Amoxicar Plus tablets p/o 500mg/125mg №14

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Amoxicar Plus tab. po 500mg/125mg in vial No. 20 in pack No. 1
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Coated tablets, 500 mg / 125 mg: oval tablets, white coated. Irregularities of the surface and edges of the tablets are allowed. The main active ingredient Amoxicillin + clavulanic acid Release form Tablets Dosage Each tablet contains: active ingredients: amoxicillin 500 mg (as trihydrate), clavulanic acid 125 mg (as potassium clavulanate); Pharmacological properties Pharmacodynamics A combined preparation containing amoxicillin, a semi-synthetic penicillin antibiotic with a wide spectrum of bactericidal action, and clavulanic acid, an inhibitor of bacterial β-lactamase. Amoxicillin is sensitive to β-lactamases and is destroyed as a result of their action; therefore, the spectrum of its antibacterial activity does not include microorganisms synthesizing this enzyme. Clavulanic acid has a ?-lactam structure similar to that of penicillins and is able to bind and inactivate bacterial ?-lactamases, thereby preventing the hydrolysis of beta-lactam antibiotics. It, providing the resistance of amoxicillin to the effects of P-lactamases, expands the spectrum of its action, including many microorganisms resistant to amoxicillin or other penicillins and cephalosporins. Amoxicar Plus has a wide spectrum of antibacterial action. Active against amoxicillin-sensitive strains, including β-lactamase-producing strains: Usually sensitive microorganisms Gram-positive aerobic microorganisms: Enterococcus faecalis Gardnerella vaginalis Staphylococcus aureus, methicillin-sensitive * Coagulase-negative staphylococci, methicillin-sensitive Streptococcus agalactiae Streptococcus pneumoniae and other beta-pyreptococcus pneumoniae1 hemolytic streptococci Streptococcus viridans group; Gram-negative aerobic microorganisms: Capnocytophaga spp. Eikenella corrodens Haemophilus influenza2 Moraxella catarrhalis Pasteurella multocida. Anaerobic microorganisms: Bacteroides fragilis Fusobacterium nucleatum Prevotella spp. Microorganisms with possible acquired resistance Aerobic gram-positive microorganisms: Enterococcus faecium** Aerobic gram-negative microorganisms: Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Proteus vulgaris Resistant microorganisms Aerobic gram-negative microorganisms: Acinetobacter sp. Citrobacter freundii Enterobacter sp. Legionella pneumophila Morganella morganii Providencia spp. Pseudomonas sp. Serratia sp. Stenotrophomonas maltophilia Other organisms: Chlamydophila pneumoniae Chlamydophila psittaci Coxiella burnetti Mycoplasma pneumoniae *All methicillin-resistant staphylococci are resistant to amoxicillin/clavulanic acid. ** Natural average susceptibility in the absence of an acquired resistance mechanism. This dosage form of amoxicillin/clavulanic acid is not suitable for the treatment of penicillin-resistant Streptococcus pneumoniae infections. 2 In some EU countries, strains with reduced susceptibility have been reported with a frequency of more than 10%. PharmacokineticsAbsorption Amoxicillin and clavulanic acid are completely soluble in aqueous solutions at physiological pH, rapidly and well absorbed after oral administration. The absorption of active substances is optimal in the case of taking the drug at the beginning of a meal. After oral administration, the bioavailability of amoxicillin and clavulanic acid is 70%. The pharmacokinetic parameters of both components are similar, the time to reach their peak plasma concentration (Tmax) is about 1 hour. The following are the pharmacokinetic parameters of amoxicillin and clavulanic acid after administration of the drug (500 mg/125 mg tablet 3 times a day) and the drug (875 mg/125 mg tablet 2 times a day) to healthy volunteers before meals. Mean values (±SD) of pharmacokinetic parameters Active ingredient Dose (mg) Сmax (mg/l) Tmax(h) AUC (mg?h/l) Т1/2(h) Amoxicillin Amoxicillin/clavulanic acid 500 mg/125 mg 1500 7 ,2 1.5 53.5 1.15 Amoxicillin/clavulanic acid 875 mg/125 mg 1750 11.64±2.78 1.5 (1-2.5) 53.52±12.31 1.19±0.21 Clavulanic acid Amoxicillin/clavulanic acid 500 mg/125 mg 375 2.4/1.82 0.5 875 mg / 125 mg 250 2.18 ± 0.99 1.25 (1-2) 