be used with caution in the early months of pregnancy. 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: symptomatic. Zinnat® is eliminated by hemodialysis or peritoneal dialysis. Release form and packaging In dark glass bottles with a capacity of 100 ml, sealed with a membrane and sealed with a screw-on plastic cap with a device to prevent children from opening the bottle. 1 bottle along with a measuring cup, a measuring spoon and instructions for use in the state and Russian languages ​​are placed in a cardboard pack. Storage conditions Store at a temperature not exceeding 30 °C. Store the prepared suspension in the refrigerator at a temperature from 2 0C to 8 0C for no more than 10 days. Keep out of the reach of children! Shelf life: 2 years Do not use after expiration date. Conditions for dispensing from pharmacies By prescription Manufacturer/packer Glaxo Operations UK Limited, UK (Harmire Road, Barnard Castle, Durham, DL12 8DT, United Kingdom). Registration certificate holder Glaxo Operations UK Ltd. Glaxo Wellcome Operations, UK (Harmire Road, Barnard Castle, Durham, DL12 8DT, United Kingdom). Address of the organization that accepts claims from consumers on the quality of products (products) in the Republic of Kazakhstan Representative office of GlaxoSmithKline Export Ltd. in Kazakhstan 050059, Almaty, Furmanov St., 273 Telephone number: +7 701 9908566, +7 727 259 09 96 Number Fax: + Email address

Zinnat bottle 125mg/5ml 50ml suspension

A country

United Kingdom
Country of origin may vary by batch. Please check with the operator for detailed information when confirming your order.

Active substance

Cefuroxime

Compound

The active ingredient is cefuroxime.

pharmachologic effect

Antibacterial (bactericidal). Inhibits transpeptidase, disrupts the biosynthesis of mucopeptide in the cell wall of microorganisms. It is practically not absorbed when taken orally. After intramuscular administration at a dose of 750 mg, the maximum concentration is achieved within 15-60 minutes. The half-life for intravenous and intramuscular administration is about 80 minutes (in newborns it can be 3-5 times higher). Excreted by the kidneys. Passes through the placenta and penetrates into breast milk. The maximum concentration in the blood is created after using tablets after 2.5-3 hours, suspensions after 2.5-3.5 hours, the half-life is 1.2-1.3 hours and 1 ,4-1.9 hours respectively. If renal function is impaired, the half-life increases. It has a wide spectrum of action, is stable in the presence of most beta-lactamases, and acts on strains resistant to ampicillin and amoxicillin. Active against aerobic gram-positive (Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes and other streptococci) and gram-negative (Enterobacter spp., Escherichia coli, Haemophilus influenzae, including strains that produce penicillinase, Haemophilus parainfluenzae, Klebsiella spp., for example Klebsiella pneumoniae, Moraxella catarrhalis, including ampicillin- and cephalosporin-resistant strains, Morganella morganii, Neisseria meningitidis, Neisseria gonorrhoeae, including penicillinase-producing strains, Proteus mirabilis, Proteus rettgeri, some strains of Citrobacter spp., Salmonella spp., Providencia spp., Shigella spp.) microorganisms, anaerobes (Clostridium spp., Peptococcus and Peptostreptococcus spp., Bacteroides, Fusobacterium spp.).

Indications for use

Infections of the upper and lower respiratory tract (acute and chronic bronchitis, infected bronchiectasis, pneumonia, lung abscess, pleural empyema), ear, throat and nose (otitis media, pharyngitis, tonsillitis, sinusitis), skin and soft tissues (erysipelas, cellulitis, pyoderma, impetigo, furunculosis), genitourinary tract (urethritis, acute and chronic pyelonephritis, cystitis, asymptomatic bacteriuria), joints, pelvic and abdominal organs, biliary tract and gastrointestinal tract, wound, gonorrhea (acute gonococcal urethritis and cervicitis), sepsis, bacterial septicemia , osteomyelitis, peritonitis, meningitis; prevention of infectious complications during operations.

Interaction

Diuretics and nephrotoxic antibiotics increase the risk of kidney damage, and NSAIDs increase the risk of bleeding. Drugs that reduce stomach acidity may reduce the bioavailability of tablets. Probenecid reduces tubular secretion, reduces renal clearance, increases maximum concentration, half-life and toxicity.

