Ekoklav powder d / prig. Susp. d / ave. inside 250 + 62.5mg / 5ml, 25 g

Infectious and inflammatory diseases caused by pathogens sensitive to the drug:

-infections of the lower respiratory tract (bronchitis, pneumonia);

- infections of ENT organs (sinusitis, tonsillitis, otitis media);

-infections of the genitourinary system and pelvic organs (pyelonephritis, pyelitis, cystitis, urethritis, bacterial prostatitis, cervicitis, salpingitis, salpingo-oophoritis, endometritis, bacterial vaginitis, septic abortion, chancre, gonorrhea);

-infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses, abscess, phlegmon, wound infection);

-infections of bones and joints (osteomyelitis)

Inside. The dosage regimen is set individually depending on the patient's body weight, the severity of the course and localization of the infectious process, as well as the sensitivity of the pathogen.

The minimum course of antibiotic therapy is from 5 days.

Treatment should not be continued for more than 14 days without reviewing the clinical situation. The duration of treatment for acute uncomplicated otitis media is 5-7 days, in children under 2 years of age - 7-10 days.

A single dose is set depending on age and body weight (calculation for amoxicillin):

Children under 3 months - 30 mg / kg / day in 2 divided doses;

Children from 3 months and older: low doses (for the treatment of infections of the skin and soft tissues, as well as chronic tonsillitis) - 20 mg / kg / day in 3 divided doses;

high doses (for the treatment of otitis media, sinusitis, lower respiratory tract infections, urinary tract infections) - 40 mg / kg / day in 3 divided doses.

Children weighing 40 kg or more should be given doses as adults.

The suspension can be used in adults with difficulty swallowing.

Recommended dosing regimen for adults:

20 ml of suspension at a dosage of 125 mg + 31.25 mg / 5 ml or 10 ml of suspension at a dosage of 250 mg + 62.5 mg / 5 ml 2-3 times / day.

The maximum daily dose of amoxicillin for adults and children over 12 years old is 6 g, for children under 12 years old - 45 mg / kg body weight. The maximum daily dose of clavulanic acid for adults and children over 12 years old is 600 mg, for children under 12 years old - 10 mg / kg.

Patients with impaired renal function:

Dose adjustments are based on the maximum recommended dose of amoxicillin and creatinine clearance.

Children

A creatinine clearance of more than 30 ml / min dose adjustment is not required;

Creatinine clearance 10-30 ml / min - 15 mg / 3.75 mg / kg 2 times / day, maximum dose 500 mg + 125 mg (20 ml suspension at a dosage of 125 mg + 31.25 mg / 5 ml or 10 ml suspension at a dosage of 250 mg +62.5 mg / 5 ml) 2 times / day;

Creatinine clearance less than 10 ml / min - 15 mg / 3.75 mg / kg 1 time / day, maximum daily dose of 500 mg + 125 mg (20 ml of suspension at a dosage of 125 mg + 31.25 mg / 5 ml or 10 ml of suspension at a dosage of 250 mg +62.5 mg / 5 ml);

Adults

A creatinine clearance of more than 30 ml / min dose adjustment is not required;

Creatinine clearance 10-30 ml / min - 500 mg + 125 mg (20 ml of suspension at a dosage of 125 mg + 31.25 mg / 5 ml or 10 ml of suspension at a dosage of 250 mg + 62.5 mg / 5 ml) 2 times / day;

Creatinine clearance less than 10 ml / min - 500 mg + 125 mg (20 ml of suspension at a dosage of 125 mg + 31.25 mg / 5 ml or 10 ml of suspension at a dosage of 250 mg + 62.5 mg / 5 ml) 1 time / day;

Patients on hemodialysis:

Dose adjustments are based on the maximum recommended dose of amoxicillin

Children - 15 mg / 3.75 mg / kg 1 time / day. One additional dose of 15 mg / 3.75 mg / kg should be taken before a hemodialysis session.

