Ekoklav® (Amoxicillin + Clavulanic acid) tablets 250 mg + 125 mg
Ecoantibiotics are antibacterial drugs manufactured in Russia, available in the most in-demand pharmacotherapeutic classes of antibiotics: aminopenicillins, protected aminopenicillins, macrolides, and fluoroquinolones. They are used for the treatment of infectious and inflammatory diseases of various organs and systems.
Description
Amoxicillin with clavulanic acid is a pharmacological product whose active ingredients are the two mentioned components. Amoxicillin is a broad-spectrum antibiotic belonging to the penicillin group. The second component of the drug is a β-lactamase inhibitor, which activates inactive resistant complex compounds and protects the first substance (amoxicillin) from degradation.
Dosage Form and Composition
The tablet contains amoxicillin in the amount of 500 mg and the second active ingredient – clavulanic acid in the volume of 125 mg.
Another tablet contains 875 mg of the first component and 125 mg of the second substance.
In addition to the main components, this drug contains the following excipients:
- Cellulose;
- A small amount of magnesium stearate;
- Sodium starch glycolate;
- Silicon dioxide.
The drug, whose main components are amoxicillin and clavulanic acid, is produced in the form of tablets. It is offered in two dosage options for the active ingredients.
The medication is also manufactured as a powder for preparing a suspension. In this case, amoxicillin with the clavulanic additive is taken orally. The product has a strawberry flavor and a white hue. It is sold in semi-transparent bottles, which also vary in dosage (the main active ingredient in amounts of 125 mg, 250 mg).
The auxiliary components used in the drug include:
- Xanthan gum and aspartame (a sweetener component);
- Colloidal silicon dioxide and strawberry flavoring;
- Succinic acid, etc.
Indications for Use
According to the instructions, amoxicillin with clavulanic acid is recommended for use in combating developing inflammatory and infectious diseases:
- Infections affecting the ENT organs and upper respiratory tract. Using the antibiotic amoxicillin with clavulanic acid, therapeutic courses can be conducted to combat chronic and acute sinusitis, acute and chronic forms of otitis media, recurrent tonsillitis, abscess, and pharyngitis;
- Acute bronchitis with bacterial superinfection, chronic bronchitis in the exacerbation stage, and a number of other diseases affecting the lower respiratory tract. This also includes pneumonia and bronchopneumonia;
- Infections that have caused disorders in the area of connective and bone tissues/joints. This is why amoxicillin with clavulanic acid is often prescribed even for osteomyelitis;
- Infections affecting the biliary tracts (cholecystitis, as well as cholangitis);
- Presence of microorganisms that have led to infectious contamination in the genitourinary system. Amoxicillin with clavulanic acid (tablets or other forms of the drug) may be prescribed for prostatitis, cystitis, urethritis, infections of the genital organs in women, pyelonephritis, salpingitis, cervicitis, and a number of other diseases;
- Infections affecting the skin and soft tissues. This refers to secondarily infected dermatoses, abscesses, and other diseases;
- Odontogenic infections, as well as meningitis, sepsis, and endocarditis;
- Peritonitis;
- Other infections of a mixed type (intra-abdominal, postpartum, or post-abortion).
- All indications for use (see full instructions)
How to Use Amoxicillin with Clavulanic Acid: Instructions for Use
The dosage of amoxicillin with clavulanic acid in tablets or another form should be determined by the attending physician, taking into account the characteristics of the current illness, as well as concomitant pathologies and other factors.
Tablets intended for oral use should be taken before meals to reduce the risk of side effects causing digestive organ dysfunction.
If necessary, a specialist may prescribe stepwise therapy, which involves the use of the drug in the form of injections. In the initial stages, intravenous therapy is performed, after which they proceed to the internal intake of the drug.
In this situation, the use of amoxicillin with clavulanic acid for children aged 12 years and older and adults is permissible in the following dosages:
- Injections of moderate and mild severity: 500 mg of the active component (+125 mg of the second substance) every 12 hours or 250 mg of the active substance + 125 mg of the second substance every 8 hours;
- Severe injections: this implies the administration of the drug (dosage 250 + 125 mg) three times a day or the use of the second dosage option (875 mg + 125 mg of the active component) twice a day.
