Ecoclave
Ecoclave: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Ecoclav
ATX code: J01CR02
Active ingredient: amoxicillin + clavulanic acid (amoxicillin + clavulanic acid)
Producer: AVVA-RUS JSC (Russia), STI-MED-SORB (Russia)
Description and photo updated: 22.11.2018
Prices in pharmacies: from 130 rubles.
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Ekoklav is a combined antibacterial drug with a wide spectrum of action.
Release form and composition
Dosage forms of Ekoklav:
- powder for preparation of suspension for oral administration: almost white or white, with a slight fruity odor; the suspension formed after dissolving the powder - from pale yellow to almost white, with a fruity smell [25 g each in a dark glass bottle with a volume of 125 ml, in a cardboard box 1 bottle complete with a measuring double-sided spoon (2.5 and 5 ml)];
- film-coated tablets: almost white or white, biconvex, oval; the core on a cross section is from almost white to pale yellow with a brown tinge, with possible splashes of white or yellow color (at a dosage of 250 mg + 125 mg and 500 mg + 125 mg: 5 or 7 pieces in a blister strip made of aluminum foil, in a cardboard box 1, 2 or 3 packs; 14 or 15 pcs. in a polymer can or a plastic bottle, in a cardboard box 1 bottle / can; at a dosage of 875 mg + 125 mg: 5 or 7 pcs. in a blister strip of foil aluminum or PVC / aluminum, in a cardboard box 1 or 2 packs; 5, 7, 10 or 14 pieces in a plastic bottle or polymer can, in a cardboard box 1 bottle / can).
5 ml of finished Ekoklav suspension contains:
- active substances: amoxicillin (in the form of trihydrate) - 125 or 250 mg, clavulanic acid (in the form of potassium clavulanate) - 31.25 or 62.5 mg, respectively;
- additional components: aspartame, lactulose, xanthan gum, colloidal silicon dioxide (aerosil), anhydrous citric acid, sodium benzoate, crospovidone (Kollidon CL-M), mannitol (mannitol), sodium citrate dihydrate, orange flavor, talc.
1 Ekoklav tablet contains:
- active substances: amoxicillin (in the form of trihydrate) - 250, 500 or 875 mg; clavulanic acid (as potassium clavulanate) 125 mg
- additional components: croscarmellose sodium, lactulose, crospovidone (Kollidon CL), ascorbic acid, microcrystalline cellulose, talc, magnesium stearate;
- film shell: a mixture for the preparation of a film coating Insta Moistsheld (ethyl cellulose, hypromellose, diethyl phthalate, talc, titanium dioxide).
Pharmacological properties
Pharmacodynamics
Ekoklav is a combined preparation, the active components of which are semi-synthetic penicillin, which has a wide spectrum of antibacterial activity (amoxicillin) and a beta-lactamase inhibitor (clavulanic acid). Amoxicillin exhibits bactericidal properties, suppressing protein synthesis of the cell wall of sensitive bacteria during the growth period. Clavulanic acid, demonstrating a high affinity for bacterial beta-lactamases, forms a stable complex with them. As a result, it is possible to avoid biodegradation of amoxicillin by beta-lactamases and to maintain the bactericidal activity of the antibiotic.
Clavulanic acid inhibits type II-V beta-lactamases according to the Richmond-Sykes classification and does not show activity against type I beta-lactamases produced by Serratia spp., Pseudomonas aeruginosa, Acinetobacter spp.
Ecoclave, according to data obtained during in vitro tests and clinical studies, is active against the following microorganisms:
- gram-negative aerobes: Klebsiella spp. (all known strains producing beta-lactamases); Enterobacter spp. (although most strains of Enterobacter are resistant in vitro, the effectiveness of the drug has been clinically proven in the treatment of infectious lesions of the urinary system caused by this bacterium); Escherichia coli, Haemophilus influenzae and Moraxella catarrhalis - strains that produce and do not produce beta-lactamases;
- gram-positive aerobes: Staphylococcus aureus (strains that produce and do not produce beta-lactamases).
According to the results of in vitro studies, the following microorganisms are sensitive to the combined use of amoxicillin and clavulanic acid:
- gram-negative aerobes: Neisseria gonorrhoeae 1, Eikenella corrodens and Proteus mirabilis 1 - strains that produce and do not produce beta-lactamases;
- gram-positive aerobes: Enterococcus faecalis 1; Streptococcus pneumoniae 1, Streptococcus spp. groups viridans 1 and Streptococcus pyogenes 1 - strains that do not produce beta-lactamase; Staphylococcus saprophyticus and Staphylococcus epidermidis - strains that produce and do not produce beta-lactamases;
- anaerobic microorganisms: Peptostreptococcus spp. (does not produce beta-lactamase); Fusobacterium spp., And Bacteroidesspp., Including Bacteroides fragilis, are beta-lactamase-producing and non-beta-lactamase-producing strains.
