Flemoxin Solutab dispersible tablets 500mg, No. 20

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BIDL3177803
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Expiration Date: 05/2027

Russian Pharmacy name:

Флемоксин Солютаб таблетки диспергируемые 500мг, №20

Flemoxin Solutab dispersible tablets 500mg, No. 20

For use as monotherapy and in combination with clavulanic acid: infectious and inflammatory diseases caused by sensitive microorganisms, incl. bronchitis, pneumonia, tonsillitis, pyelonephritis, urethritis, gastrointestinal tract infections, gynecological infections, infectious diseases of the skin and soft tissues, listeriosis, leptospirosis, gonorrhea.

For use in combination with metronidazole: chronic gastritis in the acute phase, gastric ulcer and duodenal ulcer in the acute phase, associated with Helicobacter pylori.

Individual.

For oral administration, a single dose for adults and children over 10 years old (weighing more than 40 kg) is 250-500 mg, with a severe course of the disease - up to 1 g.

For children aged 5-10 years, a single dose is 250 mg; at the age of 2 to 5 years - 125 mg. The interval between doses is 8 hours.

For children weighing less than 40 kg, the daily dose, depending on the indications and the clinical situation, may be 20-100 mg / kg in 2-3 doses.

In the treatment of acute uncomplicated gonorrhea - 3 g once (in combination with probenecid).

In patients with impaired renal function with CC 10-40 ml / min, the interval between doses should be increased to 12 hours; with CC less than 10 ml / min, the interval between doses should be 24 hours.

Dispersible tablets e. 1 tab. amoxicillin 125mg; 250mg; 500mg; 1000mg

  • Infectious mononucleosis, lymphocytic leukemia, severe gastrointestinal infections accompanied by diarrhea or vomiting, respiratory viral infections, allergic diathesis, bronchial asthma, hay fever, hypersensitivity to penicillins and / or cephalosporins.

  • For use in combination with metronidazole: diseases of the nervous system; hematopoietic disorders, lymphocytic leukemia, infectious mononucleosis; hypersensitivity to nitroimidazole derivatives.

  • For use in combination with clavulanic acid: a history of indications of liver dysfunction and jaundice associated with taking amoxicillin in combination with clavulanic acid.

pharmachologic effect

Antibiotic of the group of semi-synthetic penicillins with a broad spectrum of action. It is a 4-hydroxyl analogue of ampicillin. Has a bactericidal effect. Active against aerobic gram-positive bacteria: Staphylococcus spp. (with the exception of strains producing penicillinase), Streptococcus spp .; aerobic gram-negative bacteria: Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Shigella spp., Salmonella spp., Klebsiella spp. Microorganisms that produce penicillinase are resistant to amoxicillin. In combination with metronidazole, it is active against Helicobacter pylori. It is believed that amoxicillin inhibits the development of resistance of Helicobacter pylori to metronidazole. Cross-resistance exists between amoxicillin and ampicillin.The spectrum of antibacterial action expands with the simultaneous use of amoxicillin and a beta-lactamase inhibitor clavulanic acid. This combination increases the activity of amoxicillin against Bacteroides spp., Legionella spp., Nocardia spp., Pseudomonas (Burkholderia) pseudomallei. However, Pseudomonas aeruginosa, Serratia marcescens, and many other gram-negative bacteria remain resistant.

Pharmacokinetics

When taken orally, amoxicillin is rapidly and completely absorbed from the gastrointestinal tract, it is not destroyed in the acidic environment of the stomach. Cmax of amoxicillin in blood plasma is reached after 1-2 hours. When the dose is doubled, the concentration also doubles. In the presence of food in the stomach, it does not decrease total absorption. With intravenous, intramuscular and intramuscular administration, similar concentrations of amoxicillin are achieved in the blood. Plasma protein binding of amoxicillin is about 20%. It is widely distributed in tissues and body fluids. Reported high concentrations of amoxicillin in the liver. T1 / 2 from plasma is 1-1.5 hours. About 60% of the dose taken orally is excreted unchanged in the urine by glomerular filtration and tubular secretion; at a dose of 250 mg, the concentration of amoxicillin in the urine is more than 300 ?g / ml.A certain amount of amoxicillin is determined in the feces. In newborns and the elderly, T1 / 2 may be longer. In renal failure, T1 / 2 may be 7-20 hours. In small amounts, amoxicillin penetrates the BBB during inflammation of the pia mater. Amoxicillin is removed by hemodialysis.

ѕобочное действие

Allergic reactions: urticaria, erythema, Quincke's edema, rhinitis, conjunctivitis; rarely - fever, joint pain, eosinophilia; in isolated cases - anaphylactic shock. Effects associated with chemotherapeutic action: the development of superinfections is possible (especially in patients with chronic diseases or reduced body resistance). With prolonged use in high doses: dizziness, ataxia, confusion, depression, peripheral neuropathy, convulsions. Mainly when used in combination with metronidazole: nausea, vomiting, anorexia, diarrhea, constipation, epigastric pain, glossitis, stomatitis; rarely - hepatitis, pseudomembranous colitis, allergic reactions (urticaria, angioedema), interstitial nephritis, hematopoietic disorders. Mainly when used in combination with clavulanic acid:cholestatic jaundice, hepatitis; rarely - erythema multiforme, toxic epidermal necrolysis, exfoliative dermatitis.

Application during pregnancy and lactation

Amoxicillin crosses the placental barrier, in small amounts excreted in breast milk. If it is necessary to use amoxicillin during pregnancy, the expected benefits of therapy for the mother and the potential risk to the fetus should be carefully weighed. Use amoxicillin with caution during lactation (breastfeeding).

Application for violations of liver function

Amoxicillin in combination with metronidazole should not be used for liver disease.

Application for impaired renal function

Patients with impaired renal function, the dose and the interval between injections should be adjusted in accordance with the CC values.

Application in children

Application in children is possible according to the dosage regimen. Amoxicillin in combination with metronidazole is not recommended for use in patients under 18 years of age.

special instructions

Use with caution in patients prone to allergic reactions. Amoxicillin in combination with metronidazole is not recommended for use in patients under 18 years of age; should not be used for liver disease. Alcohol consumption is not recommended against the background of combination therapy with metronidazole.

Drug interactions

Amoxicillin may decrease the effectiveness of oral contraceptives. With the simultaneous use of amoxicillin with bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin), synergism is manifested; with bacteriostatic antibiotics (including macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonism. Amoxicillin enhances the effect of indirect anticoagulants by suppressing the intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index. Amoxicillin reduces the effect of drugs, in the process of metabolism of which PABA is formed. Probenecid, diuretics, allopurinol, phenylbutazone, NSAIDs reduce the tubular secretion of amoxicillin, which may be accompanied by an increase in its concentration in the blood plasma. Antacids, glucosamine, laxatives,aminoglycosides slow down and reduce, and ascorbic acid increases the absorption of amoxicillin. With the combined use of amoxicillin and clavulanic acid, the pharmacokinetics of both components does not change.

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