Amoxicillin+clavulanic acid EXPRESS dispersible pills 500mg+125mg, 14pcs

Product description

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

Composition

One 500 mg + 125 mg tablet contains:

Active ingredients:  

• amoxicillin trihydrate in terms of amoxicillin – 573.89 mg (500.00 mg);

• potassium clavulanate + microcrystalline cellulose (1: 1) in terms of clavulanic acid-297.82 mg (125.00 mg).

Auxiliary substances:  

• microcrystalline cellulose 302 – 87.09 mg;

• crospovidone-201.20 mg;

• vanillin-1.00 mg;

• saccharin-9.00 mg;

• magnesium stearate-5.00 mg;

• apricot flavor-9.00 mg

Pharmacological action

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

ATX code:  J01CR02

Pharmacological properties

Pharmacodynamics

Mechanism of action

Amoxicillin is a semi-synthetic 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 this enzyme.

Clavulanic acid, a beta-lactamase inhibitor structurally related to penicillins, has the ability to inactivate a wide range of beta-lactamases found in penicillin-and cephalosporin-resistant microorganisms.

Clavulanic acid is sufficiently effective against plasmid beta-lactamases, which most often cause bacterial resistance, and is not effective against chromosomal type 1 beta-lactamases, which are not inhibited by clavulanic acid. The presence of clavulanic acid in the preparation Amoxicillin + Clavulanic acid EXPRESS protects amoxicillin from destruction by beta – lactamase enzymes, which allows you to expand the antibacterial spectrum of amoxicillin.

The activity of the combination of amoxicillin with clavulanic acid in vitro is shown below.

Bacteria usually sensitive to the combination of amoxicillin and clavulanic acid

Gram-positive aerobes:

Bacillus anthracis

Enterococcus faecalis

Listeria monocytogenes

Nocardia asteroides

Streptococcus pyogenes1,2

Streptococcus agalactiae1,2

Streptococcus spp. (other beta-hemolytic streptococci)1,2

Staphylococcus aureus (methicillin-sensitive)1

Staphylococcus saprophyticus (methicillin-sensitive)

Coagulase-negative staphylococci (sensitive to methicillin).

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.

Other services:

Borrelia burgdorferi

Leptospira icterohaemorrhagiae

Treponema pallidum.

Bacteria that are likely to develop resistance to the combination of amoxicillin and clavulanic acid

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 pneumoniae1,2

streptococci of the Viridans2 group.

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.

Other services:

Chlamydia pneumoniae

Chlamydia psittaci

Chlamydia spp.

Coxiella burnetti

Mycoplasma spp.

1-for these types of microorganisms, the clinical efficacy of the combination of amoxicillin with clavulanic acid has been demonstrated in clinical studies.

2 – strains of these bacterial species do not produce β-lactamases. The sensitivity of amoxicillin monotherapy suggests a similar sensitivity to the combination of amoxicillin with clavulanic acid.

Pharmacokinetics

Suction

Amoxicillin and clavulanic acid completely dissociate in an aqueous solution at physiological pH values. Both active ingredients of the drug, amoxicillin and clavulanic acid, are rapidly and well absorbed from the gastrointestinal tract (GIT) after oral use. Absorption of active substances is optimal at the beginning of a meal. Oral bioavailability of amoxicillin and clavulanic acid is high. After a single dose of a fixed combination of amoxicillin and clavulanic acid (500 mg + 125 mg), the maximum concentration of amoxicillin in blood plasma is created after 1.5 hours (1.0-2.5 hours), and is 7.19±2.26 mcg/ml (Cmax), clavulanic acid – after 1.5 hours (1.0-2.0 hours), amounting to 2.4±0.83 mcg/ml. PFC (area under the pharmacokinetic curve indicator) amoxicillin and clavulanic acid are 53.5±8.87 mcg * h/L and 15.72±3.86 mcg * h/L, respectively. The plasma concentrations of amoxicillin and clavulanic acid achieved with amoxicillin/clavulanate are similar to those achieved with oral equivalent doses of amoxicillin and clavulanic acid separately.

Distribution

Approximately 18% of amoxicillin and 25% of clavulanic acid are bound to plasma proteins. The apparent volume of distribution is 0.3-0.4 l / kg for amoxicillin and about 0.2 l / kg for clavulanic acid. Amoxicillin is poorly distributed in the cerebrospinal fluid.

