Augmentin EC powder for oral suspension 100ml 600mg+42.9mg/5ml №1

Name:
Augmentin EU
Description:
Loose powder of almost white color with a characteristic smell of wild strawberries. When diluted with water, an almost white to yellowish-brown suspension is formed. The main active ingredient Amoxicillin + clavulanic acid Release form Powder for suspension for oral administration 600 mg + 42.9 mg / 5 ml. 23.13 g of powder (for the preparation of 100 ml of the finished suspension) in a transparent glass vial, closed with an aluminum screw cap with a PVC gasket with first opening control. 1 bottle, together with instructions for medical use and a measuring spoon, is placed in a cardboard box. Dosage 600 mg + 42.9 mg/5 ml. Pharmacological action Antibacterial agents for systemic use. Combinations of penicillins, including those with beta-lactamase inhibitors. ATX code: J01CR02. Pharmacodynamics Mechanism of action Amoxicillin is a semi-synthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (known as penicillin-binding proteins) during the biosynthesis of bacterial peptidoglycan, which is the unifying structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to thinning of the cell wall, which subsequently leads to cell lysis and death. Amoxicillin is destroyed by the action of β-lactamases produced by resistant bacteria, and therefore the spectrum of activity of amoxicillin itself does not include microorganisms that produce these enzymes. Clavulanic acid is a β-lactamase inhibitor structurally related to penicillins. Clavulanic acid blocks the action of certain β-lactamase enzymes, thereby preventing the inactivation of amoxicillin. Clavulanic acid alone does not show a clinically significant antibacterial effect. The relationship of pharmacokinetics / pharmacodynamics The main factor determining the effectiveness of amoxicillin is the time of exceeding the minimum inhibitory concentration (T>MIC). Mechanism of resistance formation There are two main mechanisms of resistance formation to amoxicillin/clavulanic acid: this target of action. In addition, changes in the permeability of the shell of the microorganism, as well as the expression of efflux pumps, can cause or contribute to the development of bacterial resistance, especially in gram-negative bacteria. Breakpoints The European Committee for Antimicrobial Susceptibility Testing (EUCAST) clinical breakpoints for the minimum inhibitory concentration of amoxicillin/clavulanic acid are shown below. Pathogen Sensitivity Breakpoints (µg/mL) Sensitive Moderate Sensitivity Resistant Haemophilus influenzae1 ? 1->1 Moraxella catarrhalis1 ? 1->1 Staphylococcus aureus2 ? 2 -> 2 Streptococcus A, B, C, G4 ? 0.25 > 0.25 Streptococcus pneumoniae3 ≥0.5 1-2 > 2 1 These values are based on amoxicillin concentrations. For sensitivity testing purposes, the concentration of clavulanic acid was fixed at 2 mg/l. 2Values obtained for the concentration of Oxacillin. 3 The cut-off values in the table are based on the cut-off values for ampicillin. 4 The cut-off values in the table are based on the cut-off values for benzylpenicillin. Bacteriological susceptibility to antibiotics varies by region and over time. It is desirable to take into account local data on sensitivity, especially when it comes to the treatment of severe infections. Experts should be consulted if local resistance data call into question the efficacy of a medicinal product in the treatment of certain types of infections. Чувствительность Чувствительные микроорганизмы Аэробные грамположительные микроорганизмы: Staphylococcus aureus, метициллин-чувствительные* Streptococcus pneumoniae1 Streptococcus pyogenes и другие бета-гемолитические стрептококки Аэробные грамотрицательные микроорганизмы Haemophilus influenzae2 Moraxella catarrhalis Микроорганизмы, для которых возможно наличие приобретенной резистентности Аэробные грамотрицательные микроорганизмы: Klebsiella pneumoniae Природно устойчивые микроорганизмы Аэробные грамотрицательные organisms Legionella pneumophila Other organisms Chlamydophilia pneumoniae Chlamodophila psittaci Coxiella burnetti Mycoplasma pneumoniae 1 This amoxicillin/clavulanic acid dosage form is suitable for the treatment of infections caused by penicillin-resistant Streptococcus pneumoniae only in approved indications (see Indications for Use section). 2 In some EU countries, strains with reduced susceptibility have been reported with a frequency of more than 10%. *All methicillin-resistant staphylococci are resistant to amoxicillin/clavulanic acid. Pharmacokinetics Absorption Amoxicillin and clavulanic acid are completely soluble in aqueous solutions at physiological pH. Both components are rapidly and well absorbed from the gastrointestinal tract (GIT) after oral administration. After oral administration, the bioavailability of amoxicillin and clavulanic acid is 70%. The pharmacokinetic parameters of both components are similar, the time to reach the maximum plasma concentration (Tmax) is about 1 hour. Below are the average pharmacokinetic parameters (± standard deviation) of amoxicillin and clavulanic acid after administration to children at a dose of 45 mg / 3.2 mg / kg every 12 hours. The average value of pharmacokinetic parameters Drug Cmax (MKG / L) Tmax (h) * AUC (0-t) (mcg in h / ml) T1 / 2 (h) Amoxicillin Augmentin at a dose of 45 mg / kg of amoxicillin and 3.2 mg / kg of clavulanic acid every 12 hours 15.7 ±7.7 2.0 (1.0-4.0) 59.8 ± 20.0 1.4 ±0.35 Clavulanic acid 1.7 ±0.9 1, 1 (1.0-4.0) 4.0 ±1.9 1.1 ±0.29 Cmax — maximum concentration in blood plasma; Tmax is the time to reach maximum plasma concentration; AUC is the area under the concentration-time curve; T1 / 2 – half-life. *Median (range) Serum concentrations of amoxicillin and clavulanic acid when using the combination drug are similar to those achieved when taking equivalent doses of amoxicillin or clavulanic acid alone. Distribution Plasma proteins bind 25% of the total amount of clavulanic acid and 18% of amoxicillin. 