10.16 ± 3.04 0.96 ± 0.12 Serum concentrations of amoxicillin and clavulanic acid in the combination drug are similar to those achieved with oral administration of equivalent doses of amoxicillin or clavulanic acid alone. Distribution About 25% of the total amount of clavulanic acid and 18% of amoxicillin bind to plasma proteins. The volume of distribution is about 0.3 – 0.4 l / kg of amoxicillin and about 0.2 l / kg of clavulanic acid. After intravenous administration, both amoxicillin and clavulanic acid are found in the gallbladder, abdominal tissues, adipose and muscle tissues, synovial and peritoneal fluids, bile and purulent discharge. Amoxicillin does not penetrate into the cerebrospinal fluid in a significant way. In animal studies, no accumulation of drug components in any organ was found. Amoxicillin, like most penicillins, passes into breast milk. In breast milk, the following amount of clavulanic acid is also found. Both amoxicillin and clavulanic acid cross the placental barrier. Biotransformation Amoxicillin is partially excreted in the urine as an inactive metabolite of penicillic acid in an amount equivalent to 10-25% of the initial dose. Clavulanic acid is extensively metabolized and excreted by the kidneys and intestines, as well as in the form of carbon dioxide with exhaled air. Excretion Amoxicillin is excreted primarily by the kidneys, while clavulanic acid is eliminated by both renal and non-renal mechanisms. The mean half-life for the amoxicillin/clavulanic acid combination is about 1 hour, and the mean total clearance is about 25 L/h in healthy volunteers. Approximately 60 – 70% of amoxicillin and approximately 40 – 60% of clavulanic acid are excreted unchanged by the kidneys within 6 hours after taking 1 tablet of the drug Amoxicar Plus, at a dosage of 500 mg / 125 mg or 875 mg / 125 mg. Various studies indicate that 50-85% of amoxicillin and 27-60% of clavulanic acid are excreted by the kidneys within 24 hours. With regard to clavulanic acid, the maximum amount of the active substance is excreted within the first two hours after administration. Simultaneous administration of probenecid slows down the excretion of amoxicillin, but does not slow down the excretion of clavulanic acid. Age The half-life of amoxicillin is the same in children aged three months to two years, as well as in older children and adults. For very young children (including premature babies) in the first week of life, the drug should not be used more than twice a day due to the underdevelopment of the renal elimination pathway. Since there is an increased likelihood of decreased renal function in elderly patients, care should be taken when choosing a dose. In addition, monitoring of renal function may be required. Gender Oral administration of the amoxicillin/clavulanic acid combination to healthy men and women showed no significant effect of gender on the pharmacokinetics of amoxicillin or clavulanic acid. Renal insufficiency The total clearance of amoxicillin/clavulanic acid in serum decreases in proportion to the decrease in renal function. The decrease in drug clearance is more pronounced for amoxicillin than for clavulanic acid, since most of the amoxicillin is excreted by the kidneys. The dosage regimen of the drug in patients with renal insufficiency should prevent the accumulation of amoxicillin, but at the same time maintain an adequate level of clavulanic acid. Hepatic insufficiency The drug should be used with caution in patients with hepatic insufficiency with constant monitoring of liver function. Amoxicar Plus is indicated for the treatment of the following infections in adults and children: Acute bacterial sinusitis (adequately diagnosed) Acute otitis media Exacerbations of chronic bronchitis (adequately diagnosed) Community-acquired pneumonia Cystitis Pyelonephritis Infections of the skin and soft tissues, in particular cellulitis, animal bites, severe dental abscess with spreading phlegmon. Infections of bones and joints, in particular osteomyelitis Official recommendations on the rational use of antibacterial agents should be taken into account. Dosage and administration Dose calculation is based on amoxicillin and clavulanic acid. When choosing the dose of the drug Amoxicar Plus