Amoxicillin Ecobol, tablets 500 mg 20 pcs

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Indications

Bacterial infections caused by sensitive microflora:

– infections of the respiratory tract and ENT organs (sinusitis, pharyngitis, tonsillitis, acute otitis media; bronchitis, pneumonia);

– infections of the genitourinary system (pyelonephritis, pyelitis, cystitis, urethritis, gonorrhea, endometritis, cervicitis);

— gastrointestinal infections (enterocolitis, typhoid fever, cholangitis, cholecystitis);

– infections of the skin and soft tissues (erysipelas, impetigo, secondary infected dermatoses);

– leptospirosis;

– listeriosis;

– Lyme disease (borreliosis);

– dysentery;

— salmonellosis, salmonella carriage;

— endocarditis (prevention).

Pharmacological effect

Pharmacotherapeutic group: Antibiotic-penicillin semi-synthetic

ATC: J01CA04 Amoxicillin
Pharmacodynamics:

Antibacterial, bactericidal, acid-resistant, broad-spectrum agent from the group of semi-synthetic penicillins.

Inhibits transpeptidase, disrupts the synthesis of peptidoglycan (supporting protein of the cell wall) during division and growth, and causes lysis of bacteria.

Active against aerobic gram-positive microorganisms: Staphylococcus spp. (except for penicillinase-producing strains), Streptococcus spp; and aerobic gram-negative bacteria: Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Shigella spp., Salmonella spp., Klebsiella spp.

Microorganisms that produce penicillinase are resistant to amoxicillin.

Pharmacokinetics:

Absorption – fast, high (93%), food intake does not affect absorption, is not destroyed in the acidic environment of the stomach.

When taken orally in the form of a suspension (or tablets) at a dose of 125 and 250 mg, the maximum concentration is 1.5-3 mcg/ml and 3.5-5 mcg/ml, respectively. Time to reach maximum concentration after oral administration is 1-2 hours.

It has a large volume of distribution – high concentrations are found in plasma, sputum, bronchial secretions (in purulent bronchial secretions the distribution is weak), pleural and peritoneal fluid, urine, the contents of skin blisters, lung tissue, intestinal mucosa, female genital organs, prostate gland, middle ear fluid, 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 determined in the plasma of a pregnant woman. It penetrates poorly through the blood-brain barrier; in case of inflammation of the meninges (meningitis), the concentration in the cerebrospinal fluid is about 20% of the level in the blood 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% unchanged by the kidneys 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 less than or equal to 15 ml/min), the half-life increases to 8.5 hours.

Amoxicillin is removed by hemodialysis.

Special instructions

During a course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver and kidneys.

Superinfection may develop due to the growth of microflora resistant to Amoxicillin, which requires a corresponding change in antibacterial therapy.

When treating patients with bacteremia, the development of an endotoxic shock reaction (Jarisch-Herxheimer reaction) is possible.

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

When treating mild diarrhea during a course of treatment, antidiarrheal drugs that reduce intestinal motility should be avoided. For severe diarrhea, consultation with a specialist is necessary.

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 if possible.

Active ingredient

Amoxicillin

Composition

1 tab. amoxicillin (in trihydrate form) 500 mg

Excipients:

lactulose – 600 mg,

low molecular weight povidone – 10 mg,

crospovidone (kollidon CL-M) – 50 mg,

croscarmellose sodium – 70 mg,

talc – 28 mg,

magnesium stearate – 14 mg,

potato starch – up to 1400 mg.

Pregnancy

The use of the drug during pregnancy is possible only if 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.

Contraindications

– hypersensitivity (including to other penicillins, cephalosporins, carbapenems);

– children under 3 years of age (for this dosage form).

The drug should be prescribed with caution in case of allergic diseases (including a history), a history of gastrointestinal diseases (especially colitis associated with the use of antibiotics), renal failure, severe liver dysfunction, pregnancy, lactation, infectious mononucleosis, lymphocytic leukemia.

Side Effects

Allergic reactions: possible urticaria, skin hyperemia, erythema, angioedema, rhinitis, conjunctivitis; rarely – fever, joint pain, eosinophilia, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, reactions similar to serum sickness; in isolated cases – anaphylactic shock.

From the digestive system: dysbacteriosis, change in taste, vomiting, nausea, diarrhea, stomatitis, glossitis, impaired liver function, moderate increase in the activity of liver transaminases, pseudomembranous enterocolitis.

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

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

Other: difficulty breathing, tachycardia, interstitial nephritis, vaginal candidiasis, superinfection (especially in patients with chronic diseases or reduced body resistance).

Interaction

Antacids, glucosamine, laxatives, food, aminoglycosides – slow down and reduce absorption; ascorbic acid increases absorption.

Bactericidal antibiotics (including aminoglycosides, cephalosporins, vancomycin, rifampicin) – 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 whose metabolism produces para-aminobenzoic acid, ethinyl estradiol – the risk of breakthrough bleeding.

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

Allopurinol increases the risk of developing skin rashes.

Reduces clearance and increases toxicity of methotrexate.

Enhances the absorption of digoxin.

Overdose

Symptoms: nausea, vomiting, diarrhea, water and electrolyte imbalance (as a result of vomiting and diarrhea).

Treatment: gastric lavage, administration of activated carbon, saline laxatives, correction of water and electrolyte balance; hemodialysis.

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life

2 years.

Do not use the drug after the expiration date.

Manufacturer

ABVA RUS, Russia