Augmentin pills 500 mg + 125 mg 14 pcs
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Active ingredients
Amoxicillin + Clavulanic Acid
Release form
Pills
Composition
1 tablet contains: Active ingredients: Amoxicillin (in the form of trihydrate) - 875 mg, clavulanic acid (in the form of potassium salt) - 125 mg. Excipients: magnesium stearate - 14.5 mg, sodium carboxymethyl starch - 29 mg, colloidal silicon dioxide - 10 mg, microcrystalline cellulose - 396.5 mg. The composition of the film shell: titanium dioxide - 13.76 mg, hypromellose (5 cps) - 10.56 mg, hypromellose (15 cps) - 3.52 mg, macrogol 4000 - 2.08 mg, macrogol 6000 - 2.08 mg, Dimethicone - 0.013 mg.
Pharmacological effect
Amoxicillin is a semi-synthetic broad-spectrum antibiotic that has activity against many gram-positive and gram-negative microorganisms. At the same time, amoxicillin is susceptible to degradation by β-lactamases, and therefore the spectrum of amoxicillin activity does not extend to microorganisms that produce these enzymes. Clavulanic acid, an β-lactamase inhibitor structurally related to penicillins, has the ability to inactivate a wide range of β-lactamases found in microorganisms resistant to penicillins and cephalosporins. Clavulanic acid is sufficiently effective against plasmid β-lactamase, which most often causes resistance of bacteria, and is not effective against chromosomal β-lactamase type 1, which are not inhibited by clavulanic acid. The presence of clavulanic acid in the preparation Augmentin protects amoxicillin from destruction by β-lactamase enzymes, which allows you to extend the antibacterial spectrum of amoxicillin. Below is the in vitro combination of amoxicillin with clavulanic acid. Bacteria usually sensitive to the combination of amoxicillin with clavulanic acid Gram-positive aerobes: Bacillus anthracis, Enterococcus faecalis, Listeria monocytogenes, Nocardia asteroides, Streptococcus pyogenes1,2, Streptococcus agalactiae1,2, Streptococcus spp. (other beta-hemolytic streptococci) 1,2, Staphylococcus aureus (sensitive to methicillin) 1, Staphylococcus saprophyticus (sensitive to methicillin), Staphylococcus spp. (coagulase-negative, methicillin-sensitive). Gram-negative aerobes: Bordetella pertussis, Haemophilus influenzae1, Helicobacter pylori, Moraxella catarrhalis1, Neisseria gonorrhoeae, Pasteurella multocida, Vibrio cholerae. Other: Borrelia burgdorferi, Leptospira icterohaemorrhagiae, Treponema pallidum. Gram-positive anaerobes: Clostridium spp., Peptococcus niger, Peptostreptococcus magnus, Peptostreptococcus micros, Peptostreptococcus spp. Gram-negative anaerobes: Bacteroides fragilis, Bacteroides spp., Capnocytophaga spp., Eikenella corrodens, Fusobacterium nucleatum, Fusobacterium spp., Porphyromonas spp., Prevotella spp.Bacteria that are likely to acquire resistance to the combination of amoxicillin with clavulanic acid Gram-negative aerobes: Escherichia coli1, Klebsiella oxytoca, Klebsiella pneumoniae1, Klebsiella spp., Proteus mirabilis, Proteus vulgaris, Proteus spp. Gram-positive aerobes: Corynebacterium spp., Enterococcus faecium, Streptococcus pneumoniae1,2, Streptococcus Viridans2 group. Bacteria with natural resistance to the combination of amoxicillin with clavulanic acid. enterocolitica. Other: Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia spp., Coxiella burnetti, Mycoplasma spp. 1 - for these types of microorganisms, the clinical efficacy of the combination of amoxicillin with clavulanic acid was demonstrated in clinical studies. 2 - strains of these types of bacteria do not produce β-lactamase. Sensitivity with amoxicillin monotherapy suggests a similar sensitivity to the combination of amoxicillin with clavulanic acid.
