Instructions for use FLEMOCLAV SOLUTAB®

Compound

Flemoklav Solutab tablets can be produced in four different dosages, including 31.25 mg + 125 mg / 62.5 mg + 250 mg / 125 mg + 500 mg / 125 mg + 875 mg of active ingredients clavulanic acid ( potassium clavulanate ) and amoxicillin ( amoxicillin trihydrate ).
Excipients are: dispersed cellulose, MCC, vanillin, crospovidone, tangerine flavor, lemon flavor, saccharin, magnesium stearate.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Flemoklav Solutab is an antibiotic with a fairly wide spectrum of action, contains clavulanic acid and amoxicillin .

The drug is active against gram-negative and gram-positive bacteria (including species that synthesize beta-lactamases), inhibits the synthesis of peptidoglycan (an element of the cell wall of microorganisms).

Clavulanic acid inhibits types 5, 4, 3 and 2 beta-lactamases and is inactive against type 1 beta-lactamases synthesized by Enterobacter spp., Pseudomonas aeruginosa, Acinetobacter spp. Forms a complex with proteins and prevents enzymatic denaturation of amoxicillin under the influence of beta-lactamases, thus expanding the spectrum of action of Flemoclav Solutab.

Microorganisms sensitive to amoxicillin in vitro:

• gram-positive aerobic bacteria: Enterococcus faecalis, Nocardia asteroids, Bacillus anthracis, Gardnerella vaginalis, Streptococcus pneumoniae, Listeria monocytogenes, Streptococcus pyogenes and some other beta-hemolytic strains of Streptococcus, methylene-sensitive strains of Staphylococcus saprophyticus, Staphylococcus aureus, coagulase-negative bacteria phylococci;
• gram-negative aerobic bacteria: Haemophilus influenza, Bordetella pertussis, Helicobacter pylori, Haemophilus parainfluenzae, Asteurella multocida, Moraxella catarrhalis, PVibrio cholera;
• gram-positive anaerobic bacteria - some species of Clostridium, Peptostreptococcus micros, Peptostreptococcus magnus, Peptococcus niger, some species of Peptostreptococcus;
• gram-negative anaerobic bacteria: some species of Bacteroides, Capnocytophaga, Eikenella corrodens, Fusobacterium, Porphyromonas, Prevotella;
• others: Leptospirosa ictterohaemorrhagiae, Treponema pallidum.

Strains in which resistance may develop:

• gram-negative aerobic bacteria: Klesiella pneumonia, Escherichia coli, Klebsiella spp., Proteus vulgaris, Proteus mirabilis, Proteus spp., Salmonella spp., Shigella spp.;
• gram-positive aerobic bacteria: Enterococcus faecium, Corynebacterium species.

Resistant microorganisms:

• gram-negative aerobic bacteria: Citrobacter freundii, Acinetobacter spp., Enterobacter spp., Providencia spp., Serratia spp., Pseudomonas spp., Hafnia alvei, Morganella morganii, Legionella pneumophila, Stenotrophomas maltophilia;
• others: Chlamydia species, Coxiella burnetti, Mycoplasma species.

Pharmacokinetics

After penetration of the drug at a dosage of 875/125 mg (amoxicillin/clavulanic acid) into the intestine, the concentration of amoxicillin in the blood reaches its maximum value after 90 minutes, clavulanic acid - after 60 minutes.

The bioavailability of amoxicillin when taken orally is about 90%, the absorption of clavulanic acid reaches 60%.

Approximately 20% of amoxicillin and 21% of clavulanic acid form bonds with blood proteins. The half-life of amoxicillin is 1 hour, clavulanic acid is 50 minutes. Approximately 70% of amoxicillin and 40% of clavulanic acid are excreted by the kidneys in the first 5.5 hours.

Therapeutic concentrations of both substances can be achieved in the gall bladder, abdominal cavity, muscle tissue, skin, bile, peritoneal and synovial fluids, and pus.

Pharmacodynamics

It has a bactericidal effect and inhibits the synthesis of the bacterial wall. Active against gram-positive and gram-negative microorganisms (including strains producing beta-lactamases). Clavulanic acid, which is part of the drug, suppresses types II, III, IV and V beta-lactamases, and is inactive against type I beta-lactamases produced by Enterobacter spp., Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid has a high tropism for penicillinases, due to which it forms a stable complex with the enzyme, which prevents the enzymatic degradation of amoxicillin under the influence of beta-lactamases and expands its spectrum of action.

