Ecoclave 125 mg, 31.25 mg, 5 ml instructions for use

Compound

Composition of components in 5 ml of the finished suspension (one dosage spoon):

active substances:

amoxicillin trihydrate 144 mg / 287 mg (in terms of amoxicillin) 125 mg / 250 mg, potassium clavulanate + silicon dioxide (1:1) 74.85 mg / 149.70 mg (in terms of clavulanic acid) 31.25 mg / 62.5 mg

Excipients:

aspartame 5.5 mg / 5.5 mg, xanthan gum 10.0 mg / 10.0 mg, crospovidone (kollidon CL-M) 28.1 mg / 28.1 mg, anhydrous citric acid 2.165 mg / 2.165 mg, sodium citrate dihydrate 8.335 mg / 8.335 mg, sodium benzoate 2.085 mg / 2.085 mg, talc 25.0 mg / 25.0 mg, strawberry flavor 40.0 mg / 40.0 mg, mannitol (mannitol) - up to powder weight 1.25 g/ 1.25 g

Description

White to almost white powder with a faint fruity odor. After dissolution in water, an almost white to light yellow suspension with a fruity odor is formed.

Pharmacotherapeutic group:

Antibiotic - semi-synthetic penicillin + beta-lactamase inhibitor.

ATX code:

J01CR02

Pharmacological properties

Pharmacodynamics

Mechanism of action

Amoxicillin is a semisynthetic broad-spectrum antibiotic that is active against many gram-positive and gram-negative microorganisms. At the same time, amoxicillin is susceptible to destruction by beta-lactamases, and therefore the spectrum of activity of amoxicillin does not extend to microorganisms that produce this enzyme.

Clavulanic acid is a beta-lactamase inhibitor, structurally related to penicillins, and has the ability to inactivate a wide range of beta-lactamases found in microorganisms resistant to penicillins and cephalosporins. Clavulanic acid is sufficiently effective against plasmid beta-lactamases, which most often cause bacterial resistance, and is not effective against type 1 chromosomal beta-lactamases, which are not inhibited by clavulonic acid.

The presence of clavulonic acid in Ecoclave® protects amoxicillin from destruction by enzymes - beta-lactamases, which allows expanding the antibacterial spectrum of amoxicillin.

in vitro activity of the combination of amoxicillin and clavulanic acid :

Bacteria usually susceptible to the combination of amoxicillin and clavulonic acid

Gram-positive
aerobes

Bacillus anthracis
Enterococcus faecalis
Listeria monocytogenes
Nocardia asteroidеs
Streptococcus pyogenes1,2
Streptococcus agalactiae1,2
Streptococcus spp. (other beta-hemolytic streptococci)1,2
Staphylococcus aureus (methicillin sensitive)1
Staphylococcus saprophyticus (methicillin sensitive)
Coagulase-negative staphylococci (methicillin sensitive)

Gram-positive anaerobes

Clostridium spp.
Peptococcus niger
Peptostreptococcus magnum
Peptostreptococcus micros
Peptostreptococcus spp.

Gram-negative aerobes

Bordetella pertussis
Haemophilus influenzae1
Helicobacter pylori
Moraxella catarrhalis1
Neisseria gonorrhoeae
Pasteurella multocida
Vibrio cholerae

Gram-negative
anaerobes

Bacteroides fragilis
Bacteroides spp.
Capnocytophaga spp.
Eikenella corrodens
Fusobacterium nucleatum
Fusobacterium spp.
Porphyromonas spp.
Prevotella spp.

Others

Borrelia burgdorferi
Leptospira icterohaemorrhagiae
Treponema pallidum

Bacteria for which acquired resistance to the combination of amoxicillin and clavulonic acid is likely

Gram-negative aerobes

Escherichia coli1
Klebsiella oxytoca
Klebsiella pneumoniae1
Klebsiella spp.
Proteus mirabilis
Proteus vulgaris
Proteus spp.
Salmonella spp.
Shigella spp.

Gram-positive
aerobes

Corynebacterium spp.
Enterococcus faecium
Streptococcus pneumoniae1,2
Streptococci of the Viridians group

Bacteria that are naturally resistant to the combination of amoxicillin and clavulonic acid

Gram-negative aerobes

Acinetobacter spp.
Citrobacter freundii
Enterobacter spp.
Hafnia alvei
Legionella pneumophila
Morganella morganii
Providencia spp.
Pseudomonas spp.
Serratia spp.
Stenotrophomonas maltophilia
Yersinia enterocolitica

Others

Chlamydia pneumoniae
Chlamydia psittaci
Chlamydia spp.
Coxiella burnetii
Mycoplasma spp.

1 – for these bacteria, the clinical effectiveness of the combination of amocricillin with clavulonic acid has been demonstrated in clinical studies.

2 – strains of these types of bacteria do not produce beta-lactamases. Sensitivity during monotherapy with amoxicillin suggests similar sensitivity to the combination of amoxicillin with clavulonic acid.

Pharmacokinetics

Suction

Both active ingredients of Ecoclave®, amoxicillin and clavulanic acid, are quickly and completely absorbed from the gastrointestinal tract (GIT) after oral administration. Absorption of the active ingredients of the drug Ecoclave® is optimal if the drug is taken at the beginning of a meal.

The following shows the pharmacokinetic parameters of amoxicillin and clavulanic acid obtained in different studies in which healthy volunteers aged 2-12 years took 40 mg/10 mg/kg per day on an empty stomach in three divided doses of amoxicillin with clavulanic acid, powder for the preparation of suspension for administration. orally, 125 mg/31.25 mg in 5 ml.

Main pharmacokinetic parameters

Dose

(mg/kg)

Сmax

(mg\ml)

Тmax

(watch)

AUC

(mgh/l)

T1/2

(watch)

Amoxicillin

73+ 1,7

2,1 (1,2-3,0)

18,6+ 2,6

1,0+ 0,33

Clavulanic acid

2,7+ 1,6

1,6 (1,0-2,0)

5,5+ 3,1

0,94+ 0,05

Cmax – maximum concentration in blood plasma.

Tmax – time to reach maximum concentration in blood plasma.

