Ecoclave® (Amoxicillin + Clavulanic acid) tablets 875 mg+125 mg

One tablet contains:

Amoxicillin trihydrate 287.00 mg / 574.00 mg / 1004.50 mg (in terms of 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 (in terms of 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 to obtain an uncoated tablet weighing 1040.00 mg / 1730.00 mg / 1850.00 mg.

Excipients of the shell:

mixture for preparing film coating "Insta Moistsheld" [hypromellose - 54.00%, ethylcellulose - 5.00%, diethyl phthalate - 12.00%, titanium dioxide - 25.00%, talc - 4.00%] - to obtain a tablet with a shell weighing 1089.00 mg/1774.30 mg/1887.70 mg.

Analogs

Level 4 ATX code matches:
Arlet

Ecoclave

Panclave

Amoxiclav

Oxamp-Sodium

Oxamp

Augmentin

Ampisid

Amoxil K 625

Flemoklav Solutab

Sultasin

The main analogues are represented by the following drugs: Amocombe, Amoxivan, Amoxiclav, Quiktab, Amoxicillin trihydrate + Potassium Clavulanate, Arlet, Augmentin, Bactoclav, Verclave, Clamosar, Liclave, Medoclav, Panklav, Ranclave, Rapiclav, Taromentin, Fibell, Flemoklav Solutab and Ecoclave.

Description

Oval biconvex tablets, film-coated, white or almost white. On a cross section, the kernel is almost white to light yellow with a brown tint; inclusions from white to yellow are acceptable.

Pharmacotherapeutic group

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

ATX code:

J01CR02

Pharmacological properties

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 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 (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).

Pharmacokinetics

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;
• the area under the concentration-time curve (AUC) of amoxicillin is 10.9 mg∙h/l, clavulanic acid is 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 µg/ml, clavulanic acid – 2.07 µg/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.

Amoxicillin+Clavulanic acid 875 mg+125 mg No. 14 tablets

Content

Pharmacodynamics Bacteria that are usually sensitive to the combination of amoxicillin with clavulanic acid Bacteria for which acquired resistance to the combination of amoxicillin with clavulanic acid is likely Bacteria that are naturally resistant to the combination of amoxicillin with clavulanic acid Indications Contraindications With caution Pregnancy and lactation Method of administration and dosage Side effects Overdose Interaction Special instructions Influence on the ability to drive vehicles and machinery Storage conditions Expiration date

Pharmacodynamics

Mechanism of action

Amoxicillin is a semisynthetic broad-spectrum antibiotic with activity 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 these enzymes.

Clavulanic acid is a beta-lactamase inhibitor structurally related to penicillins and has the ability to inactivate a wide range of beta-lactamases commonly found in microorganisms resistant to penicillins and cephalosporins. Clavulanic acid is quite effective against plasmid beta-lactamases, which most often cause bacterial resistance.

The two main mechanisms of resistance to the combination of amoxicillin and clavulanic acid are:

1. Inactivation by bacterial beta-lactamases that are not themselves inhibited by clavulanic acid, including various amino acid sequences belonging to classes B C and D according to the Ambler classification.
2. Changes in penicillin-binding proteins reduce the degree of affinity of the antibacterial agent to the target. Reduced outer membrane permeability and efflux pump mechanisms may cause or contribute to resistance, especially among Gram-negative microorganisms.

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

Pharmacodynamic effects

Below is a classification of microorganisms according to their in vitro sensitivity to the combination of amoxicillin and clavulanic acid.

Bacteria are usually sensitive to the combination of amoxicillin and clavulanic acid

Gram-positive aerobes

• Bacillus anthracis
• Enterococcus faecalis
• Listeria monocytogenes
• Nocardia asteroids
• Streptococcus pyogenes12
• Streptococcus agalactiae 12
• Streptococcus spp. (other beta-hemolytic streptococci)12
• Staphylococcus aureus (methicillin sensitive)1
• Staphylococcus saprophyticus (methicillin sensitive)
• Coagulase-negative staphylococci (methicillin sensitive)

Gram-positive anaerobes

• Clostridium spp.
• Peptococcus niger
• Peptostreptococcus magnus
• 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 clavulanic 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 pneumoniae12
• Viridans group streptococci

Bacteria that are naturally resistant to the combination of amoxicillin and clavulanic 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 amoxicillin with clavulanic acid has been demonstrated in clinical studies.

