Amoxyclav (Amoxycillin / Clavulanic acid)® QT 500 mg / 125 mg (14 tablets) dispersing.

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The instruction for medical use of medicine QT Amoxiclav the Trade name QT Amoxiclav the International unlicensed name Is not present the Dosage form of the Tablet the dispersed 500 mg / 125 mg, 875 mg / 125 mg Structure One tablet contains active agents: amoxicillin trihydrate of 574 mg or 1004.5 mg, there correspond 500 mg or 875 mg of amoxicillin, potassium clavulanate of 148.87 mg, there correspond 125 mg of clavulanic acid. excipients: Tropical Mix fragrance, sweet orange fragrance, aspartame, silicon dioxide colloidal anhydrous, ferrous oxide yellow (E 172), talc, the castor oil hydrogenated, cellulose microcrystalline silicated. The description of the Tablet of an octagonal form, with a speckled surface of yellowy-brown color, with a fragrant smell. Pharmacotherapeutic group Beta laktamnye antibacterial drugs. Penicillin in a combination with inhibitors beta laktamaz. Clavulanic acid + amoxicillin. The ATX J01CR02 code the Pharmacological Pharmacokinetics Amoxicillin properties and clavulanic acid, are completely dissolved in aqueous solution at rn to the organism environment. Both components are well absorbed after intake. To optimum accept amoxicillin/clavulanic acid in time or at the beginning of meal. After intake the bioavailability of amoxicillin and clavulanic acid is about 70%. Dynamics of concentration of drug in plasma of both components is similar. The maximum serumal concentration are reached 1 hour later after reception. Concentration of amoxicillin and clavulanic acid in blood serum at reception of a combination of drugs of amoxicillin/clavulanic acid are similar to those which are observed at oral administration of an equivalent dose of amoxicillin and clavulanic acid alone. About 25% of total amount of clavulanic acid and 18% of amoxicillin contact proteins in blood plasma. The seeming distribution volume at oral administration of drug is about 0.3-0.4 l/kg of amoxicillin and 0.2 l/kg of clavulanic acid. After intravenous administration, both amoxicillin and clavulanic acid were found in a gall bladder, belly fabric, skin, fat, muscle tissue, synovial and peritoneal fluid, bile and pus. Amoxicillin is badly distributed in cerebrospinal fluid. Amoxicillin and clavulanic acid get through a placental barrier. Both components pass also into breast milk. Amoxicillin is partially removed with urine in the form of inactive penitsilloyny acid in the quantities equivalent to 10 - 25% of an initial dose. Clavulanic acid is metabolized in an organism and removed with urine and excrements and also in the form of carbon dioxide with expired air. Average elimination half-life of amoxicillin/clavulanic acid makes about 1 hour, and average general clearance about 25 l/h. About 60 - 70% of amoxicillin and 40 - 65% of clavulanic acid are removed from an organism in an invariable view with urine during the first 6 h after reception of a single dose of tablets of amoxicillin/clavulanic acid (250 mg / 125 mg or 500 mg / 125 by mg). During various researches it was revealed that with urine 50-85% of amoxicillin and 27-60% of clavulanic acid within 24 hours are removed. The greatest number of clavulanic acid is removed within the first 2 hours after use. Simultaneous use of a probenetsid slows down amoxicillin discharge, but this drug does not influence removal of clavulanic acid through kidneys. Elimination half-life of amoxicillin is similar at children aged from 3 months up to 2 years, also at children of advanced age and adults. At prescription of medicine to very small children (including to premature newborns) in the first weeks of life, it is not necessary to administer the drug more often than two times a day that is connected with immaturity of a renal way of removal at children. Because elderly patients have renal dysfunction more often, it is necessary to appoint with care a dose to this group of patients. In this case it can be useful to carry out monitoring of renal function. The general clearance of amoxicillin/clavulanic acid in plasma decreases in direct ratio to decrease in functions of kidneys. Decrease in clearance of amoxicillin is more significant in comparison with clavulanic acid as the bigger amount of amoxicillin is removed through kidneys. Therefore, when prescribing drug, dose adjustment is necessary for patients with a renal failure to prevent excessive accumulation of amoxicillin and to keep the necessary level of clavulanic acid. When prescribing drug the patients should be careful with a liver failure when choosing a dose and to regularly control function of a liver. A pharmacodynamics of Amoksiklav® of QT – an antibiotic of a broad spectrum of activity, the combined drug of amoxicillin and clavulanic acid – inhibitors beta laktamaz. Works bakteritsidno, synthesis of a bacterial wall oppresses. It is active concerning gram-positive and gram-negative microorganisms (including the strains producing beta lactamelements). The clavulanic acid which is a part of drug suppresses ІІ, III, IV and V types beta laktamaz, is inactive concerning the beta laktamaz of the I type produced by Enterobacter spp., Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid possesses a high tropnost to penicillinases, thanks to what forms a stable complex with enzyme that prevents enzymatic degradation of amoxicillin under the influence of a beta laktamaz and expands a range of its action. Амоксиклав® QT shows activity in the relation: Aerobic gram-positive bacteria: Streptococcus pyogenes, Streptococcus viridans, Streptococcus pneumoniae, Staphylococcus aureus (including the strains producing beta lactamelements), Staphylococcus epidermidis (including the strains producing beta lactamelements), Enterococcus faecalis, Corynebacterium spp., Bacillus anthracis, Listeria monocytogenes of Anaerobic gram-positive bacteria: Clostridium spp., Peptococcus spp., Peptostreptococcus spp. Aerobic gram-negative bacteria: Escherichia coli, Klebsiella spp., Proteus mirabilis, Proteus vulgaris, Yersinia enterocolitica, Salmonella spp., Shigella spp., Haemophilus influenzae, Haemophilus ducreyi, Neisseria gonorrhoeae (including the strains of above-mentioned bacteria producing beta lactamelements), Neisseria meningitidis, Bordetella pertussis, Gardnerella vaginalis, Brucella spp., Branhamella catarrhalis, Pasteurella multocida, Campylobacter jejuni, Vibrio cholera, Moraxella catarrhalis, Helicobacter pylori of Anaerobic gram-negative bacteria: Bacteroides spp., including Bacteroides fragilis (including the strains producing beta lactamelements). Indications of an upper respiratory tract infection and ENT organs (acute bacterial sinusitis, acute average otitis) of a lower respiratory tract infection (exacerbation of chronic bronchitis, community-acquired pneumonia) of an infection of urinary tract (cystitis, pyelonephritis) of an infection of bones and joints (including osteomyelitis) infections of skin and soft tissues (in particular phlegmon, stings of animals, parodontalny abscess of a severe form with spread of phlegmon, contaminated wounds) the Route of administration and doses of the Tablet need to be dissolved in half of glass of water and to mix carefully, then to take or to take medicines in a mouth before full dissolution then to swallow. For the purpose of reduction of risk of development of side effects from a GIT it is necessary to take the drug at the beginning of food. Adults and children are more senior than 12 years (or body weight ≥ 40 kg): Амоксиклав® / 125 the mg is applied by QT of 500 mg on 1 tablet 3 times a day. Children with body weight it is lower than 40 kg: 20мг/5мг/кг/день – 60мг/15мг/кг/день, in the form of three separate / 125 the mg is recommended to apply dosed Amoksiklav® of QT of 875 mg two times a day. In heavy infections (especially for such infections as average otitis, sinusitis, lower respiratory tract infections and urinary tract infections) three times a day are applied. To children up to 12 years – in the form of pediatric forms (suspension, tablets) for intake. It is recommended to appoint to children weighing below 40 kg on 25мг/3,6мг/кг/день – 45мг/6,4мг/кг/день, two separate receptions. Doses should not exceed 70мг/10мг/кг/день and are appointed two separate receptions, in infections, such as average otitis, sinusitis and lower respiratory tract infections. Treatment duration - up to 14 days. Some infections (for example, osteomyelitis) demand longer periods of treatment. Use in a renal failure is not required correction of a dose to patients with clearance of creatinine more than 30 ml/min. Adults and children with body weight ≥ 40 kg Clearance of creatinine: 10 – 30 ml/min. 500 mg / 125 mg twice a day Clearance of creatinine: & lt, 10 ml/min. 500 mg / 125 mg once a day Hemodialysis: 500 mg / 125 mg each 24 hours, plus 500 mg / 125 mg during dialysis, with repetition at the end of dialysis (when concentration in serum of both amoxicillin, and clavulanic acid are reduced) Children with the body weight & lt, 40 kg Clearance of creatinine: 10 – 30 ml/min. 15мг/3,75мг/кг twice a day (at most 500 mg / 125 mg twice a day) Clearance of creatinine: & lt, 10 ml/min. 15мг/3,75мг/кг in the form of a single daily dose (at most 500 mg / 125 mg) the Hemodialysis: 15 mg / 3.75 mg/kg a day once a day. Before a hemodialysis 15мг/3,75мг/кг. To restore medicine level in blood circulation, 15mg/3.75mg on kg have to be applied after a hemodialysis. Амоксиклав® QT of 875 mg / 125 mg: At patients with clearance of creatinine less than 30 ml/min. are not recommended. Side effects At assessment of frequency of emergence of different side reactions were used such gradation: 'very often' –  1/10, is 'frequent' – from  1/100 to  1/10, 'infrequently' – from  1/1000 to  1/100, is 'rare' – from  1/10000 to  1/1000, is 'very rare' –  1/10000, it is not known (the available data are not enough for performance of