for the treatment of a particular infection, it is necessary to take into account: likely pathogens and their expected sensitivity to antibacterial agents; the severity and localization of the infection; age, body weight, and renal function status of the patient (see below). If necessary, the possibility of prescribing other dosage forms of the drug Amoxicar Plus (including with a different content of amoxicillin and / or a different ratio of amoxicillin / clavulanic acid) should be considered. In adults and children weighing 40 kg or more, Amoxicar Plus (500 mg/125 mg) provides a total daily dose of 1500 mg amoxicillin/375 mg clavulanic acid; Amoxicar Plus (875mg/125mg) provides a total daily dose of 1750mg amoxicillin/250mg clavulanic acid given twice daily and 2625mg amoxicillin/375mg clavulanic acid taken three times daily, provided the guidelines for the application below. In children weighing less than 40 kg, Amoxicar Plus (500 mg/125 mg) provides a maximum daily dose of 2400 mg amoxicillin/600 mg clavulanic acid; Amoxicar Plus (875 mg / 125 mg) provides a maximum daily dose of 1000 – 2800 mg amoxicillin / 143 – 400 mg clavulanic acid, provided that the recommendations below are followed. The duration of treatment is determined by the clinical picture. Some infections (such as osteomyelitis) require longer treatment. Treatment should not be continued for longer than 14 days without a review of the clinical situation. Adults and children weighing 40 kg or more: 500 mg/125 mg tablet 3 times a day. tablet 875 mg / 125 mg 2 times a day – for all indications; 1 tablet 875 mg / 125 mg 3 times a day – in particular, with otitis media, sinusitis, inflammation of the lower respiratory tract and urinary tract infections. Children weighing less than 40 kg: Amoxicar Plus (500 mg/125 mg): total dose ranging from 20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day divided into 3 doses. Amoxicar Plus (875 mg/125 mg): total dose ranging from 25 mg/3.6 mg/kg/day to 45 mg/6.4 mg/kg/day divided into 2 doses; for the treatment of certain infections (for example, otitis media, sinusitis and lower respiratory tract infections) – up to 70 mg / 10 mg / kg / day in 2 divided doses. Due to the fact that the Amoxicar Plus tablet cannot be divided, it is not recommended to prescribe this form of the drug to children weighing less than 25 kg. Children aged 6 years or less or weighing less than 25 kg should be given Amoxicar Plus in the form of a suspension. The table below shows the doses (mg/kg body weight) obtained when taking one tablet (500 mg/125 mg) / one tablet (875 mg/125 mg) in children weighing 25 kg to 40 kg. Body weight (kg) 40 35 30 25 Recommended single dose (mg/kg bw) Amoxicar Plus (500 mg/125 mg) Amoxicillin (mg/kg body weight) single dose (1 coated tablet) 12.5 14.3 16.7 20.0 6.67- 20 Clavulanic acid (mg/kg body weight) single dose (1 coated tablet) 3.1 3.6 4.2 5.0 1.67-5 Amoxicar Plus (875 mg/125 mg) Amoxicillin (mg/kg body weight) single dose (1 tablet , coated) 21.9 25.0 29.2 35.0 12.5-22.5 (up to 35) Clavulanic acid (mg/kg body weight) in a single dose (1 coated tablet) 3.1 3.6 4.2 5.0 1.8-3.2 (up to 5) Elderly patients: Not required correction of the dosing regimen. Patients with impaired renal function: The dose selection method is based on the maximum possible level of amoxicillin with a certain degree of reduction in creatinine clearance. In patients with a creatinine clearance of more than 30 ml / min, dosage adjustment is not required. In adults and children with a body weight of 40 kg or more and a creatinine clearance of 10-30 ml / min, Amoxicar Plus (500 mg / 125 mg) is used 2 times a day, with a creatinine clearance of less than 10 ml / min 500 mg / 125 mg – 1 once a day. Amoxicar Plus (875 mg/125 mg) is indicated only for the treatment of patients with creatinine clearance >30 ml/min. In renal failure with creatinine clearance < 30 ml / min, Amoxicar Plus (875 mg / 125 mg) is not used. Hemodialysis: 500 mg / 125 mg every 24 hours, additionally 500 mg / 125 mg during the session and at the end of dialysis (taking into account the decrease in the concentrations of amoxicillin and clavulanic acid in the blood serum). Children weighing less than 40 kg Creatinine clearance: 10-30 ml/min, 