Flemoklav solutab 875 instructions for use. Drugs with similar effects

When choosing an antibiotic to help eliminate an infectious disease, preference is given to agents that act on many types of bacteria. One of these drugs is Flemoklav Solutab.

Release form and composition

The medicine is presented in dispersible tablets, that is, it can dissolve when mixed with water, forming a suspension, which is why the word “solutab” is present in the name of the medicine. The drug is produced in the Netherlands in four different dosages:

125 mg + 31.25 mg;
250 mg + 62.5 mg;
500 mg + 125 mg;
875 mg + 125 mg.

The first digit in the indicated dosage of the medication is the amount of amoxicillin, presented in the form of trihydrate. The second number is the amount of clavulanic acid, which is contained in the drug in the form of potassium clavulanate.

In addition to these main components, the medication contains crospovidone, saccharin, MCC, magnesium stearate, apricot flavor and vanillin. The auxiliary components of tablets with a dosage of 875 mg + 125 mg are slightly different - dispersed cellulose is added to them, and instead of apricot flavoring, this medicine contains lemon and tangerine flavors.

In appearance, all variants of “Flemoclav Solutab” are similar to each other, since they are oblong oval tablets of white or yellowish color, the structure of which contains brown inclusions. There are no marks on the surface of the tablet, that is, its division into parts is not provided, but there is a logo of the manufacturing company and a three-digit number that differs for tablets of different dosages (for example, on a drug with 125 mg of amoxicillin you can see the number 421).

All types of medicine, except for the drug with the highest dosage, are packaged in blisters of 4 pieces and sold in boxes of 20 tablets. As for “Flemoklav” containing amoxicillin at a dose of 875 mg, such tablets are sold 14 pieces per pack and 7 pieces in one blister.

Operating principle

Amoxicillin, which is one of the main components of Flemoklav, is a penicillin antibiotic. It has a fairly wide range of bactericidal (bacteria-destroying) effects on microbes that cause infections of the respiratory tract, kidneys and other organs.

The presence of another active ingredient (clavulanic acid) in the tablets helps amoxicillin avoid destruction by beta-lactamases - enzymes that are produced by some strains of bacteria. Thanks to the combination with such an acid, the medication is effective against various types of staphylococci, enterococci, listeria, bacteroides, clostridia, Escherichia, Proteus, streptococci and other pathogens.

Indications

In addition, tablets with a dosage of 875 mg + 125 mg are prescribed for bacterial damage to joints and bones, as well as for gynecological infections.

At what age is it prescribed?

According to the instructions for the tablets, they can be given from 3 months of age. Use in children in the first months of life is also possible, but only for serious indications and under the supervision of a doctor. Babies who are already three months old are also given medicine only as prescribed by the doctor.

Tablets with the highest dose of amoxicillin are contraindicated before the age of 12, since the amount of antibiotic in such a drug (875 mg + 125 mg) is only suitable for patients weighing more than 40 kg.

Contraindications

The medication is not used in children with hypersensitivity to any of the components of the tablets, as well as allergies to other penicillin or cephalosporin antibacterial drugs. It should also not be given to patients who have had liver dysfunction or jaundice in the past while being treated with a combination of amoxicillin and clavulanic acid.

"Flemoclav" is not used for lymphocytic leukemia and infectious mononucleosis, as well as for influenza and other viral infections. The highest dosage tablets are contraindicated in cases of severe renal impairment.

If the patient has any disease of the gastrointestinal tract, kidneys or liver, the question of taking Flemoklav should be decided by the attending physician on an individual basis.

Side effects

Taking Flemoklav Solutab can sometimes cause an allergic skin reaction or negative gastrointestinal symptoms, such as vomiting or abdominal pain. In some patients, the tablets have a negative effect on the liver or hematopoiesis. In addition, the medication can cause the development of candidiasis or superinfection.

Instructions for use

To prevent the negative effects of Flemoklav Solutab on the stomach and intestines, taking the tablet is recommended immediately before meals. If a child can swallow it, it is advised not to chew the drug, but to immediately drink it with water. However, the most common “children’s” way of taking the medicine is to dissolve it in water (30-100 ml).

After thorough stirring, the resulting syrup is given to the patient in a dose appropriate for age and weight. If the child’s age is from 3 months to 12 years, then per 1 kilogram of body weight of such a patient, 20-30 mg of amoxicillin is required, and clavulanic acid is required from 5 to 7.5 mg. Often the drug is prescribed in the following dosages:

a child weighing 5-12 kg (under two years) – 125 mg + 31.25 mg twice a day;
for a patient whose weight is from 13 to 25 kg (aged 2-7 years) - 125 mg + 31.25 mg three times a day;
a child who weighs 25-37 kg (usually 7-12 years old) - 250 mg + 62.5 mg three times a day;
for a patient weighing more than 40 kg - three times a day, 500 mg + 125 mg, or twice a day, a dosage of 875 mg + 125 mg.

If the infection is severe, the indicated dosages can be doubled, but the child should not receive more than 60 mg of amoxicillin per day per kilogram of his weight, and for clavulanic acid the limit is considered to be a dose of 15 mg/kg.

The duration of use of Flemoklav should be determined taking into account the severity of the disease, but usually the course of therapy does not exceed two weeks.

Overdose

If a child accidentally takes Flemoklav in a much higher dose than the doctor prescribed, this will lead to vomiting, diarrhea or severe nausea, which in severe poisoning can lead to dehydration and electrolyte imbalance. In such a situation, you need to give the child activated charcoal and a rehydration solution, and then consult a doctor.

You should not combine Flemoklav with anticoagulants, diuretics, digoxin, methotrexate and some other medications that can be seen in the instructions for the tablets.

Terms of sale

"Flemoklav Solutab" is a prescription drug, so a doctor's examination is required before purchasing tablets. The cost of the drug depends on the dosage of its active substances. For example, for a pack of tablets containing 125 mg of amoxicillin, you need to pay from 260 to 300 rubles, and a package of medicine containing 250 mg of amoxicillin in each tablet costs approximately 400 rubles.

Storage conditions

The shelf life of dispersible tablets, with the exception of the drug with a dosage of 875 mg + 125 mg, is 3 years, but the drug with the highest dose of active substances is good for 2 years from the date of manufacture. It is recommended to store the medication at temperatures up to +25 degrees, choosing a dry place inaccessible to children.

Catad_pgroup Antibiotics penicillins

Flemoclav Solutab - official instructions for use

Registration number:

LSR-000392/09 - 060516

Tradename:

Flemoklav Solutab ®

INN or group name:

amoxicillin + clavulanic acid

Dosage form:

dispersible tablets

Compound:

One tablet contains:

Active substance: amoxicillin trihydrate (which corresponds to amoxicillin base) - 1019.8 mg (875.0 mg); potassium clavulanate (which corresponds to clavulanic acid) -148.9 mg (125 mg).

Excipients: dispersed cellulose - 30.4 mg, microcrystalline cellulose - 125.9 mg, crospovidone - 64.0 mg, vanillin - 1.0 mg, tangerine flavor - 9.0 mg, lemon flavor - 11.0 mg, saccharin - 13, 0 mg, magnesium stearate - 6.0 mg.

Description

Dispersible tablets of oblong shape from white to yellow, without marks, marked “425” and a graphic part of the company logo. Brown dotted spots are allowed.

Pharmacotherapeutic group:

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

CodeATX:

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

Mechanism of action

Amoxicillin is a semisynthetic broad-spectrum antibiotic that is active against many fam-positive and fam-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 is a beta-lactamase inhibitor, structurally related to penicillins, and has the ability to inactivate a wide range of beta-lactamases found in microorganisms resistant to penicillins and cephalosporins.

Clavulanic acid is sufficiently effective against plasmid beta-lactamases, which most often cause bacterial resistance, and is not effective against type 1 chromosomal beta-lactamases, which are not inhibited by clavulanic acid. The presence of clavulanic acid in the drug Flemoklav Solutab protects amoxicillin from destruction by enzymes - beta-lactamases, which allows expanding the antibacterial spectrum of amoxicillin. Below is the activity of the combination of amoxicillin and clavulanic acid in vitro.