AUC is the area under the concentration-time curve.

T1/2 – half-life

Distribution

As with intravenous administration of a combination of amoxicillin and clavulanic acid, therapeutic concentrations of amoxicillin and clavulonic acid are found in various tissues and interstitial fluid (gallbladder, abdominal tissue, skin, adipose and muscle tissue, synovial and peritoneal fluids, bile, purulent discharge) .

Amoxicillin and clavulanic acid have a weak degree of binding to plasma proteins. Studies have shown that about 25% of the total amount of clavulanic acid and 18% of amoxicillin in the blood plasma is bound to plasma proteins.

In animal studies, no accumulation of the components of the combination of amoxicillin and clavulanic acid was found in any organ. Amoxocillin, like most penicillins, passes into breast milk. Trace amounts of clavulanic acid may also be found in breast milk. With the exception of the possibility of sensitization, development of diarrhea and candidiasis of the oral mucosa, no other negative effects of amoxicillin and clavulanic acid on the health of breastfed children are known.

Animal reproductive studies have shown that amoxicillin and clavulanic acid cross the placental barrier. However, no negative effects on the fetus were detected.

Metabolism

10-25% of the initial dose of amoxicillin is excreted by the kidneys in the form of an inactive metabolite (penicylic acid). Clavulanic acid is extensively metabolized to 2,5-dihydro-4-(2-hydroxyethyl)-5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-butan-2-one and is excreted by the kidneys. through the gastrointestinal tract, as well as with exhaled air in the form of carbon dioxide.

Removal

Like other penicillins, amoxicillin is eliminated primarily by the kidneys, while clavulanic acid is eliminated through both renal and extrarenal mechanisms. Approximately 60-70% of amoxicillin and about 40-65% of clavulanic acid are excreted unchanged by the kidneys in the first 6 hours after administration of 1 tablet 250 mg/125 mg or 1 tablet 500 mg/125 mg. Simultaneous administration of probenecid slows down the elimination of amoxicillin, but not clavulanic acid (see section “Interaction with other drugs”)

Ecoclave - Suspension

Home / Eco-analogs / Ecoclave / Suspension

A combination drug of amoxicillin and clavulanic acid, a beta-lactamase inhibitor. Amoxicillin is a semisynthetic broad-spectrum antibiotic; acts bactericidal, inhibiting the synthesis of cell wall protein 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 maintained. Clavulanic acid inhibits type II-V beta-lactamases according to the Richmond-Sykes classification and is not active against type I beta-lactamases produced by Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clinical studies have shown that Ecoclave, with comparable effectiveness to the original drug, is safer in relation to normal intestinal microflora and is better tolerated by patients.

Registration number: Trade name of the drug: Ecoclave® International non-proprietary or generic name: amoxicillin + clavulanic acid Dosage form: powder for the preparation of a suspension for oral administration. Description: White to almost white powder with a faint fruity odor. After dissolution in water, an almost white to light yellow suspension with a fruity odor is formed. Pharmacotherapeutic group: Antibiotic - semi-synthetic penicillin + beta-lactamase inhibitor. ATX code: J01CR02

Expand all

Composition Expand

Active substance: amoxicillin trihydrate, potassium clavulanate. Excipients: aspartame, colloidal silicon dioxide (Aerosil), xanthan gum, crospovidone (Kollidon CL-M), anhydrous citric acid, sodium citrate dihydrate, sodium benzoate, talc, orange flavor, mannitol (mannitol).

Pharmacological properties Expand

A combination drug of amoxicillin and clavulanic acid, a beta-lactamase inhibitor. Amoxicillin is a semisynthetic broad-spectrum antibiotic; acts bactericidal, inhibiting the synthesis of cell wall protein 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 maintained. Clavulanic acid inhibits type II-V beta-lactamases according to the Richmond-Sykes classification and is not active 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 in the treatment of infectious diseases of the urinary system caused by this pathogen has been clinically proven); Escherichia coli (beta-lactamase producing and non-producing strains); Haemophilus influenzae (beta-lactamase producing and non-producing strains); Klebsiella spp. (all known strains producing beta-lactamases); Moraxella catarrhalis (beta-lactamase producing and non-producing strains). Based on the results of in vitro studies, the following microorganisms are sensitive to the combination of amoxicillin and clavulanic acid:

Gram-positive aerobic microorganisms: Enterococcus faecalis**; Staphylococcus epidermidis (beta-lactamase producing and non-producing strains); Staphylococcus saprophyticus (strains producing and non-producing beta-lactamases); Streptococcus pneumoniae ** (strains that do not produce beta-lactamases); Streptococcus pyogenes** (strains that do not produce beta-lactamases); Streptococcus group viridans** (strains that do not produce beta-lactamases).

Gram-negative aerobic microorganisms: Eikenella corrodens (strains producing and non-producing beta-lactamases); Neisseria gonorrhoeae** (beta-lactamase-producing and non-beta-lactamase producing strains); Proteus mirabilis** (beta-lactamase producing and non-producing strains).

Anaerobic microorganisms: Bacteroides spp., including Bacteroides fragilis (strains producing and not producing beta-lactamases); Fusobacterium spp. (strains producing and non-producing beta-lactamases); Peptostreptococcus spp. (does not produce beta-lactamase).

NOTE: ** - (amoxicillin has been clinically proven to be effective in treating a number of infections caused by these pathogens).
Pharmacokinetics Expand

Suction. After oral administration, both components of the drug are quickly absorbed from the gastrointestinal tract. Absorption of the active ingredients of the drug 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 μg/ml, clavulanic acid - 0.77 μg/ml; — Tmax of amoxicillin – 1.5 hours, clavulanic acid – 1.0 hours; — AUC of amoxicillin – 9.19 mg? h/l, clavulanic acid – 2.69 mg? h/l. When using the drug, concentrations of amoxicillin in the blood serum are similar to those after 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, uterus, ovaries), skin; fat, 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, 18% and 25%, respectively. Both components of the drug penetrate the placental barrier, but no data on negative effects on the fetus have 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 case of renal failure, the clearance of amoxicillin with clavulanic acid is reduced, so dose adjustment is required.

