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

Pharmacodynamics:antibacterial bactericidal acid-resistant broad spectrum agent from the group of semisynthetic penicillins. It inhibits transpeptidase, breaks the synthesis of peptidoglycan (the supporting protein of the cell wall) in the period of division and growth, causes 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 bacteria: Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Shigella spp., Salmonella spp., Klebsiella spp. The microorganisms 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 in the form of a suspension (or tablets) 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 time to reach 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 purulent bronchial secretion weak), pleural and peritoneal fluid, urine, 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), tissues the fetus. When the dose is doubled, the concentration also doubles. Concentration in the bile exceeds the concentration in the plasma by 2 to 4 times. In amniotic fluid and vessels of the umbilical cord, the concentration of amoxicillin is 25-30% of the level determined in the plasma of a pregnant woman. Poor penetrates the blood-brain barrier, with inflammation of the meninges (meningitis), the concentration in the cerebrospinal fluid is about 20% of the level in the blood plasma. Relationship with plasma proteins 17%.

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

Indications:

Bacterial infections caused by sensitive microflora: infections respiratory tract and ENT organs (sinusitis, pharyngitis, tonsillitis, acute otitis media, bronchitis, pneumonia), genitourinary system (pyelonephritis, pyelitis, cystitis, urethritis, gonorrhea, endometritis, cervicitis), gastrointestinal tract (enterocolitis, typhoid, cholangitis, cholecystitis), skin and soft tissue infections (rye, impetigo, secondarily infected dermatoses), leptospirosis, listeriosis, Lyme disease (borreliosis), dysentery, salmonellosis, salmonella, endocarditis (prophylaxis).

Contraindications:

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

Carefully:allergic diseases (including history), a history of gastrointestinal disease (especially colitis associated with the use of antibiotics), kidney failure, severe violations of the liver, pregnancy, lactation, infectious mononucleosis, lymphocytic leukemia.

Pregnancy and lactation:

The use of the drug during pregnancy is possible only in the case when The estimated 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; with a severe course of infection 0.75-1.0 g 3 times a day.

Children aged 5-10 years are prescribed 0.25 g; 3-5 years 0,125 g 3 times a day; with a severe course of infection 60 mg / kg / day in 3 doses (maximum daily dose). The course of treatment is 5-12 days.

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 fever) 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 prophylaxis of endocarditis with small surgical interventions for adults 3-4 g for 1 hour before the procedure. If necessary, re-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 hours; when 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: hives, hyperemia of the skin, erythema, angioedema, rhinitis, conjunctivitis; rarely - fever, joint pain, eosinophilia, exfoliative dermatitis, polymeric exudative erythema, 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, hepatic dysfunction, a moderate increase in activity of "liver" transaminases, pseudomembranous enterocolitis.

From the nervous system: agitation, anxiety, insomnia, ataxia, confusion, behavior change, depression, peripheral neuropathy, headache, dizziness, convulsive 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 reduced resistance of the body).

Overdose:

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

Treatment: gastric lavage, the appointment of activated charcoal, saline laxatives, correction of 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) - 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, drugs, in the process of metabolism of which forms para-aminobenzoic acid, 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 functions of the organs of hematopoiesis, liver and kidneys.

Perhaps the development of superinfection due to the growth of microflora resistant to Amoxicillin, which requires a corresponding change in antibacterial therapy.

In the treatment of patients with bacteremia, the development of an endotoxic shock reaction (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 should avoid antidiarrhoeal drugs that reduce peristalsis of the intestine. With severe diarrhea, a specialist consultation is necessary.

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, other or additional methods of contraception should be used whenever possible.

Form release / dosage:Tablets 250 mg, 500 mg.

Packaging:For 5 or 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

For 5 tablets in a contour mesh box made of aluminum foil of multi-layer and aluminum foil printed lacquered.

For 20 tablets in a plastic bottle with a screw cap or a polymer can with a screw cap.For 2 or 4 contour packs of 5 tablets, 1 or 2 contour packs of 10 tablets or 1 bottle or 1 jar, together with the instructions for use are placed in a pack of cardboard.

Storage conditions:In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:2 years. Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-001568/08

Date of registration:14.03.2008

The owner of the registration certificate:AVVA RUS, OJSC AVVA RUS, OJSC Russia

Manufacturer: & nbsp

AVVA RUS, OJSC Russia

Information update date: & nbsp23.09.2014

Illustrated instructions

Instructions

Ecobol® (Ecobol®)