assessment). Very often: - diarrhea Often: - the candidiasis affecting skin and mucous membranes - nausea - vomiting Infrequently: - dizziness, a headache - indigestion - increase in level of nuclear heating plant and/or ALT - rash on skin, an itching, urticaria, is rare: - reverse a leukopenia (including a neutropenia), thrombocytopenia - a multiformny erythema It is unknown: - the increased growth of insensitive organisms - a reverse agranulocytosis, hemolytic anemia, increase in a bleeding time and prothrombin vremeni1 - a Quincke's edema, an anaphylaxis, a syvorotochno-like syndrome, an allergic vasculitis - reverse hyperactivity, spasms - colitis as a result of use of antibiotics, black "fleecy" language, decolouration of teeth - hepatitis, cholestatic jaundice - Stephens-Johnson's syndrome, a toxic epidermal necrolysis, violent exfoliative dermatitis, sharp generalized exanthematous pustulez (AGEP) - iterstitsialny nephrite - mochesolevy Contraindication diathesis - hypersensitivity to amoxicillin, clavulanic acid or other components - hypersensitivity to others beta laktamnym to antibiotics, such as penicillin and cephalosporins. - jaundice or dysfunction of a liver at intake of amoxicillin/clavulanate in the anamnesis - children up to 12 years or with body weight is less than 40 kg. Medicinal interactions Oral anticoagulants and antibiotics of penicillinic group it is widely used in practice without messages about interaction. However in references the increase international normalized a ratio at the patients accepting atsenokumarol or warfarin or at patients to whom the rate of amoxicillin was appointed was noted. If simultaneous use of drugs is necessary it is necessary to control carefully a prothrombin time or the international normalized ratio during the assigning and cancellation of amoxicillin. Moreover, change in dosages of oral anticoagulants can be necessary. Removal of a methotrexate can reduce drugs of penicillinic group that causes potential increase in toxicity. Simultaneous use of a probenetsid is not recommended. Probenetsid reduces renal canalicular secretion of amoxicillin. Sharing with Amoxiclav can lead to increase in levels of amoxicillin in blood, but not clavulanic acid. Antacids, a glycosamine, laxative medicines, aminoglycosides slow down absorption, ascorbic acid – increases absorption. Diuretics, Allopyrinolum, phenylbutazone, the non-steroidal anti-inflammatory drugs and other medicines blocking canalicular secretion increase concentration of amoxicillin (clavulanic acid is removed generally by glomerular filtration). Appointment together with Allopyrinolum increases the frequency of development of a dieback. It is necessary to avoid simultaneous use with Disulfiramum. At a combination with rifampicin mutual easing of antibacterial effect. Амоксиклав® QT should be applied several hours prior to reception of bacteriostatic antibiotics (macroleads, tetracyclines), streptocides. Амоксиклав® QT reduces efficiency of oral contraceptives. Special instructions before therapy using amoxicillin/clavulanic acid, it is necessary careful to study existence at the patient of reactions of hypersensitivity to penicillin, cephalosporins or others beta laktamnye substances. As there can be anaphylactoid reactions. At emergence of allergic reaction to amoxicillin/clavulanic acid it is necessary to stop therapy by these drugs and to pass to other alternative treatment. In case the infection was steady to amoxicillin - to sensitive microorganisms, then it is necessary to consider the possibility of use of amoxicillin/clavulanic acid instead of amoxicillin, according to the instruction. At high risk of resistance of pathogens to a beta laktamnym substances should not apply Amoxiclav. It is not recommended to use drug for treatment resistant to S. pneumoniae penicillin. Patients with a renal failure and accepting a high dosage of drug, can have spasms. It is not necessary to appoint amoxicillin/clavulanic acid in an infectious mononucleosis as appearance of korepodobny rash in connection with amoxicillin use is possible. Simultaneous use of Allopyrinolum during treatment by amoxicillin can increase a likelihood of development of allergic reactions of skin. Prolonged use of drug can cause the overgrowth of insensitive organisms. Emergence in an initiation of treatment of in the fever generalized erythema with a pustule can be a symptom of development of a sharp generalized exanthematous pustulez (AGEP). At emergence of this reaction demands to stop Amoxiclav use. Patients should appoint drug with care with a liver failure. Cases of diseases of a liver were registered generally at men and elderly patients, quite seldom met at children who could arise in connection with drug use for a long time. Signs and symptoms usually arise in time or right after an initiation of treatment, but in certain cases can be shown only in several weeks after the therapy termination. These symptoms are usually reversible. Complications of