Amoxicillin capsules. 500mg 16 pieces Hemofarm

Description

Composition
Active substance:
Amoxycillin – 500 mg (in trihydrate form).
Excipients:
Magnesium stearate – 9.2 mg Microcrystalline cellulose PH 102 – 26.9 mg. The composition of the capsule shell gelatine – 96 mg, a lid of the capsule – titanium dioxide (E171) – 0.4992 mg, colorant sunset yellow (E110) – 0.13774 mg dye azorubin (E122) – 0.13336 mg capsule body – titanium dioxide (E171) – 0.576 mg iron oxide yellow dye (E172) – 0.26899 mg.
Description:
Hard gelatin capsules number 0: cap – red housing – yellow.
The granulated powder from white to light yellow in color. Presence of compressed powder the cylinder, which, when pressed lightly with a glass rod converted to free-flowing powder.
Product form:
Capsules 500 mg. 8 capsules in blister of PVC film and aluminum foil. 2 blister together with instructions for medical use the drug in a cardboard pack.
Contraindications
Hypersensitivity to amoxicillin, other beta-lactam antibiotics (other penicillins, cephalosporins, monobactams, carbapenems), or any components of the drug; infectious mononucleosis, lymphatic leukemia; children up to 3 years (for a given dosage form).
Dosage
500 mg
Indications
Infectious and inflammatory diseases caused by microorganisms susceptible to amoxicillin: upper respiratory tract infections (tonzillofaringit, sinusitis, acute otitis media); lower respiratory tract infections (acute bacterial bronchitis, acute exacerbations of chronic bronchitis, community-acquired pneumonia); genitourinary infections (pyelonephritis, pyelitis, cystitis, urethritis, endometritis, cervicitis, gonorrhea); abdominal infections (cholangitis, cholecystitis); Helicobacter pylori eradication in patients with gastric ulcer and duodenal ulcer (always in combination with other drugs); infections of skin and soft tissues (erysipelas, impetigo, secondarily infected dermatitis); leptospirosis, listeriosis; Lyme disease; infections of the gastrointestinal tract (enterocolitis, typhoid, dysentery, salmonellosis caused by Salmonella typhi, sensitive to ampicillin, salmonellonositelstvo; prophylaxis of bacterial endocarditis in surgical procedures in the mouth and upper airways.
Interaction with other drugs
Antacids, glucosamine, laxatives, aminoglycosides – slow down and reduce the absorption of amoxicillin; ascorbic acid increases the absorption. Ethanol reduces the rate of absorption of amoxicillin. Amoxicillin enhances the absorption of digoxin. Probenecid, competing for elimination pathway slows the elimination of amoxicillin, which leads to increased concentrations of amoxicillin in the blood plasma. Similarly amoxicillin is reacted with diuretics, nonsteroidal anti-inflammatory drugs (oxyphenbutazone, phenylbutazone, aspirin, indomethacin). Amoxicillin thereby reducing clearance of methotrexate, which may lead to toxic effects of the latter. At the same time taking allopurinol increases the risk of allergic skin reactions. Amoxicillin, suppressing the intestinal microflora, thereby reducing the synthesis of vitamin K and prothrombin index, which increases the efficiency of indirect anticoagulants and drugs, which are formed during the metabolism of para-aminobenzoic acid, which ultimately increases the risk of bleeding “breakthrough”. Amoxicillin reduces the effectiveness of oral contraceptives, as in the changing biocenosis intestine reabsorption of estrogen decreases. If concomitant use of amoxicillin with bactericidal antibiotics (aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) observed synergistic antibacterial action. Bacteriostatic agents (macrolide, chloramphenicol, lincosamides, tetracyclines, sulfonamides), in contrast, impaired bactericidal effect of amoxicillin. Metronidazole increases the antibacterial activity of amoxicillin.
Overdose
Symptoms include nausea, vomiting, diarrhea, disruption of water and electrolyte balance (as a result of vomiting and diarrhea), crystalluria.