Pharmacokinetics
Absorption: Both active ingredients of the drug Augmentin, amoxicillin and clavulanic acid, are rapidly and completely absorbed from the gastrointestinal tract after oral administration. The absorption of active ingredients is optimal when taking the drug at the beginning of a meal. The pharmacokinetic parameters of amoxicillin and clavulanic acid obtained in different studies, when healthy volunteers took on an empty stomach, are shown below: - 1 tablet of Augmentin 250 mg / 125 mg (375 mg); - 2 pills of the drug Augmentin 250 mg / 125 mg (375 mg); - 1 tablet of the drug Augmentin 500 mg / 125 mg (625 mg); - 500 mg of amoxicillin; - 125 mg of clavulanic acid; - 2 pills of the drug Augmentin 875 mg / 125 mg (1000 mg) Cmax - the maximum concentration in plasma Tvi-Tmax is the time to reach maximum plasma concentration. AUC is the area under the concentration-time curve. T1 / 2 is the half-life. When Augmentin is used, plasma amoxicillin concentrations are similar to oral administration of one amoxicillin at equivalent doses. Distribution: As with the on / in the introduction of a combination of amoxicillin with clavulanic acid, therapeutic concentrations of amoxicillin and clavulanic acid are created in various organs and tissues, interstitial fluid (abdominal organs , adipose, bone and muscle tissue, synovial and peritoneal fluids, skin, bile, purulent discharge). Amoxicillin and clavulanic acid have a weak degree of binding to plasma proteins.Studies have shown that blood plasma proteins bind 25% of the total amount of clavulanic acid and 18% of amoxicillin. In animal studies, the accumulation of ingredients of Augmentin is not detected. Amoxicillin, like most penicillins, passes into breast milk. Trace amounts of clavulanic acid are also found in breast milk. Except for the possibility of developing sensitization, diarrhea and candidiasis of the oral mucosa, no other negative effects of amoxicillin and clavulanic acid on the health of children fed breast milk are known. Studies of the reproductive function in animals showed that amoxicillin and clavulanic acid penetrate through the placental barrier in animals. there were no signs of negative effects on the fetus. Metabolism: 10-25% of the initial dose of amoxicillin is excreted by the kidneys as an inactive metabolite (penises lloevoy acid). Clavulanic acid, is extensively metabolized to 2,5-dihydro-4- (2-hydroxyethyl) -5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-butan-2-one and is excreted by the kidneys through the gastrointestinal tract, as well as with exhaled air in the form of carbon dioxide. Excretion: Like other penicillins, amoxicillin is excreted mainly by the kidneys, whereas clavulanic acid is excreted through both renal and extrarenal mechanisms. Studies have shown that, on average, approximately 60-70% of amoxicillin and about 40-65% of clavulanic acid are excreted by the kidneys unchanged in the first 6 hours after the administration of the drug Augmentin pills, film-coated, 250 mg / 125 mg or 500 mg / 125 mg or 875 mg / 125 mg. Simultaneous administration of probenecid slows down the elimination of amoxicillin, but does not slow down the elimination of clavulanic acid (see section Drug Interactions).
Indications
Bacterial infections caused by susceptible microorganisms: infections of the upper respiratory tract and upper respiratory tract (for example, recurrent tonsillitis, sinusitis, otitis media), usually caused by Streptococcus pneumoniae, Haemophilus influenzae *, Moraxella catarrhalis *, Streptococcus pyrophology, pyropes, etc. : exacerbations of chronic bronchitis, lobar pneumonia and bronchopneumonia, usually caused by Streptococcus pneumoniae, Haemophilus influenzae * and Moraxella catarrhalis * (except 250 mg / 125 mg pills). Urogenital tract infections: cystitis, urethritis, pyelonephritis, infections of women, women, urethritis, pyelonephritis, infections of women and women. organs usually caused by species of the family Enterobacteriaceae (mainly Escherichia coli *),Staphylococcus saprophyticus and species of the genus Enterococcus.Honorrhea caused by Neisseria gonorrhoeae * (except 250 mg / 125 mg pills). Skin and soft tissue infections usually caused by Staphylococcus aureus *, Streptococcus pyogenes and species of the Bacteroides * type. usually caused by Staphylococcus aureus *, when long-term therapy is needed. Odontogenic infections, such as periodontitis, maxillary sinusitis, severe dental abscesses with spreading cellulitis (for pills 500 mg / 125 mg or 875 mg / 125 mg). Other mixed infections (for example, septic abortion after Pregnant sepsis, intra-abdominal sepsis) within the framework of step therapy (for pills 250 mg / 125 mg or 500 mg / 125 mg, or 875 mg / 125 mg). * some representatives of the indicated kind of microorganisms produce β-lactamase, which makes them insensitive to Amoxicillin. Infections caused by microorganisms susceptible to amoxicillin can be treated with Augmentin, since amoxicillin is one of its active ingredients. The drug Augmentin is also indicated for the treatment of mixed infections caused by microorganisms sensitive to amoxicillin, as well as microorganisms producing β-lactamase sensitive to amoxicillin combination with clavulanic acid. The sensitivity of bacteria to amoxicillin combination with clavulanic acid varies depending on the region and the region. . Where possible, local sensitivity data should be taken into account. If necessary, microbiological samples and bacteriological sensitivity analysis should be carried out.