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

Indications

• upper respiratory tract infections (including ENT infections) such as recurrent tonsillitis, sinusitis, otitis media, usually caused by Streptococcus pneumoniae Haemophilus influenzae Moraxella catarrhalis and Streptococcus pyogenes;
• lower respiratory tract infections such as exacerbation of chronic bronchitis, lobar pneumonia and bronchopneumonia usually caused by Streptococcus pneumoniae Haemophilus influenzae#and Moraxella catarrhalis;
• infections of the genitourinary tract, such as cystitis, urethritis, pyelonephritis, infections of the female genital organs, usually caused by species of the Enterobacteriaceae family (mainly Escherichia coli), Staphylococcus saprophyticus and species of the genus Enterococcus, as well as gonorrhea caused by Neisseria gonorrhoeae;
• infections of the skin and soft tissues usually caused by Staphylococcus aureus Streptococcus pyogenes and species of the genus Bacteroides;
• infections of bones and joints such as osteomyelitis usually caused by Staphylococcus aureus; in this case, longer therapy may be required;
• odontogenic infections, for example, periodontitis, odontogenic maxillary sinusitis, severe dental abscesses with spreading cellulitis;
• other mixed infections (for example, septic abortion, postpartum sepsis, intra-abdominal sepsis) as part of stepwise therapy;

Contraindications

Hypersensitivity to amoxicillin, clavulanic acid, penicillins or other components of the drug; severe immediate hypersensitivity reactions (eg anaphylaxis) to other beta-lactam antibiotics (eg cephalosporins, carbapenems, monobactams); history of previous episodes of jaundice or impaired liver function when using a combination of amoxicillin and clavulanic acid; children under 12 years of age or weighing less than 40 kg; impaired renal function (creatinine clearance less than 30 ml/min) (for a dosage of 875 mg/125 mg).

Carefully

In patients with impaired liver function.

Pregnancy and lactation

Pregnancy

Animal studies have not revealed any evidence of harm from taking the drug during pregnancy or its effect on the embryonic development of the fetus.

One study in women with premature rupture of membranes found that prophylactic use of amoxicillin/clavulanic acid may be associated with an increased risk of necrotizing enterocolitis in newborns. During pregnancy and lactation, the drug is used only if the expected benefit to the mother outweighs the potential risk to the fetus and child.

Breastfeeding period

The drug Amoxicillin + Clavulanic acid can be used during breastfeeding if the expected benefit to the mother outweighs the potential risk to the child. With the exception of the possibility of sensitization of 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 infants. If adverse effects occur in breastfed infants, breastfeeding should be discontinued.

Directions for use and doses

Inside.

The dosage regimen is set individually depending on the patient’s age, body weight, renal function and the severity of the infection.

Amoxicillin + Clavulanic acid is recommended to be taken at the beginning of a meal for optimal absorption and to reduce possible side effects from the digestive system.

The minimum course of antibacterial therapy is 5 days. The duration of treatment is determined by the attending physician. Treatment should not continue for more than 14 days without repeated medical examination.

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

For the treatment of mild to moderate infections - 1 tablet 250 mg + 125 mg every 8 hours (3 times a day).

For the treatment of severe infections and respiratory infections - 1 tablet 500 mg + 125 mg every 8 hours (3 times a day) or 1 tablet 875 mg + 125 mg every 12 hours (2 times a day). Since amoxicillin and clavulanic acid combination tablets of 250 mg + 125 mg and 500 mg + 125 mg contain the same amount of clavulanic acid -125 mg, then 2 tablets of 250 mg + 125 mg are not equivalent to 1 tablet of 500 mg + 125 mg.

Patients with impaired renal function

Dose adjustments are based on the maximum recommended dose of amoxicillin and are based on creatinine clearance (CC) values.

Tablets 875 mg + 125 mg should be used only in patients with CC >30 ml/min.

Patients with liver dysfunction

Amoxicillin + Clavulanic acid should be taken with caution. It is necessary to regularly monitor liver function.

Does not require adjustment of the dosage regimen for elderly patients. In elderly patients with impaired renal function, the dose should be adjusted as for adult patients with impaired renal function.