Side effect

Diarrhea, nausea, vomiting, constipation, flatulence, abdominal cramps and pain, dyspepsia, oral ulcers, anorexia, thirst, oral candidiasis, glossitis, pseudomembranous colitis, transient increases in transaminases, alkaline phosphatase, LDH or bilirubin, liver dysfunction , cholestasis, impaired renal function, increased creatinine and/or urea nitrogen in the blood serum, decreased Cl creatinine, dysuria, itching in the perineum, vaginitis, chest pain, shortening of breathing, decreased hemoglobin and hematocrit, transient eosinophilia, neutropenia, leukopenia, aplastic and hemolytic anemia, thrombocytopenia, agranulocytosis, hypoprothrombinemia, prolongation of prothrombin time, headache, drowsiness, dysbiosis, superinfection, candidiasis, hearing impairment, convulsions (with renal failure), allergic reactions: rash, itching, urticaria; rarely - drug fever or chills, serum sickness, bronchospasm, positive Coombs test, erythema multiforme, interstitial nephritis, Stevens-Johnson syndrome and anaphylactic shock; local reactions: pain or infiltration at the injection site, thrombophlebitis after intravenous administration.

Contraindications

Hypersensitivity (including to other cephalosporins, penicillins, carbapenems), bleeding and gastrointestinal diseases in the anamnesis, incl. nonspecific ulcerative colitis; pregnancy, lactation.

Overdose

Symptoms: central nervous system stimulation, convulsions. Treatment: hemodialysis and peritoneal dialysis.

special instructions

With long-term use, it is recommended to monitor kidney function and prevent dysbacteriosis. In patients with impaired renal function, the dose is reduced. Before intramuscular administration, an aspiration test is performed. After the disappearance of clinical signs of the disease, it should be prescribed for another 2-3 days. A false positive reaction to sugar in the urine may occur. Cefuroxime suspension is active for 10 days.

Dispensing conditions in pharmacies

On prescription

Instructions for use ZINNAT™

Hypersensitivity reactions

Particular caution should be exercised when prescribing the drug to patients with a history of an allergic reaction to penicillins or other beta-lactam antibiotics due to the risk of cross-sensitivity. As with other beta-lactam antibiotics, serious and sometimes fatal hypersensitivity reactions have been reported. In case of severe hypersensitivity reactions, treatment with cefuroxime should be stopped immediately and adequate emergency treatment should be provided.

Before starting therapy, it should be established whether the patient has a history of severe hypersensitivity reactions when using cefuroxime, other cephalosporins or other beta-lactam antibiotics. Caution should be exercised when prescribing cefuroxime to patients with a history of mild hypersensitivity to other beta-lactam antibiotics.

Jarisch-Herxheimer reaction

Some patients may experience increased temperature (fever), chills, headache, muscle pain, and skin rash while taking Zinnat™ to treat Lyme disease. This reaction is known as the Jarisch-Herxheimer reaction. It is directly due to the bactericidal activity of cefuroxime axetil against the causative agent of Lyme disease, the spirochete Borrelia burgdorferi. Symptoms usually last from several hours to one day. Patients should be informed that these symptoms are a typical consequence of the use of antibiotics for this disease and, as a rule, resolve without treatment (see section "Side effects").

Excessive growth of non-susceptible microorganisms

As with other antibiotics, the use of cefuroxime axetil can lead to overgrowth of Candida fungi. Long-term use may also lead to overgrowth of other non-susceptible organisms (eg, enterococci and Clostridium difficile), which may require discontinuation of treatment (see Side Effects section).

Pseudomembranous colitis, which can range in severity from mild to life-threatening, has been reported with the use of almost all antibacterial agents, including cefuroxime. This diagnosis should be considered in patients with diarrhea occurring during or after use of cefuroxime (see section "Side effects"). Consideration should be given to discontinuing treatment with cefuroxime and initiating treatment against Clostridium difficile. You should not prescribe medications that inhibit peristalsis (see section “Side effects”).

Impact on diagnostic tests

A positive Coombs test associated with the use of cefuroxime may interfere with the cross-matching test (see section "Side effects").

When performing a ferrocyanide test, a false negative result may be observed, therefore, it is recommended to use glucose oxidase or hexokinase methods to determine the level of glucose in the blood or plasma of patients taking cefuroxime axetil.

Important information about excipients

The sucrose content of cefuroxime axetil suspension and granules should be taken into account when treating patients with diabetes and appropriate recommendations should be made. Contains 3 g of sucrose per 5 ml dose.

The drug should not be taken by patients with congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.

With long-term use (2 weeks or more), sucrose can cause damage to teeth.

Cefuroxime axetil suspension contains aspartame, which is a source of phenylalanine, so this drug should be administered with caution to patients with phenylketonuria.

Impact on the ability to drive vehicles and operate machinery

No studies have been conducted on the effect on the ability to drive vehicles and operate machinery. Because this drug may cause dizziness, patients should be warned to take precautions when driving or operating moving machinery.