Bacteria usually susceptible to the combination of amoxicillin and clavulanic acid

Gram-positive aerobes:

Bacillus anthracis
Enterococcus faecalis
Listeria monocytogenes
Nocardia asteroides
Streptococcus pyogenes 1,2
Streptococcus agalactiae 1,2
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 influenzae 1
Helicobacter pylori
Moraxella catarrhalis 1
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:

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 coli 1
Klebsiella oxytoca
Klebsiella pneumoniae 1
Klebsiella spp.
Proteus mirabilis
Proteus vulgaris,
Proteus spp.
Salmonella spp.
Shigella spp.

Gram-positive aerobes:

Corynebacterium spp.
Enterococcus faecium
Streptococcus pneumoniae 1.2

group streptococci Viridans 2

Bacteria that are naturally resistant to the combination of amoxicillin andclavulanic 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 types of microorganisms, 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 p-lactamases. Sensitivity during amoxicillin monotherapy suggests similar sensitivity to the combination of amoxicillin and clavulanic acid.

Pharmacokinetics

Suction

Both active ingredients of the drug Flemoklav Solutab®, amoxicillin and clavulanic acid, are quickly and completely absorbed from the gastrointestinal tract (GIT) after oral administration. Absorption of active substances is optimal if the drug is taken at the beginning of a meal.

After a single dose of Flemoklav Solutab® at a dose of 875/125 mg (amoxicillin/clavulanic acid), the maximum concentration of amoxicillin in the blood plasma is created after 1.5 hours (t max), and is 12 μg/ml (Cmax), clavulanic acid - after 1 hour, amounting to 3 μg/ml. The PFC (area under the pharmacokinetic curve) of amoxicillin and clavulanic acid is 33 µg/l and 6 µg/l, respectively. Absorption of amoxicillin when administered orally reaches 90%, the absolute bioavailability of clavulanic acid averages 60%.

Distribution

As with intravenous administration of a combination of amoxicillin and clavulanic acid, therapeutic concentrations of amoxicillin and clavulanic acid are found in various tissues and interstitial fluid (gallbladder, abdominal tissue, skin, adipose and muscle tissue, synovial and peritoneal fluids, bile, purulent discharge) . Amoxicillin and clavulanic acid have a weak degree of binding to plasma proteins. Approximately 17-20% of amoxicillin and 22% of clavulanic acid are bound to plasma proteins.

In animal studies, no accumulation of the components of the drug Flemoklav Solutab was found in any organ.

Amoxicillin, like most penicillins, passes into breast milk. Trace amounts of clavulanic acid have also been found in breast milk. With the exception of the possibility of sensitization, diarrhea or candidiasis of the oral mucosa, there are no other known negative effects of amoxicillin and clavulanic acid on the health of breastfed infants. Animal reproductive studies have shown that amoxicillin and clavulanic acid cross the placental barrier. However, no negative effects on the fetus were detected.

Metabolism

10-25% of the initial dose of amoxicillin is excreted in the urine in the form of an inactive metabolite (penicillic acid). Clavulanic acid is extensively metabolized to 2,5-dihydro-4-(2-hydroxyethyl)-5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-butan-2-one and is excreted by the kidneys , through the gastrointestinal tract, as well as with exhaled air in the form of carbon dioxide.

Removal

The total clearance for the two active substances is 25 l/h, the half-life (t1/2) of amoxicillin is 1.1 hours, clavulanic acid is 0.9 hours.

Approximately 60-80% of amoxicillin and 30-50% of clavulanic acid are excreted through the kidneys within the first 6 hours after taking the drug.

Simultaneous administration of probenecid slows down the elimination of amoxicillin, but not clavulanic acid (see section “Interaction with other drugs”).

INDICATIONS FOR USE

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

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 exacerbations of chronic bronchitis, lobar pneumonia and bronchopneumonia, usually caused by Streptococcus pneumoniae, Haemophilus influenzae # And Moraxella catarrhalis # .

Genitourinary tract infections, e.g. cystitis, urethritis, pyelonephritis, infections of the female genital tract, usually caused by species of the family Enterobacteriaceae 1 (mostly Escherichiacoli # ), Staphylococcussaprophyticus and species of the genus Enterococcus, A also gonorrhea, caused Neisseria gonorrhoeae#

Skin and soft tissue infections usually caused by Staphylococcus aureus # , Streptococcus pyogenes and species of the genus Basteroides # .

Bone and joint infections, such as osteomyelitis, usually caused by Staphylococcus aureus # , if necessary, long-term therapy is possible.

Odonogenic infections, for example, periodontitis, odontogenic maxillary sinusitis, severe dental abscesses with spreading cellulitis.

Other mixed infections (for example, septic abortion, puerperal sepsis, intra-abdominal sepsis) as part of stepwise therapy.

Some representatives of this genus of microorganisms produce beta-lactamase, which makes them insensitive to amoxicillin (see also section “Pharmacological properties”). Infections caused by microorganisms sensitive to amoxicillin can be treated with Flemoklav Solutab, since amoxicillin is one of its active ingredients. Flemoclav Solutab 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 with clavulanic acid.

The sensitivity of bacteria to the combination of amoxicillin and clavulanic acid varies regionally and over time. Where possible, local sensitivity data should be taken into account. If necessary, microbiological samples should be collected and bacteriological susceptibility testing should be carried out.

CONTRAINDICATIONS

History of hypersensitivity to amoxicillin, clavulanic acid, other components of the drug, beta-lactam antibiotics (for example, penicillins, cephalosporins);
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 body weight less than 40 kg;
renal dysfunction (creatinine clearance< 30 мл/мин).

Carefully: severe liver failure, gastrointestinal diseases (including a history of colitis associated with the use of penicillins), chronic renal failure.

USE IN PREGNANCY AND BREASTFEEDING

Pregnancy

In animal reproductive studies, oral and parenteral administration of amoxicillin + clavulanic acid did not cause teratogenic effects. In a single study in women with premature rupture of membranes, it was found that prophylactic therapy with the drug may be associated with an increased risk of developing necrotizing enterocolitis in newborns. Like all medications, Flemoclav Solutab is not recommended for use during pregnancy, unless the expected benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding period

Flemoclav Solutab 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 the active ingredients of this drug into breast milk, no other adverse effects were observed in breastfed children. If adverse effects occur in breastfed infants, breastfeeding should be discontinued.

METHOD OF APPLICATION AND DOSES

To prevent dyspeptic symptoms, Flemoclav Solutab® is prescribed at the beginning of a meal. The tablet is swallowed whole with a glass of water, or dissolved in half a glass of water (minimum 30 ml), stirring thoroughly before use.

For oral administration.

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.

Treatment should not continue for more than 14 days without reviewing the clinical situation.

If necessary, it is possible to carry out stepwise therapy (initially, parenteral administration of the drug, followed by switching to oral administration).

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

1 tablet 875 mg/125 mg 2 times a day.

Special patient groups

Children under 12 years of age weighing less than 40 kg

Elderly patients

No dosage regimen adjustment is required. 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

Tablets 875 mg/125 mg should be used only in patients with creatinine clearance more than 30 ml/min, and no dosage adjustment is required.

In most cases, whenever possible, parenteral therapy should be preferred. In patients with impaired renal function, convulsions may occur (see section “Side effects”, “Overdose”).

Patients with liver dysfunction

Treatment is carried out with caution; regularly monitor liver function. There is insufficient data to change the recommended dosage regimen in these patients.

SIDE EFFECTS

The adverse reactions presented below are listed according to the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows: Often(>1/10), often(>1/100, <1/10), infrequently(>1/1000, <1/100), rarely(>1/10 000, <1/1000), very rarely(<1/10 000). Категории частоты были сформированы на основании клинических исследований препарата и пострегистрационного наблюдения.

Frequency of occurrence of adverse reactions

Rare: reversible leukopenia (including neutropenia), reversible thrombocytopenia.