Side effects

• From the gastrointestinal tract: very often: diarrhea; often: nausea, vomiting. Nausea is most often observed with high doses taken orally. If gastrointestinal disorders are confirmed, they can be eliminated by taking the drug at the beginning of a meal; uncommon: indigestion; very rare: antibiotic-associated colitis (including hemorrhagic colitis and pseudomembranous colitis) black “hairy” tongue gastritis stomatitis.
• From the liver and biliary tract: uncommon: increased activity of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST). These reactions have been observed in patients receiving beta-lactam antibiotic therapy, but their clinical significance is unknown. Very rare: hepatitis and cholestatic jaundice. These reactions are observed in patients receiving therapy with penicillin antibiotics and cephalosporins. Increased alkaline phosphatase activity increases the activity of bilirubin in the blood plasma. 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 usually occur during or immediately after completion of therapy; however, 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 in extremely rare cases, deaths have been reported. In almost all cases, these were persons with serious comorbidities or persons receiving simultaneously potentially hepatotoxic drugs.
• From the immune system: very rarely: angioedema, anaphylactic reactions, allergic vasculitis, a syndrome similar to serum sickness.
• From the blood and lymphatic system: rarely: reversible leukopenia (including neutropenia), thrombocytopenia; very rare: reversible agranulocytosis anemia (including reversible hemolytic anemia) reversible increase in prothrombin time reversible increase in bleeding time (see section "Special Instructions") eosinophilia thrombocytosis.
• From the nervous system: infrequently: dizziness, headache; very rare: convulsions (may occur in patients with impaired renal function and also when taking high doses of the drug) reversible hyperactivity aseptic meningitis anxiety insomnia changes in behavior agitation.
• From the skin and subcutaneous tissues: uncommon: skin rash, skin itching, urticaria; rarely: erythema multiforme; very rare: bullous exfoliative dermatitis Stevens-Johnson syndrome acute generalized exanthematous pustulosis toxic epidermal necrolysis drug rash with eosinophilia and systemic symptoms (DRESS syndrome).
• From the kidneys and urinary tract: very rarely: interstitial nephritis, crystalluria (see section “Overdose”), hematuria.
• Infectious and parasitic diseases: often: candidiasis of the skin and mucous membranes.

Overdose

Symptoms

Gastrointestinal symptoms and fluid and electrolyte imbalance may occur. Amoxicillin crystalluria has been observed in some cases, leading to the development of renal failure. Convulsions may occur in patients with impaired renal function and in those receiving high doses of the drug.

Treatment

If symptoms from the gastrointestinal tract occur, symptomatic therapy is used, paying special attention to the normalization of water-electrolyte balance. Amoxicillin and clavulanic acid can be removed from the bloodstream by hemodialysis. The results of a prospective study involving 51 children at a poison control center showed that an overdose of amoxicillin at a dose of less than 250 mg/kg does not lead to significant clinical symptoms and does not require gastric lavage.

Interaction

The simultaneous use of the combination of amoxicillin + [clavulanic acid] and probenecid is not recommended. Probenecid reduces the renal tubular secretion of amoxicillin; therefore, the simultaneous use of amoxicillin + [clavulanic acid] and probenecid may lead to an increase in the concentration and persistence in the blood 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 renal tubular secretion; therefore, the simultaneous use of amoxicillin + [clavulanic acid] and methotrexate may increase the toxicity of methotrexate.

Like other antibacterial drugs, the combination of amoxicillin + [clavulanic acid] may affect the intestinal microflora, 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 the combined use of acenocoumarol or warfarin and amoxicillin. If concomitant use of oral anticoagulants and amoxicillin + [clavulanic acid] is necessary, the prothrombin time or INR should be carefully monitored when starting and when amoxicillin + [clavulanic acid] is discontinued. Dose adjustment of oral anticoagulants may be required.

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

special instructions

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

Serious and in some cases fatal hypersensitivity reactions (including anaphylactic and severe skin adverse reactions) to penicillins have been reported. The risk of such reactions is highest in patients with a history of hypersensitivity reactions to penicillins. If an allergic reaction occurs, treatment with amoxicillin+[clavulanic acid] should be discontinued and appropriate alternative therapy should be instituted. If serious anaphylactic reactions develop, the patient should be given epinephrine immediately. Oxygen therapy, intravenous glucocorticosteroids, and airway management including intubation may also be required.

If allergic skin reactions occur, treatment with the amoxicillin + [clavulanic acid] combination should be discontinued.

It is not recommended to prescribe amoxicillin with clavulanic acid if infectious mononucleosis is suspected, since in patients with this disease amoxicillin can cause a measles-like skin rash, which makes diagnosing the disease difficult.

Long-term treatment with amoxicillin with clavulanic acid in some cases can lead to excessive proliferation of insensitive microorganisms. Cases of pseudomembranous colitis have been described when taking 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 who develop diarrhea during or after antibiotic use. If diarrhea is prolonged or severe, or the patient experiences abdominal cramps, the drug should be stopped immediately and the patient examined. The use of drugs that inhibit intestinal motility is contraindicated.

In general, amoxicillin + [clavulanic acid] is well tolerated and has the low toxicity characteristic of all penicillins. During long-term therapy with amoxicillin with clavulanic acid, it is recommended to periodically evaluate the functions of organs and systems, including the kidneys, liver and hematopoietic system.

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

In patients with reduced diuresis, crystalluria has been observed in very rare cases, mainly during parenteral therapy. When using 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 amoxicillin + [clavulanic acid] orally leads to a high level of amoxicillin in the urine, which can lead to false-positive results when determining glucose in the 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.

Drug abuse and dependence

There was no drug dependence of addiction and euphoric reactions associated with the use of amoxicillin + [clavulanic acid].

