Active substanceAmoxicillinAmoxicillin
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  • Dosage form: & nbspcapsules
    Composition:

    Active substance: Amoxicillin trihydrate (in terms of amoxicillin) - 0.250 g.

    Excipient: potato starch.

    The composition of the gelatin capsule: titanium dioxide, methylhydroxybenzoate, propylhydroxybenzoate, acetic acid, gelatin.

    Description:Capsules of white color number 0. Contents of capsules - white granules.
    Pharmacotherapeutic group:Antibiotic, penicillin semisynthetic
    ATX: & nbsp

    J.01.C.A.04   Amoxicillin

    Pharmacodynamics:

    Semisynthetic penicillin, has a bactericidal action, has a wide spectrum of action. Violates the synthesis of peptidoglycan (supporting polymer of the cell wall) in the period of division and growth, causing bacterial lysis.

    It is active against aerobic Gram-positive microorganisms: Staphylococcus spp. (with the exception of strains producing penicillinase), 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 the action of amoxicillin.

    Pharmacokinetics:

    Absorption - fast, high (93%), food intake does not affect absorption, does not break down in the acidic environment of the stomach. When administered orally at a dose of 125 and 250 mg, the maximum concentration is 1.5-3 and 3.5-5 μg / ml, respectively.The time to reach the maximum concentration after oral administration is 1-2 hours. It has a large volume of distribution: it is found in high concentrations in plasma, sputum, bronchial secretion (in the purulent bronchial secretion the distribution is weak), pleural and peritoneal fluid, urine, skin blisters, tissue light, mucous membrane of the intestine, female genital organs, prostate gland, middle ear fluid (with its inflammation), bone, adipose tissue, gall bladder (with normal liver function), fetal tissues. When the dose is doubled, the concentration also doubles. Concentration in bile exceeds the concentration in plasma by 2-4 times. In amniotic fluid and vessels of the umbilical cord, the concentration of amoxicillin is 25-30% of the level in the plasma of a pregnant woman. Poor penetration of the hemato-encephalic barrier, with inflammation of the meninges, concentration in the cerebrospinal fluid is about 20% of the level in the plasma. The connection with plasma proteins is 17%.

    Partially metabolized with the formation of inactive metabolites. The half-life is -1-1.5 hours. It is excreted by 50-70% by kidneys in unchanged form (by tubular secretion - 80% and glomerular filtration - 20 %), liver - 10-20%. In small amounts excreted in breast milk.

    Amoxicillin is removed during hemodialysis.

    Indications:

    Bacterial infections caused by susceptible pathogens: lower respiratory infections (bronchitis, pneumonia) and ENT (sinusitis, pharyngitis, tonsillitis, acute otitis media), urinary system (pyelonephritis, pyelitis, cystitis, urethritis, gonorrhea, endometritis, cervicitis) gastrointestinal tract (cholangitis, cholecystitis, dysentery, salmonellosis, salmonella carrier), skin and soft tissue infections (erysipelas, impetigo, secondarily infected dermatoses), leptospirosis, listeriosis, Lyme disease (borreliosis), endocarditis (prophylaxis).

    Contraindications:

    Hypersensitivity (including to other penicillins, cephalosporins, carbapenems), children under 3 years (for a given dosage form).

    Carefully:

    Allergic diseases (including history), diseases of the gastrointestinal tract in history (especially colitis, associated with the use of antibiotics), kidney failure, severe liver problems, pregnancy, lactation, infectious mononucleosis, lymphatic leukemia.

    Pregnancy and lactation:

    The use of the drug during pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus. If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

    Dosing and Administration:

    Inside, before or after eating.

    Adults and children over 10 years of age (with a body weight of more than 40 kg) are prescribed 0.5 g 3 times a day; in severe infection - 0.75-1 g 3 times a day. Children aged 5-10 years are prescribed 0.25 g three times a day; younger than 5 years - is administered as a suspension. The course of treatment is 5-12 days depending on the form and severity disease. In acute uncomplicated gonorrhea appoint 3 g once; in the treatment of women, repeated intake of this dose is recommended.