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, skin, adipose and muscle tissues, synovial and peritoneal fluids, bile and purulent discharge. Amoxicillin slightly penetrates into the cerebrospinal fluid. In animal studies, no significant accumulation of drug components in any tissues was found. Amoxicillin, like most penicillins, passes into breast milk. Trace amounts of clavulanic acid are also found in breast milk. Both amoxicillin and clavulanic acid cross the placental barrier (see section “Use during pregnancy and lactation”). 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 40-65% of clavulanic acid are excreted by the kidneys unchanged within 6 hours after taking one tablet of Augmentin, a dosage of 250 mg + 125 mg or 500 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 reception of probenecid slows down the excretion of amoxicillin, but does not slow down the excretion of clavulanic acid (see section “Interaction with other drugs”). Age The elimination half-life of amoxicillin is similar 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 immaturity 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 Ingestion of the amoxicillin/clavulanic acid combination by 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 (see section “Method of application and dosage”). Hepatic insufficiency The drug should be used with caution in patients with hepatic insufficiency with constant monitoring of liver function. Indications for use Augmentin EU is indicated for the treatment of the following infections in children from 3 months and weighing up to 40 kg, caused or suspected to be caused by penicillin-resistant Streptococcus pneumoniae (see sections “Method of application and dosage”, “Precautions”, “Pharmacodynamics”): Acute otitis media Community-acquired pneumonia Official guidelines on the prudent use of antibacterial agents should be taken into account. Method of administration and doses Dosing regimen Dose calculation is based on amoxicillin and clavulanic acid, except when dosing is carried out for each component separately. When selecting a dose, the following factors should be taken into account: likely pathogens and their expected sensitivity to antibacterial agents (see section “Precautions”); severity and location of infection; age, body weight and renal function of the patient. Treatment should not be continued for longer than 14 days without reviewing the clinical situation (see section “Precautions”). Children and adults weighing ? 40 kg There is no experience with the use of the drug Augmentin EU in children and adults weighing ? 40 kg, so there are no recommendations on the dosing regimen. Children weighing < 40 kg (from the age of three months) The recommended daily dose is 90 mg of amoxicillin and 6.4 mg of clavulanic acid per 1 kg of body weight, divided into two doses. Clinical data on the use of the drug Augmentin EU in children under the age of three months have not been received. Special groups of patients Patients with impaired renal function No adjustment of the dosing regimen is required for creatinine clearance of more than 30 ml / min. The drug is not recommended for use with creatinine clearance < 30 ml / min due to the lack of recommendations on the dosing regimen. Patients with impaired liver function Treatment should be carried out with caution, with regular monitoring of liver function (see section "Contraindications for use" and "Precautions"). The use of the streets of the elderly Augmentin EU is not intended for use in the elderly. Method of application For oral administration. To minimize potential adverse effects from the gastrointestinal tract, the drug should be taken with food. 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. One study in women with preterm rupture of the membranes found that prophylactic therapy with the combination amoxicillin/clavulanic acid may be associated with an increased risk of neonatal necrotizing enterocolitis. 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, so it may be necessary to stop lactation. The possibility of sensitization must be considered. The combination of amoxicillin/clavulanic acid should be used during breastfeeding only after a benefit/risk assessment by the attending physician. Precautions Before starting treatment with amoxicillin/clavulanic acid, a detailed history of previous hypersensitivity reactions to penicillins, cephalosporins, or other beta-lactam antibiotics should be taken (see sections "Contraindications for Use" and "Side Effects"). Serious, sometimes fatal, hypersensitivity reactions (anaphylactoid reactions) to penicillins have been described. The risk of such reactions is highest in patients with a history of hypersensitivity reactions to penicillins and in individuals with atopy. In the event of an allergic reaction, it is necessary to stop treatment with Augmentin EC and start alternative therapy. If the infection has been