Flemoklav is active in relation to:

— aerobic gram-positive bacteria Streptococcus pyogenes, Streptococcus viridans, Streptococcus pneumoniae, Staphylococcus aureus (including strains producing beta-lactamases), Staphylococcus epidermidis (including strains producing beta-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 duсreyi, Neisseria gonorrhoeae (including strains of the above bacteria that produce beta-lactamases), Neisseria meningitidis , Bordetella pertussis, Gardnerella vaginalis, Brucella spp., Branhamella catarrhalis, Pasteurella multocida, Campylobacter jejuni, Vibrio cholerae, Moraxella catarrhalis, Helicobacter pylori;

— anaerobic gram-negative bacteria Bacteroides spp., including Bacteroides fragilis (including strains producing beta-lactamases).

Indications for use

Inflammatory infectious diseases caused by microorganisms sensitive to Flemoclav:

• infections of the ENT organs and respiratory tract ( COPD , exacerbation of chronic bronchitis , otitis media , tonsillitis , pharyngitis , sinusitis , community-acquired pneumonia );
• gynecological infections;
• infections of joints and bones, including osteomyelitis ;
• soft tissue and skin infections;
• infections of the genitourinary system ( cystitis , pyelonephritis ).

Indications of the drug Flemoklav Solutab®

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

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

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

skin and soft tissue infections;

urinary system (including cystitis, pyelonephritis).

Additionally for tablets 875 mg + 125 mg:

infections of bones and joints (including osteomyelitis);

in obstetrics and gynecology.

Contraindications

• severe liver damage after taking the drug in the past;
• lymphocytic leukemia;
• Infectious mononucleosis;
• renal failure (filtration below 30 ml per minute) - for tablets 875/125 mg;
• age less than 12 years and weight up to 40 kg - for tablets 875/125 mg;
• hypersensitivity to the components of the drug and any beta-lactam antibiotics ( cephalosporins and penicillins ).

Use the drug with caution in severe forms of liver and kidney failure, and diseases of the digestive system.

Contraindications to the use of the drug Flemoklav solutab

Hypersensitivity to amoxicillin, clavulanic acid and other components of the drug, as well as to other β-lactam antibiotics (penicillins, cephalosporins); a history of development of jaundice or impaired liver function after taking amoxicillin or clavulanic acid; children weighing up to 13 kg (due to the difficulty of precise dosing). In patients with mononucleosis or lymphocytic leukemia, the risk of developing a rash increases, therefore the combination of amoxicillin/clavulanic acid is not prescribed for these diseases. In patients with infectious mononucleosis or lymphocytic leukemia, the risk of exanthema increases, therefore, the combination of amoxicillin/clavulanic acid is not recommended for these diseases.

Side effects

• From the nervous system: in less than 0.001% - headache, convulsions (in case of drug overdose); less than 0.0001% have restlessness, hyperactivity, impaired consciousness, insomnia, anxiety, aggressive behavior.
• From the hematopoietic system: hemolytic anemia , thrombocytosis ; in less than 0.0001% - granulocytopenia , leukopenia , thrombocytopenia , pancytopenia , increased clotting time.
• From the digestive system: less than 0.1% - nausea, abdominal pain, diarrhea , vomiting , pseudomembranous colitis ; less than 0.001% have hemorrhagic colitis , intestinal candidiasis , discoloration of tooth enamel.
• From the side of blood vessels: less than 0.001% have vasculitis .
• From the liver: in less than 0.1% - increased transaminase activity; less than 0.001% have jaundice and hepatitis .
• From the genitourinary tract: less than 0.01% - burning, itching and vaginal discharge; less than 0.001% have nephritis .
• Allergic reactions: less than 0.1% - urticaria , itching; less than 0.001% - dermatitis , anaphylactic shock , Quincke's edema , serum sickness .
• Other: less than 0.01% have superinfection of bacterial or fungal origin (with frequent and long-term treatment with the drug).

