Flemoxin Solutab dispersible tablets. 1000 mg No. 20

Flemoxin Solutab dispersible tablets. 1000 mg No. 20

A country

Netherlands, Russia
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Active substance

Amoxicillin

Compound

1 tablet contains: amoxicillin trihydrate 1019.8 mg, potassium clavulanate 148.9 mg. Excipients: dispersed cellulose - 30.4 mg, microcrystalline cellulose - 125.9 mg, crospovidone - 64 mg, vanillin - 1 mg, tangerine flavor - 9 mg, lemon flavor - 11 mg , saccharin - 13 mg, magnesium stearate - 6 mg. Dispersible tablets of oblong shape, from white to yellow, without marks, marked “425” and a graphic part of the company logo. Brown dotted spots are allowed.

pharmachologic effect

A combination drug of amoxicillin and clavulanic acid, a beta-lactamase inhibitor. It has a bactericidal effect, inhibits the synthesis of the bacterial wall. It is active against aerobic gram-positive bacteria (including strains producing beta-lactamases): - Staphylococcus aureus; - aerobic gram-negative bacteria: Enterobacter spp., Escherichia coli, Haemophilus influenzae, Klebsiella spp., Moraxella catarrhalis. The following pathogens are sensitive only in vitro: Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus anthracis, Streptococcus pneumoniae, Streptococcus viridans, Enterococcus faecalis, Corynebacterium spp., Listeria monocytogenes;— anaerobic Clostridium spp., Peptococcus spp., Peptostreptococcus spp.;— and aerobe new gram-negative bacteria (including beta-lactamase producing strains): Proteus mirabilis, Proteus vulgaris, Salmonella spp., Shigella spp., Bordetella pertussis, Yersinia enterocolitica, Gardnerella vaginalis, Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus ducreyi, Yersinia multocida (formerly Pasteurella) , Campylobacter jejuni; - anaerobic gram-negative bacteria (including strains producing beta-lactamases): Bacteroides spp., including Bacteroides fragilis. Clavulanic acid suppresses types II, III, IV and V beta-lactamases, is not active against type I beta-lactamases , produced by Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid has a high affinity for penicillinases, due to which it forms a stable complex with the enzyme, which prevents the enzymatic degradation of amoxicillin under the influence of beta-lactamases.

Indications for use

- bacterial infections caused by sensitive pathogens: infections of the lower respiratory tract (bronchitis, pneumonia, pleural empyema, lung abscess); - infections of the ENT organs (sinusitis, tonsillitis, otitis media); - infections of the genitourinary system and pelvic organs (pyelonephritis, pyelitis , cystitis, urethritis, prostatitis, cervicitis, salpingitis, salpingoophoritis, tubo-ovarian abscess, endometritis, bacterial vaginitis, septic abortion, postpartum sepsis, pelvioperitonitis, chancroid, gonorrhea); - skin and soft tissue infections (erysipelas, impetigo, secondary infected dermatoses, abscess, phlegmon, wound infection); - osteomyelitis; - postoperative infections; - prevention of infections in surgery.

Mode of application

Orally, intravenously. Doses are given in terms of amoxicillin. The dosage regimen is set individually depending on the severity and location of the infection and the sensitivity of the pathogen. Children under 12 years of age - in the form of a suspension, syrup or drops for oral administration. A single dose is set depending on age: children under 3 months - 30 mg/kg/day in 2 doses; 3 months and older - for mild infections - 25 mg/kg/day in 2 divided doses or 20 mg/kg/day in 3 divided doses, for severe infections - 45 mg/kg/day in 2 divided doses or 40 mg/kg/day a day in 3 doses. Adults and children over 12 years of age or weighing 40 kg or more: 500 mg 2 times / day or 250 mg 3 times / day. For severe infections and respiratory tract infections - 875 mg 2 times a day or 500 mg 3 times a day. The maximum daily dose of amoxicillin for adults and children over 12 years of age is 6 g, for children under 12 years of age - 45 mg/kg body weight body. The maximum daily dose of clavulanic acid for adults and children over 12 years of age is 600 mg, for children under 12 years of age - 10 mg/kg body weight. If swallowing is difficult in adults, the use of a suspension is recommended. When preparing suspensions, syrups and drops, water should be used as a solvent. For intravenous administration, adults and adolescents over 12 years of age are administered 1 g (amoxicillin) 3 times a day, if necessary - 4 times a day. The maximum daily dose is 6 g. For children 3 months to 12 years old - 25 mg/kg 3 times a day; in severe cases - 4 times a day; for children up to 3 months: premature and in the perinatal period - 25 mg/kg 2 times a day, in the postperinatal period - 25 mg/kg 3 times a day. Duration of treatment - up to 14 days, acute otitis media - up to 10 days. To prevent postoperative infections during operations lasting less than 1 hour, a dose of 1 g is administered intravenously during induction of anesthesia. For longer operations - 1 g every 6 hours during the day. If the risk of infection is high, administration can be continued for several days. In case of chronic renal failure, the dose and frequency of administration are adjusted depending on the CC: with CC more than 30 ml/min, no dose adjustment is required; with CC 10-30 ml/min: orally - 250-500 mg/day every 12 hours; IV - 1 g, then 500 mg IV; with CC less than 10 ml/min - 1 g, then 500 mg/day IV or 250-500 mg/day orally in one dose. For children, doses should be reduced in the same way. Patients on hemodialysis - 250 mg or 500 mg orally in one dose or 500 mg intravenously, 1 additional dose during dialysis and 1 more dose at the end of the dialysis session.