Very rare: reversible agranulocytosis and reversible hemolytic anemia, prolongation of bleeding time and prothrombin time, anemia, eosinophilia, thrombocytosis.

Immune system disorders

Very rare: angioedema, anaphylactic reactions, serum sickness-like syndrome, allergic vasculitis.

Nervous system disorders

Uncommon: dizziness, headache.

Very rare: reversible hyperactivity, seizures. Seizures may occur in patients with impaired renal function, as well as in those receiving high doses of the drug (see section "Dosage and Administration" - Patients with impaired renal function,"Overdose"). Insomnia, agitation, anxiety, behavior changes.

Gastrointestinal disorders

Adults:

Very common: diarrhea. Common: nausea, vomiting.

Children:

Common: diarrhea, nausea, vomiting.

Whole population:

Nausea was most often associated with the use of high doses of the drug. If, after starting to take the drug, undesirable reactions from the gastrointestinal tract occur, they can be eliminated by taking Flemoklav Solutab at the beginning of a meal.

Uncommon: indigestion.

Very rare: antibiotic-associated colitis (including pseudomembranous colitis and hemorrhagic colitis) (see section “Special Instructions”), black “hairy” tongue, gastritis, stomatitis.

Disorders of the liver and biliary tract

Uncommon: moderate increase in aspartate aminotransferase and/or alanine aminotransferase (AST and/or ALT) activity. This reaction has been observed in patients receiving beta-lactam antibiotic therapy, but its clinical significance is unknown.

Very rare: hepatitis and cholestatic jaundice. These reactions are observed in patients receiving therapy with penicillin antibiotics and cephalosporins. Increased concentrations of bilirubin and alkaline phosphatase.

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, but 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 deaths have been reported in extremely rare cases. In almost all cases, these were individuals with serious comorbidities or patients receiving concurrent potentially hepatotoxic drugs.

Skin and subcutaneous tissue disorders

Uncommon: rash, itching, urticaria.

Rarely: erythema multiforme.

Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis.

Renal and urinary tract disorders

Very rare: interstitial nephritis, crystalluria (see section “Overdose”), hematuria.

OVERDOSE

Symptoms

Gastrointestinal symptoms and water and electrolyte imbalance may occur. Amoxicillin crystalluria has been described, in some cases leading to the development of renal failure (see section "Special instructions and precautions"). Convulsions may occur in patients with impaired renal function, as well as in those receiving high doses of the drug (see section "Dosage and Administration" - Patients withrenal dysfunction,"Side effects").

Treatment

Gastrointestinal symptoms - symptomatic therapy, paying special attention to normalizing water and electrolyte balance. Amoxicillin and clavulanic acid can be removed from the bloodstream by hemodialysis.

The results of a prospective study that was conducted in 51 children at a poison control center showed that amoxicillin administered at a dose of less than 250 mg/kg did not lead to significant clinical symptoms and did not require gastric lavage.

INTERACTIONS WITH OTHER MEDICINES

The simultaneous use of Flemoklav Solutab® and probenecid is not recommended. Probenecid reduces the tubular secretion of amoxicillin, and therefore the simultaneous use of the drug Flemoklav Solutab® and probenecid can 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, simultaneous use of the drug Flemoklav Solutab and methotrexate may increase the toxicity of methotrexate. Like other antibacterial drugs, the drug Flemoklav Solutab® 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 it is necessary to simultaneously prescribe the drug Flemoklav Solutab® with anticoagulants, prothrombin time or MHO should be carefully monitored when prescribing or discontinuing the drug Flemoklav Solutab; dose adjustment of anticoagulants for oral administration may be required.

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

SPECIAL INSTRUCTIONS

Before starting treatment with Flemoclav Solutab®, it is necessary to collect a detailed history regarding previous hypersensitivity reactions to penicillins, cephalosporins or other substances that cause an allergic reaction in the patient. Serious and sometimes fatal hypersensitivity reactions (anaphylactic 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, treatment with Flemoclav Solutab should be discontinued and appropriate alternative therapy should be initiated. For severe hypersensitivity reactions, the patient should be given epinephrine immediately. Oxygen therapy, intravenous corticosteroids, and airway management, including intubation, may also be required.

If allergic skin reactions occur, treatment with Flemoclav Solutab should be discontinued.

If infectious mononucleosis is suspected, Flemoclav Solutab should not be used, since amoxicillin can cause a measles-like skin rash in patients with this disease, which makes diagnosing the disease difficult.

Long-term treatment with Flemoklav Solutab 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 with diarrhea during or after antibiotic use. If diarrhea is prolonged or severe and the patient experiences abdominal cramps, treatment should be stopped immediately and the patient should be examined.

In general, the drug Flemoklav Solutab® is well tolerated and has the low toxicity characteristic of all penicillins. During long-term therapy with Flemoclav Solutab®, it is recommended to periodically evaluate renal, liver and hematopoietic function. In patients receiving a combination of amoxicillin and clavulanic acid together with indirect (oral) anticoagulants, an increase in prothrombin time (increase in MHO) has been reported in rare cases. When co-prescribing indirect (oral) anticoagulants with a combination of amoxicillin and 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 very rarely occurs, mainly during parenteral therapy. During administration of 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 Flemoklav Solutab® 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.

One dispersible tablet Flemoklav Solutab® 875/125 mg contains 0.64 mmol (25 mg) potassium. Potassium intake of more than 1 mmol per day requires special attention in patients with reduced renal function and in those on a controlled potassium diet.

Drug abuse and dependence

There was no drug dependence, addiction or euphoric reactions associated with the use of the drug Flemoklav Solutab.

INFLUENCE ON THE ABILITY TO DRIVE VEHICLES,MECHANISMS

No studies have been conducted to study the effect on the ability to drive vehicles and operate machinery. Since the drug may cause side effects (for example, allergic reactions, dizziness, convulsions) (see section "Side Effects"), patients should be warned about precautions when driving or working with moving machinery.

RELEASE FORM

Dispersible tablets 875 mg + 125 mg. 7 tablets in a blister, 2 blisters along with instructions for use are placed in a cardboard box.

STORAGE CONDITIONS

Store 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.

CONDITIONS OF VACATION FROM PHARMACIES

On prescription.

OWNER OF REGISTRATION CERTIFICATES

Astellas Pharma Europe B.V.
Silviusweg 62, 2333 BE Leiden, The Netherlands

MANUFACTURER

Astellas Pharma Europe B.V.,
Hogemaat 2, 7942 JG Meppel, The Netherlands

PACKED AND/OR PACKED

Astellas Pharma Europe B.V., the Netherlands or ORTAT CJSC, Russia

Quality claims are accepted by the Representative Office of the Private Limited Liability Company "Astellas Pharma Europe B.V." (Netherlands) in Moscow at the address:

109147 Moscow, Marksistskaya st., 16, “Mosalarko Plaza-1” business center, floor 3.

Flemoclav Solutab (table dispersant 125 mg + 31.25 mg N20) Netherlands Astellas Pharma Europe B.V.