Side effects of the drug Flemoklav solutab

They develop rarely and are usually mild and transient in nature. Allergic reactions: urticaria, maculopapular rash. In some cases, a so-called five-day rash (measles-like rash) develops. The severity of the reaction depends on the dose of the drug and the patient's condition. from the gastrointestinal tract: nausea, vomiting, diarrhea, impaired liver function (increased activity of transaminases, alkaline phosphatase and bilirubin levels in the blood serum), which are more often observed in men and people over the age of 65 years (develops extremely rarely in children). The risk of side effects increases when using the drug for more than 14 days. Symptoms occur during treatment or immediately after stopping it, but in some cases they may appear several weeks after stopping the drug. Side effects from the gastrointestinal tract are usually transient and minor, but sometimes they are pronounced. Below is the frequency of side effects from different organs and systems: Often From the gastrointestinal tract: nausea, vomiting, diarrhea, abdominal pain; from the immune system: type I hypersensitivity reactions (urticaria, purpura); on the skin: rash. Rarely From the blood system: changes in the cellular composition of peripheral blood (leukopenia, thrombocytopenia, hemolytic anemia), increased prothrombin time and increased bleeding time; from the hepatobiliary system: hepatitis, including cholestatic; from the immune system: serum sickness, angioedema, vasculitis; from the nervous system: dizziness, headache, convulsions (in case of impaired renal function or overdose); from the psyche: transient increased activity; from the kidneys and urinary tract: interstitial nephritis. Isolated cases: Pseudomembranous colitis, anaphylactic reactions, various forms of erythema (including Stevens-Johnson syndrome), exfoliative bullous dermatitis (including toxic epidermal necrolysis).

Instructions for Flemoclav Solutab

Instructions for use Flemoklav Solutab recommends that adults, children under 12 years of age and children under twelve years of age weighing more than 40 kilograms take this antibiotic at a dose of 875+125 mg (total dose of active ingredients - 1000 mg) twice a day (for chronic, severe, for recurrent infectious diseases, double the dose).

Children under 12 years of age and weighing less than 40 kilograms are prescribed the drug in weaker dosages (Flemoklav 250 mg + 62.5 mg and Flemoklav 500 mg + 125 mg).

For adults and children weighing over 40 kilograms, Flemoclav Solutab 500 mg + 125 mg three times a day is recommended.

The daily dose for children under 12 years of age and weighing up to 40 kilograms is 5 mg of clavulanic acid and 25 mg of amoxicillin per kilogram of weight.

In severe infectious and inflammatory diseases, these doses can be doubled, but it is prohibited to exceed the dose of 60 mg of amoxicillin and 15 mg of clavulanic acid per kilogram of body weight per day.

The duration of treatment with the drug should not exceed two weeks.

In patients with concomitant renal failure, Flemoclav Solutab 875 mg/125 mg can be used if the renal filtration rate is more than 30 ml per minute.

To reduce the risk of side effects from the digestive system, it is recommended to take the drug immediately before meals. The tablet must be swallowed whole with water, or dissolved in 50 ml of water, stirring completely before use.

Flemoclav solutab 500mg+125mg 20 pcs. dispersible tablets

pharmachologic effect

Broad spectrum antibacterial.

Composition and release form Flemoklav solutab 500 mg + 125 mg 20 pcs. dispersible tablets

Tablets - 1 tablet:

• Active ingredients: amoxicillin (in the form of amoxicillin trihydrate) - 500 mg; clavulanic acid (in the form of potassium clavulanate) - 125 mg;
• Excipients: MCC, crospovidone, vanillin, apricot flavor, saccharin, magnesium stearate.

There are 4 pcs in a blister; There are 5 blisters in a cardboard pack.

Description of the dosage form

Tablets of oblong shape from white to yellow with brown dotted spots, without marks, marked “424” and a graphic part of the company logo.

Characteristic

A combination drug containing semisynthetic penicillin and a beta-lactamase inhibitor.

Directions for use and doses

Orally, at the beginning of a meal (to prevent dyspeptic symptoms), without chewing, with a glass of water or dissolving the tablet in half a glass of water (at least 30 ml), stirring thoroughly before use.

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

For adults and children over 12 years of age, as well as children under 12 years of age weighing more than 40 kg, the drug is prescribed at 500 mg + 125 mg 3 times a day or 875 mg + 125 mg 2 times a day. A single dose is taken at regular intervals. For severe, recurrent and chronic infections, these doses can be doubled.