Interaction

Antacids, glucosamine, laxatives, aminoglycosides slow down and reduce absorption; ascorbic acid increases absorption. Bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) have an antagonistic effect. Increases the effectiveness of indirect anticoagulants (suppressing intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index). When taking anticoagulants simultaneously, it is necessary to monitor blood clotting indicators. Reduces the effectiveness of oral contraceptives, drugs during the metabolism of which PABA is formed, ethinyl estradiol - the risk of breakthrough bleeding. Diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration). Allopurinol increases the risk of developing a skin rash.

Side effect

From the digestive system: nausea, vomiting, diarrhea, gastritis, stomatitis, glossitis, increased activity of liver transaminases, in isolated cases - cholestatic jaundice, hepatitis, liver failure (more often in the elderly, men, with long-term therapy), pseudomembranous and hemorrhagic colitis ( can also develop after therapy), enterocolitis, black “hairy” tongue, darkening of tooth enamel. From the hematopoietic organs: reversible increase in prothrombin time and bleeding time, thrombocytopenia, thrombocytosis, eosinophilia, leukopenia, agranulocytosis, hemolytic anemia. From the nervous system: dizziness, headache, hyperactivity, anxiety, behavior change, convulsions. Local reactions: in some cases - phlebitis at the site of intravenous administration. Allergic reactions: urticaria, erythematous rashes, rarely - exudative erythema multiforme, anaphylactic shock, angioedema, extreme rarely - exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), allergic vasculitis, a syndrome similar to serum sickness, acute generalized exanthematous pustulosis. Others: candidiasis, development of superinfection, interstitial nephritis, crystalluria, hematuria.

Contraindications

- hypersensitivity (including to cephalosporins and other beta-lactam antibiotics); - infectious mononucleosis (including with the appearance of a measles-like rash); - phenylketonuria; - episodes of jaundice or impaired liver function as a result of the use of amoxicillin/clavulanic history of acids; - CC less than 30 ml/min (for tablets 875 mg/125 mg). With caution: pregnancy, lactation, severe liver failure, gastrointestinal diseases (including a history of colitis associated with the use of penicillins) , chronic renal failure. Use during pregnancy and lactation. With caution: pregnancy, lactation. Cases of the development of necrotizing enterocolitis in newborns and in pregnant women with premature rupture of membranes have been identified. Use in children: Children under 12 years of age - in the form of a suspension, syrup or drops for oral administration. A single dose is set depending on age: children under 3 months - 30 mg/kg/day in 2 doses; 3 months and older - for mild infections - 25 mg/kg/day in 2 divided doses or 20 mg/kg/day in 3 divided doses, for severe infections - 45 mg/kg/day in 2 divided doses or 40 mg/kg/day a day in 3 doses. The maximum daily dose of amoxicillin for children under 12 years of age is 45 mg/kg body weight. The maximum daily dose of clavulanic acid for children under 12 years of age is 10 mg/kg of body weight.

Overdose

Symptoms: dysfunction of the gastrointestinal tract and water-electrolyte balance. Treatment: symptomatic. Hemodialysis is effective.

special instructions

During a course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver and kidneys. In order to reduce the risk of side effects from the gastrointestinal tract, the drug should be taken with meals. Superinfection may develop due to the growth of microflora insensitive to it, which requires a corresponding change in antibacterial therapy .May give false positive results when determining glucose in urine. In this case, it is recommended to use the glucose oxidant method for determining the concentration of glucose in urine. After dilution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen. In patients with hypersensitivity to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible. Cases of development have been identified necrotizing enterocolitis in newborns, in pregnant women with premature rupture of membranes. Since the tablets contain the same amount of clavulanic acid (125 mg), it should be noted that 2 tablets of 250 mg (amoxicillin) are not equivalent to 1 tablet of 500 mg (amoxicillin).