Indications for use Expand

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

lower respiratory tract infections (bronchitis, pneumonia);

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

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

infections of the skin and soft tissues (erysipelas, impetigo, secondary infected dermatoses, abscess, cellulitis, wound infection);

infections of bones and joints (osteomyelitis).

Contraindications Expand

Hypersensitivity (including to cephalosporins and other beta-lactam antibiotics), infectious mononucleosis, episodes of jaundice or impaired liver function as a result of a history of use of amoxicillin/clavulanic acid, phenylketonuria (contains aspartame). Carefully. Severe liver failure, gastrointestinal diseases (including a history of colitis associated with the use of penicillins), chronic renal failure.

Use during pregnancy and lactation Expand

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

Directions for use and dosage Expand

Inside. The dosage regimen is set individually depending on the age and body weight of the patient, the severity and localization of the infectious process, as well as the sensitivity of the pathogen. The minimum course of antibacterial therapy is 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 old - 7-10 days. A single dose is set depending on age and body weight (calculation based on 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 skin and soft tissue infections, as well as chronic tonsillitis) - 20 mg/kg/day in 3 doses; - high doses (for the treatment of otitis media, sinusitis, lower respiratory tract infections, urinary tract infections) - 40 mg/kg/day in 3 doses.

Children weighing 40 kg or more should be dosed as adults. The suspension can be used in adults with difficulty swallowing. Recommended dosage 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 a day. The maximum daily dose of amoxicillin for adults and children over 12 years of age is 6 g, for children under 12 years of age - 45 mg/kg body weight. The maximum daily dose of clavulanic acid for adults and children over 12 years of age is 600 mg, for children under 12 years of age - 10 mg/kg body weight. Patients with impaired renal function Dose adjustments are based on the maximum recommended dose of amoxicillin and creatinine clearance. Children Creatinine clearance more than 30 ml/min; no dose adjustment required; Creatinine clearance 10-30 ml/min – 15 mg/3.75 mg/kg 2 times a 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 a day; Creatinine clearance less than 10 ml/min – 15 mg/3.75 mg/kg 1 time per day, maximum daily 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); Adults Creatinine clearance more than 30 ml/min; no dose adjustment required; Creatinine clearance 10-30 ml/min – 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 a day day; Creatinine clearance less than 10 ml/min – 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) once a day ; Patients on hemodialysis Dose adjustments are based on the maximum recommended dose of amoxicillin

Children - 15 mg/3.75 mg/kg 1 time per day. Before a hemodialysis session, take one additional dose of 15 mg/3.75 mg/kg. To restore the concentrations 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).

Method of preparing the suspension The suspension is prepared immediately before use.
The powder in the bottle is first shaken, then, adding a small amount of boiled and cooled to room temperature water, mixed to obtain a homogeneous suspension, then water is added to the mark on the bottle. To accurately dose the suspension, you should use a double-sided dosing spoon, which should be rinsed well with water after each use. After dilution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen. Side effects Expand

The drug is well tolerated. Side effects occur rarely, are mostly mild and transient in nature. From the digestive system: nausea, vomiting, diarrhea, gastritis, stomatitis, glossitis, cholestatic jaundice, hepatitis, liver failure (more often in the elderly, men, with long-term therapy), colitis (including pseudomembranous), black \\\\\\\ \\\\\\\\"hairy\\\\\\\\\\\\\\\\" tongue, darkening of tooth enamel, increased activity \\\\\\\\\\\\\\\\\" liver\\\\\\\\\\\\\\\" transaminases, increased bilirubin content and alkaline phosphatase activity. From the hematopoietic organs: reversible increase in prothrombin time and bleeding time, thrombocytopenia, thrombocytosis, eosinophilia, leukopenia, agranulocytosis, hemolytic anemia. From the central nervous system: dizziness, headache, hyperactivity, anxiety, behavioral changes, convulsions. Allergic reactions: urticaria, erythematous rashes, exudative erythema multiforme, anaphylactic shock, angioedema, exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), allergic vasculitis, a syndrome similar to serum sickness, acute generalized exanthematous pustulosis. From the kidneys and urinary tract: interstitial nephritis, crystalluria, hematuria. Other: candidiasis, development of superinfection.

Overdose Expand

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

Interaction with other drugs Expand

It is not recommended to use a combination drug of amoxicillin and clavulanic acid simultaneously with probenecid. Probenecid reduces the tubular secretion of amoxicillin, so their combined use may 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, non-steroidal 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 combination drug 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 simultaneous use of a combination drug of amoxicillin and clavulanic acid with indirect anticoagulants is necessary, the prothrombin time or INR should be carefully monitored when prescribing or discontinuing the drug.

Special instructions Expand

The severity of gastrointestinal symptoms decreases when taking the drug at the beginning of a meal. During a 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 when determining glucose levels in urine. In this case, it is recommended to use the glucose oxidase method for determining the concentration of glucose in the urine. In patients who are hypersensitive to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible. If infectious mononucleosis is suspected, the drug should not be used, since amoxicillin can cause a measles-like skin rash in patients with this disease, which makes diagnosing the disease difficult. Given the likelihood of developing side effects from the central nervous system, caution should be exercised when driving vehicles and working with moving mechanisms.

Release form Expand

Powder for the preparation of suspension for oral administration 125 mg + 31.25 mg/5 ml or 250 mg + 62.5 mg/5 ml. 25 g in 125 ml brown glass bottles with a label and a screw-on plastic cap. Each bottle, along with a double-sided dosing spoon (small with a capacity of 2.5 ml, large - 5 ml) and instructions for use, is placed in a cardboard pack.

Storage conditions Expand

In a dry place, protected from light, at a temperature not exceeding 25 ° C. The prepared suspension is stored at a temperature from 2? C to 8? C in a tightly closed bottle. Keep out of the reach of children.

Expiration date Expand

Shelf life: 2 years. Ready suspension – 7 days. Do not use the drug after the expiration date.

Conditions for dispensing from pharmacies Expand

Dispensed by prescription.

