Ecobol pills 500mg №20

Release form, composition and packaging

white or almost white, capsule-shaped, with a risk.

Excipients: lactulose - 300 mg, low molecular weight povidone - 5 mg, crospovidone (collidon CL-M) - 25 mg, croscarmellose sodium - 35 mg, talc - 14 mg, Magnesium stearate - 7 mg, potato starch - up to 700 mg.

white or almost white, capsule-shaped, with a risk.

Excipients: lactulose - 600 mg, low molecular weight povidone - 10 mg, crospovidone (collidon CL-M) - 50 mg, croscarmellose sodium - 70 mg, talc - 28 mg, magnesium stearate - 14 mg, potato starch - up to 1400 mg.

pharmachologic effect

Antibacterial, bactericidal, acid-resistant, broad-spectrum agent from the group of semi-synthetic penicillins. Inhibits transpeptidase, violates the synthesis of peptidoglycan (cell wall supporting protein) during the period of division and growth, causes lysis of bacteria. 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. Penicillinase-producing microorganisms are resistant to Amoxicillin.

Lactulose, which is part of Ecobol as a bifidogenic factor, is a synthetic disaccharide whose molecule consists of galactose and fructose residues. Lactulose in the stomach and upper intestines is not absorbed and does not hydrolyze. Ecobolaculose released from pills as a substrate is fermented by the normal microflora of the large intestine, stimulating the growth of bifidobacteria and lactobacilli. As a result of hydrolysis of lactulose in the colon, organic acids are formed - lactic, acetic and formic acids, which inhibit the growth of pathogenic microorganisms and, as a result, reduce the production of nitrogen-containing toxic substances.

Thus, lactulose in the composition of Ecobolreduces the damaging effect of the antibiotic on the normal intestinal microflora and the risks of side effects associated with dysbiosis.

Pharmacokinetics

Absorption - fast, high (93%), food intake does not affect absorption, does not collapse in the acidic environment of the stomach. When administered as 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. The time to reach maximum concentration after oral administration is 1-2 hours. It has a large amount of distribution - high concentrations are found in plasma, sputum, bronchial secretion (in the purulent bronchial secretion distribution is weak), pleural and peritoneal fluid, urine, blister contents, lung tissue, intestinal mucosa, female genitals, prostate gland, middle ear fluid, bone, adipose tissue, gall bladder (with normal liver function), fetal tissues. With an increase in dose of 2 times the concentration also increases by 2 times. Concentration in bile exceeds plasma concentration by 2 - 4 times. In amniotic fluid and umbilical cord vessels, amoxicillin concentration 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 plasma level. Communication with plasma proteins 17%.

Partially metabolized to form inactive metabolites. The half-life is 1-1.5 hours. It is eliminated by 50–70% by the kidneys unchanged by tubular excretion (80%) and glomerular filtration (20%), by the liver - 10–20%. In small quantities excreted in breast milk. In case of kidney dysfunction (creatinine clearance less than or equal to 15 ml / min), the elimination half-life increases to 8.5 h. Amoxicillin is removed during hemodialysis.

Lactulose, which is part of Ecobol, does not affect the main pharmacokinetic parameters characterizing the bioavailability of amoxicillin.

Dosage

Inside, before or after meals.

Adults and children over 10 years old (weighing more than 40 kg) are prescribed 0.5 g 3 times / day; with severe infection 0.75-1.0 g 3 times / day.

Children are prescribed as a suspension for oral administration: at the age of 5-10 years old 0.25 g; 3-5 years 0.125 g 3 times / day; with severe infection 60 mg / kg of body weight 3 times / day.

In acute uncomplicated gonorrhea, 3 g is administered once; When treating women, it is recommended to re-take the indicated dose.

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

In adults with leptospirosis, 0.5–0.75 g 4 times / day for 6–12 days.

For adults, Salmonello 1.5-2 g 3 times / day for 2-4 weeks.

For the prevention of endocarditis in small surgical interventions for adults 3-4 g for 1 hour before the procedure. If necessary, appoint a repeated dose after 8-9 hours. In children, the dose is halved. In patients with impaired renal function with CC 15-40 ml / min, the interval between doses increase to 12 hours; with creatinine clearance below 10 ml / min, the dose is reduced by 15-50%; Anuria with a maximum dose of 2 g / day.

Overdosage

Symptoms: nausea, vomiting, diarrhea, disruption of water and electrolyte balance.

Treatment: gastric lavage, the appointment of Activated carbon, saline laxatives, correction of water and electrolyte balance, hemodialysis.

Drug 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, linkosamides, tetracyclines, sulfonamides) - antagonistic.Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index); reduces the effectiveness of estrogen-containing oral contraceptives, drugs, in the process of metabolism of which paroaminobenzoic acid is formed,  ethinyl estradiol - the risk of bleeding "breakthrough." Diuretics, Allopurinol, oxyphenbutazone, phenylbutazone, nonsteroidal 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. Strengthens Digoxin absorption.

Pregnancy and lactation

The drug is used with caution during pregnancy. Use of the drug is contraindicated in breastfeeding.

Side effects

Nervous system disorders: arousal, anxiety, insomnia, ataxia, confusion, behavior change, depression, peripheral neuropathy, headache, dizziness, convulsive reactions.

On the part of the digestive system: dysbacteriosis, change in taste, vomiting, nausea, diarrhea, stomatitis, glossitis, abnormal liver function, a moderate increase in the activity of “liver” transaminases, pseudomembranous enterocolitis.

Hemic and lymphatic: leukopenia, neutropenia, thrombocytopenic purpura, anemia.

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

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

Terms and conditions of storage

Storage conditions:

List B. In a dry, dark place at a temperature not higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years. Do not use the drug after the expiration date.

Indications

Bacterial infections caused by sensitive microflora:

- infections of the respiratory tract and upper respiratory tract (sinusitis, pharyngitis, tonsillitis, acute otitis media; bronchitis, pneumonia);

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

- gastrointestinal tract (enterocolitis, typhoid fever, cholangitis, cholecystitis);

- infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatosis);

- leptospirosis;

- listeriosis;

- Lyme disease (borreliosis);

- dysentery;

- salmonellosis, salmonello carrier;

- endocarditis (prophylaxis).

Contraindications

- hypersensitivity (including to others.penicillins, cephalosporins, carbapenems);

- Allergic diathesis;

- bronchial asthma;

- pollinosis;

- Infectious mononucleosis;

- lymphocytic leukemia;

- liver failure;

- a history of gastrointestinal diseases (especially colitis associated with the use of antibiotics);

- lactation period;

- children's age up to 3 years (for this dosage form);

- with caution - pregnancy, renal failure, a history of bleeding, allergic reactions (including history).

special instructions

In the course of treatment, it is necessary to monitor the state of the function of the blood-forming 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 reaction of endotoxic shock (the Jarish-Herxheimer reaction) may develop.

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

When treating mild diarrhea on the background of a course of treatment, antidiarrheal drugs that reduce intestinal motility should be avoided. For severe diarrhea, specialist advice is required.

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, if possible, use other or additional methods of contraception.

Use in violation of kidney function

The drug is prescribed with caution in patients with renal impairment.

Use in violation of the liver

Contraindicated in liver failure.