To restore the concentration of the active components of the drug in the blood, a second additional dose of 15 mg / 3.75 mg / kg should be taken after a hemodialysis session.

Adults - 500 mg + 125 mg (20 ml of suspension at a dosage of 125 mg + 31.25 mg / 5 ml or 10 ml of suspension at a dosage of 250 mg + 62.5 mg / 5 ml) once every 24 hours.

Additionally 1 dose during the dialysis session and another dose at the end of the dialysis session (to compensate for the decrease in serum concentrations of amoxicillin and clavulanic acid)

Suspension preparation method:

The suspension is prepared immediately before use. The powder in the vial is pre-shaken, then, adding a small amount of boiled and cooled to room temperature water, mix, obtaining a homogeneous suspension, then add water to the mark on the vial. For accurate dosing of the suspension, use a double-sided dosing spoon, which must be rinsed well with water after each use. After reconstitution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen.

Powder for preparation of suspension for oral administration from white to almost white color, with a weak fruity odor; prepared suspension from almost white to light yellow, with a fruity odor.

5 ml ready-made suspension.

amoxicillin (in the form of trihydrate) 250 mg

clavulanic acid (in the form of potassium clavulanate) 62.5 mg

Excipients: lactulose - 400 mg, aspartame - 5.5 mg, colloidal silicon dioxide (aerosil) - 16.885 mg, xanthan gum - 10 mg, crospovidone (Kollidon CL-M) - 28.1 mg, anhydrous citric acid - 2.165 mg, sodium citrate dihydrate - 8.335 mg, sodium benzoate - 2.085 mg, talc - 25 mg, orange flavor - 4 mg, mannitol (mannitol) - up to 1.25 g.

• Hypersensitivity (including to cephalosporins and other beta-lactam antibiotics);

• Infectious mononucleosis;

• episodes of jaundice or liver dysfunction as a result of amoxicillin / clavulanic acid use in history; phenylketonuria (contains aspartame).

  Carefully:

• Severe liver failure, diseases of the gastrointestinal tract (including a history of colitis associated with the use of penicillins), chronic renal failure.

pharmachologic effect

Combined preparation of amoxicillin and clavulanic acid - a beta-lactamase inhibitor. Amoxicillin is a semi-synthetic broad-spectrum antibiotic; acts bactericidal, inhibiting the protein synthesis of the cell wall of sensitive bacteria at the growth stage. Clavulanic acid has a high affinity for bacterial beta-lactamases and forms a stable complex with them. Thus, the biodegradation of amoxicillin by beta-lactamases is prevented, and the bactericidal activity of the antibiotic is preserved. Clavulanic acid inhibits type II-V beta-lactamases according to the Richmond-Sykes classification and is inactive against type I beta-lactamases produced by Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp.The combined preparation of amoxicillin and clavulanic acid according to the results of in vitro tests and clinical studies is active against the following microorganisms: Gram-positive aerobic microorganisms: Staphylococcus aureus (strains producing and non-producing beta-lactamases); Gram-negative aerobic microorganisms: Enterobacter spp. (despite the fact that most Enterobacter strains are resistant in vitro, the effectiveness of the drug has been clinically proven in the treatment of infectious diseases of the urinary system caused by this causative agent); Escherichia coli (strains producing and non-producing beta-lactamases); Haemophilus influenzae (strains producing and non-producing beta-lactamases); Klebsiella spp. (all known strains produce beta-lactamases); Moraxella catarrhalis (strains,producing and non-producing beta-lactamases). According to the results of in vitro studies, sensitivity to the combination of amoxicillin and clavulanic acid of the following microorganisms is shown: Gram-positive aerobic microorganisms: Enterococcus faecalis **; Staphylococcus epidermidis (strains producing and non-producing beta-lactamases); Staphylococcus saprophyticus (strains producing and non-producing beta-lactamases); Streptococcus pneumoniae ** (does not produce beta-lactamase); Streptococcus pyogenes ** (does not produce beta-lactamase); Streptococcus spp. group viridans ** (does not produce beta-lactamase). Gram-negative aerobic microorganisms: Eikenella corrodens (strains producing and non-producing beta-lactamases); Neisseria gonorrhoeae ** (strains producing and non-producing beta-lactamases); Proteus mirabilis ** (strains,producing and non-producing beta-lactamases). Anaerobic microorganisms: Bacteroidesspp., Including Bacteroides fragilis (strains producing and non-producing beta-lactamases); Fusobacterium spp. (strains producing and non-producing beta-lactamases); Peptostreptococcus spp. (does not produce beta-lactamase).