Children under 12 years of age weighing up to 40 kg are prescribed Flemoclav Solutab® with lower dosages: 125 mg + 31.25 mg; 250 mg + 62.5 mg; 500 mg + 125 mg.

For children aged 2 to 12 years (body weight approximately 13–37 kg), the daily dose is 20–30 mg/kg amoxicillin and 5–7.5 mg/kg clavulanic acid. This usually amounts to: for children 2–7 years old (body weight about 13–25 kg) - 125 mg + 31.25 mg 3 times a day; for children 7–12 years old (body weight 25–37 kg) - 250 mg + 62.5 mg 3 times a day. For severe infections, these doses can be doubled (maximum daily dose - 60 mg/kg amoxicillin and 15 mg/kg clavulanic acid).

In patients with renal failure, the excretion of clavulanic acid and amoxicillin through the kidneys is slow. Flemoclav Solutab® at a dose of 875 mg + 125 mg can only be used if the glomerular filtration rate is >30 ml/min. In this case, no dose adjustment is required.

Depending on the severity of renal failure, the total dose of Flemoclav Solutab® (in doses of 125 mg + 31.25 mg, 250 mg + 62.5 mg, 500 mg + 125 mg), expressed as a dose of amoxicillin, should not exceed the dosages presented in the table:

Amoxicillin with clavulanic acid should be administered with caution to patients with liver damage. Liver function should be constantly monitored.

Pharmacodynamics

It has a bactericidal effect and inhibits the synthesis of the bacterial wall. Active against gram-positive and gram-negative microorganisms (including strains producing beta-lactamases). Clavulanic acid, which is part of the drug, suppresses types II, III, IV and V beta-lactamases, and is inactive against type I beta-lactamases produced by Enterobacter spp., Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid has a high tropism for penicillinases, due to which it forms a stable complex with the enzyme, which prevents the enzymatic degradation of amoxicillin under the influence of beta-lactamases and expands its spectrum of action.

Flemoklav is active in relation to:

• aerobic gram-positive bacteria Streptococcus pyogenes, Streptococcus viridans, Streptococcus pneumoniae, Staphylococcus aureus (including strains producing beta-lactamases), Staphylococcus epidermidis (including strains producing beta-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 duсreyi, Neisseria gonorrhoeae (including strains of the above bacteria that produce beta-lactamases), Neisseria meningitidis, Bordetella pertussis, Gardnerella vaginalis, Brucella spp., Branhamella catarrhalis, Pasteurella multocida, Campylobacter jejuni, Vibrio cholerae, Moraxella catarrhalis, Helicobacter pylori;
• anaerobic gram-negative bacteria Bacteroides spp., including Bacteroides fragilis (including strains that produce beta-lactamases).

Pharmacokinetics

Amoxicillin. The absolute bioavailability of amoxicillin reaches 94%. Absorption is independent of food intake. Cmax in plasma is observed 1–2 hours after taking amoxicillin. 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. Serum protein binding is approximately 17–20%. Amoxicillin penetrates the placental barrier and, in small quantities, into breast milk.

Amoxicillin is metabolized in the liver (10% of the administered dose). Mostly excreted through the kidneys (52±15)% of the dose (unchanged within 7 hours) and in small quantities with bile. T1/2 from blood serum in patients with normal renal function is approximately 1 hour (0.9–1.2 hours), in patients with creatinine Cl in the range of 10–30 ml/min it is 6 hours, and in the case of anuria it fluctuates in between 10 and 15 hours. It is excreted during hemodialysis.

Clavulanic acid. The absolute bioavailability of clavulanic acid is approximately 60%. Absorption is independent of food intake. Cmax of clavulanic acid in the blood is observed 1–2 hours after administration. After taking amoxicillin with clavulanic acid in a single dose of 500 mg + 125 mg, the average Cmax of clavulanic acid (0.08 mg/l) is achieved after 8 hours. Plasma protein binding is 22%. Clavulanic acid penetrates the placental barrier. There is no reliable data on penetration into breast milk.

Clavulanate is metabolized in the liver (50–70%) and about 40% is excreted through the kidneys (18–38% unchanged). Total Cl is approximately 260 ml/min. T1/2 in patients with normal renal function is approximately 1 hour, in patients with creatinine Cl 20-70 ml/min - 2.6 hours, and with anuria - within 3-4 hours. It is eliminated by hemodialysis.