When taking amoxicillin with clavulanic acid, the instructions for which contain all the rules of administration, it should be remembered that the maximum daily dose of the drug should not exceed 6000 mg (for amoxicillin) and 600 mg (for the acid).
The minimum treatment period is 5 days. It is not recommended to take the drug for more than 14 days. After a 2-week period of using the product, you should visit a specialist who, having assessed the clinical situation, will decide on the subsequent need to use the drug.
When purchasing the medicine amoxicillin with clavulanic acid, please note that 1 tablet with a dosage of 500 mg cannot be equated to 2 tablets containing the active substance in a volume of 250 mg.
The powder intended for preparing a suspension is most often prescribed to young patients. In this case, the use of amoxicillin with clavulanic acid is recommended for children under 12 years of age.
This dosage form is prepared for use as follows:
- The bottle is filled 2/3 with cooled boiled water (it should reach room temperature);
- The contents of the container should be shaken thoroughly;
- The volume of the drug must be brought to the mark of 100 ml, then shaken again.
The agent is taken in the dose recommended by the doctor, and before each use, the contents of the bottle must be shaken. A special measuring cap included in the package will help avoid errors in dosing the drug.
How to take amoxicillin with clavulanic acid depends on the patient's body weight, characteristics of the infectious process, and other nuances, which are considered by an experienced specialist when prescribing the drug.
Following the instructions for use, amoxicillin with clavulanic acid should be taken for 5 days. The maximum duration of therapy recommended by the manufacturer is 14 days, but the final decision on the period of administration should be determined by the doctor.
Most often, doctors prescribe the use of soluble compositions in a dosage of 125 mg of the main substance + 31.25 mg of the second component for children from 3 months to 12 years (body weight should be within 40 kg). The composition is taken three times a day with 8-hour intervals.
In Which Cases Is the Agent Contraindicated?
The drug amoxicillin with clavulanic acid is not recommended for use if:
- Infectious mononucleosis is observed, including if a measles-like rash has appeared;
- Liver function is significantly impaired, and cholestatic jaundice has been identified;
- The patient's age category is under 12 years;
- The patient has hypersensitivity to any components of the medication;
- Creatinine clearance is less than 30 ml/min;
- Phenylketonuria is observed. In these cases, doctors exclude the use of the drug in the form of a suspension.
The medication amoxicillin with clavulanic acid should be used with extreme caution if:
- Renal failure has reached a chronic stage of development;
- A severe form of hepatic insufficiency is observed;
- Certain types of diseases affecting the gastrointestinal tract are developing, including colitis caused by exposure to penicillins;
- A woman is breastfeeding an infant.
The drug should not be taken during pregnancy without a doctor's prescription, as indeed in all other cases.
Possible Side Effects of the Body
In some cases, the use of the medication may cause the following reactions in the body:
- Nausea, vomiting;
- Loss of appetite;
- Dizziness;
- Stomach pain and intestinal disorder;
- Nervousness, feeling of anxiety;
- Convulsions;
- Impaired function of the liver, kidneys, and intestines;
- Allergic rash and others.
If these signs are present, it is necessary to stop taking the drug and consult a doctor to relieve the complications.
Pharmacy Dispensing Terms
By prescription
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Instructions for use of Ekoklav® (Amoxicillin + Clavulanic acid) tablets 250 mg + 125 mg
Brand name: Ekoklav®
International nonproprietary or grouping name: Amoxicillin + Clavulanic acid.
Dosage form: Film-coated tablets
One tablet contains
Amoxicillin trihydrate 287.00 mg/ 574.00 mg/ 1004.50 mg (equivalent to amoxicillin) 250.00 mg/ 500.00 mg/ 875.00 mg.
Potassium clavulanate + microcrystalline cellulose (1:1) 299.40 mg/ 299.40 mg/ 299.40 mg (equivalent to clavulanic acid) 125.00 mg/ 125.00 mg/ 125.00 mg.