Treatment: gastric lavage, activated charcoal, saline laxatives, drugs for normalizing water and electrolyte balance. Amoxicillin is removed in hemodialysis.
pharmachologic effect
Pharmacological group:
an antibiotic, a semisynthetic penicillin
Pharmacodynamics:
Semisynthetic aminopenicillin, antibacterial agent of acid-broad-spectrum belongs to the group of beta-lactam antibiotics. Inhibits transpeptidase, gives peptidoglycan synthesis (reference protein cell wall) between the division and growth, causing bacterial lysis. It is active against aerobic Gram-positive bacteria: Bacillus anthracis, Corynebacterium spp, Enterococcus faecalis, Listeria monocytogenes, Staphylococcus spp.. (Except for strains producing penicillinase), Streptococcus spp., Including Streptococcus pneumoniae; Aerobic gram-negative bacteria: Bordetella pertussis, Brucella spp, Escherichia coli, Haemophilus influenzae, Klebsiella spp, Neisseria gonorrhoeae, Neisseria meningitidis, Shigella spp, Salmonella spp, Pasteurella septica, Proteus mirabilis, Vibrio cholerae;…. Other microorganisms: Clostridium spp, Leptospira spp, as well as Helicobacter pylori, Borrelia burgdorferi… Amoxicillin is exposed to destruction of beta-lactamases, so its spectrum antibacterial activity does not include microorganisms that produce beta-lactamase (penicillinase etc.).
Pharmacokinetics:
Absorption of fast, high (about 93%), food intake has no effect on absorption; Amoxicillin is not destroyed in the acidic environment of the stomach. When administered in a dose of 250 mg of the maximum plasma concentration (C max) achieved in 1-2 hours (TC max), and is 3.5-5 mg / ml. The half-life (T 1/2) – 1-1,5 hours Connection to plasma proteins about 17%.. Intensively distributed in organs and tissues, found in biological fluids and pathological the discharge; It overcomes the blood-tissue barriers, in addition to the blood-brain unchanged. In high concentrations found in plasma, lung, bone and adipose tissue, intestinal mucosa, female genital organs, prostate gland, the gallbladder (with normal liver function), fetal tissues, pleural and peritoneal fluid contents skin blisters, sputum, bronchial secret (to a lesser extent in the purulent material) during inflammation exudate in the middle ear. bile concentration higher than the concentration in the blood plasma in 2-4 times. The amniotic fluid and cord blood vessels amoxycillin concentration is 25-30% of the plasma of pregnant women. When inflammation of the meninges amoxicillin overcomes the blood-brain barrier, its concentration in the cerebrospinal fluid reaches 20% of that in plasma. In a small number of passes into breast milk. With increasing doses of amoxicillin concentration in organs and tissues is increased proportionately. The partially metabolized to inactive penitsillovoy acid. Excreted mainly by the kidneys – 50 – 70% – unchanged by tubular secretion (80%) and glomerular filtration rate (20%) through the intestine – 10 – 20%. When renal impairment (creatinine clearance less than or equal to 15 ml / min) increases the half-life to 8.5 hours.
Pregnancy and breast-feeding
Pregnancy
Results from animal studies do not indicate direct or indirect impact on the reproductive toxicity. Limited data on the use of amoxicillin during pregnancy in humans do not indicate an increased risk of congenital malformations. Amoxicillin can be used during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus.
Breast-feeding
Amoxicillin is released in breast milk in small amounts, if necessary, possible to use the drug during breastfeeding. A child who is breastfed may develop diarrhea, sensitization and fungal infection of the mucous membranes, and may require cessation of breast-feeding. Amoxicillin should be used during breast-feeding only after the evaluation of the physician benefit / risk ratio.