NOTE: ** - (clinically proven the effectiveness of amoxicillin in the treatment of a number of infections caused by these pathogens). Lactulose, which is part of the Ecoclave as a bifidogenic factor, is a synthetic disaccharide, the molecule of which consists of galactose and fructose residues. Lactulose in the stomach and upper intestines is not absorbed or hydrolyzed. The lactulose released from the Ekoklav tablets 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 large intestine, organic acids are formed - lactic, acetic and formic, which suppress the growth of pathogenic microorganisms and, as a result, reduce the production of nitrogen-containing toxic substances. Thus,lactulose in Ecoclave reduces the damaging effect of the antibiotic on the normal intestinal microflora and the risks of side effects associated with dysbiosis.

Pharmacokinetics

Suction.

After oral administration, both components of the drug are rapidly absorbed from the gastrointestinal tract. The absorption of the active ingredients of the preparation is optimal if taken at the beginning of a meal. After oral administration at a dose of 125 mg + 31.25 mg: Cmax of amoxicillin - 1.96 ?g / ml, clavulanic acid - 0.77 ?g / ml; Tmax of amoxicillin - 1.5 h, clavulanic acid - 1.0 h; AUC of amoxicillin - 9.19 mg Х h / l, clavulanic acid - 2.69 mg Х h / l. When using the drug, the concentration of amoxicillin in the blood serum is similar to those for oral administration of equivalent doses of amoxicillin alone.

Distribution.

Both components of the drug are characterized by a good volume of distribution - therapeutic concentrations of amoxicillin and clavulanic acid are created in various organs and tissues, interstitial fluid: lungs, middle ear, abdominal organs, pelvic organs (prostate gland, uterus, ovaries), skin; adipose, bone and muscle tissues; pleural, synovial and peritoneal fluids; plasma, bile, purulent discharge, sputum, bronchial secretions. Amoxicillin and clavulanic acid have a moderate degree of binding to plasma proteins, respectively, by 18% and 25%. Both components of the drug penetrate the placental barrier, however, data on a negative effect on the fetus have not been published. Amoxicillin and clavulanic acid are found in low concentrations in breast milk.

Metabolism, excretion.

Approximately 60-70% of amoxicillin is excreted by the kidneys: by tubular secretion and glomerular filtration unchanged, about 10-25% in the form of inactive penicillic acid. Clavulanic acid is actively metabolized in the liver and excreted by glomerular filtration (40-65%), partly in the form of metabolites. A smaller part is excreted by the intestines. In renal failure, the clearance of amoxicillin with clavulanic acid decreases, so a dose adjustment is required. Lactulose, which is part of Ecoclave, does not affect the main pharmacokinetic parameters characterizing the bioavailability of amoxicillin and clavulanic acid.

Side effect

The drug is well tolerated. Side effects are rare, mostly mild and transient.

From the digestive system: nausea, vomiting, diarrhea, gastritis, stomatitis, glossitis, cholestatic jaundice, hepatitis, liver failure (more often in the elderly, men, with prolonged therapy), colitis (including pseudomembranous), black 'hairy' tongue, darkening of the tooth enamel, an increase in the activity of 'hepatic' transaminases, an increase in the content of bilirubin and the activity of alkaline phosphatase.