1 - the effectiveness of amoxicillin has been clinically proven in the treatment of a number of infections caused by these microorganisms.
Lactulose, included in the preparation as a bifidogenic factor, is a synthetic disaccharide. The molecule of this substance consists of residues of fructose and galactose. In the stomach and upper intestines, lactulose is not absorbed or hydrolyzed. Released from the drug, it undergoes fermentation in the large intestine, activating the growth of lactobacilli and bifidobacteria. As a result of the process of hydrolysis of lactulose in the colon, organic acids are formed, such as acetic, lactic and formic, which prevent the growth of pathogenic microbes, as a result of which the production of nitrogen-containing toxic substances decreases. The lactulose contained in Ecoclave reduces its negative impact on the normal intestinal microflora, as well as the likelihood of developing side reactions associated with dysbiosis.
Pharmacokinetics
After oral administration, both active components of the drug are well absorbed from the gastrointestinal tract (GIT). Absorption of amoxicillin and clavulanic acid is optimal when Ekoklav is taken at the beginning of a meal.
The values of the maximum concentration (Cmax), the period of reaching Cmax (Tmax) and the area under the concentration-time curve (AUC) of the active substances of the drug when taken orally:
- dosage 125 mg + 31.25 mg: for amoxicillin Cmax - 1.96 mg / l, Tmax - 1.5 hours and AUC - 9.19 (mg × h) / l; for clavulanic acid Cmax - 0.77 mg / L, Tmax - 1.0 hour and AUC - 2.69 (mg × h) / L;
- dosage 250 mg + 125 mg: for amoxicillin Cmax - 3.7 mg / l, Tmax - 1.1 hours and AUC - 10.9 (mg × h) / l; for clavulanic acid Cmax - 2.2 mg / l, Tmax - 1.2 hours and AUC - 6.2 (mg × h) / l;
- dosage 500 mg + 125 mg: for amoxicillin Cmax - 6.5 mg / l, Tmax - 1.5 hours and AUC - 23.2 (mg × h) / l; for clavulanic acid Cmax - 2.8 mg / l, Tmax - 1.3 hours and AUC - 7.3 (mg × h) / l;
- dosage 875 mg + 125 mg: for amoxicillin Cmax - 8.8 mg / l, Tmax - 1.5 hours and AUC - 25.4 (mg × h) / l; for clavulanic acid Cmax - 2.07 mg / L, Tmax - 1.5 hours and AUC - 6.1 (mg × h) / L.
When using Ekoklav, serum concentrations of amoxicillin are similar to those for oral administration of equivalent doses of amoxicillin alone.
Both active substances have a good volume of distribution. Amoxicillin and clavulanic acid in therapeutic doses penetrate the interstitial fluid and a large number of organs and tissues, which include: skin, middle ear, abdominal organs, lungs, pelvic organs (ovaries, uterus, prostate gland); muscle, bone and adipose tissue; peritoneal, synovial and pleural fluids; bile, plasma, sputum, purulent discharge, bronchial secretions.
The degree of connection of active substances with blood proteins is moderate: amoxicillin - by 18%; clavulanic acid - by 25%. Both components pass through the placental barrier and are detected in small quantities in breast milk.
About 60–70% of amoxicillin is excreted by the kidneys by means of tubular secretion and glomerular filtration. The process of metabolic transformation of clavulanic acid actively proceeds in the liver, the substance is excreted by glomerular filtration - approximately 40–65%, partly in the form of metabolites. To a lesser extent, it is excreted through the intestines.
Indications for use
According to the instructions, Ekoklav is recommended for use for the treatment of infectious and inflammatory diseases caused by pathogens sensitive to the combination of active ingredients of the drug:
- ENT infections: tonsillitis, sinusitis, otitis media;
- lower respiratory tract infections: pneumonia, bronchitis;
- infections of the skin and soft tissues: impetigo, erysipelas, secondarily infected dermatoses, phlegmon, abscess; wound infection;
- infections of the pelvic organs and genitourinary system: cervicitis, bacterial prostatitis, urethritis, cystitis, pyelitis, pyelonephritis, salpingo-oophoritis, salpingitis, bacterial vaginitis, endometritis, septic abortion, gonorrhea, chancre;
- infections of bones and joints: osteomyelitis.