15 mg/3.75 mg/kg twice daily (maximum 500 mg/125 mg twice daily). Creatinine clearance less than 10 ml / min, a single daily dose - 15 mg / 3.75 mg / kg (maximum 500 mg / 125 mg). Hemodialysis: 15 mg/3.75 mg/kg once a day. Before hemodialysis: 15 mg/3.75 mg/kg. To restore the level of the drug in the blood plasma after hemodialysis, 15 mg / 3.75 mg / kg should be taken. Liver failure: Treatment is carried out with caution, with regular monitoring of liver function at regular intervals. How to use: Amoxicar Plus is intended for oral administration. The drug is taken immediately before a meal, which helps to minimize the risk of developing gastrointestinal intolerance, as well as to optimize the absorption of amoxicillin / clavulanic acid. If necessary, it is possible to carry out stepwise therapy (initially, intravenous administration of the drug, followed by the transition to oral administration). If you forget to take a medicine, do not take a double dose to make up for the missed one! Do not stop taking Amoxicar Plus without first consulting your doctor! If you have any doubts or questions, please contact your doctor. Use during pregnancy and lactation Pregnancy Animal studies have not revealed a direct or indirect negative effect of the drug on the course of pregnancy, embryonic / fetal development, childbirth or postpartum development. Limited data on the use of amoxicillin/clavulanic acid in women during pregnancy have not shown an increased risk of congenital anomalies. In a single study in women with premature rupture of the membranes, it was found that prophylactic therapy with the combination amoxicillin/clavulanic acid may be associated with an increased risk of necrotizing enterocolitis in newborns. The drug should be avoided during pregnancy, unless the doctor considers it necessary. Lactation Both active substances of the drug pass into breast milk (the effect of clavulanic acid on breastfed children is not known). In this regard, there is a possibility of developing diarrhea or a fungal infection of the mucous membranes in children who are breastfed, which may require cessation of lactation. The amoxicillin/clavulanic acid combination may only be used during breastfeeding after a benefit/risk assessment by the treating physician. Precautions Before starting therapy with Amoxicar Plus, it is necessary to exclude the presence of a history of hypersensitivity reactions to penicillins, cephalosporins and other beta-lactam antibiotics. Serious and sometimes fatal hypersensitivity reactions (anaphylactoid reactions) to penicillins have been described. The risk of such reactions is highest in patients with hypersensitivity reactions to penicillins and a history of atopy. In the event of an allergic reaction, it is necessary to stop treatment with the drug and start alternative therapy. In the event that amoxicillin-susceptible organisms are the proven cause of infection, consideration should be given to switching from amoxicillin/clavulanic acid to amoxicillin therapy in accordance with official recommendations. This dosage form of Amoxicar Plus is not suitable for use where there is a high risk of resistance of suspected pathogens to beta-lactam agents not mediated by beta-lactamases sensitive to clavulanic acid inhibition. This dosage form may not be effective in the treatment of penicillin-resistant S.pneumoniae. Amoxicillin/clavulanic acid is not recommended for suspected infectious mononucleosis, since amoxicillin may cause a measles-like rash in patients with this disease. The concomitant use of allopurinol and amoxicillin increases the risk of allergic skin reactions. The development at the beginning of treatment of febrile generalized erythema, manifested in the form of pustules, may be a symptom of acute generalized exanthematous pustulosis (AGEP). The occurrence of this reaction requires discontinuation of the drug and is a contraindication to the subsequent use of amoxicillin. During long-term therapy, it is recommended to periodically evaluate the function of organ systems, including the function of the kidneys, liver and hematopoiesis. Amoxicar Plus should be used with caution in patients with hepatic impairment. Adverse events were observed mainly in men and elderly