From the side of hematopoietic organs: a reversible increase in prothrombin time and bleeding time, thrombocytopenia, thrombocytosis, eosinophilia, leukopenia, agranulocytosis, hemolytic anemia.

From the side of the central nervous system: dizziness, headache, hyperactivity, anxiety, change in behavior, seizures.

Allergic reactions: urticaria, erythematous rash, exudative erythema multiforme, anaphylactic shock, angioedema, exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), allergic vasculitis, a syndrome similar to serum sickness, acute exanthema. From the kidneys and urinary tract: interstitial nephritis, crystalluria, hematuria.

Others: candidiasis, development of superinfection.

Application during pregnancy and lactation

The combined preparation of amoxicillin and clavulanic acid during pregnancy is recommended to be prescribed only in cases where the expected benefit from taking it to the mother outweighs the potential risk to the fetus. The drug can be used during breastfeeding. With the exception of the risk of sensitization associated with the penetration into breast milk of trace amounts of the active ingredients of this drug, no other adverse effects have been identified in breastfed infants.

Application for violations of liver function

Contraindicated in the presence of episodes of jaundice or abnormal liver function as a result of the use of amoxicillin / clavulanic acid in history. Prescribe with caution in severe hepatic impairment.

Application for impaired renal function

Prescribe with caution in chronic renal failure.

Application in children

Application is possible according to the dosage regimen.

special instructions

The severity of gastrointestinal symptoms is reduced when the drug is taken at the beginning of a meal. During the course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver and kidneys. The development of superinfection is possible due to the selection of resistant forms of the pathogen. False positive results may be detected in urine glucose measurements. In this case, it is recommended to use the glucose oxidase method for determining the concentration of glucose in the urine. In patients with hypersensitivity to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible. In case of suspicion of infectious mononucleosis, the drug should not be used, since in patients with this disease, amoxicillin can cause a measles-like skin rash, which makes it difficult to diagnose the disease.Given the likelihood of side effects from the central nervous system, care should be taken when driving and working with moving machinery.

Overdose

Symptoms: dysfunction of the gastrointestinal tract and water-electrolyte balance. Treatment: symptomatic. Hemodialysis is effective.

Drug interactions

It is not recommended to use the combined preparation of amoxicillin and clavulanic acid simultaneously with probenecid. Probenecid reduces the tubular secretion of amoxicillin, therefore, their combined use can lead to an increase and persistence of the concentration of amoxicillin in the serum, while the serum concentration of clavulanic acid does not change. Diuretics, allopurinol, phenylbutazone, nonsteroidal anti-inflammatory drugs and other drugs that block tubular secretion increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration). Antacids, glucosamine, laxatives slow down and reduce the absorption of amoxicillin; ascorbic acid - increases. Allopurinol increases the risk of skin rashes. Like other broad-spectrum antibiotics,the combined preparation of amoxicillin and clavulanic acid may reduce the effectiveness of oral contraceptives, and patients should be informed about this. The literature describes rare cases of an increase in the international normalized ratio (INR) in patients with the combined use of acenocoumarol or warfarin and amoxicillin. If necessary, the simultaneous use of a combined preparation of amoxicillin and clavulanic acid with indirect anticoagulants, prothrombin time or INR should be carefully monitored when prescribing or discontinuing the drug.The literature describes rare cases of an increase in the international normalized ratio (INR) in patients with the combined use of acenocoumarol or warfarin and amoxicillin. If necessary, the simultaneous use of a combined preparation of amoxicillin and clavulanic acid with indirect anticoagulants, prothrombin time or INR should be carefully monitored when prescribing or discontinuing the drug.The literature describes rare cases of an increase in the international normalized ratio (INR) in patients with the combined use of acenocoumarol or warfarin and amoxicillin. If necessary, the simultaneous use of a combined preparation of amoxicillin and clavulanic acid with indirect anticoagulants, prothrombin time or INR should be carefully monitored when prescribing or discontinuing the drug.