Contraindications
Hypersensitivity to amoxicillin, clavulanic acid, other components of the drug, beta-lactam antibiotics (for example, penicillins, cephalosporins) in history. Previous episodes of jaundice or abnormal liver function when using a combination of amoxicillin with clavulanic acid in history. Children's age up to 12 years and body weight less than 40 kg (for pills 250 mg / 125 mg or 500 mg / 125 mg, or 875 mg / 125 mg). Children up to 3 months (for powder for the preparation of oral suspension 200 mg / 28.5 mg and 400 mg / 57 mg). Kidney dysfunction (kc ≤ 30 ml / min) (for pills 875 mg / 125 mg, for powder for preparation of suspension for oral administration of 200 mg / 28.5 mg and 400 mg / 57 mg). Phenylketonuria (for the powder for the preparation of suspension for oral administration). With caution: abnormal liver function.
Precautionary measures
With care: abnormal liver function.
Use during pregnancy and lactation
Pregnancy: In animals' reproductive function studies, oral and parenteral administration of the drug Augmentin did not cause teratogenic effects. In a single study in women with premature rupture of the membranes, it was found that preventive drug therapy may be associated with an increased risk of necrotizing enterocolitis in the newborn. Like all drugs, Augmentin is not recommended for use during pregnancy, except in cases where the expected benefit to the mother outweighs the potential risk to the fetus. Breastfeeding period: Augmentin can be used during breastfeeding. With the exception of the possibility of developing sensitization, diarrhea or candidiasis of the oral mucous membranes associated with the penetration into the breast milk of trace amounts of the active ingredients of this drug, no other adverse effects were observed in breastfed children. In the event of adverse effects in breastfed babies, breastfeeding should be discontinued.
Dosage and administration
The dosage regimen is set individually depending on the age, body weight, renal function of the patient, as well as the severity of the infection. For optimal absorption and reduction of possible side effects from the digestive system, Augmentin is recommended to be taken at the beginning of a meal. The minimum course of antibiotic therapy is 5 days. Treatment should not last more than 14 days without a review of the clinical situation. If necessary, it is possible to conduct stepwise therapy (at the beginning of therapy, parenteral administration of the drug with the subsequent transition to oral administration). Adults and children over 12 years old or with a body weight of 40 kg or more 1 tablet of 250 mg / 125 mg 3 times / day (for mild to moderate infections), or 1 tablet of 500 mg / 125 mg 3 times / day, or 1 tablet of 875 mg / 125 mg 2 times / day, or 11 ml of suspension 400 mg / 57 mg / 5 ml 2 times / day (equivalent to 1 tablet of 875 mg / 125 mg). 2 pills of 250 mg / 125 mg are not equivalent to 1 tablet of 500 mg / 125 mg.Children from 3 months and up to 12 years old with a body weight less than 40 kg The drug is prescribed in the form of a suspension for receiving Inside. The dose calculation is made depending on the age and body weight, indicated in mg / kg body weight / day (calculation of amoxicillin) or in ml of suspension. The frequency of receiving the suspension is 125 mg / 31.25 mg in 5 ml - 3 times / day every 8 hours. The frequency of receiving the suspension is 200 mg / 28.5 mg in 5 ml or 400 mg / 57 mg in 5 ml - 2 times / day every 12 hours. Low doses of the drug Augmentin are used to treat infections of the skin and soft tissues, as well as recurrent tonsillitis. High doses of the drug Augmentin are used to treat diseases such as otitis media, sinusitis, lower respiratory infections and urinary tract infections, infections of bones and joints. There is not enough clinical data to recommend the use of Augmentin at a dose of more than 40 mg / kg / day in 3 doses (4: 1 suspension) in children under 2 years of age. Children from birth to 3 months Owing to the immaturity of the excretory function of the kidneys, the recommended dose of Augmentin (calculated on amoxicillin) is 30 mg / kg / day in 2 doses in the form of a 4: 1 suspension. The use of suspension 7: 1 (200 mg / 28.5 mg in 5 ml or 400 mg / 57 mg in 5 ml) in this population is not recommended. Children born prematurely There are no recommendations regarding the dosing regimen.
