The drug Ecoclave - indications for use, methods of administration and dosage.

Ecoclave - Tablets

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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: film-coated tablets. Description: Film-coated tablets, white or almost white, oval, biconvex. On a cross section from white with a yellowish tint to light yellow with a brown tint, inclusions of white are acceptable. Pharmacotherapeutic group: Antibiotic - semi-synthetic penicillin + beta-lactamase inhibitor. ATX code: J01CR02

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Composition Expand

Active substance: amoxicillin trihydrate, potassium clavulanate. Excipients: lactitol, crospovidone (kollidon CL), croscarmellose sodium, talc, magnesium stearate, microcrystalline cellulose Excipients of the shell: Mixture for preparing film coating “Insta Moistshield” (hypromellose, ethylcellulose, diethyl phthalate, titanium dioxide, talc)

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 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 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 (strains producing and not producing beta-lactamases); 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).
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 250 mg + 125 mg: - maximum concentration (Cmax) of amoxicillin - 3.7 μg/ml, clavulanic acid - 2.2 μg/ml; — time to reach maximum concentration (Tmax) of amoxicillin – 1.1 hours, clavulanic acid – 1.2 hours; — area under the concentration-time curve (AUC) of amoxicillin – 10.9 mg? h/l, clavulanic acid – 6.2 mg? h/l. After oral administration at a dose of 500 mg + 125 mg: - Cmax of amoxicillin - 6.5 μg/ml, clavulanic acid - 2.8 μg/ml; — Tmax of amoxicillin – 1.5 hours, clavulanic acid – 1.3 hours; — AUC of amoxicillin – 23.2 mg? h/l, clavulanic acid – 7.3 mg? h/l. After oral administration at a dose of 875 mg + 125 mg: - Cmax of amoxicillin - 8.8 mcg/ml, clavulanic acid - 2.07 mcg/ml; — Tmax of amoxicillin – 1.5 hours, clavulanic acid – 1.5 hours; — AUC of amoxicillin – 25.4 mg? h/l, clavulanic acid – 6.1 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. 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 the use of amoxicillin/clavulanic acid in the anamnesis. Children under 12 years of age or with a body weight of less than 40 kg (for this dosage form). Chronic renal failure (creatinine clearance less than 30 ml/min) for tablets with a dosage of 875 mg + 125 mg. 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. For adults and children over 12 years of age or weighing more than 40 kg: - Mild and moderate infections - 1 tablet of 250 mg + 125 mg 3 times a day or 1 tablet of 500 mg + 125 mg 2 times a day. - Severe infections or lower respiratory tract infections - 1 tablet of 875 mg + 125 mg 2 times a day or 1 tablet of 500 mg + 125 mg 3 times a day. Since the tablets contain the same amount of clavulanic acid (125 mg), it should be noted that 2 tablets of 250 mg + 125 mg are not equivalent to 1 tablet of 500 mg + 125 mg. The maximum daily dose of amoxicillin for adults and children over 12 years of age is 6 g, clavulanic acid is 600 mg. In case of chronic renal failure, the dose and frequency of administration are adjusted depending on creatinine clearance (CC): - with creatinine clearance more than 30 ml/min, no dose adjustment is required; - with CC 10-30 ml/min: 1 tablet of 250 mg + 125 mg 2 times a day (for mild and moderate infections) or 1 tablet of 500 mg + 125 mg 2 times a day (for severe infections or lower respiratory infections paths); - with CC less than 10 ml/min: 1 tablet of 250 mg + 125 mg once a day (for mild and moderate infections) or 1 tablet of 500 mg + 125 mg once a day (for severe infections or lower respiratory tract infections ); Patients on hemodialysis: 1 tablet of 500 mg + 125 mg or 2 tablets of 250 mg + 125 mg every 24 hours in combination with 1 dose during hemodialysis and 1 dose after hemodialysis, as the concentration of amoxicillin and clavulanic acid decreases.

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 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.

