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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

special instructions

Patients with a history of allergic reactions to penicillins may have hypersensitivity to cephalosporin antibiotics. During treatment, monitoring of renal function is necessary, especially in patients receiving the drug in high doses. Treatment is continued for 48-72 hours after the disappearance of symptoms; in the case of infections caused by Streptococcus pyogenes, the course of treatment is at least 7-10 days. During treatment, a false-positive direct Coombs test and a false-positive urine test for glucose are possible. The ready-to-use solution can be stored at room temperature for 7 hours, in the refrigerator for 48 hours. It is allowed to use a solution that has turned yellow during storage. In patients receiving Cefuroxime, it is recommended to use glucose oxidase or hexokinase tests when determining blood glucose concentrations. When switching from parenteral administration to oral administration, the severity of the infection, the sensitivity of microorganisms and the general condition of the patient should be taken into account. If 72 hours after taking Cefuroxime orally there is no improvement, it is necessary to continue parenteral administration.

pharmachologic effect

II generation cephalosporin antibiotic for parenteral use. Acts bactericidal (disturbs the synthesis of bacterial cell walls). 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 beta-hemolytic streptococci), Streptococcus pneumoniae, group B Streptococcus (Streptococcus agalactiae), Streptococcus mitis (viridans group), Bordetella pertussis, most Clostridium spp.); gram-negative microorganisms (Escherichia coli, Klebsiella spp., Proteus mirabilis, Providencia spp., Proteus rettgeri, Haemophilus influenzae, including strains resistant to ampicillin; Haemophilus parainfluenzae, including strains resistant to ampicillin; Moraxella catarrhalis, Neisseria gonorrhoeae, including strains producing and not producing penicillinase, 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 sp. p ., 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.

Directions for use and doses

Adults are prescribed 750 mg intravenously and intramuscularly 3 times a day; for severe infections, the dose is increased to 1500 mg 3-4 times a day (if necessary, the interval between doses can be reduced to 6 hours). The average daily dose is 3-6 g.

Children are prescribed 30-100 mg/kg/day in 3-4 doses. For most infections, the optimal dose is 60 mg/kg/day. Newborns and children up to 3 months are prescribed 30 mg/kg/day in 2-3 doses.

For gonorrhea - IM, 1500 mg (in the form of 2 injections of 750 mg with injection into different areas, for example into both gluteal muscles).

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

For operations on the abdominal cavity, pelvic organs and orthopedic operations - IV, 1500 mg during induction of anesthesia, then additionally - IM, 750 mg, 8 and 16 hours after surgery. For total joint replacement, 1500 mg of powder is mixed dry with each packet of methyl methacrylate cement polymer before adding the liquid monomer.

For operations on the heart, lungs, esophagus and blood vessels - intravenously, 1500 mg during induction of anesthesia, then intramuscularly, 750 mg 3 times a day over the next 24-28 hours.

For pneumonia - intravenously, 1500 mg 2-3 times a day for 48-72 hours, then switch to oral administration, 500 mg 2 times a day for 7-10 days.

In case of exacerbation of chronic bronchitis, it is prescribed intramuscularly or intravenously, 750 mg 2-3 times a day for 48-72 hours, then switch to oral administration, 500 mg 2 times a day for 5-10 days.

In case of chronic renal failure, correction of the dosage regimen is necessary: with a creatinine clearance (CC) of 10-20 ml/min, 750 mg is prescribed intravenously or intramuscularly, 2 times a day, with a creatinine clearance of less than 10 ml/min - 750 mg once a day.

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

Preparation of solution for injection:

Solution for intramuscular injection:

Add 3 ml water for injection to 750 mg Cefuroxime. Shake gently until a suspension forms. When administered intramuscularly, Cefuroxime is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.

Cefuroxime at a dose of 1500 mg is intended for intravenous administration only.

Solution for intravenous administration:

Dissolve

- 750 mg Cefuroxime in 6 ml or more water for injection,

- 1.5 g of Cefuroxime in 15 ml or more water for injection.

For short-term intravenous infusions (up to 30 minutes), 1.5 g of the drug is dissolved in 50 ml of water for injection. These solutions can be injected directly into a vein or into an infusion line.

