Amoxicillin - instructions for use, dose, side effects, contraindications

Excipients: Potato starch is 104.5 mg or 170.7 mg, talc is 11.1 mg or 21.0 mg, Tween 80 (polysorbate 80) 0.7 mg or 1.3 mg, magnesium stearate 3, 7 mg or 7.0 mg.

Description:Tablets are white or almost white in color, flat-cylindrical, with a facet and a risk.

Pharmacotherapeutic group:Antibiotic, penicillin semisynthetic

ATX: & nbsp

J.01.C.A.04 Amoxicillin

Pharmacodynamics:

Antibacterial bactericidal acid-resistant broad spectrum agent from the group of semisynthetic penicillins. Inhibits transpeptidase, breaks the synthesis of peptidoglycan (supporting cell wall protein) in the period of division and growth; causes bacterial lysis. Due to the broad spectrum of action, the drug is active against both gram-positive and gram-negative microorganisms. Clinically significant, gram-negative microorganisms, sensitive to amoxicillin include. Escherichia coli, Proteus mirabilis, Salmonella, Shigella, Campilobacter, Haemophilus influenzae, Bordetella pertussis, Leptospira, Chlamydia.

Besides, amoxicillin is active against all microorganisms sensitive to penicillin G, for example, group streptococci A,B,C,G,H,I,M, Streptococcus pneumoniae, staphylococci and Neisseria spp, not producing penicillinase, Erysipelothrix rhysiopathiae, Corynebacterium, Bacillus anthracis, Actinomycetes, Streptobacilli, Spirillium minus, Pastereulla multocida, Listeria, Spirochaeta (Leptospira, Treponema, Borrelia) and others, as well as various anaerobic microorganisms (including peptococci, peptostreptococcus, clostridia and fuso bacteria).

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 μg / ml and 3.5-5 μg / ml, respectively. The effect develops 15-30 minutes after application and lasts 8 hours. The time of reaching the maximum concentration after oral administration is 1-2 hours.

Has a large volume of distribution - high concentrations are found in plasma, sputum, bronchial secretion (in the purulent bronchial secretion is weak), pleural and peritoneal fluid, urine, skin blisters, lung tissue, intestinal mucosa, female genital organs, prostate gland, fluid middle ear, 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. The amniotic fluid and cord blood vessels, the concentration of amoxicillin of 25-30% of the level in the plasma of pregnant women. Poorly penetrates the blood-brain barrier, inflammation of the meninges (meningitis) concentrations in the cerebrospinal fluid - approximately 20%. The connection with plasma proteins is 17%.

Partially metabolized with, the formation of inactive metabolites. Half-life is 1-1.5 hours. It is excreted 50-70% by kidneys in unchanged form by tubular excretion (80%) and glomerular filtration (20%), liver - 10-20%. In small amounts excreted in breast milk. When violation of renal function (creatinine clearance less than or equal to 15 ml / min) half-life was increased to 8.5 hours. Amoxicillin is removed during hemodialysis.

Indications:Bacterial infections caused by susceptible to amoxicillin microorganisms: respiratory infections and ENT (sinusitis, pharyngitis, tonsillitis, acute otitis media, bronchitis, pneumonia), urinary system (pyelonephritis, pyelitis, cystitis, urethritis, gonorrhea, endometritis, cervicitis) , the gastrointestinal tract (peritonitis, enterocolitis, typhoid fever,cholangitis, cholecystitis), skin and soft tissue infections (erysipelas, impetigo, secondarily infected dermatoses), leptospirosis, acute and latent listeriosis, Lyme disease (borreliosis), dysentery, salmonellosis, salmonellae, bacterial meningitis (depending on the results of sensitivity testing. in children), infective endocarditis, for example, enterococcal (isolatedbut or in combination with aminoglycosides), septicemia caused by microorganisms that are sensitive to amoxicillin.

Contraindications:

Hypersensitivity to the drug components (including other penicillins, cephalosporins, carbapenems), allergic diseases (in including history), bronchial asthma, pollinosis, infectious mononucleosis, lymphocytic leukemia, hepatic insufficiency, colitis associated with the use of antibiotics, including history, lactation, children under 10 years of age with a body weight of less than 40 kg.