Conditions of supply of pharmacies
On prescription.
side effects
The most commonly reported adverse reactions are diarrhea, nausea, and skin rash. Classification of the incidence of side effects, recommended by the World Health Organization (WHO): very common (> 10%); often (> 1, and 0.1 and 0.01 and
Infectious and parasitic diseases:
rarely – superinfection, especially in patients with chronic diseases or low resistance of the organism; very rarely – candidiasis of the skin and mucous membranes.
Blood disorders and lymphatic system: very rarely – reversible leucopenia (including severe neutropenia or agranulocytosis), reversible thrombocytopenia and hemolytic anemia, increased blood clotting time, prothrombin time increase (see section “Special Instructions”.).
Disorders of immune system: very rarely – severe allergic reactions, including angioedema, anaphylaxis, serum sickness and hypersensitivity vasculitis (see section “Special Instructions”.); the frequency is unknown – Jarisch-Herxheimer, allergic acute coronary syndrome (Kounisa syndrome) (see “Special Instructions” section.).
Violations by the endocrine system: rarely – anorexia; very rarely – hypoglycemia, particularly in patients with diabetes mellitus.
Disorders of the nervous system: common: somnolence, headache; rarely – nervousness, agitation, anxiety, ataxia, behavior change, peripheral neuropathy, anxiety, sleep disturbances, depression, paraesthesia, tremor, confusion; very rarely – hyperkinesia (increased muscle excitability), dizziness and cramps (spasms can occur in patients with renal dysfunction, epilepsy, meningitis or receiving high dose), hyperesthesia, visual, olfactory and tactile sensitivity, hallucinations; the frequency is unknown – aseptic meningitis.
Violations of the heart and blood vessels: often – tachycardia, phlebitis; seldom – a decrease in blood pressure; very rarely – a lengthening of the interval QT.
Violations of the respiratory system: rarely – bronchospasm, shortness of breath; very rarely – hypersensitivity pneumonitis.
Disorders of the gastrointestinal tract: * often – diarrhea and nausea; * rarely – vomiting; rarely – indigestion, pain in the epigastric region; very rarely – colitis associated with the use of antibiotics (including pseudomembranous colitis and hemorrhagic colitis, see “Special Instructions”.), black “hairy” tongue; the frequency is unknown – a change of taste, stomatitis, glossitis.
Violations by the liver and zhelchevyvyvodyaschih tract: often – increased bilirubin in the serum; very rarely – hepatitis and cholestatic jaundice, a moderate increase in aspartate aminotransferase activity (ACT) and / or alanine aminotransferase (ALT), alkaline phosphatase, gamma-glutamyl transferase in blood plasma, acute liver failure.
Violations of the skin and subcutaneous tissue: * often – skin rash; * rarely – urticaria, and pruritus; very rarely – photosensitivity, swelling of the skin and mucous membranes, skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis, acute generalized exanthematous pustulosis (OGEP) (see “Special instructions.”) and drug rash with eosinophilia and systemic symptoms (DRESS-syndrome).
Violations of the musculoskeletal tissue: rarely – arthralgia, myalgia, tendon disorders including tendinitis; very rarely – tendon rupture (possible bilateral and 48 hours after starting treatment), muscle weakness, rhabdomyolysis.
Violations by the kidneys and urinary tract: rarely – increased creatinine concentration in blood serum; very rarely – interstitial nephritis, crystalluria (see “Special Instructions” and “Overdose”.).
General disorders and at the injection site: rarely – weakness; very rare – fever.
* The incidence of these adverse reactions was obtained by the results of clinical studies involving, in all, about 6,000 adult and pediatric patients being treated with amoxicillin.