Contraindications
- Infectious mononucleosis;
- a history of liver dysfunction or episodes of jaundice caused by the use of amoxicillin / clavulanic acid;
- phenylketonuria - for powder for preparing a suspension (since this form contains aspartame);
- chronic renal failure (CRF), with creatinine clearance (CC) below 30 ml / min - for tablets with a dosage of 875 mg + 125 mg;
- age under 12 years old and body weight less than 40 kg - for tablets;
- hypersensitivity to any component of the drug, as well as to other beta-lactam antibiotics and to cephalosporins.
Caution is required to use the drug for the following diseases:
- severe liver failure;
- Chronic renal failure;
- diseases of the gastrointestinal tract (including colitis caused by the use of penicillins in history).
Instructions for the use of Ecoclave: method and dosage
Ecoclave is taken orally.
The dosage regimen is determined individually, taking into account the age and body weight of the patient, the sensitivity of the pathogen, the location and severity of the infectious process. The minimum course of treatment is 5 days. The duration of therapy should not exceed 14 days; a longer course is possible when the clinical situation is reviewed.
Powder for oral suspension
The course of treatment for acute uncomplicated otitis media in children under 2 years of age is 7–10 days, in patients over 2 years of age - 5–7 days.
Recommended single doses of Ekoklav depending on the body weight and age of the child (calculated for amoxicillin):
- children younger than 3 months: 30 mg / kg per day, divided into 2 doses;
- children from 3 months and older: chronic tonsillitis, infections of the skin and soft tissues - 20 mg / kg per day, divided into 3 doses; sinusitis, otitis media, urinary tract infections, lower respiratory tract infections - 40 mg / kg per day, divided into 3 doses.
Children weighing 40 kg or more are prescribed doses similar to those for adults.
If it is difficult to swallow tablets, the suspension can also be used in adults: 2-3 times a day, 10 ml at a dosage of 250 / 62.5 mg or 20 ml at a dosage of 125 / 31.25 mg.
The maximum daily doses of the active substances of the drug:
- children under 12 years old: amoxicillin - 45 mg / kg body weight, clavulanic acid - 10 mg / kg;
- adults and adolescents over 12 years old: amoxicillin - 6000 mg, clavulanic acid - 600 mg.
In case of impaired renal function, the dose is adjusted based on the maximum recommended dose of amoxicillin and CC values.
For children with impaired renal function, the Ekoklav suspension is prescribed at a dose of 15 mg / 3.75 mg / kg; with CC below 10 ml / min - 1 time per day, with CC 10-30 ml / min - 2 times a day.
The maximum dose for children is 500 mg + 125 mg [10 ml in a dosage (250 mg + 62.5 mg) / 5 ml or 20 ml in a dosage (125 mg + 31.25 mg) / 5 ml]; with CC below 10 ml / min - 1 time per day, with CC 10-30 ml / min - 2 times a day.
For adults, the suspension is prescribed in a dose of 500 mg + 125 mg [10 ml in a dosage (250 mg + 62.5 mg) / 5 ml or 20 ml in a dosage (125 mg + 31.25 mg) / 5 ml]; with CC below 10 ml / min - 1 time per day, with CC 10-30 ml / min - 2 times a day.
If QC is more than 30 ml / min, children and adults do not need to adjust Ekoklav doses.
For patients on hemodialysis, the dose adjustment is based on the maximum recommended dose of amoxicillin.
Children are prescribed (15 mg / 3.75 mg) / kg once a day. Before the hemodialysis session, it is recommended to take one additional dose (15 mg / 3.75 mg) / kg, as well as a second identical dose after the session in order to restore the serum concentrations of the active substances of the drug.
Adults should take Ekoklav once every 24 hours at a dose of 500 mg + 125 mg [10 ml in a dosage (250 mg + 62.5 mg) / 5 ml or 20 ml in a dosage (125 mg + 31.25 mg) / 5 ml] … Additionally, one dose is prescribed during the dialysis session and one more at the end.
The suspension should be prepared immediately before taking. The bottle with the powder must first be shaken, and then adding a small amount of boiled water cooled to room temperature, stir the contents until a homogeneous suspension is obtained. After that, you need to add water to the mark applied to the bottle. For accurate dosing of Ekoklav, it is recommended to use a dosing double-sided spoon, which must be thoroughly rinsed with water after each use.
