Ekobol

General characteristics. Structure:

Active agent: amoxicillin (in the form of trihydrate) 250 mg

Excipients: lactulose - 300 mg, povidone low-molecular - 5 mg, кросповидон (коллидон CL-M) - 25 mg, croscarmellose sodium - 35 mg, talc - 14 mg, magnesium stearate - 7 mg, potato starch - to 700 mg.

Active agent: amoxicillin (in the form of trihydrate) 500 mg

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

Pharmacological properties:

Antibacterial bactericidal acid resisting broad-spectrum agent from group of semi-synthetic penicillin. Inhibits transpeptidase, breaks synthesis of a peptidoglikan (basic protein of a cell wall) during division and growth, causes a lysis of bacteria. It is active concerning aerobic gram-positive microorganisms: Staphylococcus spp. (except for the strains producing a penicillinase), Streptococcus spp; and aerobic gram-negative bacteria: Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Shigella spp., Salmonella spp., Klebsiella spp. The microorganisms producing a penicillinase, rezistentna to effect of amoxicillin.
The lactulose which is Ekobol's part as a bifidogenny factor is synthetic disaccharide which molecule consists of the remains of a galactose and fructose. Lactulose in a stomach and upper parts of intestines is not soaked up and not hydrolyzed. Ekobolalaktuloza who is released from tablets as substrate is fermented by normal microflora of a large intestine, stimulating growth of bifidobacteria and lactobacilli. As a result of hydrolysis of lactulose in a large intestine organic acids - milk, acetic and ant, suppressing growth of pathogenic microorganisms and reducing thereof products of nitrogen-containing toxic substances are formed.
Thus, lactulose as a part of Ekobol reduces the damaging action of an antibiotic on the normal intestinal microflora and risks of side effects connected with disbioza.

Pharmacokinetics. Absorption – bystry, high (93%), meal does not exert impact on absorption, does not collapse in acid medium of a stomach. At intake in the form of suspension (or tablets) in a dose of 125 and 250 mg, the maximum concentration – 1.5-3 mkg/ml and 3.5-5 mkg/ml, respectively. Time of achievement of the maximum concentration after oral administration 1-2 hours. Has the large volume of distribution - high concentration are found in plasma, a phlegm, a bronchial secret (in a purulent bronchial secret distribution weak), pleural and peritoneal liquid, urine, contents of skin blisters, lung tissue, a mucous membrane of intestines, female generative organs, a prostate, liquid of a middle ear, a bone, fatty tissue, a gall bladder (at normal function of a liver), fruit fabrics. At increase in a dose twice concentration also increases twice. Concentration in bile exceeds concentration in plasma by 2 - 4 times. In amniotic liquid and vessels of an umbilical cord concentration of amoxicillin - 25-30% of the level determined in plasma of the pregnant woman. Badly gets through a blood-brain barrier, at an inflammation of a meninx (meningitis) concentration in cerebrospinal fluid about 20% of plasma level. Communication with proteins of plasma of 17%.

Partially metabolizes with formation of inactive metabolites. Elimination half-life 1-1,5 hours. It is brought to 50-70% by kidneys in not changed look by canalicular excretion (80%) and glomerular filtering (20%), to cookies - 10-20%. In a small amount it is allocated with breast milk. At a renal failure (the clearance of creatinine less or is equal to 15 ml/min.) the elimination half-life increases to 8.5 h. Amoxicillin is removed at a hemodialysis.

The lactulose which is Ekobol's part does not exert impact on the key pharmacokinetic parameters characterizing bioavailability of amoxicillin.

Indications to use:

The bacterial infections caused by sensitive microflora:
— respiratory infection and ENT organs (sinusitis, pharyngitis, tonsillitis, acute average otitis; bronchitis, pneumonia);
— infections of urinogenital system (pyelonephritis, pyelitis, cystitis, urethritis, gonorrhea, endometritis, cervicitis);
— digestive tract (coloenteritis, typhoid, cholangitis, cholecystitis);
— infections of skin and soft tissues (the ugly face, impetigo for the second time infected a dermatosis);
— hay fever;
— listeriosis;
— disease Laima (borreliosis);
— dysentery;
— salmonellosis, salmonellonositelstvo;
— endocarditis (prevention).

Route of administration and doses:

Inside, to or after meal.

To adults and children 10 years are more senior (with body weight more than 40 kg) appoint 0.5 g 3 times/days; at the heavy course of an infection of 0.75-1.0 g 3 times/days.
To children appoint in the form of suspension for intake: at the age of 5-10 years 0.25 g; 3-5 years 0.125 g 3 times/days; at the heavy course of an infection of 60 mg/kg of weight of 3 times/days.
At acute uncomplicated gonorrhea appoint 3 g once; at treatment of women repeated reception of the specified dose is recommended.
At GIT acute infectious diseases (paratyphus, a typhoid) and bilious ways, at gynecologic infectious diseases of adult 1.5-2 g 3 times a day or 1-1.5 g 4 times/days.
At a hay fever of adult 0.5-0.75 g 4 times / сут.в current of 6-12 days.
At a salmonellonositelstvo of adult 1.5-2 g 3 times/days within 2-4 weeks.
For prevention of an endocarditis at small surgical interventions of adult 3-4 g in 1 hour prior to holding a procedure. If necessary appoint a repeated dose in 8-9 hours. At children the dose is reduced twice. At patients with a renal failure at KK of 15-40 ml/min., the interval between receptions is increased till 12 o'clock; at clearance of creatinine lower than 10 ml/min. reduce a dose by 15-50%; at an anury the maximum dose of 2 g/days.