Owner of the registration certificate Expand

JSC "AVVA RUS", Russia, 121614 Moscow, st. Krylatsky Hills. 30, building 9. Tel. www.avva-rus.ru

Manufacturer/organization receiving claims Expand

JSC "AVVA RUS", Russia, 610044 Kirov, st. Luganskaya, 53A. Tel. www.avva-rus.ru, www.ecoantibiotic.ru Consumer complaints should be directed to the manufacturer.

Share information:

Indications for use

The combination of amoxicillin with clavulanic acid is indicated for the treatment of bacterial infections of the following localizations caused by microorganisms sensitive to the combination of amoxicillin and clavulanic acid:

Upper respiratory tract infections (including ENT infections), such as recurrent tonsillitis, sinusitis, otitis media, usually caused by Streptococcus pneumoniae, Haemophilus influenza*, Moraxella catarrhalis* and Streptococcus pyogenes.
Lower respiratory tract infections, such as exacerbations of chronic bronchitis, lobar pneumonia and bronchopneumonia, usually caused by Streptococcus pneumonia, Haemophilus influenza*, Moraxella catarrhalis*.
Infections of the genitourinary tract, such as cystitis, urethritis, pyelonephritis, infections of the female genital tract, usually caused by species of the family Enterobacteriaceae* (mainly Escherichia coli*), Staphylococcus saprophyticus and species of the genus Enterococcus, and gonorrhea caused by Neisseria gonorrhoeae*.
Infections of the skin and soft tissues, usually caused by Staphylococcus aureus*, Streptococcus pyogenes and Bacteroides species*.

Bone and joint infections, such as osteomyelitis, usually caused by Staphylococcus aureus*, may require long-term therapy if necessary.

*Some representatives of this genus of microorganisms produce beta-lactamase, which makes them insensitive to amoxicillin (see also section “Pharmacological properties”).

Infections caused by microorganisms sensitive to amoxicillin can be treated with Ecoclave®, since amoxicillin is one of its active ingredients.

The drug Ecoclave® is also indicated for the treatment of mixed infections caused by microorganisms sensitive to amoxicillin, as well as beta-lactamase-producing microorganisms sensitive to the combination of amoxicillin with clavulanic acid.

The sensitivity of bacteria to the combination of amoxicillin and clavulanic acid varies regionally and over time. Where possible, local sensitivity data should be taken into account. If necessary, microbiological samples should be collected and bacteriological susceptibility testing should be carried out.

Ecoclav®

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 not 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 in the treatment of infectious diseases of the urinary system caused by this pathogen has been clinically proven);

Escherichia coli (strains producing and not producing beta-lactamases);

Haemophilus influenzae (strains producing and not producing beta-lactamases);

Klebsiella spp. (all known strains produce beta-lactamases);

Moraxella catarrhalis (strains producing and not producing beta-lactamases).

Based on the results of in vitro studies, the following microorganisms are sensitive to the combination of amoxicillin and clavulanic acid:

Gram-positive aerobic microorganisms:

Enterococcus faecalis**;

Staphylococcus epidermidis (strains producing and not producing beta-lactamases);

Staphylococcus saprophyticus (strains producing and not producing beta-lactamases);

Streptococcus pneumoniae** (does not produce beta-lactamase);

Streptococcus pyogenes** (does not produce beta-lactamase);

Streptococcus viridans** (does not produce beta-lactamase).

Gram-negative aerobic microorganisms:

Eikenella corrodens (strains producing and not producing beta-lactamases);

Neisseria gonorrhoeae** (strains producing and not producing beta-lactamases);

Proteus mirabilis** (strains producing and not producing beta-lactamases).

Anaerobic microorganisms:

Bacteroides spp., including Bacteroides fragilis (beta-lactamase-producing and non-beta-lactamase producing strains);

Fusobacterium spp. (strains producing and not producing beta-lactamases);

Peptostreptococcus spp. (does not produce beta-lactamase).

NOTE: ** - (amoxicillin has been clinically proven to be effective in treating a number of infections caused by these pathogens).

Lactulose, which is part of Ecoclave as a bifidogenic factor, is a synthetic disaccharide, the molecule of which consists of galactose and fructose residues. Lactulose is not absorbed or hydrolyzed in the stomach and upper intestines. Ecoclavalactulose released from the 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 the hydrolysis of lactulose in the large intestine, organic acids are formed - lactic, acetic and formic, which suppress the growth of pathogenic microorganisms and consequently reduce the production of nitrogen-containing toxic substances.

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

Carefully

Ecoclave® should be used with caution in patients with impaired liver function.

Use during pregnancy and breastfeeding

Pregnancy

In animal reproductive studies, oral and parenteral administration of a combination of ammoxicillin and clavulanic acid did not cause teratogenic effects.

In a single study in women with premature rupture of membranes, it was found that prophylactic therapy with the drug may be associated with an increased risk of developing necrotizing enterocolitis in newborns. Like all medications, Ecoclave® is not recommended for use during pregnancy, unless the expected benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding period

Ecoclave® can be used during breastfeeding. With the exception of the possibility of sensitization, diarrhea or candidiasis of the oral mucosa associated with the penetration of trace amounts of the active ingredients of this drug into breast milk, no other adverse effects were observed in breastfed children. If adverse effects occur in breastfed infants, breastfeeding should be discontinued.

Directions for use and doses

For oral administration.

The dosage regimen is set individually depending on the age, body weight, kidney function of the patient, as well as the severity of the infection.

To reduce potential gastrointestinal disturbances and to optimize absorption, the drug should be taken at the beginning of a meal.

Treatment should not continue for more than 14 days without reviewing the clinical situation.

If necessary, it is possible to carry out step therapy (parenteral administration of a combination of amoxicillin with clavulanic acid in a dosage form, powder for the preparation of a solution for intravenous administration, followed by a transition to the drug Ecoclave® in dosage forms for oral administration).

Adults and children 12 years and older or weighing 40 kg or more

It is recommended to use other dosage forms of Ecoclave® or a suspension with a ratio of amoxicillin to clavulanic acid of 7:1 (400 mg/57 mg in 5 ml).