patients and may be associated with long-term therapy. These phenomena are very rarely observed in children. Signs and symptoms of impaired liver function usually occur during or immediately after therapy, but in some cases may not appear for several weeks after therapy is completed and, as a rule, are reversible. Adverse events from the liver can be severe, in extremely rare cases there have been reports of deaths. In almost all cases, these were individuals with serious comorbidities or individuals receiving concomitantly potentially hepatotoxic drugs. Cases of antibiotic-associated colitis observed during therapy with almost all antibacterial drugs, including amoxicillin, can vary in severity from mild to life-threatening. It is important to consider this diagnosis in patients with diarrhea during or after completion of any course of antibiotic therapy. In the event of the development of antibiotic-associated colitis, Amoxicar Plus therapy is immediately stopped, a doctor is consulted and appropriate treatment is carried out. In this situation, the use of drugs that depress peristalsis is contraindicated. In patients with severe renal impairment, the dosage regimen must be adjusted according to the severity of renal failure. Convulsions may occur in patients with impaired renal function or when taking high doses of the drug. Occasionally, in patients taking Amoxicar Plus, prolongation of prothrombin time is noted. When taking anticoagulants at the same time, appropriate monitoring is necessary. In patients with reduced diuresis, crystalluria was observed in rare cases, mainly against the background of parenteral therapy. Sufficient fluid intake is recommended during high-dose amoxicillin therapy to reduce the likelihood of amoxicillin-associated crystalluria. In patients with a catheter installed in the bladder, it is imperative to regularly monitor its patency. During the treatment of glucosuria, glucose levels are assessed using enzymatic methods with glucose oxidase, since non-enzymatic methods sometimes give false positive results. The presence of clavulanic acid in Amoxicar Plus may cause non-specific binding of IgG and albumin to erythrocyte membranes, which may lead to false positive Coombs test results. There have been cases of positive results of enzyme-linked immunosorbent assay (ELISA) for Aspergillus in patients treated with the drug, in whom the absence of infections caused by Aspergillus was subsequently determined. Cross-reactions with non-Aspergillus polysaccharides and polyfuranoses have been noted in the ELISA test for Aspergillus. Positive test results in patients taking Amoxicar Plus should be interpreted with caution and confirmed by other diagnostic methods. High concentrations give a false positive test for glucose in the urine when using Benedict's reagent or Felling's solution (it is recommended to use enzymatic reactions with glucose oxidase). This medicinal product contains less than 1 mmol sodium (less than 23 mg) per tablet, i.e. essentially “sodium-free”. The medicinal product contains lactose and should therefore not be used in patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Interactions with other drugs Oral anticoagulants and penicillin antibiotics are widely used in clinical practice in the absence of reports of their interaction. However, the literature describes rare cases of an increase in the international normalized ratio (INR) in patients with the combined use of acenocoumarol or warfarin and amoxicillin. If necessary, the simultaneous use of the drug Amoxicar Plus with indirect anticoagulants, prothrombin time or INR should be carefully monitored when prescribing or canceling amoxicillin. In addition, dose adjustment of oral anticoagulants may be required. Methotrexate Penicillins can reduce the excretion of methotrexate, resulting in increased toxicity. Mycophenolate mofetil In patients taking mycophenolate mofetil, when co-administered with amoxicillin/clavulanic acid, the concentration of the active metabolite of mycophenolic acid at the initial dose is reduced by approximately 50%. The change in concentration at the initial dose may not reflect the change in the total exposure of mycophenolic acid. Thus, a change in the dosing regimen of