Side effects
Infectious and parasitic diseases are often candida of the skin and mucous membranes. For the blood and lymphatic system, there is rarely a reversible leukopenia (including neutropenia) and reversible thrombocytopenia. very rarely - reversible agranulocytosis and reversible hemolytic anemia, prolonged prothrombin time and bleeding time, anemia, eosinophilia, trombotsitoz.So the immune system is very rarely - angioneurotic edema, anaphylactic reactions, a syndrome similar to serum sickness, allergic vaskulit.So the nervous system infrequently - dizziness, headache. very seldom - reversible hyperactivity, convulsions (convulsions can be observed in patients with impaired renal function, as well as in those who receive high doses of the drug), insomnia, agitation, anxiety, behavior change. nausea, vomiting. children - often - diarrhea, nausea, vomiting. The entire population of nausea is most often observed when taking high doses of the drug. If, after starting the drug, undesirable reactions from the gastrointestinal tract are observed, they can be eliminated if you take the drug at the beginning of the meal.Infrequently - digestive disorders. very rarely, antibiotic-associated colitis induced by antibiotics (including pseudomembranous colitis and hemorrhagic colitis), black hairy tongue, gastritis, stomatitis. In children, when using the suspension, very rarely was a change in the color of the surface layer of the tooth enamel. Oral care helps prevent discoloration of tooth enamel, because it is enough to brush your teeth. On the side of the liver and biliary tract, it is not often - a moderate increase in the activity of ACT and / or ALT (seen in patients receiving beta-lactam antibiotics, but its clinical significance unknown). very rarely - hepatitis and cholestatic jaundice (these phenomena were observed during therapy with other penicillins and cephalosporins), an increase in the concentration of bilirubin and alkaline phosphatase. Adverse effects of the liver were observed mainly in men and elderly patients, and may be associated with long-term therapy. These adverse events are very rarely observed in children. The listed signs and symptoms usually occur during or immediately after the end of therapy, but in some cases they may not appear for several weeks after the end of therapy. Adverse events are usually reversible. Adverse effects on the part of the liver can be severe, in extremely rare cases there have been reports of deaths. In almost all cases, these were persons with serious comorbidities or persons receiving potentially hepatotoxic drugs at the same time. On the side of the skin and subcutaneous tissues it is not often - a rash, itching, urticaria. rarely erythema multiforme. very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exantymatous pustules. In the case of allergic skin reactions, treatment with Augmentin must be stopped.
Overdose
Symptoms: Gastrointestinal symptoms and water-electrolyte imbalance may occur.Amoxicillin crystalluria has been described, in some cases leading to the development of renal failure. Seizures may occur in patients with impaired renal function, as well as in those who receive high doses of the drug. Treatment: symptoms of the gastrointestinal tract - symptomatic therapy, focusing on the normalization of water and electrolyte balance. In case of overdose, amoxicillin and clavulanic acid can be removed from the bloodstream by hemodialysis. The results of a prospective study, which was conducted with the participation of 51 children in the poison control center, showed that the administration of amoxicillin in a dose of less than 250 mg / kg did not lead to significant clinical symptoms and did not require gastric lavage.