Features of use:

At course treatment it is necessary to carry out control of a condition of function of bodies of a hemopoiesis, a liver and kidneys.
Development of superinfection due to growth of microflora, resistant to Amoksitsillin, is possible that demands corresponding change of antibacterial therapy.
At treatment of patients with bacteremia development of reaction of endotoxic shock (Yarisha-Gerksgeymer's reaction) is possible.
At the patients having hypersensitivity to penicillin cross allergic reactions with tsefalosporinovy antibiotics are possible.
At treatment of slight diarrhea against the background of course treatment it is necessary to avoid the antidiarrheal drugs reducing an intestines peristaltics. At heavy diarrhea consultation of the specialist is necessary.
Treatment surely continues 48-72 more h after disappearance of clinical signs of a disease.
At simultaneous use of estrogensoderzhashchy oral contraceptives and amoxicillin, it is necessary to use whenever possible other or additional methods of contraception.

Side effects:

From a nervous system: excitement, uneasiness, sleeplessness, ataxy, confusion of consciousness, change of behavior, depression, peripheral neuropathy, headache, dizziness, convulsive reactions.
From the alimentary system: dysbacteriosis, taste change, vomiting, nausea, diarrhea, stomatitis, glossitis, abnormal liver function, moderate increase in activity of "hepatic" transaminases, pseudomembranous coloenteritis.
From system of a hemopoiesis: leukopenia, neutropenia, Werlhof's disease, anemia.
Allergic reactions: the small tortoiseshell, a dermahemia, an erythema, a Quincke's disease, rhinitis, conjunctivitis are possible; seldom - fever, joint pains, an eosinophilia, exfoliative dermatitis, a poliformny exudative erythema, Stephens-Johnson's syndrome; reactions similar to a serum disease; in isolated cases - an acute anaphylaxis.
Others: the complicated breath, tachycardia, intersticial nephrite, vagina candidiasis, superinfection (especially at patients with chronic diseases or the lowered resistance of an organism).

Interaction with other medicines:

Antacids, glycosamine, purgatives, food, aminoglycosides - slow down and reduce absorption; ascorbic acid increases absorption. Bactericidal antibiotics (including aminoglycosides, cephalosporins, Vancomycinum, rifampicin) - sinergidny action; bacteriostatic drugs (macroleads, chloramphenicol, linkozamida, tetracyclines, streptocides) - antagonistic. Increases efficiency of indirect anticoagulants (suppressing intestinal microflora, reduces synthesis of vitamin K and a prothrombin ratio); reduces efficiency of estrogensoderzhashchy oral contraceptives, medicines in the course of which metabolism paroaminobenzoyny acid, ethinylestradiol - risk of development of bleedings of "break" is formed. Diuretics, Allopyrinolum, оксифенбутазон, the phenylbutazone, non-steroidal anti-inflammatory drugs, drugs blocking canalicular secretion - reducing canalicular secretion, increase concentration. Allopyrinolum increases risk of development of skin rash. Reduces clearance and increases toxicity of a methotrexate. Strengthens digoxin absorption.

Contraindications:

— hypersensitivity (including to other penicillin, cephalosporins, karbapenema);
— allergic diathesis;
— bronchial asthma;
— pollinosis;
— infectious mononucleosis;
— lymphoid leukosis;
— liver failure;
— digestive tract diseases in the anamnesis (especially the colitis connected using antibiotics);
— lactation period;
— children's age up to 3 years (for this dosage form);
— with care – pregnancy, a renal failure, bleedings in the anamnesis, allergic reactions (including in the anamnesis).

Use of the drug EKOBOL® at pregnancy and feeding by a breast
Drug with care is used at pregnancy. Use of drug when breastfeeding is contraindicated.

Use at abnormal liver functions
It is contraindicated at a liver failure.

Use at renal failures
Drug with care is appointed the patient with a renal nedostastochnost.

Use for children
It is contraindicated for children up to 3 years (for this dosage form). Appointment in the form of suspension for intake is recommended.

Overdose:

Symptoms: nausea, vomiting, diarrhea, disturbance of water and electrolytic balance.

Treatment: gastric lavage, purpose of absorbent carbon, salt laxatives, correction of water and electrolytic balance, hemodialysis.

Storage conditions:

List B. In the dry, protected from light place, at a temperature not above 25 °C.
To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets of 250 mg: 10 or 20 pieces.

Tablets of 500 mg: 10 or 20 pieces.