Children aged 3 months to 12 years weighing less than 40 kg

The dose is calculated depending on age and body weight, indicated in mg/kg body weight per day or in ml of suspension. The daily dose is divided into 3 doses every 8 hours. The recommended dosage regimen and frequency of administration are presented in the table below.

Table of dosage regimen for the drug Ecoclave ® (dose calculation is based on amoxicillin)

Suspension 4:1 (125 mg/31.25 mg in 5 ml or 250 mg/62.5 mg in 5 ml) in 3 doses every 8 hours
Low doses	20 mg/kg/day
High doses	40 mg/kg/day

Low doses of Ecoclave® are recommended for the treatment of skin and soft tissue infections, as well as recurrent tonsillitis.

High doses of Ecoclave® are recommended for the treatment of diseases such as otitis media, sinusitis, lower respiratory tract and urinary tract infections, bone and joint infections.

There is insufficient clinical data to recommend the use of Ecoclave® at a dose of more than 40 mg/10 mg/kg/day in 3 doses (4:1 suspension) in children under 2 years of age.

Children from birth to 3 months

Due to the immaturity of the excretory function of the kidneys, the recommended dose of Ecoclave® (calculated according to amoxicillin) is 30 mg/kg/day in 2 divided doses in the form of a 4:1 suspension

Children born prematurely

No recommendations regarding dosage regimen

Ecoclave por d/susp orally 250mg+62.5mg/5ml 25g (Avva-Rus)

Inside. The dosage regimen is set individually depending on the patient’s body weight, the severity and localization of the infectious process, as well as the sensitivity of the pathogen. The minimum course of antibacterial therapy is 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. The single dose is set depending on age and body weight (calculation for amoxicillin): - low doses (for the treatment of skin and soft tissue infections , 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. For children weighing bodies 40 kg or more should be prescribed doses as for adults. The suspension can be used in adults with difficulty swallowing. Recommended dosage 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 a day. The maximum daily dose of amoxicillin for adults and children over 12 years of age is 6 g, for children under 12 years of age - 45 mg/kg body weight. The maximum daily dose of clavulanic acid for adults and children over 12 years old - 600 mg, for children under 12 years old - 10 mg/kg body weight. Patients with impaired renal function: Dose adjustment is based on the maximum recommended dose of amoxicillin and the creatinine clearance value. Children Creatinine clearance more than 30 ml/min dose adjustment not required; Creatinine clearance 10-30 ml/min – 15 mg/3.75 mg/kg 2 times a day, maximum dose 500 mg + 125 mg (20 ml 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 a day; Creatinine clearance less than 10 ml/min – 15 mg/3.75 mg/kg 1 time per day, maximum daily dose 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 Creatinine clearance more than 30 ml/min, no dose adjustment required; Creatinine clearance 10 -30 ml/min – 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 a day; Clearance creatinine less than 10 ml/min – 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) once a day; Patients on hemodialysis: Dose adjustments are based on the maximum recommended dose of amoxicillin. One additional dose of 15 mg/3.75 mg/kg should be taken before the hemodialysis session. To restore the concentrations 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 the hemodialysis session. An additional 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 acids).

Special patient groups

Patients with impaired renal function

Correction of the dosage regimen is based on the maximum recommended dose of amoxicillin and the creatinine clearance value.

Creatinine clearance	Dosage regimen for Ecoclave® suspension 4:1 (125 mg/31.25 mg in 5 ml or 250 mg/62.5 mg in 5 ml)
> 30 ml/min	No dosage adjustment required
10-30 ml/min	15 mg/3.75 mg/kg 2 times a day maximum daily dose 500 mg/125 mg 2 times a day
< 10 ml/min	15 mg/3.75 mg/kg 1 time per day maximum daily dose 500 mg/125 mg 1 time per day

In most cases, whenever possible, parenteral therapy should be preferred.

Patients on hemodialysis

Recommended dosage regimen:

15 mg/3.75 mg/kg 1 time per day.

Before a hemodialysis session, one additional dose of 15 mg/3.75 mg/kg should be administered. To restore the concentrations of the active components of the drug Ecoclave® in the blood, a second additional dose of 15 mg/3.75 mg/kg should be administered after a hemodialysis session.

Patients with liver dysfunction

Treatment is carried out with caution, and liver function is regularly monitored. Insufficient data to change dosage recommendations in these patients

Ecoclave, 1 piece, 25 g, 250 mg+62.5 mg/5 ml, powder for the preparation of suspension for oral administration

Inside.

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

The minimum course of antibacterial therapy is 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 based on amoxicillin):

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

- children from 3 months and older:

for the treatment of skin and soft tissue infections, as well as chronic tonsillitis:

low doses - 20 mg/kg/day in 3 divided doses;

for the treatment of otitis media, sinusitis, lower respiratory tract infections, urinary tract infections:

high doses - 40 mg/kg/day in 3 divided doses.

Children weighing 40 kg or more should be dosed as adults.

The suspension can be used in adults with difficulty swallowing.

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

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

The maximum daily dose of clavulanic acid for adults and children over 12 years of age is 600 mg, for children under 12 years of age - 10 mg/kg.

Patients with impaired renal function.

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

For children

Creatinine Cl >30 ml/min - no dose adjustment required;

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

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

For adults

Creatinine Cl >30 ml/min - no dose adjustment required;

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

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

For patients on hemodialysis

, dose adjustments are based on the maximum recommended dose of amoxicillin.

For children

- 15 mg/3.75 mg/kg 1 time per day.

Before a hemodialysis session, take one additional dose of 15 mg/3.75 mg/kg. To restore the concentrations 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.

For adults

- 500+125 mg (20 ml of suspension at a dosage of 125+31.25 mg/5 ml or 10 ml of suspension at a dosage of 250+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).

Method of preparing the suspension

The suspension is prepared immediately before use.

The powder in the bottle is first shaken, then, adding a small amount of boiled and cooled to room temperature water, mixed to obtain a homogeneous suspension, then water is added to the mark on the bottle. To accurately dose the suspension, you should use a double-sided dosing spoon, which should be rinsed well with water after each use. After dilution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen.

Method of preparing the suspension

The suspension is prepared immediately before the first use.