Excipients: Lactitol 300.00 mg/ 600.00 mg/ 300.00 mg, Crospovidone (Kollidon CL) 24.00 mg/ 45.00 mg/ 50.00 mg, Croscarmellose sodium 24.00 mg/ 45.00 mg/ 50.00 mg, Talc 8.00 mg/ 12.00 mg/ 10.00 mg, Ascorbic acid 5.00 mg/ 5.00 mg/ 5.00 mg, Magnesium stearate 5.20 mg/ 13.84 mg/ 18.50 mg, Microcrystalline cellulose up to a core tablet weight of 1040.00 mg/ 1730.00 mg/ 1850.00 mg.
Coating excipients: Mixture for film coating "Insta Moistshield" [hypromellose - 54.00 %, ethylcellulose - 5.00 %, diethyl phthalate - 12.00 %, titanium dioxide - 25.00 %, talc - 4.00 %] – up to a coated tablet weight of 1089.00 mg/1774.30 mg/ 1887.70 mg.
Description
Oval, biconvex, film-coated tablets, white or almost white in color. The cross-section shows a core ranging from almost white to light yellow with a brownish tint; inclusions from white to yellow are acceptable.
Pharmacotherapeutic group
Antibiotic - semi-synthetic penicillin + beta-lactamase inhibitor.
ATC code: J01CR02
Pharmacological properties
A combined preparation of amoxicillin and clavulanic acid - a beta-lactamase inhibitor. Amoxicillin is a broad-spectrum semi-synthetic antibiotic; it acts bactericidally by inhibiting the synthesis of the cell wall protein of susceptible bacteria during the growth stage. Clavulanic acid has a high affinity for bacterial beta-lactamases and forms a stable complex with them. Thus, the biodegradation of amoxicillin by beta-lactamases is prevented, and the bactericidal activity of the antibiotic is preserved. Clavulanic acid inhibits beta-lactamases of types II-V according to the Richmond-Sykes classification and is not active against type I beta-lactamases produced by Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp.
Based on in vitro tests and clinical studies, the combined preparation of amoxicillin and clavulanic acid is active against the following microorganisms:
Gram-positive aerobic microorganisms:
Staphylococcus aureus (beta-lactamase producing and non-producing strains);
Gram-negative aerobic microorganisms:
- Enterobacter spp. (although most strains of Enterobacter are resistant in vitro, clinical efficacy of the drug in treating urinary system infections caused by this pathogen has been proven);
- Escherichia coli (beta-lactamase producing and non-producing strains);
- Haemophilus influenzae (beta-lactamase producing and non-producing strains);
- Klebsiella spp. (all known strains are beta-lactamase producing);
- Moraxella catarrhalis (beta-lactamase producing and non-producing strains).
Based on in vitro studies, the following microorganisms have shown susceptibility to the amoxicillin/clavulanic acid combination:
Gram-positive aerobic microorganisms:
- Enterococcus faecalis **;
- Staphylococcus epidermidis (beta-lactamase producing and non-producing strains);
- Staphylococcus saprophyticus (beta-lactamase producing and non-producing strains);
- Streptococcus pneumoniae ** (strains not producing beta-lactamases);
- Streptococcus pyogenes** (strains not producing beta-lactamases);
- Streptococcus group viridans ** (strains not producing beta-lactamases).
Gram-negative aerobic microorganisms:
- Eikenella corrodens (beta-lactamase producing and non-producing strains);
- Neisseria gonorrhoeae ** (beta-lactamase producing and non-producing strains);
- Proteus mirabilis** (beta-lactamase producing and non-producing strains).
Anaerobic microorganisms:
- Bacteroides spp., including Bacteroides fragilis (beta-lactamase producing and non-producing strains);
- Fusobacterium spp. (beta-lactamase producing and non-producing strains);
- Peptostreptococcus spp. (does not produce beta-lactamases).
NOTE: ** - (clinical efficacy of amoxicillin in treating a number of infections caused by these pathogens has been proven).
Pharmacokinetics
Absorption. After oral administration, both components of the drug are rapidly absorbed from the gastrointestinal tract. Absorption of the active ingredients is optimal when the drug is taken at the beginning of a meal.
After a single oral 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 h, clavulanic acid – 1.2 h;
- area under the concentration-time curve (AUC) of amoxicillin – 10.9 mg∙h/L, clavulanic acid – 6.2 mg∙h/L.
