Description
Release form
Film-coated tablets.
Packing
15 pcs.
Pharmacological action
Ecoclave – a combined preparation of amoxicillin and clavulanic acid – a beta-lactamase inhibitor.
Amoxicillin is a semi-synthetic broad-spectrum antibiotic that acts bactericidally, 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.
Indications
Infectious and inflammatory diseases caused by drug-sensitive pathogens:
lower respiratory tract infections (bronchitis, pneumonia)
infections of the ENT organs (sinusitis, tonsillitis, otitis media)
infections of the urinary tract, pyelitis and pyelitis , cystitis, urethritis, bacterial prostatitis, cervicitis, salpingitis, salpingoophoritis, endometritis, bacterial vaginitis, septic abortion, soft chancre, gonorrhea)
infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses, abscess, phlegmon, wound infection)
infection of bones and joints (osteomyelitis).
Contraindications
Hypersensitivity (including to cephalosporins and other beta-lactam antibiotics).
Infectious mononucleosis.
Episodes of jaundice or impaired liver function due to a history of amoxicillin / clavulanic acid.
Children under 12 years old 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.
Use during pregnancy and lactation
Pregnancy
The combined preparation of amoxicillin and clavulanic acid during pregnancy is recommended only in cases where the expected benefits of taking it for the mother outweigh the potential risk to the fetus.
Breastfeeding
The drug can be used during breastfeeding. With the exception of the risk of sensitization associated with the penetration into breast milk of trace amounts of the active ingredients of this drug, no other adverse effects were detected in breast-fed infants.
Special instructions
The severity of gastrointestinal symptoms decreases when taking the drug at the beginning of a meal.
During the course of treatment, it is necessary to monitor the state of the function of the blood, liver and kidneys.
Perhaps the development of superinfection due to the selection of resistant forms of the pathogen.
False positive results in urine glucose testing can be detected. In this case, it is recommended to use the glucose oxidase method for determining the concentration of glucose in the urine.
In patients with hypersensitivity to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible.
In case of suspected infectious mononucleosis, the drug should not be used, since in patients with this disease, amoxicillin can cause a measles-like skin rash, which makes it difficult to diagnose the disease.
Effect on the ability to drive vehicles and other mechanisms that require an increased concentration of attention
Given the likelihood of side effects from the central nervous system, caution should be exercised when driving vehicles and working with moving mechanisms.
Composition
1 tablet contains:
Active substances: amoxicillin trihydrate (in terms of amoxicillin) -250 mg, potassium clavulanate (in terms of clavulanic acid) – 125 mg.
Dosage and administration of
Ecoclave taken orally. The dosage regimen is set individually depending on the age and body weight of the patient, the severity of the course and localization of the infectious process, as well as the sensitivity of the pathogen.
The minimum course of antibiotic therapy is from 5 days. Treatment should not be continued for longer than 14 days without a review of the clinical situation.
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 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 tablets contain the same amount of clavulanic acid (125 mg), it should be borne in mind 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 old is 6 g, clavulanic acid is 600 mg.
Side effects
The drug is well tolerated. Side effects rarely occur, they are mostly mild and are 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 prolonged therapy), colitis (including pseudomembranous), black hairy tongue, darkening of tooth enamel, increased activity of hepatic transaminases, increased bilirubin content and alkaline phosphatase activity.
From the hemopoietic organs: a reversible increase in prothrombin time and bleeding time, thrombocytopenia, thrombocytosis, eosinophilia, leukopenia, agranulocytosis, hemolytic anemia.
From the central nervous system: dizziness, headache, hyperactivity, anxiety, behavior change, convulsions.
Allergic reactions: urticaria, erythematous rashes, multiforme exudative erythema, anaphylactic shock, angioedema, exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), allergic vasculitis, syndrome similar to serum sick acute generalized exanthematous pustulosis.
From the kidneys and urinary tract: interstitial nephritis, crystalluria, hematuria.
Other: candidiasis, development of superinfection.
Drug Interactions
It is not recommended to use the combined preparation of amoxicillin and clavulanic acid simultaneously with probenecid. Probenecid reduces the tubular secretion of amoxicillin, so their combined use can lead to an increase and persistence of the concentration of amoxicillin in 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 rash.
Like other broad-spectrum antibiotics, the combined preparation of amoxicillin and clavulanic acid can reduce the effectiveness of oral contraceptives, and patients should be informed about this.
The literature describes rare cases of increasing international normalized ratio (INR) in patients with the combined use of acenocoumarol or warfarin and amoxicillin. If it is necessary to simultaneously use the combined preparation of amoxicillin and clavulanic acid with indirect anticoagulants, prothrombin time or INR should be carefully monitored when prescribing or discontinuing the drug.
Overdose
Symptoms: impaired gastrointestinal and water / electrolyte balance.
Treatment: symptomatic. Hemodialysis is effective.
Storage Conditions
Store in a dry, dark place at a temperature not exceeding 25 ° C.
Shelf life
2 years.
Active ingredient
Amoxicillin, Clavulanic acid
dosage form
tablets