Add approximately 60 ml of boiled water, cooled to room temperature, to the bottle with the powder, then close the bottle with a lid and shake until the powder is completely diluted, let the bottle stand for 5 minutes to ensure complete dilution. Then add water up to the mark on the bottle and shake the bottle again. In total, about 92 ml of water is required to prepare the suspension.

The bottle should be shaken well before each use. For precise dosing of the drug, you should use a double-sided dosing spoon, which should be rinsed well with water after each use. After dilution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen.

For children under 2 years of age, a measured single dose of Ecoclave® suspension can be diluted twice with water.

Side effects

The adverse reactions presented below are listed according to the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is defined as follows: “very often” (>10), “often” (>1/100, <1/10), “infrequently” (>1/1000, <1/100), “rarely” (> 1/10,000, <1/1000), “very rare” (<10,000), “frequency unknown.”

Infectious and parasitic diseases

Often

: candidiasis of the skin and mucous membranes.

From the hematopoietic and lymphatic system

Rarely

: reversible leukopenia (including neutropenia) and reversible thrombocytopenia.

Very rarely

: reversible agranulocytosis and reversible hemolytic anemia, prolongation of prothrombin time and bleeding time, anemia, eosinophilia, thrombocytosis.

Immune system disorders

Very rarely

: angioedema, anaphylactic reactions; syndrome similar to serum sickness, allergic vasculitis.

Disorders of the skin and subcutaneous tissues:

Infrequently

: skin rash, itching, urticaria.

Rarely

: erythema multiforme.

Very rarely

: Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis.

If any allergic skin reactions develop, you should stop using the drug.

Nervous system disorders:

Infrequently

: dizziness, headache.

Very rarely

: seizures (may occur in patients with impaired renal function, as well as in those receiving high doses of the drug), insomnia, agitation, anxiety, behavioral changes, reversible hyperactivity.

Gastrointestinal disorders:

Adults:

Often

: diarrhea.

Often

: nausea, vomiting.

Children:

Often

: diarrhea, nausea, vomiting.

Whole population:

nausea most often occurred when using high doses of the drug. If, after starting to take the drug, undesirable reactions from the gastrointestinal tract are observed, they can be eliminated by taking Ecoclave® at the beginning of the meal.

Infrequently

: digestive disorders.

Very rarely

: antibiotic-associated colitis (including pseudomembranous and hemorrhagic), gastritis, stomatitis, black “hairy” tongue, discoloration of the surface layer of tooth enamel in children.

Disorders of the liver and biliary tract:

Infrequently

: Moderate increase in aspartate aminotransferase activity. This reaction has been observed in patients receiving beta-lactam antibiotic therapy, but its clinical significance is unknown.

Very rarely

: hepatitis and cholestatic jaundice (these reactions are observed in patients receiving therapy with penicillin antibiotics and cephalosporins), increased alkaline phosphatase activity and/or bilirubin concentration.

Adverse reactions from the liver were observed mainly in men and elderly patients and may be associated with long-term therapy. These adverse reactions are very rarely observed in children. The listed signs and symptoms very rarely occur during or immediately after completion of therapy, but in some cases they may not appear for several weeks after completion of therapy. Adverse reactions are usually reversible. Adverse reactions from the liver can be severe, and deaths have been reported in extremely rare cases. In almost all cases, these were patients with serious comorbidities or patients receiving concomitantly potentially hepatotoxic drugs.

Renal and urinary tract disorders:

Very rarely

: interstitial nephritis, crystalluria, hematuria.

Ecoclave 250mg+62.5mg/5ml 25g powder for oral suspension

pharmachologic effect

A combination drug of amoxicillin and clavulanic acid, a beta-lactamase inhibitor.
Amoxicillin is a semisynthetic broad-spectrum antibiotic; acts bactericidal, inhibiting the synthesis of cell wall protein 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 maintained. Clavulanic acid inhibits type II-V beta-lactamases according to the Richmond-Sykes classification and is not active 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 (beta-lactamase producing and non-producing strains);

Gram-negative aerobic microorganisms:

Escherichia coli (beta-lactamase producing and non-producing strains);

Haemophilus influenzae (beta-lactamase producing and non-producing strains);

Klebsiella spp. (all known strains produce beta-lactamases);

Moraxella catarrhalis (beta-lactamase producing and non-producing strains).

Based on the results of in vitro studies, the following microorganisms are sensitive to the combination of amoxicillin and clavulanic acid:

Gram-positive aerobic microorganisms:

Enterococcus faecalis**;

Staphylococcus epidermidis (beta-lactamase producing and non-producing strains);

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. viridans** group (does not produce beta-lactamase).

Gram-negative aerobic microorganisms:

Eikenella corrodens (beta-lactamase producing and non-producing strains);

Neisseria gonorrhoeae** (beta-lactamase-producing and non-beta-lactamase producing strains);

Proteus mirabilis** (beta-lactamase producing and non-producing strains).

Anaerobic microorganisms:

Bacteroidesspp., including Bacteroides fragilis (beta-lactamase-producing and non-beta-lactamase producing strains);

Fusobacterium spp. (strains producing and non-producing beta-lactamases);

Peptostreptococcus spp. (does not produce beta-lactamase).

NOTE: ** - (amoxicillin has been clinically proven to be effective in treating a number of infections caused by these pathogens).

Lactulose, which is part of Ecoclave as a bifidogenic factor, is a synthetic disaccharide, the molecule of which consists of galactose and fructose residues. Lactulose is not absorbed or hydrolyzed in the stomach and upper intestines. Lactulose released from Ecoclave 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 the hydrolysis of lactulose in the large intestine, organic acids are formed - lactic, acetic and formic, which suppress the growth of pathogenic microorganisms and consequently 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.

Composition and release form Ecoclave 250mg+62.5mg/5ml 25g powder for the preparation of suspension for oral administration

Powder for preparing a suspension for oral administration - 5 ml of ready-made suspension:

Active substance: 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.

25 g - dark glass bottles with a volume of 125 ml (1) complete with a double-sided dosage spoon (2.5 ml and 5 ml) - cardboard packs.

Description of the dosage form

Powder for the preparation of a suspension for oral administration is white to almost white in color, with a faint fruity odor; the prepared suspension is almost white to light yellow in color, with a fruity odor.