confirmed to be caused by amoxicillin-susceptible organisms, consideration should be given to switching from amoxicillin/clavulanic acid therapy to amoxicillin therapy in accordance with official guidelines. In patients with impaired renal function or when taking high doses of the drug, convulsions may occur (see section "Side Effects"). Amoxicillin/clavulanic acid is not recommended for suspected infectious mononucleosis, as such patients have a measles-like rash after taking amoxicillin. The combined use of allopurinol and amoxicillin increases the risk of allergic skin reactions. Prolonged treatment with the drug may lead to overgrowth of non-susceptible microorganisms. The appearance of pustules on erythematous areas of the skin with fever at the beginning of treatment may be a symptom of acute generalized exanthematous pustulosis (see section "Side Effects"). The occurrence of this adverse reaction requires discontinuation of the drug and is a contraindication to the further use of amoxicillin. The combination of amoxicillin / clavulanic acid should be used with caution in patients with signs of hepatic insufficiency (see sections "Method of application and dosage", "Contraindications for use", "Precautions"). Adverse events from the liver were observed mainly in men and elderly patients and may be associated with long-term therapy. These adverse events are very rare 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. They are usually 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 people with serious comorbidities or people receiving potentially hepatotoxic drugs at the same time (see the section "Side Effects"). Antibiotic-associated colitis has been reported with virtually all antibacterial agents, including amoxicillin. This adverse reaction can vary in severity from mild to life-threatening (see section "Side Effects"). Therefore, consideration should be given to making this diagnosis in patients who develop diarrhea during treatment or after the administration of any antibiotics. If antibiotic-associated colitis occurs, the drug should be immediately discontinued. The patient needs to consult a doctor who will prescribe the appropriate treatment. In such a situation, the use of drugs that inhibit peristalsis is contraindicated. During long-term therapy with Augmentin EC, it is recommended to periodically evaluate the function of the kidneys, liver and hematopoiesis. In patients treated with a combination of amoxicillin and clavulanic acid, prolongation of prothrombin time was observed in rare cases. When co-administering a combination of amoxicillin and clavulanic acid with anticoagulants, appropriate monitoring should be carried out. To maintain the desired level of anticoagulants, dose adjustment may be required (see section "Interaction with other drugs" and "Side effects"). In patients with reduced diuresis, crystalluria has been reported in very rare cases, mainly with parenteral use of the drug. While taking high doses of amoxicillin, it is recommended to take a sufficient amount of fluid and maintain adequate diuresis to reduce the likelihood of amoxicillin crystal formation. In patients with urinary catheters, the patency of the catheter should be checked regularly (see section "Overdose"). During treatment with amoxicillin, if tests for the presence of glucose in the urine are necessary, enzymatic methods for determining glucose oxidase should be used due to the possibility of obtaining a false positive result when using non-enzymatic methods . The presence of clavulanic acid in the preparation can cause non-specific binding of IgG and albumin to erythrocyte membranes, which can lead to a false positive Coombs test result. Patients taking the amoxicillin/clavulanic acid combination may experience a false positive test result for Aspergillus infection using Platelia Aspergillus EIA tests. There have been reports of cross-reactions between the Platelia Aspergillus EIA test and non-Aspergillus polysaccharides and polyfuranoses. Therefore, positive test results in patients taking the amoxicillin/clavulanic acid combination should be interpreted with caution and confirmed by other diagnostic methods. Augmentin EC in the form of a powder for oral suspension contains 2.72 mg of aspartame (E951) per ml of suspension, which is a source of phenylalanine, and therefore the drug should be used with caution in patients with phenylketonuria. This medicinal product contains maltodextrin (glucose). The drug should not be administered to patients with malabsorption of glucose-galactose. Interactions with other drugs Oral anticoagulants: oral anticoagulants and penicillin antibiotics are widely used in clinical practice without reported interactions. However, the literature describes 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 prothrombin time or INR should be carefully monitored when prescribing or canceling amoxicillin. In addition, dose adjustment of oral anticoagulants may be required (see sections "Precautions" and "Side Effects"). Methotrexate: Penicillins may decrease the excretion of methotrexate, leading to a potential increase in toxicity. Probenecid: It is not recommended to use Augmentin EC simultaneously with probenecid. Probenicid reduces the tubular secretion of amoxicillin, and therefore the simultaneous use of the drug Augmentin EC and probenecid can lead to a steady and prolonged increase in the blood concentration of amoxicillin, but not clavulanic