P N016067/01.INN Amoxicillin+[Clavulanic acid]&
Trade name Flemoklav Solutab
Registration number P N016067/01
Registration date 11/17/2009
Cancellation date
Manufacturer: Astellas Pharma Europe B.V. - Netherlands
Packer Ortat CJSC Russia

Packaging:
No. Packaging ND EAN
1 dispersible tablets 125 mg+31.25 mg 35000 pcs., plastic bags (1) - metal drums ~ ~
2 dispersible tablets 125 mg+31.25 mg 4 pcs., strip packs - cardboard packs ~ ~
3 dispersible tablets 125 mg+31.25 mg 4 pcs., strip packs - cardboard packs ~ ~
4 dispersible tablets 125 mg+31.25 mg 4 pcs., contour blister packs (5) - cardboard packs ~ 4607098450012
5 dispersible tablets 250 mg+62.5 mg 35000 pcs., plastic bags (1) - metal drums ~ ~
6 dispersible tablets 250 mg+62.5 mg 4 pcs., strip packs - cardboard packs ~ ~
7 dispersible tablets 250 mg + 62.5 mg 4 pcs., strip packs - cardboard packs ~ ~
8 dispersible tablets 250 mg+62.5 mg 4 pcs., contour blister packs (5) - cardboard packs ~ 4607098450036
9 dispersible tablets 500 mg+125 mg 35000 pcs., plastic bags (1) - metal drums ~ ~
10 dispersible tablets 500 mg+125 mg 4 pcs., strip packs - cardboard packs ~ ~
11 dispersible tablets 500 mg+125 mg 4 pcs., strip packs - cardboard packs ~ ~
12 dispersible tablets 500 mg+125 mg 4 pcs., contour blister packs (5) - cardboard packs ~ 4607098450050

FLEMOCLAV SOLUTAB®

Representation:
ASTELLAS PHARMA EUROPE B.V. ATX code: J01CR02 Marketing authorization holder:
ASTELLAS PHARMA EUROPE, B.V.
amoxicillin + clavulanic acid

Release form, composition and packaging

Dispersible tablets are oblong, from white to yellow in color with brown dotted spots, without marks, marked “421” and the company logo. 1 tab.
amoxicillin trihydrate 145.7 mg,
which corresponds to the content of amoxicillin 125 mg
potassium clavulanate 37.2 mg,
which corresponds to the content of clavulanic acid 31.25 mg

Dispersible tablets are oblong, from white to yellow in color with brown dotted spots, without marks, marked “422” and the company logo. 1 tab.
amoxicillin trihydrate 291 mg,
which corresponds to the content of amoxicillin 250 mg
potassium clavulanate 74.5 mg,
which corresponds to the content of clavulanic acid 62.5 mg

Excipients: microcrystalline cellulose, crospovidone, vanillin, apricot flavor, saccharin, magnesium stearate.

4 - blisters (5) - cardboard packs.

Dispersible tablets are oblong, from white to yellow in color with brown dotted spots, without marks, marked “424” and the company logo. 1 tab.
amoxicillin trihydrate 528.8 mg,
which corresponds to the content of amoxicillin 500 mg
potassium clavulanate 148.9 mg,

Excipients: microcrystalline cellulose, crospovidone, vanillin, apricot flavor, saccharin, magnesium stearate.

4 - blisters (5) - cardboard packs.

Dispersible tablets, oblong, from white to yellow, without marks, marked “425” and a graphic part of the company logo; brown dotted spots are allowed. 1 tab.
amoxicillin trihydrate 1019.8 mg,
which corresponds to the content of amoxicillin 875 mg
potassium clavulanate 148.9 mg,
which corresponds to the content of clavulanic acid 125 mg

Excipients: dispersed cellulose, microcrystalline cellulose, crospovidone, vanillin, tangerine flavor, lemon flavor, saccharin, magnesium stearate.

7 - blisters (2) - cardboard packs.

Clinical and pharmacological group: Broad-spectrum penicillin antibiotic with beta-lactamase inhibitor

Registration No.:
dispersible tablets 125 mg+31.25 mg: 20 - P No. 016067/01, 09.15.06
dispersible tablets 250 mg+62.5 mg: 20 - P No. 016067/01, 09.15.06
dispersible tablets 500 mg+125 mg: 20 - P No. 016067/01, 09.15.06
dispersible tablets 875 mg+125 mg: 14 - LSR-000392/09, 01/26/09
The description of the medicinal product FLEMOCLAV SOLUTAB® is based on the officially approved instructions for use of the drug FLEMOCLAV SOLUTAB® for specialists and approved by the manufacturer for the 2010 edition.
Pharmacological action | Pharmacokinetics | Indications | Dosage regimen | Side effect | Contraindications | Pregnancy and lactation | Special instructions | Overdose | Drug interactions | Terms of release from pharmacies | Storage conditions and expiration dates
pharmachologic effect

Broad-spectrum antibiotic; a combination drug of amoxicillin and clavulanic acid, a β-lactamase inhibitor. Active against gram-positive and gram-negative microorganisms (including strains producing β-lactamases).

Amoxicillin is bactericidal and inhibits the synthesis of peptidoglycan in the bacterial cell wall. Clavulanic acid inhibits β-lactamases types II, III, IV and V - according to the Richmond-Sykes classification). Not active against type I β-lactamases produced by Enterobacter spp., Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid has a high affinity for penicillinases, due to which it forms a stable complex with the enzyme, which prevents the enzymatic degradation of amoxicillin under the influence of β-lactamases and expands its spectrum of action.

Flemoclav Solutab® is active against aerobic gram-positive bacteria: Streptococcus spp., Staphylococcus spp. (except methicillin-resistant strains), Enterococcus spp., Corynebacterium spp., Bacillus anthracis, Listeria monocytogenes; anaerobic gram-positive bacteria: Clostridium spp. (except Clostridium difficile), Peptococcus spp., Peptostreptococcus spp.; aerobic gram-negative bacteria: Escherichia coli, Klebsiella spp., Proteus spp., Yersinia enterocolitica, Salmonella spp., Shigella spp., Haemophilus influenzae, Haemophilus ducreyi, Neisseria gonorrhoeae, Neisseria meningitidis, Bordetella pertussis, Moraxella catarrhalis, Gardnerella vaginalis, Brucella spp. , Pasteurella multocida, Vibrio cholerae, Helicobacter pylori; anaerobic gram-negative bacteria: Bacteroides spp., including Bacteroides fragilis, Fusobacterium spp.

Pharmacokinetics

Amoxicillin

Suction

After oral administration, it is quickly absorbed from the gastrointestinal tract. Absorption of amoxicillin after oral administration is 90-94%. Absolute bioavailability reaches 94%. Concomitant food intake does not affect absorption.

Cmax in blood plasma is achieved 1-2 hours after administration. After taking a single dose of 500 mg/125 mg (amoxicillin/clavulanic acid), the average concentration of amoxicillin (after 8 hours) is 0.3 mg/l.

After a single dose of 875 mg/125 mg (amoxicillin/clavulanic acid), the Cmax of amoxicillin in blood plasma is 12 mcg/ml.

Distribution

After a single dose of 875 mg/125 mg (amoxicillin/clavulanic acid), the AUC of amoxicillin is 33 mcg x h/l. Serum protein binding is approximately 17-20%.

Amoxicillin crosses the placental barrier and is excreted in small quantities into breast milk.

Metabolism

A small part of amoxicillin is metabolized by hydrolysis of the beta-lactam ring to inactive metabolites (the main ones are penicillic and penamaldic acids).

Removal

Approximately 60-80% of amoxicillin is excreted through the kidneys during the first 6 hours after taking the drug. T1/2 is 0.9-1.2 hours.

In case of impaired renal function (creatinine clearance within 10-30 ml/min), T1/2 is 6 hours, and in the case of anuria it ranges between 10 and 15 hours. It is excreted by hemodialysis.

Clavulanic acid

Suction

After oral administration, it is quickly absorbed from the gastrointestinal tract. Absolute bioavailability is approximately 60%. Concomitant food intake does not affect absorption. Cmax in blood plasma is achieved approximately 1-2 hours after administration. After taking a single dose of 500/125 mg (amoxicillin/clavulanic acid), the average concentration of clavulanic acid reaches 0.08 mg/l (after 8 hours).

After a single dose of 875 mg/125 mg (amoxicillin/clavulanic acid), the Cmax of clavulanic acid in blood plasma is 3 mcg/ml.

Distribution

Following a single dose of 875 mg/125 mg (amoxicillin/clavulanic acid), the AUC of clavulanic acid is 6 mcg x h/L.

Serum protein binding is 22%. Clavulanic acid penetrates the placental barrier. There is no reliable data on excretion in breast milk.

Metabolism

Clavulanic acid undergoes extensive metabolism through hydrolysis and subsequent decarboxylation.

Removal

Approximately 30-50% of clavulanic acid is excreted through the kidneys during the first 6 hours after taking the drug. T1/2 is approximately 1 hour.

The total clearance for amoxicillin and clavulanic acid is 25 l/h.