Indications for use Flemoklav solutab 500mg+125mg 20 pcs. dispersible tablets

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

• diseases of the upper respiratory tract and ENT organs (including otitis media, sinusitis, tonsillitis, pharyngitis);
• lower respiratory tract (including exacerbation of chronic bronchitis, COPD, community-acquired pneumonia);
• skin and soft tissue infections;
• urinary system (including cystitis, pyelonephritis).

Contraindications

• hypersensitivity to amoxicillin, clavulanic acid and other components of the drug;
• hypersensitivity to other beta-lactam antibiotics (penicillins and cephalosporins);
• a history of jaundice or liver dysfunction when taking amoxicillin + clavulanic acid;
• Infectious mononucleosis;
• lymphocytic leukemia

Carefully:

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

Application Flemoklav solutab 500mg+125mg 20 pcs. dispersible tablets during pregnancy and breastfeeding

There were no adverse effects of amoxicillin/clavulanate on the fetus or newborns when used by pregnant women. Use in the second and third trimesters of pregnancy is possible after a medical assessment of the risks/benefits of treatment. In the first trimester, the use of the drug should be avoided.

Both components of the drug penetrate the hematoplacental barrier and are excreted into 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.

special instructions

If anaphylactic reactions occur, treatment should be stopped immediately and replaced with another appropriate therapy.

To recover from a state of anaphylactic shock, urgent administration of adrenaline, corticosteroids and elimination of respiratory failure may be required.

There is a possibility of cross-resistance and hypersensitivity to other penicillins or cephalosporins. As with the use of other broad-spectrum penicillins, superinfections of fungal or bacterial origin (in particular candidiasis) may occur, especially in patients with chronic diseases and/or impaired immune system function. If superinfection occurs, the drug is discontinued and/or appropriate therapy is selected.

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 is contraindicated in these cases.

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

Flemoclav Solutab® at a dose of 875 mg + 125 mg can be prescribed only if the glomerular filtration rate is >30 ml/min.

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.

If seizures occur during therapy, the drug is discontinued. One dispersible tablet Flemoclav Solutab® 875 mg + 125 mg contains 25 mg of potassium.

In patients with impaired renal function, the dose must be adjusted based on the severity of the condition.

In patients with impaired liver function, the amoxicillin/clavulanic acid combination should be administered with caution and under constant medical supervision. Flemoklav Solutab® should not be used for more than 14 days without assessing liver function.

Amoxicillin/clavulanic acid should be administered with caution to patients receiving anticoagulant therapy.

Non-enzymatic methods for determining urine sugar, as well as the urobilinogen test, can give false positive results.

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

Overdose

Symptoms: nausea, vomiting and diarrhea with possible disturbance of water and electrolyte balance.

Treatment: administration of activated carbon. Maintaining water and electrolyte balance. Symptomatic therapy. For convulsions, diazepam is prescribed. In case of severe renal failure - hemodialysis.

Side effects Flemoklav solutab 500mg+125mg 20 pcs. dispersible tablets

Allergic skin reactions: urticaria, exanthema; erythematous rashes, rarely - exudative erythema multiforme, extremely rarely - exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), erythema multiforme. Reactions depend on the dose of the drug and the patient's condition.

From the gastrointestinal tract: nausea, vomiting, diarrhea, abdominal pain; impaired liver function, increased activity of liver transaminases, 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 elderly patients, especially over 65 years of age. 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. To prevent side effects, it is recommended to take the drug at the beginning of a meal. The risk of such changes increases when taking the drug for more than 14 days.

From the blood and lymphatic system: rarely - changes in the composition of the blood (leukopenia, thrombocytopenia, hemolytic anemia); prolongation of prothrombin time (reversible).

From the hepatobiliary system: rarely - cholestatic jaundice, hepatitis.

From the immune system: rarely - angioedema, vasculitis.

From the urinary system: interstitial nephritis.

Other: candidiasis, development of superinfection. In isolated cases - anaphylactic shock.

Drug interactions

Antacids, glucosamine, laxatives, aminoglycosides slow down and reduce absorption; ascorbic acid - increases.

Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) have a synergistic effect; bacteriostatic antimicrobial agents (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonistic.

Increases the effectiveness of indirect anticoagulants (suppresses intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index). When taking anticoagulants simultaneously, it is necessary to monitor blood clotting indicators.