acid. Mycophenolate mofetil: in patients treated with mycophenolate mofetil, after the start of oral administration of the combination of amoxicillin with clavulanic acid, a decrease in the concentration of the active metabolite, mycophenolic acid, was observed before taking the next dose of the drug by approximately 50%. Changes in this concentration may not accurately reflect overall changes in mycophenolic acid exposure. In this regard, as a rule, no dose adjustment of mycophenolate mofetil is required in the absence of clinical signs of graft dysfunction. However, careful clinical monitoring should be carried out while taking the combination of drugs, as well as shortly after the end of antibiotic treatment. Contraindications Hypersensitivity to active substances, penicillins or any of the components of the drug. History of a severe immediate hypersensitivity reaction (eg, anaphylaxis) to previous administration of beta-lactam antibiotics (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 (see section "Side Effects"). Composition 5 ml of the finished suspension contains: Active ingredients: Amoxicillin 600 mg (as amoxicillin trihydrate 759.04 mg), clavulanic acid 42.9 mg (as a complex of potassium clavulanate / silicon dioxide 122.95 mg, equivalent to potassium clavulanate 61.475 mg). Excipients: Xanthan gum, aspartame (E951), anhydrous colloidal silicon dioxide, sodium carmellose (sodium carboxymethylcellulose 12), strawberry flavor, silicon dioxide. Overdose Symptoms and signs Gastrointestinal disorders and disturbances in water and electrolyte balance may occur. Amoxicillin crystalluria has been described, in some cases leading to the development of renal failure (see section "Precautions"). 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, so regular checks of the patency of the catheter should be carried out (see section "Precautions"). Treatment Symptomatic correction of disorders of the gastrointestinal tract can be carried out, with special attention to the normalization of water and electrolyte balance. Amoxicillin and clavulanic acid can be removed from the bloodstream by hemodialysis. Side effects The most common side effects are diarrhea, nausea and vomiting. Adverse events identified during clinical trials and post-marketing surveillance are listed by body system and according to frequency of occurrence. The frequency of occurrence is defined as follows: very often (?1/10), often (?1/100 and <1/10), infrequently (?1/1000 and <1/100), rarely (?1/10000 and < 1/1,000), very rare (< 1/10,000, including isolated cases), frequency not known (frequency cannot be estimated from the available data). Frequency of occurrence of adverse events Infectious diseases Often: candidiasis of the skin and mucous membranes; frequency not known: overgrowth of non-susceptible organisms. From the side of the hematopoietic and lymphatic system Rarely: reversible leukopenia (including neutropenia), thrombocytopenia; frequency not known: reversible agranulocytosis, hemolytic anemia, prolongation of bleeding time and prothrombin time (see section "Precautions"). On the part of the immune system (see sections "Contraindications" and "Precautions") The frequency is not known: angioedema, anaphylaxis, a syndrome similar to serum sickness, allergic vasculitis. From the nervous system Uncommon: dizziness, headache; frequency not known: reversible hyperactivity, convulsions (see section "Precautions"), aseptic meningitis. From the gastrointestinal tract Often: diarrhea, nausea, vomiting; infrequently: digestive disorders; frequency not known: antibiotic-induced colitis (including pseudomembranous colitis and hemorrhagic colitis, see Precautions section), black "hairy" tongue, discoloration of the surface layer of tooth enamel. Nausea is more common with high doses taken orally. Reactions from the gastrointestinal tract may be reduced when taking the drug with meals. A change in the color of the surface layer of tooth enamel was very rarely observed in children. Good oral hygiene helps prevent discoloration of tooth enamel, which is usually corrected by brushing your teeth. On the part of the liver and biliary tract Infrequently: increased activity of aspartate aminotransferase (AST) and / or alanine aminotransferase (ALT) A moderate increase in AST and / or ALT activity is observed in patients receiving therapy with beta-lactam antibiotics, but the clinical significance of this phenomenon is not known. Frequency not known: hepatitis and cholestatic jaundice. These adverse reactions have been reported with other penicillins and cephalosporins (see Precautions section). On the part of the skin and subcutaneous fat Uncommon: rash, itching, urticaria; rarely: erythema multiforme; frequency not known: Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis (see Precautions section). In the event of any allergic reactions, treatment with Augmentin EC should be discontinued. From the side of the kidneys and urinary tract Frequency is not known: interstitial nephritis, crystalluria (see section "Overdose"). Storage conditionsStore at a temperature not exceeding 25 °C. Store the prepared suspension in a refrigerator at a temperature of 2-8 ° C in a tightly closed vial, do not freeze. Keep out of the reach of children. Buy Augmentin EC powder for oral suspension 100ml 600mg+42.9mg/5ml #1 Price for Augmentin EC powder for oral suspension 100ml 600mg+42.9mg/5ml #1 oral suspensions 600mg+42.9mg/5ml №1