Interaction with other drugs
Simultaneous use of the drug Augmentin and probenecid is not recommended. Probenecid reduces the tubular secretion of amoxicillin, and therefore the simultaneous use of the drug Augmentin and probenecid can lead to an increase and persistence in the blood concentration of amoxicillin, but not clavulanic acid. The simultaneous use of allopurinol and amoxicillin may increase the risk of skin allergic reactions. Currently there are no data in the literature about the simultaneous use of a combination of amoxicillin with clavulanic acid and allopurinol. Penicillins can slow down the elimination of methotrexate from the body by inhibiting its tubular secretion; therefore, the simultaneous use of Augmentin and methotrexate can increase the toxicity of methotrexate. Like other antibacterial drugs, Augmentin may affect the intestinal microflora, leading to a decrease in the absorption of estrogen from the gastrointestinal tract and a decrease in the effectiveness of combined oral contraceptives. The literature describes rare cases of an increase in MHO in patients with co-administration of acenocoumarol or warfarin and amoxicillin. If necessary, the simultaneous appointment of the drug Augmentin with anticoagulants prothrombin time or MHO should be carefully monitored when prescribing or discontinuing the drug Augmentin, it may be necessary to adjust the dose of anticoagulants for oral administration.In patients receiving mycophenolate mofetil, after starting the combination of amoxicillin with clavulanic acid, there was a decrease in the concentration of the active metabolite, mycophenolic acid, before taking the next dose of the drug by about 50%. Changes in this concentration may not accurately reflect general changes in the exposure to mycophenolic acid.
special instructions
Before starting treatment with the drug Augmentin, a detailed history should be collected regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. Described serious, and sometimes lethal, hypersensitivity reactions (anaphylactic reactions) to penicillins. The risk of such reactions is highest in patients with a history of hypersensitivity reactions to penicillins. In the event of an allergic reaction, it is necessary to discontinue treatment with Augmentin and initiate appropriate alternative therapy. For serious hypersensitivity reactions, epinephrine should be administered immediately. Oxygen therapy, intravenous administration of the GCS and airway management, including intubation, may also be required. In case of skin allergic reactions, treatment with Augmentin should be stopped. The administration of the drug Augmentin in case of suspected infectious mononucleosis is not recommended, since amoxicillin can cause a core-like rash in patients with this disease, making it difficult to diagnose the disease. Long-term treatment with Augmentin sometimes leads to overproduction of insensitive microorganisms. Cases of pseudomembranous colitis occur when taking antibiotics, the severity of which can range from mild to life-threatening. Therefore, it is important to consider the possibility of developing pseudomembranous colitis in patients with diarrhea during or after the use of antibiotics. If the diarrhea is prolonged or severe, or the patient experiences abdominal cramps, treatment should be stopped immediately and the patient should be examined. In general, the drug Augmentin is well tolerated and has a low toxicity peculiar to all penicillins.During prolonged therapy with the drug Augmentin, it is recommended to periodically evaluate the function of the kidneys, liver, and blood formation. In patients who received the combination of amoxicillin with clavulanic acid, together with indirect (oral) anticoagulants, an increase in prothrombin time (increase in MHO) was reported in rare cases. When co-administration of indirect (oral) anticoagulants with a combination of amoxicillin with clavulanic acid, control of the relevant indicators is necessary. To maintain the desired effect of oral anticoagulants, it may be necessary to adjust their dose. In patients with reduced diuresis, in very rare cases, the development of crystalluria has been reported, mainly with parenteral use of the drug. During the administration of high doses of amoxicillin, it is recommended to take a sufficient amount of liquid and maintain adequate diuresis to reduce the likelihood of the formation of amoxicillin crystals (see the section Overdose). Taking the drug Augmentin orally leads to a high content of amoxicillin in the urine, which can lead to false positive results in the determination of glucose in the urine (for example, Benedict test, Fehling test). In this case, it is recommended to use the glucose oxidant method for determining the concentration of glucose in the urine. Clavulanic acid can cause nonspecific binding of immunoglobulin G and albumin to erythrocyte membranes, which leads to false-positive results of the Coombs test. It is necessary to use the drug Augmentin within 30 days from the moment of opening the package of laminated aluminum foil. Abuse and drug dependence: There was no drug dependence, addiction or euphoria reactions associated with the use of the drug Augmentin. Impact on the ability to drive vehicles and control mechanisms: Since the drug can cause dizziness, it is necessary to warn patients about the precautions when driving or working with moving machinery.