In animal studies, the accumulation of drug components in the body tissues was not detected.

Like most penicillins, amoxicillin passes into breast milk. Clavulanic acid is also found in breast milk in trace concentrations. Amoxicillin and clavulanic acid cross the placental barrier.

Metabolism

10-25% of the initial dose of amoxicillin is excreted by the kidneys as an inactive metabolite (penicillic acid). Clavulanic acid undergoes intensive metabolism and is excreted by the kidneys, intestines, and exhaled air in the form of carbon dioxide.

Deduction

After a single dose of a fixed combination of amoxicillin and clavulanic acid (500 mg + 125 mg), the half-life of amoxicillin is 1.15±0.20 hours, clavulanic acid is 0.98±0.12 hours, and the total clearance is about 25 l/h. Approximately 60-70% of amoxicillin and about 40-65% of clavulanic acid is excreted unchanged by the kidneys within the first 6 hours after taking 1 tablet of the drug 500/125 mg. The greatest amount of clavulanic acid is excreted during the first 2 hours after ingestion. Various studies have shown that up to 50-85% of amoxicillin and up to 27-60% of clavulanic acid are excreted through the kidneys within 24 hours.

Concomitant use of probenecid delays the elimination of amoxicillin, but does not affect the excretion of clavulanic acid by the kidneys (see the section “Interaction with other drugs”).

Pharmacokinetics in special cases

Age-specific features

The half-life of amoxicillin in children from 3 months to 2 years does not differ from that in older children and adults. Children of the first week of life (including premature infants) should not be prescribed the drug more than 2 times a day due to the immaturity of the renal elimination pathway. Due to a possible decrease in renal function, the dosage of the drug for elderly patients should be selected with caution. Monitoring of renal function may be required.

Sexual characteristics

When amoxicillin/clavulanic acid was administered orally by healthy men and women, there was no significant effect of the patient’s gender on the pharmacokinetics of the active components of the drug.

Impaired renal function

The total clearance of amoxicillin/clavulanic acid decreases in proportion to the decrease in renal function. The clearance of amoxicillin is particularly noticeably impaired, since most of it is excreted by the kidneys. Thus, if renal function is impaired, the dose of the drug should be adjusted to avoid excessive concentrations of amoxicillin and to maintain the necessary level of clavulanic acid.

Impaired liver function

In patients with impaired liver function, the drug should be administered with caution.Liver function should be monitored regularly.

Indications

The combination of amoxicillin with clavulanic acid is indicated for the treatment of bacterial infections of the following locations caused by microorganisms sensitive to the combination of amoxicillin with clavulanic acid:

– infections of the upper respiratory tract (including infections of ENT organs), such as: recurrent tonsillitis, sinusitis, otitis media, usually caused by Streptococcus pneumoniae1,2, influenzae1 Haemophilus, Moraxella and Streptococcus catarrhalis1 pyogenes1,2;

– infections of the lower Airways, such as acute exacerbations of chronic bronchitis, lobar pneumonia and bronchopneumonia, usually caused by Streptococcus pneumoniae1,2, Haemophilus and Moraxella influenzae1 catarrhalis1;

– urinary tract infections e. g. cystitis, urethritis, pyelonephritis, infection of the female genital organs, usually caused by species of the family Enterobacteriaceae (mostly Escherichia coli1), Staphylococcus saprophyticus and Enterococcus species of the genus, as well as gonorrhea caused by Neisseria gonorrhoeae;

infections of skin and soft tissues, usually caused by Staphylococcus aureus1, Streptococcus pyogenes1, and 2 species of the genus Bacteroides;

– infections of bones and joints, such as osteomyelitis, usually caused by Staphylococcus aureus1, if necessary, you can conduct long-term therapy;

– odontogenic infections, such as periodontitis, odontogenic maxillary sinusitis, severe dental abscess with spreading cellulitis;

– other mixed infection (e. g. septic abortion, puerperal sepsis, intra-abdominal sepsis) in the framework of sequential therapy.

 Some representatives of this genus of microorganisms produce beta-lactamase, which makes them insensitive to amoxicillin (see also the section “Pharmacological properties”). Infections caused by microorganisms sensitive to amoxicillin can be treated with Amoxicillin + Clavulanic Acid EXPRESS, since amoxicillin is one of its active components. Amoxicillin + Clavulanic Acid EXPRESS is also indicated for the treatment of mixed infections caused by microorganisms sensitive to amoxicillin, as well as beta-lactamase-producing microorganisms sensitive to the combination of amoxicillin and clavulanic acid.