Film-coated tablets
Recommended dosage regimen of Ekoklava for adults and adolescents over 12 years of age or with a body weight of more than 40 kg:
- mild and moderate infections: 3 times a day, 1 tablet 250 mg + 125 mg, or 2 times a day, 1 tablet 500 mg + 125 mg;
- severe infections or infections of the lower respiratory tract: 3 times a day, 1 tablet 500 mg + 125 mg, or 2 times a day, 1 tablet 875 mg + 125 mg.
It should be borne in mind that since clavulanic acid is contained in all dosages of Ekoklav tablets in the same amount (125 mg), then 2 tablets 250 mg + 125 mg are not equivalent to 1 tablet 500 mg + 125 mg.
The maximum permissible daily dose of amoxicillin is 6000 mg, clavulanic acid is 600 mg.
In the presence of chronic renal failure, the dose and frequency of use of the tablets are adjusted depending on the CC:
- mild and moderate infections: at a dose of 1 tablet 250 mg + 125 mg with CC below 10 ml / min - 1 time per day, with CC 10-30 ml / min - 2 times a day;
- severe infections or infections of the lower respiratory tract: at a dose of 1 tablet 500 mg + 125 mg with CC below 10 ml / min - 1 time per day, with CC 10-30 ml / min - 2 times a day;
- with CC over 30 ml / min, dose adjustment is not necessary.
Patients on hemodialysis are advised to take every 24 hours 1 tablet Ecoclav 500 mg + 125 mg or 2 tablets 250 mg + 125 mg, and also appoint 1 dose during hemodialysis and 1 dose after the session to normalize the concentration of amoxicillin and clavulanic acids in the blood.
Side effects
- hematopoietic system: thrombocytosis, thrombocytopenia, reversible increase in prothrombin time and bleeding time, agranulocytosis, leukopenia, eosinophilia, hemolytic anemia;
- digestive system: darkening of tooth enamel, stomatitis, glossitis, black "hairy" tongue, diarrhea, nausea, gastritis, vomiting, hepatitis, cholestatic jaundice, liver failure (mainly in the elderly, men on the background of long-term therapy), colitis (including pseudomembranous), increased activity of hepatic transaminases, increased activity of alkaline phosphatase and bilirubin concentration;
- nervous system: dizziness, hyperactivity, headache, behavior change, anxiety, seizures;
- allergic reactions: exudative erythema multiforme, urticaria, erythematous rash, angioedema, anaphylactic shock, exfoliative dermatitis, a syndrome similar to serum sickness, allergic vasculitis, acute generalized exanthematous pustulosis, malignant exudative syndrome;
- kidneys and urinary tract: crystalluria, interstitial nephritis, hematuria;
- others: the development of superinfection, candidiasis.
Ecoclave is generally well tolerated. The above adverse reactions are rare, in most cases mild and transient.
Overdose
Overdose symptoms are gastrointestinal tract dysfunction and water-electrolyte balance.
Therapy is prescribed symptomatic. Hemodialysis is effective.
special instructions
To reduce the risk of adverse reactions from the gastrointestinal tract, as well as to reduce their severity, it is recommended to take Ekoklav at the beginning of a meal.
In the case of a course therapy, it is necessary to monitor the state of hematopoiesis, liver and kidney activity.
During the treatment period, there is a risk of developing superinfection due to the selection of antibiotic-insensitive forms of the pathogen.
While taking Ekoklav, it is possible to obtain false positive results when glucose is detected in the urine. In this case, the glucose oxidase method of determining the level of glucose in urine should be used.
In the presence of hypersensitivity to penicillins, cross-allergic reactions with cephalosporin antibiotics may occur.
If there is a suspicion of the development of infectious mononucleosis, the drug cannot be taken, since in patients with this disease, amoxicillin can provoke the appearance of a measles-like skin rash, which can complicate the diagnosis of the disease.
Influence on the ability to drive vehicles and complex mechanisms
Due to possible disturbances from the nervous system, while using the Ecoclave, care must be taken when driving vehicles and controlling complex equipment.
Application during pregnancy and lactation
The active components of the drug pass through the placental barrier, but data on negative effects on the fetus have not been recorded. If it is necessary to use the Ecoclave during pregnancy, it is necessary to carefully correlate the expected benefits of treatment for a woman with a possible threat to the health of the fetus.
The drug is allowed to be taken during lactation, since in addition to the risk of sensitization caused by the ingestion of trace amounts of active substances into breast milk, no other disorders were found in breastfed children.