Reduces the effectiveness of oral contraceptives, drugs, during the metabolism of which para-aminobenzoic acid, ethinyl estradiol are formed (risk of breakthrough bleeding).

Diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration). Allopurinol increases the risk of developing skin rashes.

Amoxicillin should not be given with disulfiram.

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

Tablets 875 mg + 125 mg

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

Disulfiram. Amoxicillin/clavulanic acid should not be used concomitantly with disulfiram.

Medicines that inhibit the renal excretion of amoxicillin. Simultaneous administration of probenecid, phenylbutazone, oxyphenbutazone and, to a lesser extent, acetylsalicylic acid, indomethacin and sulfinpyrazone helps to increase the concentration and longer presence of amoxicillin in the blood plasma and bile. The excretion of clavulanic acid is not impaired.

Antacids, glucosamine, laxatives, aminoglycosides slow down and reduce absorption; ascorbic acid increases the absorption of amoxicillin.

Allopurinol. Prescription of allopurinol and amoxicillin may increase the risk of developing skin rash.

Sulfasalazine. Aminopenicillins may decrease serum concentrations of sulfasalazine.

Methotrexate. 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.

Digoxin. While taking amoxicillin/clavulanic acid, digoxin absorption may be increased.

Anticoagulants. When taken simultaneously with indirect anticoagulants, the risk of bleeding may increase.

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

Overdose

The effects of overdose are usually limited to intestinal symptoms such as nausea and diarrhea .

Less commonly, when using large doses of the drug, convulsions , coma , hemolysis , and renal failure .

Treatment of overdose

Taking activated carbon and osmodiuretics. Maintaining water and mineral balance. Treat seizures with Diazepam . In case of severe renal impairment, hemodialysis is necessary. Otherwise, treatment is symptomatic.

Interaction

Other antibiotics

Flemoklav Solutab should not be used together with bacteriostatic drugs, chemotherapy, Disulfiram , antibiotics ( chloramphenicol , macrolides, Tetracycline , sulfonamides).

Drugs that inhibit the excretion of amoxicillin by the kidneys

Concomitant use with Phenylbutazone , probenecid , oxyphenbutazone , Indomethacin , Acetylsalicylic acid and sulfinpyrazone may cause an increase in the concentration of amoxicillin in the blood and bile. The excretion of clavulanic acid in such cases does not change.

Allopurinol

Use with amoxicillin increases the risk of skin rash.

Methotrexate

Taking amoxicillin reduces the excretion of Methotrexate , so toxic effects may occur. It is necessary to monitor the level of the latter in the blood.

Digoxin

Flemoklav Solutab increases the absorption of Digoxin in the intestine.

Anticoagulants

Combining the drug with indirect anticoagulants may increase the risk of bleeding.

Hormonal contraceptives

Amoxicillin in rare cases may inhibit the effects of oral contraceptives.