mycophenolate mofetil is usually not required in the absence of clinically proven graft dysfunction. However, with simultaneous use with amoxicillin, as well as after a course of antibiotics, clinical monitoring is required. Probenecid Co-administration of probenecid is not recommended because it reduces the tubular secretion of amoxicillin. Its simultaneous use with Amoxicar Plus can lead to an increase in the level of amoxicillin in the blood plasma for a long time; does not affect the level of clavulanic acid. Contraindications hypersensitivity to the active ingredients, any penicillins or drug excipients; a history of a severe immediate hypersensitivity reaction (eg, anaphylaxis) to prior administration of other beta-lactam antibiotics (eg, cephalosporins, carbapenems, or monobactams); a history of jaundice or impaired liver function that developed against the background of the use of a combination of amoxicillin / clavulanic acid. Composition Each tablet contains: active ingredients: amoxicillin 500 mg (as trihydrate), clavulanic acid 125 mg (as potassium clavulanate); excipients: croscarmellose sodium, magnesium stearate, colloidal silicon dioxide, talc powder, microcrystalline cellulose, crospovidone XL, povidone PVP KZO, Opadry OY-L-28920 white. shell composition: polyethylene glycol, titanium dioxide, lactose monohydrate, hypromellose. Overdose Symptoms: in most cases, nausea, diarrhea, vomiting, possible - agitation, insomnia, dizziness, in some cases - convulsive seizures. There are no reports of death or life-threatening side effects. Amoxicillin crystalluria has been described, in some cases leading to the development of renal failure. Convulsions may occur when taking high doses of the drug or in patients with impaired renal function. There are reports of deposition of amoxicillin in urinary catheters, mainly after intravenous administration in large doses, regular checks of catheter patency should be carried out. Treatment: symptomatic, in case of recent intake (less than 4 hours), remove the drug from the gastrointestinal tract (gastric lavage, taking activated charcoal to reduce absorption); correction of water and electrolyte disturbances is carried out, hemodialysis is effective. Side effect On the part of the digestive system: nausea (when using high doses), vomiting, diarrhea; rarely: dyspepsia, moderate increase in liver transaminases (clinical significance unknown); very rarely: antibiotic-associated colitis (including pseudomembranous and hemorrhagic colitis), hepatitis, discoloration of the tongue and teeth. Side effects from the gastrointestinal tract that occur during oral therapy may be reduced by the use of Amoxicar Plus at the beginning of a meal. From the side of the liver and biliary tract: the frequency is not known: cholestatic jaundice (noted during therapy with other penicillins and cephalosporins). From the hemopoietic system: rarely - reversible leukopenia (including neutropenia) and thrombocytopenia; very rarely: reversible agranulocytosis and hemolytic anemia, increased bleeding time and prothrombin index. From the nervous system: infrequently: dizziness, headache. Very rare: reversible hyperactivity and convulsions. Convulsions may occur in case of impaired renal function or in patients receiving high doses of the drug, the frequency is not known: aseptic meningitis. From the immune system: infrequently: itching, urticaria, skin rashes; very rarely: angioedema, bronchospasm, a syndrome similar to serum sickness, allergic vasculitis, anaphylactic shock. On the part of the skin and subcutaneous tissue: rarely: erythema multiforme; frequency not known: Steven-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis. Other: the development of superinfection (including candidiasis of the skin and mucous membranes), very rarely: interstitial nephritis, crystalluria. In most cases, side effects are mild and transient. If the listed adverse reactions occur, as well as reactions not indicated in the instructions, the patient is advised to contact their doctor. Storage conditionsStore in a place protected from moisture at a temperature not exceeding +25°C. Use within 15 days after opening. Keep out of the reach of children Buy Amoxicar Plus tablets p/o 500mg/125mg No. 14