Pharmacokinetics in special clinical situations

In case of impaired renal function (creatinine clearance from 20 to 70 ml/min), T1/2 is 2.6 hours, and in case of anuria it ranges from 3-4 hours. It is excreted by hemodialysis.

Indications for use of the drug FLEMOCLAV SOLUTAB®

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

- infections of the upper respiratory tract and ENT organs (including otitis media, sinusitis, tonsillitis, pharyngitis);

— infections of the lower respiratory tract (including exacerbation of chronic bronchitis, COPD, community-acquired pneumonia);

- infections of bones and joints, incl. osteomyelitis (only for tablets 875 mg/125 mg);

- infections in obstetrics and gynecology (only for tablets 875 mg/125 mg);

- infections of the skin and soft tissues;

- kidney and urinary tract infections (including cystitis, pyelonephritis).

Dosage regimen

For adults and children over 12 years of age and children under 12 years of age weighing more than 40 kg, Flemoclav Solutab® at a dose of 875 mg/125 mg is prescribed 2 times (every 12 hours).

Children under 12 years of age weighing less than 40 kg are prescribed Flemoclav Solutab® in lower dosages.

For adults and children weighing more than 40 kg, the drug is prescribed at 500 mg/125 mg 3. For severe, chronic, recurrent infections, this dose can be doubled.

The dosage regimen for children is presented in the table. The daily dose is usually 20-30 mg of amoxicillin and 5-7.5 mg of clavulanic acid per kg of body weight. Age Body weight Daily dose
from 3 months to 2 years from 5 to 12 kg tablets 125 mg/31.25 mg 2
from 2 to 7 years from 13 to 25 kg tablets 125 mg/31.25 mg 3
from 7 to 12 years from 25 to 37 kg tablets 250 mg/62.5 mg 3

For severe infections, these doses can be doubled (the maximum daily dose is 60 mg amoxicillin and 15 mg clavulanic acid per kg body weight).

The duration of treatment depends on the severity of the infection and should not exceed 14 days unless necessary.

Flemoclav Solutab® at a dose of 875 mg/125 mg can only be used if the glomerular filtration rate is more than 30 ml/min. In this case, no dose adjustment is required.

In case of liver dysfunction, the drug should be prescribed with caution. It is necessary to monitor liver function.

To prevent side effects from the digestive system, it is recommended to take the drug at the beginning of a meal. The tablet is swallowed whole with a glass of water, or dissolved in half a glass of water (minimum 30 ml), stirring thoroughly before use.

Side effect

The incidence of adverse events was classified as follows: often (≥1/100,<1/10), нечасто (≥1/1000, <1/100), редко (≥1/10 000, <1/1000), очень редко (<1/10 000).

From the hematopoietic system: rarely - thrombocytosis, hemolytic anemia; very rarely - leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, anemia. These adverse reactions are reversible and disappear after discontinuation of therapy.

From the coagulation system: very rarely - an increase in prothrombin time and bleeding time. These adverse reactions are reversible and disappear after discontinuation of therapy.

From the nervous system: rarely - dizziness, headache, convulsions (in case of impaired renal function or drug overdose); very rarely - hyperactivity, restlessness, anxiety, insomnia, impaired consciousness, aggressive behavior.

From the cardiovascular system: rarely - vasculitis.

From the digestive system: often - abdominal pain, nausea (more often in case of overdose), vomiting, flatulence, diarrhea (generally, reactions from the digestive system are transient and rarely pronounced; their intensity can be reduced by taking the drug at the beginning of treatment food); pseudomembranous colitis (in case of severe and persistent diarrhea while taking the drug or within 5 weeks after completion of therapy), in most cases caused by Clostridium difficile; rarely - intestinal candidiasis, hemorrhagic colitis, discoloration of the surface layer of tooth enamel.

From the liver: often - a slight increase in the activity of liver enzymes; rarely - hepatitis and cholestatic jaundice. Symptoms of liver dysfunction occur during treatment or immediately after stopping therapy, but in some cases they may appear several weeks after stopping the drug; more often observed in men and patients over 60 years of age; observed very rarely in children (< 1/10 000). Риск возникновения нежелательных реакций увеличивается при применении препарата более 14 дней. Нарушение функции печени, как правило, обратимые, однако иногда бывают тяжелыми и в очень редких случаях (< 1/10 000) (только у пациентов с тяжелыми сопутствующими заболеваниями или при одновременном приеме потенциально гепатотоксичных препаратов) могут привести к летальному исходу.

From the genitourinary system: infrequently - itching, burning and vaginal discharge; rarely - interstitial nephritis.

Allergic reactions: often - skin rash and itching; morbilliform exanthema, appearing 5-11 days after the start of therapy. The appearance of urticaria immediately after starting to take the drug is highly likely to be a manifestation of an allergic reaction and requires discontinuation of the drug. Rarely - bullous or exfoliative dermatitis (erythema multiforme exudative, Stevens-Johnson syndrome, toxic epidermal necrolysis), anaphylactic shock, drug fever, eosinophilia, angioedema (Quincke's edema), laryngeal edema, serum sickness, hemolytic anemia, allergic vasculitis, interstitial nephritis .

Contraindications to the use of the drug FLEMOCLAV SOLUTAB®

- liver dysfunction (including jaundice) with a history of taking amoxicillin/clavulanic acid;

- Infectious mononucleosis;

— lymphocytic leukemia;

- renal failure (glomerular filtration ≤ 30 ml/min) - for dispersible tablets 875 mg/125 mg;

- children under 12 years of age weighing less than 40 kg (for dispersible tablets 875 mg/125 mg);

- hypersensitivity to amoxicillin, clavulanic acid and other components of the drug;

- hypersensitivity to other beta-lactam antibiotics (penicillins and cephalosporins).

The drug should be prescribed with caution in case of severe liver failure, chronic renal failure, gastrointestinal diseases (including a history of colitis associated with the use of penicillins).

Use of the drug FLEMOCLAV SOLUTAB® during pregnancy and breastfeeding

In a single study, prophylactic amoxicillin/clavulanate in women with premature rupture of membranes increased the risk of neonatal necrotizing enterocolitis.

Amoxicillin and clavulanic acid penetrate the blood-placental barrier and are excreted in breast milk. It is possible to use the drug during breastfeeding.

If a child develops sensitization, diarrhea or candidiasis of the mucous membranes, breastfeeding should be stopped.

Use for liver dysfunction

The drug should be prescribed with caution in severe liver failure.

Use for renal impairment

The drug should be prescribed with caution in chronic renal failure.

If renal function is impaired, the excretion of clavulanic acid and amoxicillin by the kidneys slows down. Depending on the severity of renal failure, the dose of Flemoclav Solutab® (calculated as amoxicillin) should not exceed that presented in the table. Creatinine clearance Adults Children
10-30 ml/min 500 mg 2 15 mg/kg 2
less than 10 ml/min 500 mg/ 15 mg/kg/
hemodialysis 500 mg/ and 500 mg during and after dialysis 15 mg/kg/ and 15 mg/kg during and after dialysis

special instructions

When taking Flemoklav Solutab®, there is a possibility of cross-resistance and hypersensitivity with other penicillins or cephalosporins.

If anaphylactic reactions develop, the drug should be stopped immediately and appropriate therapy administered: treatment of anaphylactic shock may require urgent administration of epinephrine (adrenaline), corticosteroids and elimination of respiratory failure.

Superinfection (in particular, candidiasis) may develop, especially in patients with chronic diseases and/or impaired immune system function. If superinfection occurs, the drug is discontinued and/or antibacterial therapy is adjusted accordingly.

For patients with severe gastrointestinal disorders accompanied by vomiting and/or diarrhea, the administration of Flemoclav Solutab® is not advisable until the above symptoms are eliminated, because Possible disruption of drug absorption from the gastrointestinal tract.

The appearance of severe and persistent diarrhea may be associated with the development of pseudomembranous colitis, in which case the drug is discontinued and the necessary treatment is prescribed. In case of development of hemorrhagic colitis, immediate discontinuation of the drug and corrective therapy are also necessary. The use of drugs that weaken intestinal motility in these cases is contraindicated.