Directions for use and doses

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

The minimum course of antibacterial therapy is 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 old - 7-10 days.

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

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

Children 3 months and older:

low doses (for the treatment of skin and soft tissue infections, as well as chronic tonsillitis) – 20 mg/kg/day in 3 doses;
high doses (for the treatment of otitis media, sinusitis, lower respiratory tract infections, urinary tract infections) - 40 mg/kg/day in 3 doses.

Children weighing 40 kg or more should be dosed as adults.

The suspension can be used in adults with difficulty swallowing.

Recommended dosage 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 a day.

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

The maximum daily dose of clavulanic acid for adults and children over 12 years of age is 600 mg, for children under 12 years of age - 10 mg/kg.

Patients with impaired renal function:

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

Children

Creatinine clearance more than 30 ml/min; no dose adjustment is 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 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);

Adults

Creatinine clearance more than 30 ml/min; no dose adjustment is required;

Creatinine clearance 10-30 ml/min – 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 – 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) 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.

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)

Method for preparing the suspension:

The suspension is prepared immediately before use.

Pharmacokinetics

Absorption. After oral administration, both components of the drug are quickly absorbed from the gastrointestinal tract. Absorption of the active ingredients of the drug 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 µg/ml, clavulanic acid – 0.77 µg/ml;

Tmax of amoxicillin – 1.5 hours, clavulanic acid – 1.0 hours;

AUC of amoxicillin – 9.19 mg•h/l, clavulanic acid – 2.69 mg•h/l.

When using the drug, concentrations of amoxicillin in the blood serum are similar to those after 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, uterus, ovaries), skin; fat, 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, 18% and 25%, respectively.

Both components of the drug penetrate the placental barrier, but no data on negative effects on the fetus have 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 case of renal failure, the clearance of amoxicillin with clavulanic acid is reduced, so dose adjustment is required.

Indications for use Ecoclave 250mg+62.5mg/5ml 25g powder for the preparation of suspension for oral administration

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

lower respiratory tract infections (bronchitis, pneumonia);
infections of the ENT organs (sinusitis, tonsillitis, otitis media);
infections of the genitourinary system and pelvic organs (pyelonephritis, pyelitis, cystitis, urethritis, bacterial prostatitis, cervicitis, salpingitis, salpingoophoritis, endometritis, bacterial vaginitis, septic abortion, chancroid, gonorrhea);
infections of the skin and soft tissues (erysipelas, impetigo, secondary infected dermatoses, abscess, cellulitis, wound infection);
infections of bones and joints (osteomyelitis).

Contraindications

hypersensitivity (including to cephalosporins and other beta-lactam antibiotics);
Infectious mononucleosis;
a history of episodes of jaundice or impaired liver function as a result of the use of amoxicillin/clavulanic acid;
phenylketonuria (contains aspartame).

Carefully:

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

Application Ecoclave 250mg+62.5mg/5ml 25g powder for the preparation of suspension for oral administration during pregnancy and breastfeeding

The drug can be used during breastfeeding. Except for the risk of sensitization associated with trace amounts of the active ingredients of this drug passing into breast milk, no other adverse effects have been observed in breastfed infants.

special instructions

The severity of gastrointestinal symptoms decreases when taking the drug at the beginning of a meal.

During a 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 when determining glucose levels in urine. In this case, it is recommended to use the glucose oxidase method for determining the concentration of glucose in the urine.

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

If infectious mononucleosis is suspected, the drug should not be used, since amoxicillin can cause a measles-like skin rash in patients with this disease, which makes diagnosing the disease difficult.

Given the likelihood of developing side effects from the central nervous system, caution should be exercised when driving vehicles and working with moving mechanisms.

Overdose

Symptoms: dysfunction of the gastrointestinal tract and water-electrolyte balance.

Treatment: symptomatic. Hemodialysis is effective.

Side effects Ecoclave 250mg+62.5mg/5ml 25g powder for the preparation of suspension for oral administration

The drug is well tolerated. Side effects occur rarely, are mostly mild and transient in nature.

From the digestive system: nausea, vomiting, diarrhea, gastritis, stomatitis, glossitis, cholestatic jaundice, hepatitis, liver failure (more often in the elderly, men, with long-term therapy), colitis (including pseudomembranous), black “hairy” tongue, darkening of the teeth enamel, increased activity of “liver” transaminases, increased bilirubin content and alkaline phosphatase activity.

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

From the central nervous system: dizziness, headache, hyperactivity, anxiety, behavioral changes, convulsions.

Allergic reactions: urticaria, erythematous rashes, exudative erythema multiforme, anaphylactic shock, angioedema, exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), allergic vasculitis, a syndrome similar to serum sickness, acute generalized exanthematous pustulosis.

From the kidneys and urinary tract: interstitial nephritis, crystalluria, hematuria.

Other: candidiasis, development of superinfection.

Drug interactions

Diuretics, allopurinol, phenylbutazone, non-steroidal 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 combination drug 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 simultaneous use of a combination drug of amoxicillin and clavulanic acid with indirect anticoagulants is necessary, the prothrombin time or INR should be carefully monitored when prescribing or discontinuing the drug.

Overdose

Symptoms

Gastrointestinal symptoms and disturbances in water and electrolyte metabolism may be observed.

Amoxicillin crystalluria has been described, in some cases leading to the development of renal failure (see section "Special Instructions").

Convulsions may occur in patients with impaired renal function, as well as in those receiving high doses of the drug.

Treatment

Symptoms from the gastrointestinal tract - symptomatic therapy, paying attention to the normalization of water and electrolyte metabolism. Amoxicillin and clavulanic acid can be removed from the bloodstream by hemodialysis.

The results of a prospective study that was conducted in 51 children at a poison control center showed that amoxicillin administered at a dose of less than 250 mg/kg did not lead to significant clinical symptoms and did not require gastric lavage.