The sensitivity of bacteria to the combination of amoxicillin and clavulanic acid varies depending on the region and over time. Where possible, local sensitivity data should be taken into account. If necessary, microbiological samples should be collected and analyzed for bacteriological sensitivity.

1-for these types of microorganisms, the clinical efficacy of the combination of amoxicillin with clavulanic acid has been demonstrated in clinical studies.

2 – strains of these bacterial species do not produce β-lactamases. The sensitivity of amoxicillin monotherapy suggests a similar sensitivity to the combination of amoxicillin with clavulanic acid.

Use during pregnancy and lactation

Pregnancy

In studies of reproductive function in animals, oral and parenteral use of amoxicillin + clavulanic acid did not cause teratogenic effects.

In a single study in women with premature rupture of the fetal membranes, it was found that preventive therapy with the drug may be associated with an increased risk of developing necrotizing enterocolitis in newborns.

The drug is not recommended for use during pregnancy, except in cases where the expected benefit of use for the mother exceeds the potential risk to the fetus.

Breast-feeding period

The drug Amoxicillin + Clavulanic acid EXPRESS can be used during breastfeeding.

With the exception of the possibility of sensitization, diarrhea or candidiasis of the oral mucosa associated with the penetration of trace amounts of active substances of this drug into breast milk, no other adverse effects were observed in children who are breastfed.

In case of adverse effects in children who are breastfed, it is necessary to stop breastfeeding.

Recommendations for use

Before starting treatment with Amoxicillin + Clavulanic acid EXPRESS, it is necessary to collect a detailed history of previous hypersensitivity reactions to penicillins, cephalosporins or other substances that cause an allergic reaction in the patient.

Serious, and sometimes fatal, hypersensitivity reactions (including anaphylactic and severe skin adverse reactions) to penicillins have been described. The risk of such reactions is highest in patients with a history of hypersensitivity reactions to penicillins. If an allergic reaction occurs, it is necessary to stop treatment with Amoxicillin + Clavulanic acid EXPRESS and start appropriate alternative therapy.

If the infection is proven to be caused by an amoxicillin-sensitive organism, consideration should be given to replacing the amoxicillin/clavulanic acid combination with amoxicillin in accordance with official clinical guidelines.

Amoxicillin/clavulanic acid is not suitable for use in cases where there is a high risk that suspected pathogens have reduced sensitivity or resistance to beta-lactam drugs, which is not due to beta-lactamases susceptible to clavulanic acid inhibition.

Amoxicillin/clavulanic acid should not be used for the treatment of infections caused by penicillin-resistant S. pneumoniae strains.

Acute coronary syndrome associated with hypersensitivity (Kounis syndrome)

In rare cases, hypersensitivity reactions have been reported during treatment with amoxicillin (acute coronary syndrome associated with hypersensitivity), in these cases, the drug should be discontinued and appropriate treatment should be prescribed.

In patients with impaired renal function, as well as when taking high doses of the drug, seizures may occur (see the section “Side effects”).

If infectious mononucleosis is suspected, do not use the drug Amoxicillin + Clavulanic acid EXPRESS, since in patients with this disease, amoxicillin can cause exanthema (a crust-like skin rash).

Concomitant use of allopurinol during treatment with amoxicillin may increase the likelihood of allergic skin reactions.

Long-term treatment with Amoxicillin + Clavulanic acid EXPRESS can lead to excessive proliferation of insensitive microorganisms.

The occurrence of generalized erythema with fever accompanied by pustule formation at the beginning of treatment may be a symptom of acute generalized exanthematous pustulosis (OGEP). Such a reaction requires the withdrawal of the drug containing amoxicillin/clavulanic acid, and is a contraindication to the subsequent use of amoxicillin preparations.

Drugs containing amoxicillin/clavulanic acid should be used with caution in patients with impaired liver function.

Adverse events from the liver were observed mainly in men and elderly patients and may be associated with long-term therapy. These adverse events are very rare in children. In all populations, these signs and symptoms usually occur during or shortly after the end of therapy, but in some cases they may not appear for several weeks after the end of therapy. They are usually reversible. Adverse events from the liver can be severe, and in extremely rare cases, deaths have been reported. In almost all cases, these were patients with a serious comorbid condition or patients receiving concomitant medications that potentially affect the liver.