When mixing a solution of Cefuroxime (1.5 g in 15 ml of water for injection) and metronidazole (50 mg/100 ml), both components remain active for up to 24 hours at a temperature of 4°C or up to 6 hours at a temperature below 25°C.

Cefuroxime is compatible with the most widely used liquids for intravenous administration.

The drug is stable for up to 24 hours at room temperature when mixed with the following solutions:

— 0.9% sodium chloride solution;

— 5% dextrose solution;

- Ringer's solution;

- Hartmann's solution.

Cefuroxime remains stable in 0.9% sodium chloride and 5% dextrose in the presence of hydrocortisone sodium phosphate.

Cefuroxime is compatible with the following solutions for 24 hours at room temperature:

- heparin (10 units/ml and 50 units/ml) in 0.9% sodium chloride solution;

- potassium chloride (10 mEq/L and 40 mEq/L) in 0.9% sodium chloride solution.

Cefuroxime should not be mixed in the same syringe with antibiotics from the aminoglycoside group.

A 2.74% sodium bicarbonate solution has a pH value that significantly affects the color of the Cefuroxime solution, so it is not recommended for use for dilution. If necessary, the sodium bicarbonate solution can be injected directly into the patient's infusion system.

Indications for use

Infectious and inflammatory diseases caused by sensitive microorganisms: infections of the respiratory tract (bronchitis, pneumonia, lung abscess, pleural empyema, etc.), ENT organs (sinusitis, tonsillitis, pharyngitis, otitis, etc.), urinary tract (pyelonephritis, cystitis, asymptomatic bacteriuria, gonorrhea, etc.), skin and soft tissues (erysipelas, pyoderma, impetigo, furunculosis, phlegmon, wound infection, erysipeloid, etc.), bones and joints (osteomyelitis, septic arthritis, etc.), pelvic organs ( endometritis, adnexitis, cervicitis), sepsis, meningitis, Lyme disease (borreliosis), prevention of infectious complications during operations on the chest, abdominal cavity, pelvis, joints (including operations on the lungs, heart, esophagus, vascular surgery with a high risk of infectious complications, orthopedic operations).

Interaction with other drugs

Simultaneous oral administration of loop diuretics slows down tubular secretion, reduces renal clearance, increases plasma concentrations and increases T1/2 of Cefuroxime.

When used simultaneously with aminoglycosides and diuretics, the risk of nephrotoxic effects increases. Pharmaceutically compatible with aqueous solutions containing up to 1% lidocaine hydrochloride, 0.9% sodium chloride solution, 5 and 10% dextrose solution, 0.18% sodium chloride solution and 4% dextrose solution, 5% dextrose solution and 0.9% sodium chloride solution, Ringer's solution, Hartmann's solution, sodium lactate solution, heparin (10 U/ml and 50 U/ml) in 0.9% sodium chloride solution. Pharmaceutically incompatible with aminoglycosides, sodium bicarbonate solution 2.74%.

Pharmacokinetics

Parenteral administration: after intramuscular administration of 750 mg, the maximum concentration (Cmax) is reached after 15-60 minutes and is 27 mcg/ml. With intravenous administration of 0.75 and 1.5 g, Cmax after 15 minutes is 50 and 100 μg/ml, respectively. The therapeutic concentration lasts 5.3 and 8 hours, respectively. The half-life (T1/2) with IV and IM administration is 1.3-1.5 hours, in newborns - 2-2.5 hours. Bonding with plasma proteins is 33-50%. Not metabolized in the liver. Excreted by the kidneys by glomerular filtration and tubular secretion 85-90% unchanged within 8 hours (most of the drug is excreted within the first 6 hours, creating high concentrations in the urine); after 24 hours it is completely eliminated (50% by tubular secretion, 50% by glomerular filtration). Therapeutic concentrations are recorded in pleural fluid, bile, sputum, myocardium, skin and soft tissues. Cefuroxime concentrations exceeding the minimum inhibitory concentration (MIC) for most microorganisms can be achieved in bone tissue, synovial and intraocular fluids. In meningitis, it penetrates the blood-brain barrier (BBB). Passes through the placenta and enters breast milk.