diseases of a liver can wear a severe form, and, in extremely exceptional cases, from the death. They almost always arise at patients with serious basic diseases of a liver or at the patients taking other drugs which influence a liver. Perhaps development of the colitis connected with use of antibacterial drugs including amoxicillin, defiant heavy or easy symptoms. Therefore, it is important to consider this diagnosis when prescribing drug to patients, having diarrhea, in time or after use of any antibiotics. When developing the colitis connected with use of an antibiotic it is necessary to stop Amoxiclav use immediately. After consultation of the doctor the corresponding therapy has to be appointed. Drugs of antiperistaltic group are contraindicated in this situation.At long therapy it is regularly recommended to estimate function of a system of bodies, including kidneys, a liver and the haematogenic function. It is necessary correction of a dose of oral anticoagulants for maintenance of desirable level of anti-coagulation. At patients with disturbances of functions of kidneys, correction of a dose depending on severity is required. At patients with a reduced diuresis, the crystalluria was very seldom noted, mainly during parenteral therapy. During treatment recommend to the patient plentifully drink to avoid possible emergence of a crystalluria. At patients with catheterization mochev
go a bubble it is necessary to check a catheter regularly. During treatment using amoxicillin it is necessary to use enzymatic methods of glucose oxydas when carrying out analyses on presence of glucose in urine as use not of enzymatic methods false positive results are possible. Presence of clavulanic acid in drug can lead to nonspecific binding of immunoglobulin G and albumine with membranes of erythrocytes and to false positive analyses of Koombs. Data on positive takes of the analysis of Bio-Rad Laboratories Platelia Aspergillus EIA at the patients accepting amoxicillin/clavulanic acid who were recognized as healthy from Aspergillus infection subsequently were obtained. However there are no data on cross-reactions using non-Aspergillus polysaccharides and polifuranoz as a result of the analysis of Bio-Rad Laboratories Platelia Aspergillus EIA. Thus, positive takes of analyses of the patients accepting amoxicillin/clavulanic acid should be interpreted with care and to confirm with other diagnostic methods. Pregnancy and the period of a lactation of Amoksiklav® of QT is not recommended to be applied during pregnancy unless, according to the doctor, it is necessary. Амоксиклав® QT can be appointed when breastfeeding. Except for risk of development of a sensitization in connection with trace amounts of the drug getting into breast milk, undesirable effects at the children who are on breastfeeding are not revealed. At women at a premature rupture of fetal membranes and premature births it was revealed that preventive treatment by a combination of amoxicillin and clavulanate was associated with increase in risk of developing a necrotizing coloenteritis at newborns. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms In rare instances Amoxiclav can cause such undesirable reactions as dizziness, spasms, allergic reaction. At emergence, any adverse reactions it is necessary to refrain from driving or potentially dangerous mechanisms. Overdose Symptoms Are possible gastrointestinal symptoms and disturbances of water and electrolytic balance. Amoksitsillin's crystalluria in certain cases leads to a renal failure. At patients with renal failures or at the patients accepting high doses of drug spasms are possible. According to the obtained data Amoxicillin accumulates in bladder catheters, mainly at intravenous administration big dosed In this case it is necessary to control passability of a catheter regularly. Treatment: symptomatic, considering water/electrolytic balance. Amoxicillin/clavulanic acid can be removed from an organism by means of a hemodialysis. The form of release and packing On 2 tablets place in blister strip packaging from aluminum foil. On 7 planimetric packs together with the instruction for medical use in the state and Russian languages place in a pack from cardboard. To Store storage conditions at a temperature not higher than 25 wasps, in the place protected from moisture. To store out of children's reach! 3 years not to use a period of storage after the expiry date specified on packing. Prescription status According to the prescription the Producer/packer Lek Pharmasyyutikals of of., Slovenia Address: Perzonali 47, SI-2391 Prevalje, Slovenia Owner of the registration certificate Lek Pharmasyyutikals of d, Slovenia Address: Verovskova, 57, 1526 Ljubljana, Slovenia the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) Representative office of JSC Sandoz Pharmasyyutikals d. d. in Republic of Kazakhstan Almaty, Luganskogo St. 96, the Phone number - 258 10 48, fax: +7 727 258 10 47
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