Cases of pseudomembranous colitis with antibiotics, the severity of which can vary from mild to life-threatening, are described. Therefore, it is important to consider the possibility of developing pseudomembranous colitis in patients with diarrhea during or after the use of antibiotics. If you experience antibiotic-associated colitis, you should immediately stop treatment with the combination of amoxicillin/clavulanic acid, consult a doctor and start appropriate treatment. Drugs that inhibit peristalsis are contraindicated in this situation. During long-term therapy with Amoxicillin + Clavulanic acid EXPRESS, it is recommended to periodically evaluate the function of the kidneys, liver and hematopoiesis.

In patients receiving a combination of amoxicillin and clavulanic acid, in rare cases, an increase in prothrombin time (increased INR) has been reported. When co-prescribing indirect (oral) anticoagulants with a combination of amoxicillin and clavulanic acid, monitoring of appropriate indicators is necessary. Dose adjustments may be necessary to maintain the desired effect of oral anticoagulants.

In patients with impaired renal function, the dose of Amoxicillin + Clavulanic acid EXPRESS should be reduced accordingly to the degree of impairment (see section “Dosage and use” – Patients with impaired renal function).

Crystalluria is very rare in patients with reduced diuresis, mainly during parenteral therapy. When managing high doses of amoxicillin, it is recommended to take sufficient fluids and maintain adequate diuresis to reduce the likelihood of amoxicillin crystal formation (seesection “Overdose”). Patients with bladder catheters should have their patency checked regularly. Taking the drug Amoxicillin + Clavulanic acid EXPRESS inside leads to a high content of amoxicillin in the urine, which can lead to false positive results in determining glucose in the urine (for example, the Benedict test, the Fehling test). In this case, it is recommended to use a glucose-oxidant method for determining the concentration of glucose in the urine.

Clavulanic acid can cause non-specific binding of immunoglobulin G and albumin to the membranes of red blood cells, which leads to false positive results of the Coombs test.

Positive results of the Aspergillus Platelium ELISA test from Bio-Rad Laboratories have been reported in patients treated with the amoxicillin/clavulanic acid combination who were subsequently not found to have Aspergillus infection. Cross-reactions with polysaccharides and polyfurans that are not characteristic of the Aspergillus genus were reported during the Aspergillus Platelium ELISA test. Therefore, the positive results of the Platelius Aspergillus ELISA test in patients treated with the amoxicillin/clavulanic acid combination should be interpreted with caution and confirmed by other diagnostic methods.

One dispersible tablet of Amoxicillin + Clavulanic acid 125 mg / 31.25 mg contains 0.16 mmol (6.13 mg) of potassium,250 mg/62.5 mg-0.32 mmol (12.3 mg),500 mg/125 mg-0.64 mmol (24.53 mg),875 mg /125 mg-0.64 mmol (25 mg).

Potassium intake of more than 1 mmol per day requires special attention in patients with reduced renal function and those on a controlled potassium diet.

Influence on the ability to drive vehicles and mechanisms

No studies have been conducted to study the effect on the ability to drive vehicles and work with mechanisms. Since the drug can cause side effects (for example, allergic reactions, dizziness, convulsions) (see the section “Side effects”), it is necessary to warn patients about precautions when driving a vehicle or working with moving mechanisms.

Contraindications

– hypersensitivity to amoxicillin, clavulanic acid, to other penicillins or to any other component of the drug;

– a history of severe reactions of immediate hypersensitivity (e. g., anaphylaxis) to another beta-lactam antibiotics (e. g., cephalosporins, carbapenems or monobactam);

– a history of jaundice or liver failure as a result of receiving amoxicillin/clavulanic acid;

– children’s age up to 1 year and/or a body weight up to 10 kg (due to the inability of dosing formulations in this category of patients).

The drug is contraindicated in a dose of 875 mg + 125 mg for children under 12 years of age with creatinine clearance < 30 ml/min.

With caution

Severe liver failure, diseases of the gastrointestinal tract (including colitis in the anamnesis associated with the use of penicillins), chronic renal failure.