Storage conditions

Room temperature

Dispensing conditions in pharmacies

On prescription

Flemoxin Solutab 250 mg No. 20 dispersible tablet.

Instructions for medical use of the drug Flemoxin Solutab® Trade name Flemoxin Solutab® International nonproprietary name Amoxicillin Dosage form Dispersible tablets 125 mg, 250 mg, 500 mg, 1000 mg Composition One tablet contains the active substance: amoxicillin in the form of amoxicillin trihydrate 125 mg, 250 mg , 500 mg, 1000 mg excipients: dispersible cellulose, microcrystalline cellulose, crospovidone, vanillin, tangerine flavor, lemon flavor, saccharin, magnesium stearate. Description Tablets from white to light yellow, oval in shape with the company logo and digital designation on one side (125 mg - “231”, 250 mg - “232”, 500 mg - “234”, 1000 mg - “236”) and take risks on the other side. Pharmacotherapeutic group Antimicrobial drugs for systemic use. Beta-lactam antibacterial drugs. Broad-spectrum penicillins. Amoxicillin. ATC code J01СA04 Pharmacological properties Pharmacokinetics Absorption After oral administration, amoxicillin is absorbed quickly and almost completely (about 93%), acid-stable. Food intake has virtually no effect on the absorption of the drug. The maximum concentration of the active substance in plasma is observed after 1-2 hours. After oral administration of 500 mg of amoxicillin, the maximum concentration of the active substance of 5 mcg/ml is observed in the blood plasma after 2 hours. When the dose of the drug is increased or decreased by 2 times, the maximum concentration in the blood plasma also changes by 2 times. Distribution About 20% of amoxicillin is bound to plasma proteins. Amoxicillin penetrates well into mucous membranes, bone tissue, intraocular fluid and sputum in therapeutically effective concentrations. The concentration of amoxicillin in bile exceeds its concentration in blood plasma by 2-4 times. In amniotic fluid and umbilical vessels, the concentration of amoxicillin is 25-30% of its level in the blood plasma of a pregnant woman. Amoxicillin does not penetrate the blood-brain barrier well; however, with inflammation of the meninges, the concentration in the cerebrospinal fluid is about 20% of the concentration in the blood plasma. Metabolism Amoxicillin is partially metabolized in the liver; most of its metabolites do not have microbiological activity. Excretion Amoxicillin is eliminated primarily by the kidneys, about 80% by tubular excretion, 20% by glomerular filtration. In the absence of renal dysfunction, the half-life of amoxicillin is 1-1.5 hours. In premature infants, newborns and children under 6 months. – 3-4 hours. Pharmacokinetics in special clinical cases. The half-life of amoxicillin does not change with impaired liver function. Pharmacodynamics Flemoxin Solutab® is a bactericidal, acid-resistant, broad-spectrum antibiotic from the group of semisynthetic penicillins. Active against gram-positive and gram-negative microorganisms, such as Streptococcus pyogenes, Streptococcus pneumoniae, Clostridium tetani, Clostridium welchii, Neisseria gonorrhoeae, Neisseria meningitidis, Staphylococcus aureus (not producing beta-lactamase), Bacillus anthracis, Listeria monocytogenes, Helicobacter pylori. Less active against Enterococcus faecalis, Escherichia coli, Proteus mirabilis, Salmonella typhi, Shigella sonnei, Vibrio cholerae. Not active against microorganisms producing beta-lactamases, Pseudomonas spp., indole-positive Proteus spp., Serratia spp., Enterobacter spp. Indications for use - respiratory infections - infections of the genitourinary system - infections of the gastrointestinal tract - infections of the skin and soft tissues Method of administration and dosage The drug is used orally before or after meals. The tablet can be swallowed whole, divided into pieces or chewed with a glass of water, and can also be diluted in water to form a syrup (20 ml) or suspension (100 ml) with a pleasant fruity taste. The dose is set individually, taking into account the severity of the disease and the patient’s age. In the case of infectious and inflammatory diseases of mild to moderate severity, it is recommended to use the drug according to the following scheme: Adults and children over 9 years of age are prescribed 500 - 750 mg 2 times / day or 375 (one and a half tablets of 250 mg) - 500 mg 3 times / day . The minimum single dose is 375 mg (one and a half tablets of 250 mg), the maximum daily dose is 1500 mg. Children from 3 to 9 years old are prescribed 375 mg (one and a half tablets of 250 mg) 2 times a day or 250 mg 3 times a day. The minimum single dose is 250 mg, the maximum daily dose is 750 mg. Children aged 1 to 3 years are prescribed 250 mg 2 times a day or 125 mg 3 times a day. The minimum single dose is 125 mg, the maximum daily dose is 500 mg. The daily dose of the drug for children is 30-60 mg/kg/day, divided into 2-3 doses. The minimum single dose is 10 mg/kg, the maximum daily dose is 60 mg/kg. When treating severe infections and diseases such as acute otitis media, a three-time dose is preferable. For chronic diseases, recurrent infections and severe infections, the dose of the drug can be increased: adults are prescribed 750 mg - 1 g 3 times a day, the minimum single dose is 750 mg, the maximum daily dose is 3 g; children 60 mg/kg/day, divided into 3 doses, minimum single dose 20 mg/kg, maximum daily dose 60 mg/kg. For acute uncomplicated gonorrhea, 3 g of the drug is prescribed in 1 dose in combination with 1 g of probenecid. For patients with impaired renal function with a creatinine clearance of 15-40 ml/min, the interval between doses is increased to 12 hours; with CC below 10 ml/min, the dose of the drug is reduced to 15-50%; for anuria - maximum dose 2 g/day. In case of mild to moderate infections, the drug is taken for 5-7 days. However, for infections caused by Streptococcus pyogenes, the duration of treatment should be at least 10 days. When treating chronic diseases and severe infections, the dose of the drug should be determined by the clinical picture of the disease. The drug must be continued for 48 hours after the symptoms of the disease disappear. Side effects Often - allergic skin reactions (maculopapular rash) Rarely - changes in taste - nausea, vomiting, diarrhea, anal itching - exudative erythema multiforme (Stevens-Johnson syndrome) - pseudomembranous and hemorrhagic colitis Very rarely - interstitial nephritis Possible - agranulocytosis, neutropenia, thrombocytopenia, hemolytic anemia - specific maculopapular rash In some cases - moderate increase in the activity of "liver" transaminases - anaphylactic shock - angioedema Contraindications - hypersensitivity to the drug and other beta-lactam antibiotics - infectious mononucleosis and lymphocytic leukemia Drug interactions Probenecid, phenylbutazone, oxyphenbutazone and To a lesser extent, acetylsalicylic acid, indomethacin and sulfinpyrazole inhibit tubular secretion of penicillins, prolonging plasma half-life and increasing plasma levels. Amoxicillin is used in therapy in combination with probenecid. Bactericidal antibiotics (including aminoglycosides, cephalosporins, vancomycin, rifampicin) have a synergistic effect when taken simultaneously. Antagonism is possible when taken with some bacteriostatic drugs (for example, tetracyclines, macrolides chloramphenicol, sulfonamides). Concomitant use with estrogen-containing oral contraceptives may lead to a decrease in their effectiveness and an increased risk of developing acyclic bleeding. Co-administration with allopurinol increases the frequency of skin reactions. Special instructions A history of erythroderma is not a contraindication for the use of Flemoxin Solutab®. Cross-resistance with penicillin drugs and cephalosporins is possible. As with other penicillin drugs, superinfection may develop. The appearance of severe diarrhea, characteristic of pseudomembranous colitis, is an indication for discontinuation of the drug. During combination therapy with metronidazole, you should not drink alcohol. Use in pediatrics: Use in children under 1 year of age is not recommended. Children under 9 years of age are not recommended to use the dosage of Flemoxin Solutab® 500 mg and 1000 mg. Pregnancy and lactation. Use during pregnancy is possible after a medical assessment of the risks/benefits of treatment. In small quantities, the drug is excreted in breast milk, which can lead to the development of sensitization phenomena in the child. Effect of the drug on the ability to drive vehicles and other potentially dangerous mechanisms Does not affect Overdose Symptoms: nausea, vomiting, diarrhea; water-electrolyte imbalance. Treatment: gastric lavage, activated carbon, saline laxatives; measures to restore water and electrolyte balance. Release form and packaging 5 tablets each in a blister pack made of polyvinyl chloride film and aluminum foil. 4 contour packages together with instructions for medical use in the state and Russian languages ​​are placed in a cardboard box. Storage conditions Store in a place protected from light, at a temperature not exceeding 25 °C. Keep out of the reach of children! Shelf life: 5 years Do not use after expiration date! Conditions for dispensing from pharmacies By prescription Manufacturer Astellas Pharma Europe B.V., Silviusweg 62, 2333 EE, Leiden, the Netherlands Registration certificate holder Astellas Pharma Europe B.V., Silviusweg 62, 2333 EE, Leiden, the Netherlands Address of the receiving organization on the territory of the Republic of Kazakhstan, claims from consumers regarding product quality. Representative office in the Republic of Kazakhstan. Almaty, Al-Farabi Ave. 15, PFC "Nurly Tau", building 4B. office 20 tel., fax