If liver function is impaired, the drug should be prescribed with caution and under constant medical supervision. The drug should not be used for more than 14 days without assessing liver function.

While taking the drug, an increase in prothrombin time may be observed. Therefore, Flemoklav Solutab® should be prescribed with caution to patients receiving anticoagulant therapy (blood clotting parameters must be monitored).

Due to the high concentration of amoxicillin in the urine, it can be deposited on the walls of the urinary catheter, so such patients require periodic catheter changes. Forced diuresis accelerates the elimination of amoxicillin and reduces its plasma concentration.

When used simultaneously with some bacteriostatic drugs (for example, chloramphenicol, sulfonamides), antagonism with amoxicillin/clavulanic acid in vitro was observed.

Amoxicillin/clavulanic acid should not be co-administered with disulfiram.

The simultaneous use of drugs that inhibit the renal excretion of amoxicillin (probenecid, phenylbutazone, oxyphenbutazone and, to a lesser extent, acetylsalicylic acid, indomethacin and sulfinpyrazone) increases the concentration and longer presence of amoxicillin in the blood plasma and bile. The excretion of clavulanic acid is not impaired.

When used simultaneously with Flemoklav Solutab®, antacids, glucosamine, laxatives, aminoglycosides slow down and reduce the absorption of amoxicillin, while ascorbic acid increases the absorption of amoxicillin.

Concomitant use of Flemoclav Solutab® with allopurinol may increase the risk of developing a skin rash.

Aminopenicillins may decrease serum concentrations of sulfasalazine.

Amoxicillin reduces the renal clearance of methotrexate, which may lead to an increased risk of toxicity. When taken concomitantly with amoxicillin, monitoring of the concentration of methotrexate in the blood serum is necessary.

Concomitant use of amoxicillin/clavulanic acid and digoxin may lead to increased absorption of digoxin.

With the simultaneous use of Flemoclav Solutab® and indirect anticoagulants, the risk of bleeding may increase.

In rare cases, while taking amoxicillin, a decrease in the effectiveness of oral contraceptives has been observed, so the patient should be advised to use non-hormonal methods of contraception.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

List B. The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life - 3 years. The shelf life of dispersible tablets 875 mg/125 mg is 2 years.

A broad-spectrum penicillin antibiotic with a beta-lactamase inhibitor.

A drug: FLEMOCLAVE SOLUTAB ®
Active substance: amoxicillin, clavulanic acid
ATX code: J01CR02
KFG: Broad-spectrum penicillin antibiotic with beta-lactamase inhibitor
Reg. number: P No. 016067/01
Registration date: 09/15/06
Owner reg. cred.: ASTELLAS PHARMA EUROPE B.V. (Netherlands)

DOSAGE FORM, COMPOSITION AND PACKAGING

Dispersible tablets oblong, white to yellow with brown dotted spots, without marks, marked “421” and the company logo.

Excipients:

Dispersible tablets oblong, from white to yellow with brown dotted spots, without marks, marked “422” and the company logo.

Excipients: microcrystalline cellulose, crospovidone, vanillin, apricot flavor, saccharin, magnesium stearate.

4 things. - blisters (5) - cardboard packs.

Dispersible tablets oblong, from white to yellow with brown dotted spots, without marks, marked “424” and the company logo.

Excipients: microcrystalline cellulose, crospovidone, vanillin, apricot flavor, saccharin, magnesium stearate.

4 things. - blisters (5) - cardboard packs.

The description of the drug is based on the officially approved instructions for use.

PHARMACHOLOGIC EFFECT

Amoxicillin has a bactericidal effect and inhibits the synthesis of the bacterial wall. Clavulanic acid inhibits β-lactamases types II, III, IV and V - according to the Richmond-Sykes classification). Inactive against type I β-lactamases produced by Enterobacter spp., Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid has a high affinity for penicillinases, due to which it forms a stable complex with the enzyme, which prevents the enzymatic degradation of amoxicillin under the influence of β-lactamases and expands its spectrum of action.

Flemoklav Solutab active against aerobic gram-positive bacteria: Streptococcus pyogenes, Streptococcus viridans, Streptococcus pneumoniae, Staphylococcus aureus (including strains producing β-lactamases), Staphylococcus epidermidis (including strains producing β-lactamases), Enterococcus faecalis, Corynebacterium spp., Bacillus anthracis, Listeria monocytogenes; anaerobic gram-positive bacteria: Clostridium spp., Peptococcus spp., Peptostreptococcus spp.; aerobic gram-negative bacteria: Escherichia coli, Klebsiella spp., Proteus mirabilis, Proteus vulgaris, Yersinia enterocolitica, Salmonella spp., Shigella spp., Haemophilus influenzae, Haemophilus ducreyi, Neisseria gonorrhoeae (including strains of the above bacteria that produce β-lactamases), Neisseria meningitidis, Bordetella pertussis, Gardnerella vaginalis, Brucella spp., Pasteurela multocida, Campylobacter jejuni, Vibrio cholerae, Moraxella catarrhalis, Helicobacter pylori; anaerobic gram-negative bacteria: Bacteroides spp., including Bacteroides fragilis (including β-lactamase-producing strains).

PHARMACOKINETICS

Amoxicillin

Suction

After oral administration, it is quickly absorbed from the gastrointestinal tract. Absolute bioavailability reaches 94%. Concomitant food intake does not affect absorption. Cmax in blood plasma is achieved 1-2 hours after administration. After taking a single dose of 500/125 mg (amoxicillin/clavulanic acid), the average amoxicillin concentration (after 8 hours) is 0.3 mg/l.

Distribution

Serum protein binding is approximately 17-20%. Amoxicillin crosses the placental barrier and is excreted in small quantities into breast milk.

Metabolism

Amoxicillin is metabolized in the liver (10% of the administered dose).

Removal

It is excreted by the kidneys (52±15% of the dose unchanged within 7 hours) and a small amount is excreted in the bile. T1/2 in patients with normal renal function is approximately 1 hour (0.9-1.2 hours).

In case of impaired renal function (creatinine clearance within 10-30 ml/min) T1/2 is 6 hours, and in the case of anuria it ranges between 10 and 15 hours. It is excreted by hemodialysis.

Clavulanic acid

Suction

After oral administration, it is quickly absorbed from the gastrointestinal tract. Absolute bioavailability is approximately 60%. Concomitant food intake does not affect absorption. Cmax in blood plasma is reached approximately 1-2 hours after administration. After taking a single dose of 500/125 mg (amoxicillin/clavulanic acid), the average concentration of clavulanic acid reaches 0.08 mg/l (after 8 hours).

Distribution

Serum protein binding is 22%. Clavulanic acid penetrates the placental barrier. There is no reliable data on excretion in breast milk.

Metabolism

Metabolized in the liver (50-70%).

Removal

About 40% of the administered dose is excreted by the kidneys (18-38% unchanged). The total clearance is approximately 260 ml/min.

T1/2 in patients with normal renal function is approximately 1 hour.

Pharmacokinetics in special clinical situations

In case of impaired renal function (creatinine clearance from 20 to 70 ml/min) T1/2 is 2.6 hours, and in case of anuria it ranges from 3-4 hours. It is eliminated by hemodialysis.

INDICATIONS

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

Infections of the upper respiratory tract and ENT organs (including otitis media, sinusitis, tonsillitis, pharyngitis);

Infections of the lower respiratory tract (chronic bronchitis and its exacerbation, community-acquired pneumonia);

Skin and soft tissue infections;

Kidney and urinary tract infections.

DOSING REGIME

For adults And children weighing more than 40 kg the drug is prescribed at 500/125 mg 3 times a day. At severe, chronic, recurrent infections this dose can be doubled.

Dosage regimen for children presented in the table. The daily dose is usually 20-30 mg of amoxicillin and 5-7.5 mg of clavulanic acid per kg of body weight.

At severe infections these doses can be doubled (the maximum daily dose is 60 mg amoxicillin and 15 mg clavulanic acid per kg body weight).