Side effects

The adverse reactions listed below are listed according to the lesion of organs and organ systems and frequency of occurrence. The frequency of occurrence is defined as follows: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10 000, <1/1000), very rare ( Frequency categories were formed based on clinical studies of the drug and post-marketing surveillance. Frequency of adverse reactio Nsinfectious and parasitic diseases: common: candidiasis of the skin and mucous membranes; unknown: overgrowth of insensitive microorganisms. Blood and lymphatic system disorders: rare: reversible leukopenia (including neutropenia), thrombocytopenia; unknown: reversible agranulocytosis and reversible hemolytic anemia, prolongation of bleeding time and prothrombin time. Immune system disorders: unknown: angioedema, anaphylactic reactions, serum sickness-like syndrome, allergic vasculitis; acute coronary syndrome associated with hypersensitivity (Kounis syndrome). Nervous system disorders: infrequently: dizziness, headache; unknown: reversible hyperactivity, aseptic meningitis, convulsions in cases of impaired renal function or drug overdose. Gastrointestinal disorders: adults: very common: diarrhoea; common: nausea, vomiting; children: common: diarrhoea, nausea, vomiting; whole population: nausea was most often associated with the use of high doses of the drug. If after starting taking the drug there are undesirable reactions from the gastrointestinal tract, they can be eliminated if you take the drug Amoxicillin + Clavulanic acid EXPRESS at the beginning of a meal; infrequently: digestive disorders; unknown: antibiotic-associated colitis (including pseudomembranous colitis and hemorrhagic colitis), black “hairy” tongue. Liver and biliary tract disorders: infrequently: moderate increase in aspartate aminotransferase and/or alanine aminotransferase (ACT and/or ALT)activity. This reaction is observed in patients receiving beta-lactam antibiotics, but its clinical significance is unknown; unknown: hepatitis and cholestatic jaundice. These reactions are observed in patients receiving penicillin-type antibiotics and cephalosporins. Hepatic adverse reactions have been observed mainly in men and elderly patients and may be associated with long-term therapy. These adverse reactions are very rare in children. These signs and symptoms usually occur during or immediately after the end of therapy, but in some cases they may not appear for several weeks after the end of therapy. Adverse reactions are usually reversible. Adverse reactions from the liver can be severe, and in extremely rare cases, fatal outcomes have been reported. In almost all cases, these were people with serious comorbidities or patients receiving potentially hepatotoxic drugs at the same time. Skin and subcutaneous tissue disorders: infrequent: rash, pruritus, urticaria; rare: erythema multiforme; unknown: Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis (OGEP), drug rash with eosinophilia and systemic symptoms (DRESS-syndrome). In case of allergic skin reactions, treatment with Amoxicillin + Clavulanic acid EXPRESS should be discontinued. Renal and urinary tract disorders: unknown: interstitial nephritis, crystalluria.

Interaction

Concomitant use of Amoxicillin + Clavulanic acid EXPRESS and probenecid is not recommended. Probenecid reduces the tubular secretion of amoxicillin, and therefore the simultaneous use of the drug Amoxicillin + Clavulanic acid EXPRESS and probenecid may lead to an increase and persistence in the blood concentration 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 tubular secretion, therefore, the simultaneous use of Amoxicillin + Clavulanic acid EXPRESS and methotrexate may increase the toxicity of methotrexate. Like other antibacterial drugs, Amoxicillin + Clavulanic acid EXPRESS can 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 Amoxicillin + Clavulanic acid EXPRESS with anticoagulants is necessary, prothrombin time or INR should be carefully monitored when prescribing or discontinuing Amoxicillin + Clavulanic acid EXPRESS, and dose adjustment of oral anticoagulants may be required. In patients treated with mycophenolate mofetil, after starting the combination of amoxicillin with clavulanic acid, the concentration of the active metabolite, mycophenolic acid, decreased by approximately 50% before taking the next dose of the drug. Changes in this concentration may not accurately reflect overall changes in mycophenolic acid exposure.

How to take it, course of use and dosage

For oral use.

The dosage regimen is set individually depending on the age, body weight, kidney function of the patient, as well as the severity of the infection. To reduce potential gastrointestinal disorders and optimize absorption, the drug should be taken at the beginning of a meal. The tablet is swallowed whole, washed down with a glass of water, or dissolved in half a glass of water (at least 30 ml), stirring thoroughly before use.

The minimum course of antibacterial therapy is 5 days.

Treatment should not be continued for more than 14 days without reviewing the clinical situation. If necessary, it is possible to conduct step therapy (first parenteral use of amoxicillin + clavulanic acid, followed by switching to oral use).