After a single oral dose of 500 mg+125 mg:
- Cmax of amoxicillin – 6.5 µg/ml, clavulanic acid – 2.8 µg/ml;
- Tmax of amoxicillin – 1.5 h, clavulanic acid – 1.3 h;
- AUC of amoxicillin – 23.2 mg∙h/L, clavulanic acid – 7.3 mg∙h/L.
After a single oral dose of 875 mg+125 mg:
- Cmax of amoxicillin – 8.8 µg/ml, clavulanic acid – 2.07 µg/ml;
- Tmax of amoxicillin – 1.5 h, clavulanic acid – 1.5 h;
- AUC of amoxicillin – 25.4 mg∙h/L, clavulanic acid – 6.1 mg∙h/L.
When using the drug, serum concentrations of amoxicillin are similar to those after oral administration of equivalent doses of amoxicillin alone.
Distribution
Both components of the drug have a good volume of distribution – therapeutic concentrations of amoxicillin and clavulanic acid are achieved in various organs and tissues, interstitial fluid: lungs, middle ear, abdominal organs, pelvic organs (prostate, uterus, ovaries), skin; adipose, bone and muscle tissues; pleural, synovial and peritoneal fluids; plasma, bile, purulent discharge, sputum, bronchial secretions.
Amoxicillin and clavulanic acid have a moderate degree of binding to plasma proteins, 18% and 25% respectively.
Both components of the drug cross the placental barrier, but no data on negative effects on the fetus have been published.
Amoxicillin and clavulanic acid are found in breast milk in low concentrations.
Metabolism, Excretion
Approximately 60-70% of amoxicillin is excreted by the kidneys: via tubular secretion and glomerular filtration. Clavulanic acid is actively metabolized in the liver and excreted via glomerular filtration (40-65%), partially as metabolites. A smaller portion is excreted via the intestines.
In renal failure, the clearance of amoxicillin with clavulanic acid decreases, requiring dose adjustment.
Indications for use
Infectious-inflammatory diseases caused by pathogens susceptible to the drug:
- Lower respiratory tract infections (bronchitis, pneumonia);
- ENT infections (sinusitis, tonsillitis, otitis media);
- Infections of the genitourinary system and pelvic organs (pyelonephritis, pyelitis, cystitis, urethritis, bacterial prostatitis, cervicitis, salpingitis, salpingo-oophoritis, endometritis, bacterial vaginitis, septic abortion, chancroid, gonorrhea);
- Skin and soft tissue infections (erysipelas, impetigo, secondarily infected dermatoses, abscess, phlegmon, wound infection);
- Bone and joint infections (osteomyelitis).
Contraindications
Hypersensitivity (including to cephalosporins and other beta-lactam antibiotics), infectious mononucleosis, history of jaundice or impaired liver function resulting from the use of amoxicillin/clavulanic acid.
Children under 12 years of age or weighing less than 40 kg (for this dosage form).
Chronic renal failure (creatinine clearance less than 30 ml/min) for 875 mg+125 mg tablets.
With caution
Severe hepatic insufficiency, gastrointestinal diseases (including history of colitis associated with penicillin use), chronic renal failure.
Use during pregnancy and lactation
The combined preparation of amoxicillin and clavulanic acid during pregnancy is recommended only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.
The drug can be used during breastfeeding. Except for the risk of sensitization associated with the passage of trace amounts of the active ingredients into breast milk, no other adverse effects have been identified in breastfed infants.
Dosage and administration
Orally. The dosage regimen is set individually depending on the age and body weight of the patient, severity and location of the infection, and 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 review of the clinical situation.
Adults and children over 12 years 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 is 6 g, clavulanic acid - 600 mg.
In chronic renal failure, dose and frequency adjustment is required depending on creatinine clearance (CrCl):
- CrCl > 30 ml/min: no dose adjustment required;
- CrCl 10-30 ml/min: 1 tablet of 250 mg+125 mg twice daily (for mild and moderate infections) or 1 tablet of 500 mg+125 mg twice daily (for severe infections or lower respiratory tract infections);
- CrCl < 10 ml/min: 1 tablet of 250 mg+125 mg once daily (for mild and moderate infections) or 1 tablet of 500 mg+125 mg once daily (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, plus 1 dose during hemodialysis and 1 dose after hemodialysis, as concentrations of amoxicillin and clavulanic acid decrease.