The duration of treatment depends on the severity of the infection and should not exceed 14 days unless necessary.

At renal dysfunction excretion of clavulanic acid and amoxicillin by the kidneys slows down. Depending on the severity of renal failure, the dose of Flemoklav Solutab (calculated as amoxicillin) should not exceed that presented in the table.

SIDE EFFECT

Allergic reactions: urticaria, erythematous rash; rarely - exudative erythema multiforme; in isolated cases - exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), anaphylactic shock, angioedema. In some cases, a so-called “fifth day rash” (measles exanthema) appears. Allergic reactions depend on the dose of the drug and the patient's condition.

From the digestive system: nausea, vomiting, diarrhea, abdominal pain, impaired liver function, increased activity of liver transaminases; rarely - hepatitis, cholestatic jaundice; in isolated cases - pseudomembranous colitis. An increase in the activity of transaminases (AST and ALT), bilirubin and alkaline phosphatase is usually observed in males and in elderly patients, especially over 65 years of age. The risk of such changes increases when taking the drug for more than 14 days. These phenomena are very rarely observed in children. The above changes usually appear during treatment or immediately after. Sometimes they may appear several weeks after stopping the drug. Basically, reactions from the digestive system are transient and minor, but sometimes they are pronounced.

From the hematopoietic system: rarely - leukopenia, thrombocytopenia, hemolytic anemia.

Other: development of superinfection (including candidiasis), exanthema; rarely - a reversible increase in prothrombin time, interstitial nephritis, vasculitis.

CONTRAINDICATIONS

Liver dysfunction (including jaundice) when taking amoxicillin/clavulanic acid in the anamnesis;

Infectious mononucleosis or lymphocytic leukemia (risk of exanthema);

Hypersensitivity to amoxicillin, clavulanic acid and other components of the drug;

Hypersensitivity to other beta-lactam antibiotics such as penicillins and cephalosporins.

WITH caution the drug should be prescribed for severe liver failure, chronic renal failure, gastrointestinal diseases (including a history of colitis associated with the use of penicillins).

PREGNANCY AND LACTATION

When using Flemoclav Solutab during pregnancy, no negative effects on the fetus or newborn were noted. The use of the drug in the second and third trimester of pregnancy is considered safe. In the first trimester of pregnancy, Flemoclav Solutab should be used with caution.

Amoxicillin is excreted in breast milk. There is no data on the secretion of clavulanic acid into breast milk. No negative effects on the baby during breastfeeding while taking Flemoclav Solutab were noted.

SPECIAL INSTRUCTIONS

When taking Flemoclav Solutab, there is a possibility of cross-resistance and hypersensitivity with other penicillins or cephalosporins.

If liver function is impaired, the drug should be prescribed with caution and under constant medical supervision. The drug should not be used for more than 14 days without assessing liver function.

While taking the drug, an increase in prothrombin time may be observed. Therefore, Flemoklav Solutab should be prescribed with caution to patients receiving anticoagulant therapy (blood clotting parameters must be monitored).

Amoxicillin should not be given with disulfiram.

During the period of use of Flemoklav Solutab, non-enzymatic methods for determining glucose in urine, as well as a test for urobilinogen, may give false positive results.

During a course of treatment, it is necessary to monitor the functions of the hematopoietic organs, liver and kidneys.

OVERDOSE

Symptoms: nausea, vomiting, diarrhea with possible disturbances in water and electrolyte balance.

Treatment: activated carbon is prescribed, it is necessary to maintain water and electrolyte balance, and symptomatic therapy is carried out. For convulsions, diazepam is prescribed. In case of severe renal failure, hemodialysis is performed.

DRUG INTERACTIONS

When used simultaneously with Flemoklav Solutab, antacids, glucosamine, laxatives, aminoglycosides slow down and reduce the absorption of the active components of the drug; ascorbic acid - increases.

When used simultaneously with Flemoclav Solutab, bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) exhibit synergism; bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonism.

With simultaneous use, Flemoklav Solutab increases the effectiveness of indirect anticoagulants by suppressing intestinal microflora, reducing the synthesis of vitamin K and the prothrombin index.

Flemoclav Solutab, when used simultaneously, reduces the effectiveness of oral contraceptives, drugs that metabolize PABA, and ethinyl estradiol (the risk of developing acyclic bleeding).

Diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion, when used simultaneously with Flemoklav Solutab, increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).

The simultaneous use of Flemoclav Solutab with allopurinol increases the risk of developing a skin rash.

The simultaneous use of amoxicillin and digoxin may lead to an increase in the concentration of digoxin in the blood plasma.

CONDITIONS OF VACATION FROM PHARMACIES

The drug is available with a prescription.

CONDITIONS AND DURATION OF STORAGE

List B. The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life - 3 years.

Before using FLEMOCLAV SOLUTAB you should consult your doctor. These instructions for use are for informational purposes only. For more complete information, please refer to the manufacturer's instructions.

Clinical and pharmacological group

06.007 (Broad-spectrum penicillin antibiotic with beta-lactamase inhibitor)

Release form, composition and packaging

Dispersible tablets are oblong, from white to yellow in color with brown dotted spots, without marks, marked “421” and the company logo.

Dispersible tablets are oblong, from white to yellow in color with brown dotted spots, without marks, marked “422” and the company logo.

Excipients: microcrystalline cellulose, crospovidone, vanillin, apricot flavor, saccharin, magnesium stearate.

4 things. - blisters (5) - cardboard packs.

Dispersible tablets are oblong, from white to yellow in color with brown dotted spots, without marks, marked “424” and the company logo.

Excipients: microcrystalline cellulose, crospovidone, vanillin, apricot flavor, saccharin, magnesium stearate.

4 things. - blisters (5) - cardboard packs.

Dispersible tablets, oblong, from white to yellow, without marks, marked “425” and a graphic part of the company logo; brown dotted spots are allowed.

Excipients: dispersed cellulose, microcrystalline cellulose, crospovidone, vanillin, tangerine flavor, lemon flavor, saccharin, magnesium stearate.

7 pcs. - blisters (2) - cardboard packs.

pharmachologic effect

Amoxicillin is bactericidal and inhibits the synthesis of peptidoglycan in the bacterial cell wall. Clavulanic acid inhibits β-lactamases types II, III, IV and V. Not active against type I β-lactamases produced by Enterobacter spp., Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid has a high affinity for penicillinases, due to which it forms a stable complex with the enzyme, which prevents the enzymatic degradation of amoxicillin under the influence of β-lactamases and expands its spectrum of action.

Pharmacokinetics

Amoxicillin

Suction

After a single dose of 875 mg/125 mg (amoxicillin/clavulanic acid), the Cmax of amoxicillin in blood plasma is 12 mcg/ml.

Distribution

After a single dose of 875 mg/125 mg (amoxicillin/clavulanic acid), the AUC of amoxicillin is 33 mcg x h/l. Serum protein binding is approximately 17-20%.

Amoxicillin crosses the placental barrier and is excreted in small quantities into breast milk.

Metabolism

A small part of amoxicillin is metabolized by hydrolysis of the beta-lactam ring to inactive metabolites (the main ones are penicillic and penamaldic acids).

Removal

Approximately 60-80% of amoxicillin is excreted through the kidneys during the first 6 hours after taking the drug. T1/2 is 0.9-1.2 hours.

In case of impaired renal function (creatinine clearance within 10-30 ml/min), T1/2 is 6 hours, and in the case of anuria it ranges between 10 and 15 hours. It is excreted by hemodialysis.

Clavulanic acid

Suction

After a single dose of 875 mg/125 mg (in blood plasma is 3 mcg/ml.

Distribution

Following a single dose of 875 mg/125 mg (amoxicillin/clavulanic acid), the AUC of clavulanic acid is 6 mcg x h/L.

Serum protein binding is 22%. Clavulanic acid penetrates the placental barrier. There is no reliable data on excretion in breast milk.

Metabolism

Clavulanic acid undergoes extensive metabolism through hydrolysis and subsequent decarboxylation.