special instructions
Before the appointment of amoxicillin like all penicillins should be carefully collected history for allergic reactions to penicillins, cephalosporins and other beta-lactam antibiotics, taking into account possible cross-reactions. Serious and occasionally fatal hypersensitivity reactions (including anaphylactic and severe skin reactions) have been reported in patients treated with penicillin. The development of these reactions are more likely in patients with hypersensitivity to penicillin in history and those with atopy. If you experience an allergic reaction it is necessary to discontinue therapy with amoxicillin and assign the appropriate alternative therapy. There were rare cases of hypersensitivity reaction of allergic type of acute coronary syndrome (syndrome Kounisa), the appropriate treatment applied in the case of its development in the treatment of amoxicillin. With prolonged use may develop cases of superinfection, candidiasis (particularly vulvovaginal candidiasis). Seizures may occur in patients with impaired renal function or in patients receiving high doses, or with predisposing factors (e.g., the presence of a history of seizures, epilepsy or treatment of meningitis). In renal insufficiency, it is necessary to adjust the dosing regimen, depending on the degree of renal failure. The appearance of generalized erythema with fever accompanied pustules, early treatment can be symptomatic OGEP (see. The section “Side effect”). This adverse reaction requires discontinuation of treatment with amoxicillin and is a contraindication to its use in the future under any circumstances. It should avoid the use of amoxycillin in suspected patient of infectious mononucleosis as appearance morbilliform rash has been associated with the use of amoxycillin in the treatment of infectious mononucleosis. Jarisch-Herxheimer observed after administration of amoxicillin in patients with Lyme disease (see. Section “Side effects”). Its immediate cause is the bactericidal activity of amoxicillin against bacteria which cause Lyme disease spirochete Borrelia burgdorferi. Patients should be reassured that this reaction is a frequent and usually the result of their own extending the use of antibiotics in patients with Lyme disease. Treatment necessarily continues for 48-72 hours after the disappearance of clinical signs of disease. When you receive almost all antibiotics may develop antibiotic-associated colitis up to life-threatening condition. This should be considered when a diarrhea during antibiotic treatment or after its completion. In the case of an antibiotic-associated colitis, drug therapy should be discontinued immediately and consult your doctor for appropriate treatment. The use of drugs that inhibit intestinal peristalsis, are contraindicated. If treatment is necessary to control the state functions of blood, liver and kidneys. It reported increased activity of “liver” enzymes, and changes in the number of blood cells. At simultaneous reception with anticoagulants there is an increase in prothrombin time. There should be proper monitoring and possibly correction (reduction) of the dose of anticoagulant. In patients with reduced urine output crystalluria rarely observed, mainly with parenteral therapy. When high doses of amoxycillin is recommended to maintain an adequate fluid intake and urine output to reduce the possibility of crystalluria associated with the use of amoxycillin. In patients with bladder catheterization is necessary to regularly check the patency of the catheter. High concentrations of amoxicillin give a false positive reaction in the glucose urine using Benedict’s reagent or Fehling’s solution. We recommend using the glucose oxidase enzyme test. The use of amoxicillin may distort the results of the quantitative determination of estriol in the urine of pregnant women. Caution should be used drug in the elderly, pregnant women, lactating. In applying amoxicillin for treatment of Helicobacter pylori infection should take into account the information specified in the text document for medical use other simultaneously used drugs.
Ability to drive is not carried out mechanisms. Patients should be warned about the possibility of allergic reactions, dizziness and cramps, which may affect the ability to drive vehicles, machinery. When the described adverse events should refrain from carrying out these activities.
Storage conditions
At temperatures above 25 ° C in a consumer package. Keep out of the reach of children.
Dosing and Administration
Inside, before or after a meal.
Dose Amoxicillin depends on the sensitivity of the pathogen, disease severity and localization of the infectious process.
To ensure the below dosage regimen for children up to 12 years, preferably taking the drug Amoxicillin granules for suspension for oral administration, 250 mg / 5 ml.
Adults and children over 13 years old and / or weighing more than 40 kg
Typically prescribed 250 mg – 500 mg 3 times a day, or 500 mg – 1000 mg 2 times a day. Sinusitis, pneumonia and other serious infections, it is recommended to appoint 500 mg – 1000 mg 3 times a day. The maximum daily dose – 6 g
Children 3 to 5 years and / or a body weight of 15 kg to 19 kg
Typically prescribed 250 mg 2 times a day. In cases where a high probability of infection caused by resistant Streptococcus pneumoniae, higher recommended dose – 500 mg 2-3 times a day.