Pediatric use
For children under 12 years of age and / or with a body weight of less than 40 kg, taking Ekoklav in the form of tablets is contraindicated.
With impaired renal function
In the presence of chronic renal failure (CC below 30 ml / min), taking tablets at a dosage of 875 mg + 125 mg is contraindicated. Ekoklava tablets in other dosages and powder for the preparation of a suspension for patients with chronic renal failure should be used with caution, due to the fact that the clearance of active ingredients in renal failure decreases.
For violations of liver function
The use of the drug is contraindicated in case of existing liver dysfunction or episodes of jaundice due to a history of amoxicillin / clavulanic acid intake.
In case of severe liver failure, Ekoklav should be taken with caution.
Drug interactions
- phenylbutazone, allopurinol, diuretics, nonsteroidal anti-inflammatory drugs and other drugs that block tubular secretion: the concentration of amoxicillin increases (due to the fact that clavulanic acid is excreted mainly through glomerular filtration);
- ascorbic acid: amoxicillin absorption is enhanced;
- allopurinol: the threat of developing a skin rash is aggravated;
- glucosamine, antacids, laxatives: absorption of amoxicillin slows down and decreases;
- probenecid: the tubular secretion of amoxicillin decreases, which can lead to an increase and persistence of its serum concentration, while the concentration of clavulanic acid in the serum does not change (this combination is not recommended for use);
- oral contraceptives: the effectiveness of these drugs decreases;
- indirect anticoagulants: it is required to carefully monitor the international normalized ratio (INR) or prothrombin time at the beginning and at the end of treatment with Ekoklav.
Analogs
Ekoklav's analogues are Amovikomb, Amoxicillin + Clavulanic acid, Amoxiclav, Amoxivan, Amoxiclav Kviktab, Amoxicillin + Clavulanic acid-Vial, Augmentin, Arlet, Augmentin EC, Baktoklav, Augmentin SR, Verklav, Novoklav, Panclav, Clamosar Flemoklav Solutab, Fibell, Foraclav.
Terms and conditions of storage
Store in a place protected from moisture and light, out of reach of children, at a temperature not exceeding 25 ° C. The prepared suspension must be stored in a carefully closed vial at a temperature of 2–8 ° C, without freezing.
Shelf life - 2 years, ready-made suspension - 7 days.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Ecoclave
The reviews about Ecoclave are mostly good. Patients indicate the effectiveness of the drug in the treatment of a significant number of infectious and inflammatory diseases, while many note its sparing effect on the normal intestinal microflora. A positive result of treatment, according to reviews, is noted on the third day of admission.
However, there are also reports of no effect when using this tool (mainly in the form of tablets). The disadvantages of the antibiotic include the development of side effects, mainly in the form of rash and diarrhea. In some cases, patients express dissatisfaction with the short duration of the finished suspension and some difficulties in calculating the dose for the child.
Price for Ecoclave in pharmacies
The approximate price for the Ecoclave may vary within the following limits:
- film-coated tablets: in a dosage of 250 + 125 mg, 15 pcs. in the package - from 170 to 245 rubles; at a dosage of 500 + 125 mg, 15 pcs. - from 280 to 390 rubles; at a dosage of 875 + 125 mg, 14 pcs. - from 300 to 440 rubles;
- powder for preparation of a suspension for oral administration: in a dosage (125 mg + 31.25 mg) / 5 ml - 25 g in a bottle with a dosage spoon - from 140 to 190 rubles; in a dosage (250 mg + 62.5 mg) / 5 ml - from 260 to 295 rubles.
Ekoklav: prices in online pharmacies
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Drug name Price Pharmacy |
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Ekoklav 250 mg + 125 mg film-coated tablets 15 pcs. 130 RUB Buy |
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Ekoklav 125 mg + 31.25 mg / 5 ml powder for preparation of suspension for oral administration 25 g 1 pc. 140 RUB Buy |
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Ekoklav 875 mg + 125 mg film-coated tablets 14 pcs. RUB 150 Buy |
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Ekoklav 250 mg + 62.5 mg / 5 ml powder for preparation of suspension for oral administration 25 g 1 pc. 199 RUB Buy |
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Ekoklav 500 mg + 125 mg film-coated tablets 15 pcs. RUB 200 Buy |
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Ecoclave pore. d / inv. suspension for oral administration 250mg + 62.5mg / 5ml fl. 25g No. 1 257 r Buy |
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Ekoklav tablets pp 500mg + 125mg 15 pcs. 396 r Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