Removal

Approximately 30-50% of clavulanic acid is excreted through the kidneys during the first 6 hours after taking the drug. T1/2 is approximately 1 hour.

The total clearance for amoxicillin and clavulanic acid is 25 l/h.

Pharmacokinetics in special clinical situations

In case of impaired renal function (creatinine clearance from 20 to 70 ml/min), T1/2 is 2.6 hours, and in case of anuria it ranges from 3-4 hours. It is excreted by hemodialysis.

FLEMOCLAV SOLUTAB: DOSAGE

For adults and children over 12 years of age and children under 12 years of age weighing more than 40 kg, Flemoclav Solutab® at a dose of 875 mg/125 mg is prescribed 2 times a day (every 12 hours).

Children under 12 years of age weighing less than 40 kg are prescribed Flemoclav.

For adults and children weighing more than 40 kg, the drug is prescribed 500 mg/125 mg 3 times a day. For severe, chronic, recurrent infections, this dose can be doubled.

A possible dosage regimen for children is presented in the table. The daily dose is usually 20-30 mg of amoxicillin and 5-7.5 mg of clavulanic acid per kg of body weight.

For severe infections, these doses can be doubled (the maximum daily dose is 60 mg amoxicillin and 15 mg clavulanic acid per kg body weight).

The duration of treatment depends on the severity of the infection and should not exceed 14 days unless necessary.

Flemoclav Solutab® at a dose of 875 mg/125 mg can only be used if the glomerular filtration rate is more than 30 ml/min. In this case, no dose adjustment is required.

In case of liver dysfunction, the drug should be prescribed with caution. It is necessary to monitor liver function.

Age
Body mass
Daily dose
from 3 months to 2 years
from 5 to 12 kg
tablets 125 mg/31.25 mg 2 times/day
from 2 to 7 years
from 13 to 25 kg
tablets 125 mg/31.25 mg 3 times/day
from 7 to 12 years
from 25 to 37 kg
tablets 250 mg/62.5 mg 3 times/day
Glomerular filtration rate
Adults
Children
10-30 ml/min
500 mg 2 times/day
15 mg/kg 2 times/day
less than 10 ml/min
500 mg/day
15 mg/kg/day
hemodialysis

Overdose

Symptoms: nausea, vomiting, diarrhea with possible disturbances in water and electrolyte balance.

Treatment: activated carbon and osmodiuretics are prescribed, it is necessary to maintain water and electrolyte balance, and symptomatic therapy is carried out. For convulsions, diazepam is prescribed. In case of severe renal failure, hemodialysis is performed.

Drug interactions

When used simultaneously with some bacteriostatic drugs (for example, chloramphenicol, sulfonamides), antagonism with amoxicillin/clavulanic acid in vitro was observed.

Amoxicillin/clavulanic acid should not be co-administered with disulfiram.

Concomitant use of Flemoclav Solutab® with allopurinol may increase the risk of developing a skin rash.

Aminopenicillins may decrease serum concentrations of sulfasalazine.

Concomitant use of amoxicillin/clavulanic acid and digoxin may lead to increased absorption of digoxin.

With the simultaneous use of Flemoclav Solutab® and indirect anticoagulants, the risk of bleeding may increase.

In rare cases, while taking amoxicillin, a decrease in the effectiveness of oral contraceptives has been observed, so the patient should be advised to use non-hormonal methods of contraception.

Pregnancy and lactation

When using Flemoklav Solutab® during pregnancy, no negative effects on the fetus or newborn were noted. The use of the drug in the second and third trimester of pregnancy is possible after a medical assessment of the risk/benefit. In the first trimester of pregnancy, the use of Flemoclav Solutab® should be avoided (only for dispersible tablets 875 mg/125 mg). Dispersible tablets 125 mg/31.25 mg, 250 mg/62.5 mg, 500 mg/125 mg in the first trimester of pregnancy should be prescribed with caution.

Amoxicillin and clavulanic acid penetrate the blood-placental barrier and are excreted in breast milk. It is possible to use the drug during the period.

If a child develops sensitization, diarrhea or candidiasis of the mucous membranes, breastfeeding should be stopped.

FLEMOCLAV SOLUTAB: SIDE EFFECTS

The incidence of adverse events was classified as follows: often (≥1/100,

From the coagulation system: very rarely - an increase in prothrombin time and bleeding time. These adverse reactions are reversible and disappear after discontinuation of therapy.

From the cardiovascular system: rarely - vasculitis.

From the genitourinary system: infrequently - itching, burning and vaginal discharge; rarely - interstitial nephritis.

Other: uncommon - bacterial or fungal superinfections (with long-term therapy or repeated courses of therapy).

Storage conditions and periods

List B. The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life - 3 years. The shelf life of dispersible tablets 875 mg/125 mg is 2 years.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

infections of the upper respiratory tract and ENT organs (incl.
otitis media,
sinusitis,
tonsillitis,
pharyngitis);
lower respiratory tract infections (incl.
exacerbation of chronic bronchitis,
COPD,
community-acquired pneumonia);
infections of bones and joints,
incl.
osteomyelitis (only for tablets 875 mg/125 mg);
infections in obstetrics and gynecology (only for tablets 875 mg/125 mg);
skin and soft tissue infections;
kidney and urinary tract infections (incl.
cystitis,
pyelonephritis).

Contraindications

liver dysfunction (incl.
jaundice) with a history of taking amoxicillin/clavulanic acid;
Infectious mononucleosis;
lymphocytic leukemia;
renal failure (glomerular filtration ≤ 30 ml/min) - for dispersible tablets 875 mg/125 mg;
children under 12 years of age weighing less than 40 kg (for dispersible tablets 875 mg/125 mg);
hypersensitivity to amoxicillin,
clavulanic acid and other components of the drug;
hypersensitivity to other beta-lactam antibiotics (penicillins and cephalosporins).

The drug should be prescribed with caution in case of severe liver failure, chronic renal failure, gastrointestinal diseases (including a history of colitis associated with the use of penicillins).

special instructions

When taking Flemoklav Solutab®, there is a possibility of cross-resistance and hypersensitivity with other penicillins or cephalosporins.

Superinfection (for example, candidiasis) may develop, especially in patients with chronic diseases and/or impaired immune system function. If superinfection occurs, the drug is discontinued and/or antibacterial therapy is adjusted accordingly.

If liver function is impaired, the drug should be prescribed with caution and under constant medical supervision. The drug should not be used for more than 14 days without assessing liver function.

In a single study, prophylactic amoxicillin/clavulanate in women with premature rupture of membranes increased the risk of neonatal necrotizing enterocolitis.

During the period of use of Flemoclav Solutab®, non-enzymatic methods for determining glucose in urine, as well as a test for urobilinogen, may give false positive results.

During a course of treatment, it is necessary to monitor the functions of the hematopoietic organs, liver and kidneys.

If seizures occur during therapy, the drug is discontinued.

It should be taken into account that 1 dispersible tablet 875 mg/125 mg contains 25 mg of potassium.

Use for renal impairment

The drug should be prescribed with caution in chronic renal failure.

Creatinine clearance
Adults
Children
10-30 ml/min
500 mg 2 times/day
15 mg/kg 2 times/day
less than 10 ml/min
500 mg/day
15 mg/kg/day
hemodialysis
500 mg/day and 500 mg during and after dialysis
15 mg/kg/day and 15 mg/kg during and after dialysis

Use for liver dysfunction

The drug should be prescribed with caution in severe liver failure.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Registration numbers

tab. dispersible 875 mg+125 mg: 14 pcs. LSR-000392/09 (2026-01-09 – 0000-00-00) tab. dispersible 250 mg+62.5 mg: 20 pcs. P N016067/01 (2017-11-09 – 0000-00-00) tab. dispersible 500 mg+125 mg: 20 pcs. P N016067/01 (2017-11-09 – 0000-00-00) tab. dispersible 125 mg+31.25 mg: 20 pcs. P N016067/01 (2017-11-09 – 0000-00-00)