Impact on the ability to drive vehicles and machinery

If undesirable reactions from the nervous system develop (for example, dizziness, convulsions), you should refrain from driving a car or engaging in other activities that require increased concentration and speed of psychomotor reactions.

Storage conditions

In original packaging at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Best before date

2 years.

Do not use after the expiration date stated on the package.

Indications for use

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).

Use during pregnancy and lactation

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.

Reviews for Amoxicillin + Clavualanic acid

As you know, antibiotics are the most discussed drugs on various forums. Patients are almost equally concerned about both the effectiveness and safety of such drugs. At the same time, reviews of the drugs Amoxicillin + Clavualanic acid are in most cases positive.

No one doubts the effectiveness of this antibiotic, which is why it is prescribed for the treatment of even the most complex forms of diseases. However, patients are often interested in clavulanic acid, what it is and how it is combined with amoxicillin, that is, it enhances or softens its effect. It should be noted that this substance has its own antibacterial activity.

This drug is also often found in discussions related to the treatment of pregnant women. But many experts advise taking the drug Amoxiclav . This is confirmed by women who were treated with this drug at various stages of pregnancy . As a rule, treatment always helps eliminate the disorder without causing harm to either the patient or the fetus.

Antibiotics are components of many therapeutic regimens associated with the treatment of bacterial infections. It should be remembered that such medications can only be taken as prescribed by a doctor. But first you should determine the sensitivity of the pathogen to this drug. Only then can a positive outcome of treatment be expected without additional harm to the body.

Directions for use and doses

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.

Adults and children over 12 years of age or weighing more than 40 kg:

Mild to 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 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.

For chronic renal failure

The dose and frequency of administration are adjusted depending on creatinine clearance (CC):

• when CC is 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 tract infections );
• 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.

Amoxicillin + Clavualanic acid, instructions for use (Method and dosage)

Preparations based on these substances can be used for oral, intravenous or intramuscular administration. In this case, the dosage, regimen and duration of therapy are established taking into account the complexity of the disease, the sensitivity of the pathogen, the location of the infection and the characteristics of the patient.

For example, patients under 12 years of age are recommended to take the drug in the form of syrup, suspension or drops, which are intended for internal use. A single dosage is determined depending on the weight and age of the patients.

The maximum daily dosage of amoxicillin for children over 12 years of age and adult patients is 6 g, and for small patients less than 12 years old it is recommended to calculate the dose of 45 mg per kg of weight.

The maximum permissible dosage of clavulanic acid for children over 12 years of age and adults is 600 mg, and for children under 12 years of age at the rate of 10 mg per kg of weight.

The average duration of treatment can be 10-14 days.

Side effects

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, behavior changes, convulsions.

Allergic reactions:

urticaria, erythematous rashes, erythema multiforme exudative, 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.

Others:

candidiasis, development of superinfection.

Interaction with other drugs

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.

Pharmacodynamics and pharmacokinetics

The combined drug Amoxicillin + Clavulanic acid is a beta-lactamase inhibitor that has a bactericidal effect that inhibits the synthesis of the bacterial wall. Moreover, the activity of the drug is manifested against various aerobic gram-positive bacteria, including strains that produce beta-lactamases, for example: Staphylococcus aureus, some aerobic gram-negative bacteria: Haemophilus influenzae, Enterobacter spp., Escherichia coli, Klebsiella spp. and other sensitive pathogens, anaerobic gram-positive bacteria, anaerobic and aerobic gram-negative bacteria and so on.

Clavulanic acid is able to suppress types II-V beta-lactamases, without showing activity against type 1 beta-lactamases produced by Pseudomonas aeruginosa, Acinetobacter spp and Serratia spp. This substance is also characterized by high tropism for penicillinases, forming a stable complex with the enzyme and preventing the enzymatic degradation of amoxicillin under the influence of beta-lactamases.

Inside the body, each of the components undergoes rapid absorption in the gastrointestinal tract. Therapeutic concentration is observed within 45 minutes. Moreover, in various preparations, the ratio of clavulanic acid to amoxicillin is the same dose of 125 to 250, 500 and 850 mg - in tablets.

The drug is slightly bound to plasma proteins: clavulanic acid by approximately 22-30%, amoxicillin by 17-20%. The metabolism of these substances is carried out in the liver: clavulanic acid is almost 50%, and amoxicillin is 10% of the received dosage.

The drug is excreted unchanged mainly by the kidneys within 6 hours from the moment of use.

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 in urine. In this case, it is recommended to use the glucose oxidant method for determining the concentration of glucose in 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

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 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 plastic bottles with a screw cap with tamper evident with a moisture-absorbing insert or a polymer jar with a screw-on lid with tamper-evident control and a 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.