ECOCLAVE

Pharmacodynamics

A combination drug of amoxicillin and clavulanic acid, a beta-lactamase inhibitor.
Amoxicillin is a semisynthetic broad-spectrum antibiotic; acts bactericidal; inhibiting the synthesis of cell wall protein 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 maintained. Clavulanic acid inhibits type II-V beta-lactamases according to the Richmond-Sykes classification and is not active 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 not producing beta-lactamases);

Gram-negative aerobic microorganisms:

Escherichia coli (strains producing and not producing beta-lactamases);

Haemophilus influenzae (strains producing and not producing beta-lactamases);

Klebsiella spp. (all known strains producing beta-lactamases);

Moraxella catarrhalis (strains producing and not producing beta-lactamases).

Based on the results of in vitro studies, the following microorganisms are sensitive to the combination of amoxicillin and clavulanic acid:

Gram-positive aerobic microorganisms:

Enterococcus faecalis**;

Staphylococcus epidermidis (strains producing and not producing beta-lactamases);

Staphylococcus saprophyticus (strains producing and not producing beta-lactamases);

Streptococcus pneumoniae ** (strains that do not produce beta-lactamases);

Streptococcus pyogenes** (strains that do not produce beta-lactamases);

Streptococcus viridans group** (strains that do not produce beta-lactamases).

Gram-negative aerobic microorganisms:

Eikenella corrodens (strains producing and not producing beta-lactamases);

Neisseria gonorrhoeae ** (strains producing and not producing beta-lactamases);

Proteus mirabilis** (strains producing and not producing beta-lactamases).

Anaerobic microorganisms:

Bacteroides spp., including Bacteroides fragilis (beta-lactamase-producing and non-beta-lactamase producing strains); *

Fusobacterium spp. (strains producing and not producing beta-lactamases);

Peptostreptococcus spp. (does not produce beta-lactamase).

NOTE: ** - (amoxicillin has been clinically proven to be effective in treating a number of infections caused by these pathogens).

Interaction with other drugs

The simultaneous use of Ecoclave® and probenecid is not recommended. Probenecid reduces the tubular secretion of amoxicillin, therefore the simultaneous use of Ecoclave® and probenecid may lead to an increase and persistence in the blood level of amoxicillin, but not clavulanic acid.

Concomitant use of allopurinol and amoxicillin may increase the risk of allergic skin reactions. Currently, there is no data in the literature on the simultaneous use of a combination of amoxicillin with clavulanic acid and allopurinol.

Penicillins can slow down the elimination of methotrexate from the body by inhibiting its tubular secretion, therefore the simultaneous use of Ecoclave® and methotrexate may increase the toxicity of methotrexate.

Like other antibacterial drugs, Ecoclave® can affect the intestinal flora, leading to a decrease in the absorption of estrogens from the gastrointestinal tract and a decrease in the effectiveness of combined oral contraceptives.

The literature describes rare cases of an increase in the international normalized ratio (INR) in patients with simultaneous use of acenocoumarol or warfarin and amoxicillin. If it is necessary to simultaneously prescribe Ecoclave® with anticoagulants, prothrombin time or INR should be carefully monitored when prescribing or discontinuing Ecoclave®; Dosage adjustment of oral anticoagulants may be required.

In patients taking mycophenolate mofetil, after starting the combination of amoxicillin with clavulanic acid, a decrease in the concentration of the active metabolite, mycophenolic acid, was observed before taking the next dose of the drug by approximately 50%. Changes in this concentration may not accurately reflect overall changes in mycophenolic acid exposure.

special instructions

Before starting treatment with Ecoclave®, it is necessary to collect a detailed history regarding previous hypersensitivity reactions to penicillins, cephalosporins or other substances that cause an allergic reaction in the patient.

Serious and sometimes fatal hypersensitivity reactions (anaphylactic reactions) to penicillins have been described. The risk of such reactions is highest in patients with a history of hypersensitivity reactions to penicillins. If an allergic reaction occurs, treatment with Ecoclav® should be discontinued and appropriate alternative therapy should be initiated. In case of serious anaphylactic reactions, the patient should be given epinephrine immediately. Oxygen therapy, intravenous corticosteroids, and airway management, including intubation, may also be required.

If infectious mononucleosis is suspected, Ecoclave® should not be used, since amoxicillin can cause a measles-like skin rash in patients with this disease, which makes diagnosing the disease difficult.

Long-term treatment with Ecoclave® may lead to excessive proliferation of insensitive microorganisms.

In general, Ecoclave® is well tolerated and has the low toxicity characteristic of all penicillins. During long-term therapy with Ecoclave®, it is recommended to periodically evaluate renal, liver and hematopoietic function.

Cases of pseudomembranous colitis have been described with the use of antibiotics, the severity of which can vary from mild to life-threatening. Therefore, it is important to consider the possibility of developing pseudomembranous colitis in patients with diarrhea during or after antibiotic use. If diarrhea is prolonged and severe or the patient experiences abdominal cramps, treatment should be stopped immediately and the patient should be examined.

In patients receiving a combination of amoxicillin and clavulanic acid together with indirect (oral) anticoagulants, an increase in prothrombin time (increase in INR) has been reported in rare cases. When co-prescribing indirect (oral) anticoagulants with a combination of amoxicillin and clavulanic acid, monitoring of relevant indicators is necessary. Dosage adjustments may be required to maintain the desired effect of oral anticoagulants.

In patients with impaired renal function, the dose of Ecoclave® should be reduced according to the degree of impairment (see Section "Dosage and Administration" - Patients with impaired renal function

In patients with reduced diuresis, crystalluria very rarely occurs, mainly during parenteral therapy. During administration of high doses of amoxicillin, it is recommended to take sufficient fluids and maintain adequate diuresis to reduce the likelihood of amoxicillin crystal formation. (see section "Overdose")

Taking Ecoclave® orally leads to a high level of amoxicillin in the urine, which can lead to false-positive results when determining glucose in urine (for example, Benedict's test, Fehling's test). In this case, it is recommended to use the glucose oxidant method for determining the concentration of glucose in the urine.

Clavulanic acid may cause nonspecific binding of immunoglobulin G and albumin to red blood cell membranes, leading to false-positive Coombs test results.

Oral care helps prevent tooth discoloration associated with taking Ecoclave® by simply brushing your teeth.