Pharmacological properties of the drug Flemoklav solutab

Broad-spectrum antibiotic, active against gram-positive and gram-negative microorganisms (including strains that produce β-lactamases). Clavulanic acid, which is part of the drug, ensures the resistance of amoxicillin to the action of β-lactamases, expanding the spectrum of its antimicrobial activity. The drug is active against aerobic gram-positive bacteria: Staphylococcus aureus (including strains producing β-lactamases), Staphylococcus epidermidis (including strains producing β-lactamases) , Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Streptococcus agalactiae, Enterecoccus faecalis, Enterococcus faec ium, Bacillus anthracis, Nocardia asteroids, Corynebacterium spp., Listeria monocytogenes; anaerobic gram-positive bacteria: Clostridium spp., Peptococcus spp., Peptostreptococcus spp.; aerobic gram-negative bacteria: Escherichia coli (including strains producing β-lactamases), Proteus mirabilis (including strains producing β-lactamases), Proteus vulgaris (including strains producing β-lactamases), Neisseria menengitidis, Neisseria gonorrhoeae (including strains producing β-lactamases), Moraxella catarrhalis (Branhamella catarrhalis), Haemophilus influenzae (including strains producing β-lactamases), Haemophilus ducreyi (including strains producing β-lactamases), Helicobacter pylori, Klebsiella spp. (including strains producing β-lactamases), Salmonella spp. (including strains producing β-lactamases), Shigella spp. (including strains producing β-lactamases), Bordetella pertussis, Yersinia enterocolitica (including strains producing β-lactamases), Gardnerella vaginalis, Brucella spp., Pasteurella multocida, Legionella spp., Campylobacter jejuni, Vibrio cholerae; anaerobic gram-negative bacteria: Bacteroides spp., including Bacteroides fragilis (including strains producing β-lactamases) , Fusobacterium spp.; other microorganisms: Borrelia burgdorferi, Leptospira icterohaemorrhagiae, Treponema pallidum. Amoxicillin The absolute bioavailability of amoxicillin is dose dependent and varies up to approximately 94%. Bioavailability when used in the dose range of 250–750 mg is directly proportional to the dose. As the dose increases, the degree of absorption decreases. Absorption is independent of food intake. The maximum concentration in blood plasma is achieved 1–2 hours after administration. After a single dose of 500/125 mg amoxicillin/clavulanic acid, the average amoxicillin concentration after 8 hours is 0.3 mg/l. The volume of distribution is 0.3–0.4 l/kg body weight, the degree of binding to plasma proteins is 17–20%. Amoxicillin is excreted mainly in the urine (52±15% unchanged within 7 hours), a small amount is excreted in the bile. The total clearance is 250–370 ml/min. The half-life from the blood serum in patients with impaired renal function is about 1 hour (0.9–1.2 hours), and in anuria it is 10–15 hours. It is eliminated by hemodialysis. Clavulanic acid The absolute bioavailability of clavulanic acid is about 60%. Absorption is independent of food intake. The maximum concentration of clavulanic acid in the blood serum is achieved approximately 1–2 hours after oral administration. After a single dose of 500/125 mg of amoxicillin/clavulanic acid, the concentration of clavulanic acid in the blood serum reaches 0.08 mg/l after 8 hours. The volume of distribution is about 0.2 l/kg body weight, binding to plasma proteins is approximately 22%. Clavulanic acid penetrates the placental barrier. No penetration into breast milk was observed. About 40% is excreted in the urine (18–38% unchanged). The total clearance is about 260 ml/min. The half-life in patients with impaired renal function is about 1 hour, with anuria - 3-4 hours. It is eliminated by hemodialysis. Therapeutic concentrations of both substances are achieved in the gall bladder, abdominal tissues, skin, subcutaneous fat and muscle tissue, as well as in synovial and peritoneal fluid, bile and pus.

special instructions

Before starting treatment with Flemoklav Solutab, it is necessary to exclude the presence in the past of allergic reactions to cephalosporins , penicillins or components of the drug.

infectious mononucleosis is suspected , as cases of morbilliform rashes have been reported with the use of amoxicillin in this situation.

Persons with severe forms of allergies and a history of bronchial asthma

There is a possibility of cross-resistance and allergic reactions with other cephalosporins or penicillins.

Long-term use of the drug causes the appearance and growth of microflora resistant to Flemoclav Solutab, as well as fungal or bacterial superinfections.

Use with caution in persons with liver disease, there is a risk of jaundice.

Due to the high content of amoxicillin in the urine, it may settle on the walls of the urethral catheter, so it is necessary to regularly change the catheter.

The occurrence at the beginning of therapy of generalized erythema , accompanied by fever and pustular rash, may be a sign of acute exanthematous pustulosis . In this case, you must stop taking the drug.

If seizures , treatment with the drug is discontinued.

It should be remembered that one tablet of Flemoklav Solutab 875/125 mg contains 0.025 g of potassium.

Flemoclav Solutab®

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 (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, treatment with Flemoclav Solutab® should be discontinued and appropriate alternative therapy should be initiated.

If the infection is proven to be caused by organisms sensitive to amoxicillin, 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 the suspected pathogen has reduced sensitivity or resistance to beta-lactam drugs that is not due to beta-lactamases susceptible to inhibition by clavulanic acid.

Amoxicillin/clavulanic acid should not be used to treat infections caused by penicillin-resistant strains of S. pneumoniae.

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, convulsions may occur (see section "Side effects").

If infectious mononucleosis is suspected, Flemoclav Solutab® should not be used, since amoxicillin can cause exanthema (measles-like skin rash) in patients with this disease.