Adults and children over 12 years of age with a body weight ≥ 40 kg are prescribed 500 mg / 125 mg 3 times / day or 875 mg / 125 mg 2 times / day.

The maximum daily dose should not exceed 2400 mg / 600 mg per day.

For children aged 1 to 12 years with a body weight of 10 to 40 kg, the dosage regimen is set individually based on the clinical situation and the severity of the infection.

The recommended daily dose ranges from 20 mg / 5 mg / kg per day to 60 mg/15 mg / kg per day and is divided into 2-3 doses. There are no clinical data on the use of amoxicillin/clavulanic acid in a 4:1 ratio at doses > 40 mg/10 mg / kg per day in children under two years of age. The maximum daily dose for children is 60 mg / 15 mg / kg per day.

Low doses of the drug are recommended for the treatment of skin and soft tissue infections, as well as recurrent tonsillitis; high doses of the drug are recommended for the treatment of diseases such as otitis media, sinusitis, lower respiratory tract and urinary tract infections, bone and joint infections.

There are insufficient clinical data to recommend the use of the drug at a dose of more than 40 mg / 10 mg / kg / day in 3 doses (ratio 4:1) for children under 2 years of age. An approximate dosage regimen for paediatric patients is shown in the table below:

Child’s weight, kg Age (approx. ) Use of low doses of the drug Use of high doses of the drug:

10-12 1-2 years 2 times a day 1 tablet 125 mg/ 31,25 mg 3 times a day 1 tablet 125 mg/ 31,25 mg*

2-4 years,12-15 3 times a day 1 tablet 125 mg/ 31,25 mg 3 times a day 1 tablet of 250 mg/62.5 mg

4-6 15-20 years,3 times a day 1 tablet of 250 mg/62.5 mg 3 times a day 1 tablet of 250 mg/62.5 mg or 2 times a day for 500 mg/125 mg

20-30 6-10 years 3 times a day 1 tablet of 250 mg/62.5 mg 2 times a day 1 tablet 500 mg/125 mg

30-40 10-12 years 2 times a day 1 tablet 500 mg/125 mg 3 times daily 1 tablet 500 mg/125 mg

≥40 ≥12 years,3 times a day 1 tablet 500 mg/125 mg 3 times daily 1 tablet 500 mg/125 mg

*insufficient clinical data to recommend use of the drug in a dose of 40 mg/10 mg/kg/ day in 3 divided doses (ratio 4:1) for children under 2 years of age.

In children < 6 years of age, it is preferable to take the drug in dissolved form.

Overdose

Symptoms There may be gastrointestinal symptoms and disturbances in the water-electrolyte balance. Amoxicillin crystalluria is described, which in some cases leads to the development of renal failure (see the section “Special instructions”). Seizures may occur in patients with impaired renal function, as well as in those receiving high doses of the drug (see the section “Dosage and use”, “Side effects”, “Special instructions”). Treatment of gastrointestinal symptoms-symptomatic therapy, paying special attention to the normalization of water and electrolyte balance. Amoxicillin and clavulanic acid can be removed from the bloodstream by hemodialysis. The results of a prospective study conducted with 51 children in a toxicology center showed that use of amoxicillin at a dose of less than 250 mg / kg did not lead to significant clinical symptoms and did not require gastric lavage.

Special instructions

Special patient groups Elderly patients do not need to adjust the dosage regimen. In elderly patients with impaired renal function, the dose should be adjusted as indicated below for adults with impaired renal function. Patients with impaired renal function in patients with renal insufficiency, the excretion of clavulanic acid and amoxicillin through the kidneys is slow. Depending on the severity of renal failure, the total dose of the drug Amoxicillin + Clavulanic acid EXPRESS (expressed in the dose of amoxicillin) should not exceed the amount. Tablets 875 mg / 125 mg should only be used in patients with creatinine clearance greater than 30 ml / min, and no dosage adjustment is required. In most cases, if possible, parenteral therapy should be preferred. Patients on hemodialysis Correction of the dosage regimen is based on the maximum recommended dose of amoxicillin, shown in the table. Patients with impaired liver function are treated with caution, and liver function is regularly monitored. There is insufficient data to change the recommended dosage regimen in these patients.

Storage conditions

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

Keep out of the reach of children.

Shelf

life is 2 years.

Active ingredient

Amoxicillin, Clavulanic Acid

Conditions of release from pharmacies

By prescription

Dosage form

tablets soluble