Side effects
The drug is well tolerated. Side effects are rare, mostly mild and transient.
Gastrointestinal system: Nausea, vomiting, diarrhea, gastritis, stomatitis, glossitis, cholestatic jaundice, hepatitis, hepatic failure (more often in the elderly, men, with long-term therapy), colitis (including pseudomembranous), black "hairy" tongue, darkening of tooth enamel, increased activity of "liver" transaminases, increased bilirubin and alkaline phosphatase activity.
Hematopoietic organs: Reversible increase in prothrombin time and bleeding time, thrombocytopenia, thrombocytosis, eosinophilia, leukopenia, agranulocytosis, hemolytic anemia.
Central nervous system: Dizziness, headache, hyperactivity, anxiety, behavior changes, convulsions.
Allergic reactions: Urticaria, erythematous rashes, multiform exudative erythema, anaphylactic shock, angioedema, exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), allergic vasculitis, serum sickness-like syndrome, acute generalized exanthematous pustulosis.
Kidneys and urinary tract: Interstitial nephritis, crystalluria, hematuria.
Other: Candidiasis, development of superinfection.
Overdose
Symptoms: Impaired gastrointestinal function and water-electrolyte balance.
Treatment: Symptomatic. Hemodialysis is effective.
Interaction with other medicinal products
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 co-administration may lead to an increase and persistence of amoxicillin concentration 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 it.
Allopurinol increases the risk of skin rash.
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 combined preparation of amoxicillin and clavulanic acid may reduce the effectiveness of oral contraceptives, and patients should be informed of this.
Rare cases of increased International Normalized Ratio (INR) in patients with simultaneous use of acenocoumarol or warfarin and amoxicillin have been described in the literature. If it is necessary to prescribe the combined preparation of amoxicillin and clavulanic acid concurrently with indirect anticoagulants, prothrombin time or INR should be carefully monitored when prescribing or discontinuing the drug.
Special instructions
The severity of gastrointestinal symptoms decreases when the drug is taken at the beginning of a meal.
During course treatment, it is necessary to monitor the state of the hematopoietic organs, liver and kidneys.
The development of superinfection due to the selection of resistant forms of the pathogen is possible.
False-positive results may be detected when determining glucose in urine. In this case, it is recommended to use the glucose oxidase method for determining urine glucose concentration.
In patients with hypersensitivity to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible.
If infectious mononucleosis is suspected, the drug should not be used, since in patients with this disease, amoxicillin can cause a measles-like skin rash, which complicates the diagnosis of the disease.
Given the possibility of side effects from the central nervous system, caution should be exercised when driving vehicles and operating machinery.
Dosage form
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 multilayer aluminum foil and printed varnished aluminum foil.
14 or 15 tablets of 250 mg+125 mg and 500 mg+125 mg, 5, 7, 10 or 14 tablets of 875 mg+125 mg in plastic bottles with a screw cap with first-opening control and a moisture-absorbing insert or polymer jars with a screw cap with first-opening control and a moisture-absorbing insert.
1, 2 or 3 blister packs of 250 mg+125 mg and 500 mg+125 mg, 1 or 2 blister packs of 875 mg+125 mg or 1 bottle together with the instructions for use are placed in a cardboard box.
Storage conditions
Store in a dry, light-protected place, at a temperature not exceeding 25 °C. Keep out of reach of children.
Shelf life
2 years. Do not use after the expiration date.
Pharmacy supply terms
By prescription.
Name and address of the legal entity in whose name the registration certificate is issued / Organization accepting claims:
JSC "AVVA RUS", Russia,
121614, Moscow, Krylatskie Kholmy st., 30, bld. 9.
Tel.: +7 (495) 956-75-54.
avva.com.ru
ecoantibiotic.ru
Address of the production site:
JSC "AVVA RUS", Russia,
610044, Kirov region, Kirov, Luganskaya st., 53a.
Tel.: +7 (8332) 25-12-29; +7 (495) 956-75-54.