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

Long-term treatment with Flemoclav Solutab® may lead to excessive proliferation of insensitive microorganisms.

The occurrence at the beginning of treatment of generalized erythema with fever, accompanied by the formation of pustules, may be a symptom of acute generalized exanthematous pustulosis (AGEP). Such a reaction requires discontinuation 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 liver events have been observed primarily in men and elderly patients and may be associated with long-term therapy.

These adverse events are very rarely observed in children. In all populations, the signs and symptoms listed usually occur during or shortly after completion of therapy, but in some cases may not appear until several weeks after completion of therapy. They are usually reversible.

Hepatic adverse events may be severe and death has been reported in extremely rare cases. In almost all cases, these were patients with serious underlying medical conditions or patients concomitantly receiving drugs that potentially affect the liver.

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 antibiotic-associated colitis occurs, you should immediately stop treatment with the amoxicillin/clavulanic acid combination, consult a doctor and begin appropriate treatment. Drugs that inhibit peristalsis are contraindicated in this situation.

During long-term therapy with Flemoclav Solutab®, it is recommended to periodically evaluate renal, liver and hematopoietic function.

An increase in prothrombin time (increase in INR) has been reported in rare cases in patients receiving a combination of amoxicillin and clavulanic acid. 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 impaired renal function, the dose of Flemoclav Solutab® should be reduced according to the degree of impairment (see section “Dosage and Administration” - Patients with impaired renal function).

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"). Patients with bladder catheters should have their patency checked regularly. 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.

Positive results of the Bio-Rad Laboratories Platelia Aspergillus ELISA have been reported in patients receiving the amoxicillin/clavulanic acid combination who were subsequently found not to have Aspergillus infection. Aspergillus genus have been reported in the Aspergillus Platelium ELISA test.

. Therefore, positive Aspergillus Platelia ELISA results in patients treated with amoxicillin/clavulanic acid should be interpreted with caution and confirmed by other diagnostic methods.

One dispersible tablet Flemoklav Solutab® 125 mg/31.25 mg contains 0.16 mmol (6.13 mg) potassium, 250 mg/62.5 mg contains 0.32 mmol (12.3 mg), 500 mg /125 mg - 0.64 mmol (24.53 mg).
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.

Analogues of Flemoklav Solutab

Level 4 ATX code matches:
Arlet

Ecoclave

Panclave

Amoxiclav

Oxamp-Sodium

Oxamp

Amoxicillin + Clavulanic acid

Augmentin

Ampisid

Amoxil K 625

Sultasin

The price of the analogues listed below is often more attractive to patients:

• Amoxiclav
• Augmentin
• Ecoclave
• Klamosar
• Amoxivan
• Arlet
• Rapiklav
• Bactoclav
• Klavam
• Honeyclave
• Panclave
• Rekut
• Trifamox IBL

What is the difference between Flemoxin Solutab and Flemoklav Solutab?

Patients often ask questions: what is the difference Flemoxin and Flemoklav? It is not difficult to understand the difference: Flemoklav, unlike Flemoxin, contains clavulonic acid, which prevents the destruction of antibiotic molecules by bacterial enzymes, which has a better effect on many indicators characterizing the effectiveness of the drug.

Which is better: Amoxiclav or Flemoklav Solutab?

The difference between Amoxiclav and Flemoklav is only in the variety of dosages produced; the latter has more, which allows better control over the dose used and reduces the number of side effects. The price category of both drugs is comparable.

Price Flemoklav Solutab

In Russia, the price of Flemoklav 1000 mg (875/125 mg) is close to 500 rubles. The price of 250 mg (250 mg + 62.5 mg) of the drug is about 300 rubles.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine
• Online pharmacies in KazakhstanKazakhstan

Pharmacy Dialogue

• Flemoclav Solutab tablets 250 mg + 62.5 No. 20Astellas Pharma
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Pharmacy24

• Flemoclav Solutab 125 mg/31.25 mg No. 20 tablets Astellas Pharma Europe B.V., Netherlands
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PaniPharmacy

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• Flemoklav tablets Flemoklav solutab, tablet. 125 mg/31.25 mg. No. 20 Netherlands, Astellas Pharma Europe

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• Flemoklav tablets Flemoklav solutab tablets. dispers. 250 mg/62.5 mg No. 20 Netherlands, Astellas Pharma Europe

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