Carefully:Pregnancy, allergic reactions, (including in the anamnesis), a history of the gastrointestinal tract, renal insufficiency, as well as with a history of bleeding.

Pregnancy and lactation:

Possible use of amoxicillin during pregnancy in the case when the benefit to the mother exceeds the potential risk to the fetus

Amoxicillin is excreted in breast milk in low concentrations. If it is necessary to use the drug during lactation, it should be decided whether to stop breastfeeding.

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 once a day; in severe infection - 0.75-1 g 3 times a day.

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.

In severe infections (meningitis, septicemia), adults - up to 6 g per day in 3-4 reception. Children - 250-500 mg 3 times a day. The duration of treatment depends on the indications and the clinical picture and is usually 5-7 days. When otitis and similar infections, children have a two-time intake of Amoxicillin.In cases of chronic diseases, recurrent infections, infections of severe course, adults are prescribed 750 mg -1 g 3 times a day, children up to 60 mg / kg per day divided into 3 doses.

When leptospirosis adults - 0.5-0.75 g 4 times a day for 6-12 days. With adult listeriosis, 0.5 g 3 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 half.

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

Side effects:

Allergic reactions: skin rash, hyperemia, itching, urticaria, erythema, angioedema, rhinitis, conjunctivitis; fever, joint pain, eosinophilia, exfoliative dermatitis, polymeric exudative erythema, Stevens-Johnson syndrome; reactions similar to serum sickness, toxic epidermal necrolysis, generalized exanthematous pustules, allergic vasculitis, anaphylactic shock.

From the digestive system: dysbacteriosis, taste change, vomiting, nausea, diarrhea, stomatitis, glossitis, impaired liver function, moderate increase in the activity of "liver" transaminases, cholestatic jaundice, hepatic cholestasis, acute cytolytic hepatitis, pseudomembranous colitis.

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

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

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

Overdose:

Symptoms: nausea, vomiting, diarrhea, violation of water-electrolyte balance (as a consequence of vomiting and diarrhea).

Treatment: gastric lavage, Activated carbon, salt laxatives, preparations for maintaining 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, cycloserine, vancomycin, rifampicin) - synergistic effect; bacteriostatic drugs (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, means, in the process of metabolism of which parahaminobenzoic acid is formed, ethinyl estradiol - the risk of bleeding "breakthrough".

Diuretics,allopurinol, oxyphenbutazone, phenylbutazone non-steroidal anti-inflammatory drugs; drugs that block tubular secretion - reducing tubular secretion, increase concentration.

Allopurinol increases the risk of skin rash. Reduces clearance and increases the toxicity of methotrexate. Increases the absorption of digoxin.

Special instructions:

In course treatment it is necessary to monitor the status of the function 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.

In the treatment of patients with bacteremia, the development of a reaction, bacteriolysis (the Yarisch-Gerxheimer reaction) is possible.

In patients who are hypersensitive to penicillins, there may be cross-allergic reactions with cephalosporin antibiotics.

In the treatment of mild diarrhea against the background of course treatment, antidiarrheal drugs should be avoided, which reduce intestinal peristalsis; 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.

With the simultaneous use of estrogen-containing oral contraceptives and amoxicillin, as far as possible other or additional methods of contraception.

Effect on the ability to drive transp. cf. and fur:

Data on the adverse effects of the drug at recommended doses for the ability to drive or work with machinery is not available.

Form release / dosage:

Tablets of 250 mg and 500 mg.

Packaging:10 tablets per contour cell pack. On -1 or 2 contour packs along with the instruction are placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N001781 / 01-2002

Date of registration:03.12.2008 / 13.10.2011

Expiration Date:Unlimited

The owner of the registration certificate:BIOCHEMIST, OJSC BIOCHEMIST, OJSC Russia

Manufacturer: & nbsp

BIOCHEMIST, OJSC Russia

Information update date: & nbsp19.08.2017

Illustrated instructions

Instructions

Amoxicillin (Amoxicillin)