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Amosin 250 mg No. 10 tablet.

Instructions for medical use of the drug AMOSIN® Trade name AMOSIN® International nonproprietary name Amoxicillin Dosage form Tablets, 250 mg, 500 mg Composition One tablet contains the active substance - amoxicillin trihydrate (in terms of amoxicillin) 250 mg, 500 mg, excipients: starch potato, magnesium stearate, talc, povidone, calcium stearate. Description Tablets are white or almost white, flat-cylindrical with a chamfer and a score. Pharmacotherapeutic group Antibacterial drugs for systemic use. Beta-lactam antibacterial drugs - penicillins. Broad-spectrum penicillins. Amoxicillin ATC code J01CA04 Pharmacological properties Pharmacokinetics Absorption - fast, high (93%), food intake does not affect absorption, is not destroyed in the acidic environment of the stomach. When taken orally at a dose of 125 and 250 mg, the maximum concentration is 1.5-3 and 3.5-5 mcg/ml, respectively. The time to reach maximum concentration after oral administration is 1-2 hours. It has a large volume of distribution: found in high concentrations in plasma, sputum, bronchial secretions (distribution in purulent bronchial secretions is weak), pleural and peritoneal fluid, urine, contents of skin blisters, tissue lung, intestinal mucosa, female genital organs, prostate gland, middle ear fluid (with inflammation), bone, adipose tissue, gall bladder (with normal liver function), fetal tissue. When the dose is doubled, the concentration also doubles. The concentration in bile exceeds the concentration in plasma by 2-4 times. In the amniotic fluid and umbilical cord vessels, the concentration of amoxicillin is 25-30% of the level in the plasma of a pregnant woman. It penetrates poorly through the blood-brain barrier, but with inflammation of the meninges, the concentration in the cerebrospinal fluid is about 20% of the level in plasma. Communication with plasma proteins - 17%. Partially metabolized to form inactive metabolites. The half-life is 1-1.5 hours. It is excreted 50-70% by the kidneys unchanged (by tubular secretion - 80% and glomerular filtration - 20%), by the liver - 10-20%. A small amount is excreted in breast milk. If renal function is impaired (creatinine clearance (CC) less than or equal to 15 ml/min), the half-life increases to 8.5 hours. Amoxicillin is removed by hemodialysis. Pharmacodynamics Amosin® is a broad-spectrum bactericidal antibiotic from the group of semisynthetic penicillins. It disrupts the synthesis of peptidoglycan (the supporting polymer of the cell wall) during division and growth, causing lysis of bacteria. Active against: aerobic gram-positive microorganisms: Staphylococcus spp. (except for penicillinase-producing strains), Streptococcus spp. and aerobic gram-negative microorganisms: Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Shigella spp., Salmonella spp., Klebsiella spp. Strains producing penicillinase are resistant to amoxicillin. Indications for use - bronchitis, pneumonia - sinusitis, pharyngitis, tonsillitis, acute otitis media - pyelonephritis, pyelitis, cystitis, urethritis, gonorrhea, endometritis, cervicitis - cholangitis, cholecystitis, dysentery, salmonellosis, salmonellosis carriage - erysipelas, impetigo, secondary infected dermatoses - leptospirosis - listeriosis - Lyme disease (borreliosis) - endocarditis (prevention) Method of administration and dosage: Orally, taken regardless of meals. The tablet can be swallowed whole, split into pieces, or chewed with a glass of water. Adults and children over 10 years of age (weighing more than 40 kg) are prescribed 500 mg 3 times a day; for severe infection - 750-1000 mg 3 times a day. Children aged 6-10 years are prescribed 250 mg 3 times a day; for severe infection – 60 mg/kg/day 3 times a day. The course of treatment is 5-12 days. For acute uncomplicated gonorrhea, 3000 mg is prescribed once; when treating women, it is recommended to re-take the indicated dose every other day. For acute infectious diseases of the gastrointestinal tract (paratyphoid fever, typhoid fever) and biliary tract, for gynecological infectious diseases for adults - 1500-2000 mg 3 times a day or 1000-1500 mg 4 times a day. For leptospirosis in adults - 500-750 mg 4 times a day for 6-12 days. For salmonella carriage in adults - 1500-2000 mg 3 times a day for 2-4 weeks. For the prevention of endocarditis during minor surgical interventions in adults – 3000-4000 mg 1 hour before the procedure. If necessary, a repeat dose is prescribed after 8-9 hours. In children, the repeat dose is reduced by 2 times. In patients with impaired renal function with CC 15-40 ml/min, the interval between doses is increased to 12 hours; when CC is below 10 ml/min, the dose is reduced by 15-50%; for anuria - maximum dose 2000 mg/day. Side effects - dysbacteriosis, taste changes, stomatitis, glossitis, vomiting, nausea, diarrhea, moderate increase in the activity of "liver" transaminases - pseudomembranous enterocolitis - agitation, anxiety, insomnia, ataxia, confusion, behavior changes, depression, peripheral neuropathy, headache , dizziness, epileptic reactions - leukopenia, neutropenia, thrombocytopenic purpura, anemia - urticaria, skin hyperemia, erythematous rashes, angioedema, rhinitis, conjunctivitis; rarely - fever, arthralgia, eosinophilia, exfoliative dermatitis, exudative erythema multiforme (including Stevens-Johnson syndrome), reactions similar to serum sickness, very rarely - anaphylactic shock - other: vaginal candidiasis, difficulty breathing, tachycardia, interstitial nephritis, superinfection (especially in patients with chronic diseases or reduced body resistance) Contraindications - hypersensitivity to the drug (including other penicillins, cephalosporins, carbapenems) - children under 6 years of age (for this dosage form) - lactation period Drugs interactions Antacids, glucosamine, laxatives, food, aminoglycosides slow down and reduce absorption; ascorbic acid increases absorption. Bactericidal antibiotics (including aminoglycosides, cephalosporins, vancomycin, rifampicin) have a synergistic effect; bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonistic. Increases the effectiveness of indirect anticoagulants (suppressing intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index); reduces the effectiveness of estrogen-containing oral contraceptives; drugs, during the metabolism of which para-aminobenzoic acid is formed, ethinyl estradiol - the risk of developing “breakthrough” bleeding. Amoxicillin reduces the clearance and increases the toxicity of methotrexate; enhances the absorption of digoxin. Diuretics, allopurinol, oxyphenbutazone, phenylbutazone, nonsteroidal anti-inflammatory drugs, and other drugs that block tubular secretion increase the concentration of amoxicillin in the blood. Allopurinol increases the risk of developing skin rashes. Special instructions With caution: allergic diseases (including a history), a history of gastrointestinal diseases (especially colitis associated with the use of antibiotics), renal failure, severe liver dysfunction, infectious mononucleosis, lymphocytic leukemia. During a course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver and kidneys. It is possible that superinfection may develop due to the growth of microflora that is insensitive to it, which requires a corresponding change in antibacterial therapy. When prescribed to patients with sepsis, a bacteriolysis reaction (Jarisch-Herxheimer reaction) may develop (rarely). In patients who are hypersensitive to penicillins, cross-allergic reactions with other beta-lactam antibiotics are possible. When treating mild diarrhea during a course of treatment, antidiarrheal drugs that reduce intestinal motility should be avoided; You can use kaolin- or attapulgite-containing antidiarrheal agents. If diarrhea is severe, consult a doctor. Treatment must continue for another 48-72 hours after the disappearance of clinical signs of the disease. When using estrogen-containing oral contraceptives and amoxicillin simultaneously, other or additional methods of contraception should be used. Pregnancy and lactation The use of the drug during pregnancy is possible when the expected benefit to the mother outweighs the potential risk to the fetus. If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped. Features of the effect of the drug on the ability to drive a vehicle or operate potentially dangerous mechanisms There have been no reports of the effect of amoxicillin on driving or operating machinery. However, some patients may experience headache and dizziness. If they occur, the patient must take special precautions when driving and operating machinery. Overdose Symptoms: nausea, vomiting, diarrhea, water and electrolyte imbalance (as a result of vomiting and diarrhea). Treatment: gastric lavage, activated carbon, saline laxatives, medications to maintain water and electrolyte balance; hemodialysis. Release form and packaging Tablets 250 mg, 500 mg. 10 tablets in a blister pack made of polyvinyl chloride film and printed varnished aluminum foil. 1 blister pack with instructions for medical use in the state and Russian languages is placed in a cardboard pack. Storage conditions Store in a dry place, protected from light at a temperature not exceeding 25 ºС. Keep out of the reach of children! Shelf life: 2 years Do not use after expiration date. Conditions for dispensing from pharmacies By prescription. 640008, Russia, Kurgan, Constitution Avenue, 7 Tel/fax E-mail Website: https://www.kurgansintez.ru Manufactured by order of POLLO LLC 640000, Russia, Kurgan, st. Lenina, 5, of. 320 Owner of the registration certificate POLLO LLC, Russia Address of the organization that accepts claims from consumers on the quality of products on the territory of the Republic of Kazakhstan STOFARM LLP, 000100, Republic of Kazakhstan, Kostanay region, Kostanay, st. Uralskaya, 14 tel.