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 joint administration may lead to an increase and persistence of amoxicillin concentrations in the serum, while the serum concentration of clavulanic acid does not change. Antacids, glucosamine, laxatives slow down and reduce the absorption of amoxicillin; ascorbic acid - increases. Allopurinol increases the risk of skin rashes. 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). 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 it is necessary to simultaneously prescribe a combination drug of amoxicillin and clavulanic acid with indirect anticoagulants, 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 in urine. In this case, it is recommended to use the glucose oxidant 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 operating machinery.

Release form Expand

Film-coated tablets 250 mg+125 mg, 500 mg+125 mg, 875 mg+125 mg. 5 or 7 tablets in a blister pack made of polyvinyl chloride film and printed varnished aluminum foil. 5 or 7 tablets in a blister pack made of multilayer aluminum foil and printed varnished aluminum foil. 14 or 15 tablets with a dosage of 250 mg + 125 mg and 500 mg + 125 mg, 5, 7, 10 or 14 tablets with a dosage of 875 mg + 125 mg in bottles for medicines made of plastic, tamper evident with screw caps with moisture-absorbing insert. 1, 2 or 3 blister packs with a dosage of 250 mg + 125 mg and 500 mg + 125 mg, 1 or 2 blister packs with a dosage of 875 mg + 125 mg or 1 bottle along with instructions for use are placed in a cardboard pack.

Storage conditions Expand

In a dry place, protected from light, at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Expiration date Expand

Shelf life: 2 years. Do not use the drug after the expiration date.

Conditions for dispensing from pharmacies Expand

Dispensed by prescription.

Owner of the registration certificate Expand

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Antibiotic Ecoclave has a broad bactericidal effect.

Amoxicillin , which is part of it, inhibits the production of protein in the cell wall of bacteria sensitive to it.

Clavulanic acid is related to bacterial lactamases and forms a stable compound with them, preventing the biodegradation of amoxicillin by beta-lactamases, while maintaining the bactericidal activity of the antibiotic. The drug is active against a wide range of gram-positive and gram-negative aerobic and anaerobic microorganisms.

Pharmacokinetics

Ecoclave, after ingestion, is quickly absorbed from the gastrointestinal tract. Tmax of the drug is about one hour. Both components of Ecoclave are well distributed in various organs and tissues, quickly creating the required therapeutic concentration. The degree of binding to blood proteins is moderate: 18% for amoxicillin and 25% for clavulanic acid. Metabolism occurs in the liver, is excreted through the kidneys and partially through the intestines.

Ecoclave price, where to buy

The price of Ecoclave tablets 250 mg + 125 mg No. 15 varies within 170 rubles per pack. The cost of Ecoclave powder for suspension 125 mg + 31.25 mg / 5 ml in a bottle is about 140 rubles per package. You can easily purchase the drug in the pharmacy chain of Moscow and other cities.

Online pharmacies in RussiaRussia

ZdravCity

Ecoclave por.
d/prig. susp. for oral administration 250 mg + 62.5 mg/5 ml vial. 25g No. 1 JSC "AVVA RUS" 243 rub. order

Side effects

The drug is well tolerated by most patients. Side effects are mostly mild and transient.

Side effects include nausea, diarrhea , vomiting, liver failure (with long-term therapy), gastritis , hepatitis , colitis , thrombocytopenia , leukopenia , hemolytic anemia , agranulocytosis , thrombocytosis , eosinophilia , dizziness , behavioral changes, headache, hyperactivity, anxiety, local allergies reactions. Possible nephritis , hematuria , candidiasis .

Interaction

Ecoclave should not be taken simultaneously with probenecid .

Laxatives, antacids and glucosamine reduce and slow down the absorption process of amoxicillin. Ascorbic acid increases absorption .

NSAIDs, diuretics, phenylbutazone and other drugs that slow down tubular secretion increase the concentration of amoxicillin. The drug reduces the effectiveness of oral contraceptives.