    In acute infectious diseases of the gastrointestinal tract (paratyphoid, typhoid) and biliary tract, with gynecological infectious diseases, adults -1.5-2 g 3 times a day or 1-1.5 g 4 times a day.

    When leptospirosis adults - 0.5-0.75 g 4 times a day for 6-12 days.

    With salmonella carrying adults - 1.5-2 g 3 times a day for 2-4 weeks. For the prevention of endocarditis with small surgical interventions for adults - 3-4 g for 1 h before the procedure.If necessary, appoint a second dose after 8-9 hours. In children, the dose is reduced by 2 times.

    In patients with impaired renal function with creatinine clearance (CK) of 15-40 ml / min, the interval between doses is increased to 12 h; at CC below 10 ml / min the dose is reduced by 15-50%; with anuria - the maximum dose of 2 g / day.

    Side effects:

    Allergic reactions: possible urticaria, skin hyperemia, erythematous rashes, angioedema, rhinitis, conjunctivitis; rarely - fever, arthralgia, eosinophilia, exfoliative dermatitis, multiform exudative erythema (including Stevens-Johnson syndrome); reactions similar to serum sickness; in isolated cases - anaphylactic shock.

    From the gastrointestinal tract: dysbacteriosis, taste change, vomiting, nausea, diarrhea, stomatitis, glossitis, moderate increase in the activity of "liver" transaminases, rarely - pseudomembranous enterocolitis.

    From the nervous system: agitation, anxiety, insomnia, ataxia, confusion, behavior change, depression, peripheral neuropathy, headache, dizziness, epileptic reactions.

    Laboratory indicators: leukopenia, neutropenia, thrombocytopenic purpura, anemia.

    Other: shortness of breath, tachycardia, interstitial nephritis, vaginal candidiasis, superinfection (especially in patients with chronic diseases or low resistance body).

    Overdose:

    Symptoms include nausea, vomiting, diarrhea, disruption of water and electrolyte balance (as a result of vomiting and diarrhea).

    Treatment: gastric lavage, Activated carbon, salt laxatives, medicines to maintain the water-electrolyte balance; hemodialysis.

    Interaction:

    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 medicinal products (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonistic.

    Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index); reduces the effectiveness of estrogen-containing oral contraceptives; medicines,in the process of metabolism of which forms para-aminobenzoic acid, ethinyl estradiol - the risk of bleeding "breakthrough".

    Amoxicillin reduces clearance and increases the toxicity of methotrexate; increases absorption of digoxin.

    Diuretics, allopurinol, oxyphenbutazone, phenylbutazone, non-steroidal anti-inflammatory drugs, and other drugs that block tubular secretion, increase the concentration of amoxicillin in the blood.

    Allopurinol increases the risk of skin rash.

    Special instructions:

    In course treatment it is necessary to monitor the status of the functions of the organs of hematopoiesis, liver and kidneys.

    It is possible to develop superinfection due to the growth of insensitive microflora, which requires a corresponding change in antibacterial therapy.

    When appointing patients with sepsis, the development of a bacteriolysis reaction (the Yarisch-Gerxheimer reaction) is possible (rarely).

    In patients who have increased sensitivity to penicillins, there may be cross-allergic reactions with other beta-lactam antibiotics.

    In the treatment of mild diarrhea against the background of course treatment should be avoided antidiarrheal drugs,reducing peristalsis of the intestine; it is possible to use kaolin- or attapulgite-containing antidiarrhoeic agents. With severe diarrhea, you should see a doctor.

    Treatment necessarily continues for another 48-72 hours after the disappearance of clinical signs of the disease.

    When using estrogen-containing oral contraceptives and amoxicillin concomitantly, other or additional methods of contraception should be used whenever possible.

    Form release / dosage:Capsules 250 mg.
    Packaging:

    For 10 pieces in a planar cell pack.

    1 or 2 contour cells with instructions for use are placed in a pack of cardboard.
    Storage conditions:

    List B. In a dry, the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:

    4 years. Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:P N000748 / 01
    Date of registration:08.10.2007
    Expiration Date:Unlimited
    The owner of the registration certificate:POLLO, LLC POLLO, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspSYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products SYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products Russia
    Information update date: & nbsp19.08.2017
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