Children aged 5 to 13 years and / or a body weight of 19 kg to 40 kg
Usually recommend 250 mg 3 times a day. In cases where a high probability of infection caused by resistant Streptococcus pneumoniae, higher doses are recommended – 500-1000 mg three times a day. The maximum daily dose for children – 100 mg / kg / day.
Lyme disease (borreliosis) – early stage
Adults and children over 13 years old and / or weighing more than 40 kg
500-1000 мг 3 раза в сутки до максимальной суточной дозы, равной 4 г, поделенной на несколько приемов, в течение 14 дней (10-21 день).
Дети от 3 до 5 лет и/или массой тела от 15 кг до 19 кг
250 мг 3 раза в сутки.
Дети от 5 до 13 лет и/или массой тела от 19 кг до 40 кг
500 мг 2-3 раза в сутки (из расчета 50 мг/кг/сут, поделенные на 3 приема).
Эрадикация Helicobacter pylori у больных с язвенной болезнью желудка или двенадцатиперстной кишки (всегда в комбинации с другими препаратами)
Взрослым 1000 мг 2 раза в сутки в комбинации с ингибиторами протонной помпы (например, омепразол, лансопразол) и другим антибиотиком (например, кларитромицин, метронидазол) в течение 7 дней.
Детям старше 13 лет и/или массой тела более 40 кг — 1000 мг 2 раза в составе комбинированной терапии.
Дети от 3 до 5 лет и/или массой тела от 15 кг до 19 кг 250-500 мг 2 раза в сутки.
Дети от 5 до 13 лет и/или массой тела от 19 кг до 40 кг 500-1000 мг 2 раза в сутки (из расчета 50 мг/кг/сут, поделенные на 2 приема).
Профилактика бактериального эндокардита
Взрослые и дети старше 13 лет и/или массой тела более 40 кг
Рекомендуется 2 г (или из расчета 50 мг/кг/сут) за 0,5-1 час до хирургического вмешательства.
Дети от 3 до 5 лет и/или массой тела от 15 кг до 19 кг 750-1000 мг (из расчета 50 мг/кг/сут) перед процедурой.
Дети от 5 до 13 лет и/или массой тела от 19 кг до 40 кг
1000-2000 мг (из расчета 50 мг/кг/сут) перед процедурой.
При почечной недостаточности
У пациентов с клиренсом креатинина (КК) >30 мл/мин отсутствует необходимость в коррекции дозы. При КК
КК Режим дозирования препарата у взрослых и детей с массой тела 40 кг и более
Режим дозирования препарата у детей с массой тела менее 40 кг 10-30 мл/мин
Максимальная доза 500 мг 2 раза в сутки
Стандартная доза 2 раза в сутки (что соответствует приему 2/3 дозы)
Стандартная доза 1 раз в сутки (что соответствует приему 1/3 дозы)
Пациенты, находящиеся на гемодиализе Амоксициллин может быть удален из кровообращения путем гемодиализа.
Гемодиализ
Взрослые и дети с массой тела более 40 кг 500 мг каждые 24 часа. Перед процедурой гемодиализа следует дополнительно назначить дозу 500 мг. Для восстановления уровня концентрации циркулирующего препарата необходимо после окончания процедуры гемодиализа также назначить 500 мг.
Дети с массой тела менее 40 кг 15 мг/кг/сутки 1 раз в сутки. Перед процедурой гемодиализа следует назначить дополнительную дозу из расчета 15 мг/кг массы тела. Для восстановления уровня концентрации циркулирующего препарата необходимо после окончания процедуры гемодиализа также назначить дозу из расчета 15 мг/кг массы тела.
Пациенты, находящиеся на перитонеальном диализе
Максимальная доза амоксициллина 500 мг/сутки).
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist