Flemoclav - instructions for use and indications, composition, dosage, release form and price. Flemoklav Solutab: a famous antibiotic in a unique form

Antibacterial drug Flemoklav Solutab® – combined medicine, intended for the treatment of infections caused by gram-positive and gram-negative flora, including pathogenic microorganisms, producing beta-lactamase enzymes (destroying penicillins and many cephalosporins).

It is characterized by low toxicity, high efficiency and a wide spectrum of antimicrobial activity.

It belongs to the penicillin antibiotics (a group of inhibitor-protected penicillins), representing a combination of semi-synthetic amoxicillin with clavulanic acid (potassium clavulanate) and is available in a convenient-to-use form of soluble tablets.

Flemoklav Solutab ® – instructions for use of tablets 500 mg

This drug is a combined semisynthetic antibiotic from the group of inhibitor-protected penicillins.

The main active ingredient is amoxicillin + clavulanic acid.

– characterized by a pronounced bactericidal effect against most pathogenic microorganisms:

  • Gram-positive and gram-negative aerobes Enterococcus faecalis, Gardnerella vaginalis, Streptococcus pyogenes, Nocardia asteroids, Staphylococcus saprophyticus and aureus, Listeria monocytogenes, Helicobacter pylori, Haemophilus influenza and parainfluenzae, Vibrio cholera, Bordetella pertussis and others.
  • Anaerobes Peptostreptococcus micros and magnus, Eikenella corrodens, some species of fusobacteria, clostridia and peptococci.
  • Atypical pathogens of leptospirosis and syphilis.

Potassium clavulanate (or clavulanic acid) in the composition of the drug significantly increases the spectrum of antimicrobial activity of the antibiotic and its resistance due to the inhibition of beta-lactamases produced by bacteria. Mechanism bactericidal action consists of introducing the active substance into the cell and blocking the biosynthesis of peptidoglycan. This connection is necessary to build cell wall, therefore its lack leads to the death of the microorganism.

Is Flemoclav Solutab an antibiotic or not ®?

Yes, it is an antibiotic of the penicillin group.

Chemical composition

The main component of the drug is amoxicillin, enhanced with clavulanic acid.

Synthesized in 1972, amoxicillin showed much greater acid resistance and bactericidal activity than amoxicillin, but was also subject to destruction by beta-lactamases. It is absorbed by the body almost completely (94%), quickly distributed, and excreted mainly by the kidneys.

The problem of antibiotic destruction by beta-lactamases was solved by adding clavulanic acid, a powerful inhibitor of destructive enzymes. Due to the additional beta-lactam ring, the drug acquired increased stability and more wide range antimicrobial action. The bioavailability of potassium clavulanate is about 60%, like the main component, it does not depend on the presence of food in the stomach.

Release form

The drug is produced in tablet form by the pharmaceutical company Astellas ® from the Netherlands. White tablets (sometimes with brown spots) colors, large, oblong, without marks. They dissolve in water, that is, they are dispersed, and have a digital marking on one side. The numbers indicate dosage options, of which this drug has four:

  • “421” - tablets contain 125 mg of amoxicillin and 31.25 mg of clavulanic acid;
  • “422” – 250 and 62.5 active components, respectively;
  • “424” – 500 and 125 milligrams;
  • “425” - 875 and 125 (this option is also called Flemoklav Solutab ® 1000 - based on the amount of the main ingredients).
Photo of packaging Flemoklav ® 875 mg+125 mg from Astellas ®

Auxiliary formative additives are microcrystalline cellulose, crospovidone, magnesium stearate, saccharin, vanillin and apricot flavor. The tablets are packaged in foil blisters of 5 pieces, a total of 20 tablets per package. The exception is the option marked with the number “425” - the cardboard pack contains 2 blisters, 7 tablets each.

What does Flemoklav Solutab ® help with?

Resistant to destructive impact beta-lactamase antibiotic is widely used to treat inflammatory processes various localizations. Easy to use dissolvable tablets are prescribed in case bacterial infections all departments respiratory tract(both lower and upper), ENT organs. The drug is especially effective for purulent sinusitis - inflammation paranasal sinuses nose The remedy is also effective for pharyngitis, otitis, bronchitis, pneumonia, etc.

This drug is also used in urology for antibiotic therapy of pyelonephritis and cystitis. In gynecology, Flemoklav ® is indicated for infection of female reproductive organs bacteria sensitive to the drug. Effective when purulent inflammations musculoskeletal system (muscles, joints, bones) and skin.

It is prescribed to both adults and children due to its low toxicity, however, the peculiarities of the dosage form do not allow it to be given to children under 2 years of age. In these cases, it is recommended to use chemical analogues produced in the form of powders for the preparation of suspensions.

Flemoclav ® indications

The antibiotic Flemoklav Solutab ®, according to the instructions, should be used in case of the development of the following diseases:

  • inflammation of the mucous membranes of the paranasal sinuses (sinusitis) - sinusitis, frontal sinusitis, sphenoiditis, etc.;
  • otitis media;
  • tonsillitis (sore throat) and pharyngitis;
  • bronchitis;
  • community-acquired pneumonia;
  • genitourinary (including gynecological) infections – cystitis, pyelonephritis and others;
  • purulent lesions of the skin, muscles and bones (osteomyelitis, purulent arthritis);
  • abscesses, phlegmon;
  • peritonitis;
  • septic complications.

Contraindications for prescribing the drug

Since the drug is low-toxic, the list of strict contraindications includes only liver dysfunction caused in the past by Flemoklav ®, mononucleosis, body weight less than 13 kg, lymphocytic leukemia and individual hypersensitivity to beta-lactams. Also, tablets are not used in the treatment of children under 12 years of age and persons with severe kidney failure.

Flemoklav Solutab ® during lactation and pregnancy

When prescribing an antibiotic to pregnant women clinical practice no teratogenic effect was detected, despite the fact that amoxicillin and potassium clavulanate penetrate well through the hematoplacental barrier. The active substances do not affect the fetus, congenital pathologies not recorded.

Maximum caution when using should be observed in the first trimester (during this period, the advisability of treatment and potential risks should be strictly assessed by a doctor). The medicine must be used strictly according to the recommendation of a therapist or other specialist.

Flemoklav Solutab ® can also be prescribed for hepatitis B: both components penetrate into breast milk in fairly large volumes, but they do not harm the child. During clinical trials was not recorded negative impact antibiotic for microflora and general state babies. However, if a newborn exhibits hypersensitivity and diarrhea, mucosal candidiasis or allergic reactions, breastfeeding should be suspended during the mother's treatment. It is advisable to express milk so that lactation does not stop.

Flemoklav Solutab ®: dosage and regimen

The tablets can be taken in two ways: by first dissolving in half a glass clean water or simply swallowing and drinking. This should be done immediately before meals, since dispersible dosage forms can produce irritant effect gastric mucosa. Availability of food in digestive tract does not affect the absorption and bioavailability of clavulanic acid and amoxicillin.

Therapeutic doses and the optimal dosage schedule are determined by the attending physician (self-medication is unacceptable) in accordance with the severity and nature of the disease itself.

Dose calculations are based on amoxicillin.

Typically the medicine is prescribed as follows:

  • Adult patients and children over the age of twelve are recommended to take either 500 mg every 8 hours (that is, three times a day), or 875 milligrams of the active substance at intervals of 12 hours. In case of recurrent and especially severe chronic diseases daily dose may be increased. Prescribe 875-1000 mg of amoxicillin three times a day.
  • For children under twelve years of age, Flemoclav Solutab ® is prescribed at 125 mg, that is, in a lower dosage. Tablets containing 250 and 500 mg of antibiotic are also used if the infection is severe. Starting from the age of two years of the patient, the daily dose should be calculated according to his body weight - 20-30 mg for each kilogram of weight. On average, this is 125 mg three times a day for a child from 2 to 7 years old and 250 milligrams according to the same regimen for children aged 7 to 12.
  • Tablets containing 875 mg of active substance are not prescribed to persons with renal failure and a glomerular filtration rate of less than 30 ml per minute. In this case, the dose is usually halved.

Careful use requires treatment of patients with severe liver dysfunction. Constant monitoring of the patient's condition and control of tests are mandatory.

The duration of antibiotic therapy under any circumstances should not exceed 2 weeks.

Exceeding recommended doses is fraught with dyspeptic disorders. The patient develops nausea, vomiting, and diarrhea. The latter can occur in severe form and lead to dehydration. Overdose is treated symptomatically with the use of enterosorbent ( activated carbon) and restoration of water and electrolyte balance. When convulsive symptom Diazepam ® is prescribed, and renal failure requires hemodialysis.

Flemoklav Solutab ®: overdose and side effects

Amoxicillin in combination with potassium clavulanate rarely affects the patient's body Negative influence, since penicillin antibiotics are generally low-toxic. However, during tests in clinical settings and post-marketing independent studies revealed the following responses to the drug from internal organs and systems:

  • Digestive tract and liver. Epigastric pain, bowel movements (diarrhea), vomiting and nausea - uncommon. Liver dysfunction in the form of jaundice was even less common, and the development of pseudomembranous colitis was observed in isolated cases. As a rule, digestive problems do not arise if you take the drug as recommended in the instructions - before meals.
  • The immune system. Rarely (in less than one case in every thousand) allergic reactions such as exanthema and urticaria may occur. Malignant and multiforme erythema, vasculitis, angioedema, as well as exfoliative dermatitis are even less common.
  • Urinary organs. Interstitial nephritis may develop.

Other things side effects These include candidiasis characteristic of antibiotic therapy, provoked by the activation of opportunistic microflora of the mucous membranes. There is also a possibility of superinfection and anaphylactic shock.

Listed negative reactions organism are typical for the drug in a dosage of 125 to 500 mg. An increased dose (tablets labeled "425") may cause rare additional side effects: reversible hematopoietic disorders ( hemolytic anemia), more severe allergies, headache and cramps, increased anxiety, insomnia, increased activity of liver enzymes.

Flemoklav and Amoxiclav ®: what is the difference?

The drug Amoxiclav ®, produced by the pharmaceutical company Lek (Slovenia), also belongs to the group of inhibitor-protected semi-synthetic penicillins.

Main active substance is the antibiotic amoxicillin in trihydrate form, an inhibitor protected by clavulanic acid. That is this drug is complete chemical analogue Flemoklava ® is sold in pharmacy chains at reasonable prices.

Differences between the two antibacterial agents lies in diversity dosage forms Slovenian version and some features component composition. Amoxiclav ® is produced both in the form of dispersible and conventional tablets, and in the form of powder for suspensions and solution for parenteral use.

Film-coated tablets contain different doses antibiotic (from 250 to 875 mg), but the amount of potassium clavulanate is always the same - 125 milligrams. The dispersible variety Amoxiclav-Quiktab ® is characterized by the same thing. The powder contains the same active ingredients in various doses.

The variety of dosage forms significantly expands the scope of use of the antibiotic. Abdominal infections have been added to the list of indications, chancroid and gonorrhea. In addition, the drug solution is used as prophylactic at surgical interventions. Also filmed age restrictions: the medicine can be prescribed parenterally from the first days of a child’s life, and in the form of a suspension - from 2 months.

Composition and release form

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

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

7 pcs in blister; There are 2 blisters in a cardboard pack.

Description of the dosage form

Pills oblong shape from white to yellow color with brown dotted spots, without marks, marked: “421” - at a dosage of 125 mg + 31.25 mg; “422” - 250 mg + 62.5 mg; “424” - 500 mg + 125 mg; “425” - 875 mg + 125 mg and a graphic part of the company logo.

Characteristic

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

pharmachologic effect

pharmachologic effect- broad spectrum antibacterial.

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 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 beta-lactamase producing strains).

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 quantity- with bile. T1/2 from blood serum in patients with normal function kidneys 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 ranges between 10 and 15 hours. It is eliminated by 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.

Tablets 875 mg + 125 mg

After a single dose of Flemoklav Solutab ® at a dose of 875 mg + 125 mg (amoxicillin + clavulanic acid), the Cmax of amoxicillin in the blood plasma is created after 1.5 hours and is 12 μg/ml, clavulanic acid - after 1 hour, amounting to 3 μg/ml . The AUC of amoxicillin and clavulanic acid is 33 mcg h/l and 6 mcg h/l, respectively. Absorption of amoxicillin at oral administration reaches 90%, the absolute bioavailability of clavulanic acid averages 60%.

Approximately 17-20% of amoxicillin and 22% of clavulanic acid are bound to plasma proteins. The total Cl for the two active substances is 25 l/h, half-life 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 during the first 6 hours after taking the drug. Amoxicillin is excreted predominantly unchanged, a small part is metabolized by hydrolysis of the beta-lactam ring to inactive metabolites (the main ones are penicillic and penamaldic acids). Clavulanic acid undergoes extensive metabolism through hydrolysis and subsequent decarboxylation.

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 (incl. otitis media, sinusitis, tonsillitis, pharyngitis);

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

skin and soft tissue infections;

urinary system (including cystitis, pyelonephritis).

infections of bones and joints (including osteomyelitis);

in obstetrics and gynecology.

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

Additionally for tablets 875 mg + 125 mg:

renal failure with glomerular filtration ≤ 30 ml/min;

children under 12 years of age with body weight<40 кг.

Carefully:

severe liver failure;

gastrointestinal diseases (including a history of colitis associated with the use of penicillins);

chronic renal failure.

Use 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.

Side effects

Tablets 125 mg + 31.25 mg; 250 mg + 62.5 mg; 500 mg + 125 mg

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 blood composition (leukopenia, thrombocytopenia, hemolytic anemia); prolongation of prothrombin time (reversible).

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.

Tablets 875 mg + 125 mg

Infections: uncommon (≥1/1000,<1/100) — бактериальные или грибковые суперинфекции (при длительной терапии или повторных курсах терапии).

From the blood system and hematopoietic organs: rare (≥1/10000,<1/1000) — тромбоцитоз, гемолитическая анемия; очень редко (<1/10000) — лейкопения, гранулоцитопения, тромбоцитопения, панцитопения, анемия, увеличение ПВ и времени кровотечения. Эти нежелательные реакции обратимы и исчезают после прекращения терапии.

Allergic reactions: often (≥1/100,< 1/10) — кожные высыпания и зуд; кореподобная экзантема, появляющаяся на 5-11-й день после начала терапии. Появление крапивницы сразу после начала приема препарата с высокой степенью вероятности является проявлением аллергической реакции и требует отмены препарата; редко (≥1/10000, <1/1000) — буллезный или эксфолиативный дерматит (мультиформная экссудативная эритема, синдром Стивенса-Джонсона, токсический эпидермальный некролиз), анафилактический шок; другие аллергические реакции — лекарственная лихорадка, эозинофилия, ангионевротический отек (отек Квинке), отек гортани, сывороточная болезнь, гемолитическая анемия, аллергический васкулит, интерстициальный нефрит.

From the nervous system: rare (≥1/10000,<1/1000) — головокружение, головная боль, судороги (в случае нарушения функции почек или передозировки препарата); очень редко (<1/10000) — гиперактивность, беспокойство (тревога), бессонница, нарушение сознания, агрессивное поведение.

From the cardiovascular system: rare (≥1/10000,<1/1000) — васкулит.

Reactions from the digestive system: often (≥1/100,<1/10) — боль в животе, тошнота (чаще при передозировке), рвота, метеоризм, диарея (в основном реакции со стороны системы пищеварения носят преходящий характер и редко бывают выраженными; интенсивность их можно уменьшить, принимая препарат в начале приема пищи); псевдомембранозный колит (в случае тяжелой и стойкой диареи на фоне приема препарата или в течение 5 нед после завершения терапии) в большинстве случаев вызывается токсинопродуцирующими штаммами Clostridium difficile; rare (≥ 1/10000,<1/1000) — кандидоз кишечника, геморрагический колит, дисколорация поверхностного слоя зубной эмали.

From the hepatobiliary system: often (≥ 1/100,<1/10) — незначительное повышение активности печеночных ферментов; редко (≥1/10000, <1/1000) — гепатит и холестатическая желтуха. Симптомы нарушения функции печени возникают во время лечения или сразу после прекращения терапии, однако в некоторых случаях они могут проявляться через несколько недель после прекращения приема препарата; чаще наблюдаются у мужчин и пациентов старше 60 лет; у детей — очень редко (<1/10000). Риск возникновения нежелательных реакций увеличивается при применении препарата более 14 дней. Нарушения функции печени, как правило обратимые, иногда бывают тяжелыми и в очень редких случаях (<1/10000) и только у пациентов с тяжелыми сопутствующими заболеваниями или при одновременном приеме потенциально гепатотоксичных препаратов могут привести к летальному исходу.

From the genitourinary system: uncommon (≥ 1/1000,<1/100) — зуд, жжение и выделения из влагалища; редко (>1/10000, <1/1000) — интерстициальный нефрит.

Interaction

Tablets 125 mg + 31.25 mg; 250 mg + 62.5 mg; 500 mg + 125 mg

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.

Directions for use and doses

Inside, 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 Flemoklav 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:

Glomerular filtration rate, ml/min Adults Children
10-30 500 mg 2 times a day 15 mg/kg 2 times a day
<10 500 mg per day 15 mg/kg per day
Hemodialysis 500 mg daily and 500 mg during and after dialysis 15 mg/kg per day and 15 mg/kg during and after dialysis

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

Overdose

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

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

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 Flemoklav 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 Flemoklav 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.

Storage conditions for the drug Flemoklav Solutab ®

At a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf life of the drug Flemoklav Solutab ®

dispersible tablets 125 mg + 31.25 mg - 3 years.

dispersible tablets 250 mg + 62.5 mg - 3 years.

dispersible tablets 500 mg + 125 mg - 3 years.

dispersible tablets 875 mg+125 mg 875 mg+125 - 2 years.

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

Synonyms of nosological groups

Category ICD-10Synonyms of diseases according to ICD-10
H66.9 Otitis media, unspecifiedMiddle ear infections
Otitis
Otitis media
Otitis media in children
Chronic otitis media
J01 Acute sinusitisInflammation of the paranasal sinuses
Inflammatory diseases of the paranasal sinuses
Purulent-inflammatory processes of the paranasal sinuses
Sinus infection
Combined sinusitis
Exacerbation of sinusitis
Acute inflammation of the paranasal sinuses
Acute bacterial sinusitis
Acute sinusitis in adults
Subacute sinusitis
Acute sinusitis
Sinusitis
J02.9 Acute pharyngitis, unspecifiedPurulent pharyngitis
Lymphonodular pharyngitis
Acute nasopharyngitis
J03.9 Acute tonsillitis, unspecified (angina agranulocytic)Angina
Sore throat, alimentary-hemorrhagic
Sore throat secondary
Primary tonsillitis
Sore throat follicular
Sore throats
Bacterial tonsillitis
Throat infections
Catarrhal sore throat
Lacunar tonsillitis
Acute sore throat
Acute tonsillitis
Tonsillitis
Acute tonsillitis
Tonsillar tonsillitis
Follicular tonsillitis
Follicular tonsillitis
J04 Acute laryngitis and tracheitisInfectious and inflammatory disease of ENT organs
Laryngitis
Laryngitis acute
Acute tracheitis
Pharyngolaryngitis
J06 Acute upper respiratory tract infections of multiple and unspecified localizationBacterial infections of the upper respiratory tract
Bacterial respiratory infections
Pain due to colds
Pain in infectious and inflammatory diseases of the upper respiratory tract
Viral respiratory disease
Viral respiratory tract infections
Inflammatory disease of the upper respiratory tract
Inflammatory diseases of the upper respiratory tract
Inflammatory diseases of the upper respiratory tract with difficult to separate sputum
Inflammatory diseases of the respiratory tract
Secondary infections with influenza
Secondary infections due to colds
Influenza conditions
Difficulty secreting sputum in acute and chronic respiratory diseases
Upper respiratory tract infections
Upper respiratory tract infections
Respiratory tract infections
Respiratory and lung infections
ENT infections
Infectious and inflammatory diseases of the upper respiratory tract
Infectious and inflammatory diseases of the upper respiratory tract and ENT organs
Infectious and inflammatory diseases of the upper respiratory tract in adults and children
Infectious and inflammatory diseases of the upper respiratory tract
Infectious inflammation of the respiratory tract
Respiratory tract infection
Qatar of the upper respiratory tract
Catarrhal inflammation of the upper respiratory tract
Catarrhal disease of the upper respiratory tract
Catarrhal phenomena from the upper respiratory tract
Cough in diseases of the upper respiratory tract
Cough with a cold
Fever due to influenza
ARVI
acute respiratory infections
Acute respiratory infection with symptoms of rhinitis
Acute respiratory infection
Acute infectious-inflammatory disease of the upper respiratory tract
Acute cold
Acute respiratory disease
Acute respiratory disease of influenza nature
Sore throat or nose
Cold
Colds
Colds
Respiratory infection
Respiratory viral infections
Respiratory diseases
Respiratory infections
Recurrent respiratory tract infections
Seasonal colds
Seasonal colds
Frequent colds and viral diseases
J15.9 Bacterial pneumonia, unspecifiedBacterial pneumonia
Bacterial exacerbation of chronic obstructive pneumonia
Bacterial pneumonia
J31.2 Chronic pharyngitisAtrophic pharyngitis
Inflammatory process of the pharynx
Hypertrophic pharyngitis
Infectious and inflammatory diseases of the pharynx
Infectious and inflammatory diseases of the oral cavity and pharynx
Throat infection
Exacerbation of inflammatory diseases of the pharynx and oral cavity
Chronic pharyngitis
J32.9 Chronic sinusitis, unspecifiedInflammation of the lateral sinuses
Inflammation of the sinuses
Polypous rhinosinusitis
J35.0 Chronic tonsillitisChronic sore throat
Inflammatory diseases of the tonsils
Chronic tonsillitis
Tonsillar tonsillitis
Chronic hypertrophic tonsillitis
J42 Chronic bronchitis, unspecifiedAllergic bronchitis
Asthmoid bronchitis
Allergic bronchitis
Asthmatic bronchitis
Chronic bronchitis
Inflammatory disease of the respiratory tract
Bronchial disease
Qatar smoker
Cough due to inflammatory diseases of the lungs and bronchi
Exacerbation of chronic bronchitis
Recurrent bronchitis
Chronic bronchitis
Chronic obstructive pulmonary diseases
Chronical bronchitis
Chronic bronchitis of smokers
Chronic spastic bronchitis
N15.9 Tubulointerstitial kidney disease, unspecifiedKidney infections

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

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. 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 (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.

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.

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.

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.

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 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 (

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 .

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 Flemoclav 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 (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.

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.

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

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.

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 noted 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.

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 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)

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, from 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

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 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.

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

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

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.

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

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.

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.

Its activity is directed against gram-positive and gram-negative organisms, including bacteria that produce beta-lactomoses. Instructions for the drug "Flemoclav Solutab", reviews of the treatment of patients of different ages and other important provisions are presented in this article.

General characteristics

The drug "Flemoklav Solutab" is available in tablets that have a smooth surface and an oblong oval shape. The color varies from white to yellow with brown dots. Each tablet has a company logo and markings. There are such markings as “421”, “422”, “424”, “425”, which indicates different amounts of clavulanic acid and amoxicillin in the composition of the drug.

"Flemoklav Solutab" is produced in a blister, which is packed in a cardboard box. The antibiotic is prescribed by the attending physician, and the drug is administered orally. The package contains:

  • 2 blisters with tablets "Flemoklav Solutab",
  • instructions for use.

Reviews from those who have taken the drug fully agree with the instructions.

Purpose of the drug

"Flemoklav Solutab" is prescribed by your attending physician. Under no circumstances should you self-medicate.

Patients often characterize the drug in a positive way. It suits everyone and helps with everything. People note the effectiveness of the medicine and its pleasant taste. This antibiotic can be used to treat a wide variety of diseases. The medicine has proven itself very well.

The drug is prescribed for the treatment of infectious diseases caused by microorganisms sensitive to this antibiotic. These are pathologies such as:

  • postoperative infections;
  • infections of the upper and lower respiratory tract (pharyngitis, sinusitis, pneumonia, bronchitis, etc.);
  • infections of the genitourinary system and pelvic organs (cystitis, prostatitis, gonorrhea);
  • osteomyscitis;
  • kidney infections;
  • infections of soft tissues of the skin (dermatosis, abscess).

The drug is also used for prophylaxis during surgical operations.

How is this antibiotic used?

The antibiotic "Flemoclav Solutab" is administered orally. It is recommended to swallow the tablet of the drug whole or chew it with plain water. Those who cannot swallow the tablets have the option of dissolving it in half a glass of water and drinking it.

"Flemoklav Solutab" should be taken immediately before meals. This will reduce the effect of the antibiotic on the intestinal microflora.

How long should I take Flemoclav Solutab?

The duration of antibiotic use is determined by the attending physician. Typically, treatment should be continued for at least three days after the painful symptoms disappear. But in some cases, the course of treatment lasts from 7 to 10 days. The maximum period of admission is two weeks.

According to patient reviews, the drug helps to quickly cope with purulent sore throat. According to them, the antibiotic does not greatly affect the intestinal microflora and is relatively inexpensive.

Dosage of the drug

As already mentioned, the drug is administered orally and is usually washed down with water. According to the instructions, children over 12 years of age and adults need to take 1 tablet (500/125 mg) 2-3 times a day. Children from 2 to 12 years old and weighing from 13 to 37 kg are recommended to be given 20-30 mg per kilogram of body weight per day. This daily dose should be divided into three parts. In some cases, your doctor may prescribe an increase in dose. It depends on the disease and physiological characteristics of the patient.

In elderly patients, adult dosage is usually prescribed.

In what cases should you not take Flemoclav Solutab?

Doctors do not recommend taking this drug for people with hypersensitivity to any components of the drug. You should also be very careful when using it in patients with lymphocytic leukemia or infectious monocucleosis. The fact is that Flemoclav Solutab contains components that can lead to eczema. It is not recommended to give the drug to children under two years of age. The antibiotic is contraindicated in people with jaundice.

The use of the drug "Flemoklav Solutab" should be carried out under the close supervision of a doctor, especially for people suffering from severe liver or kidney failure, having diseases of the gastrointestinal tract, as well as those experiencing pregnancy and lactation.

What happens when there is a drug overdose?

In case of overdose, a number of symptoms may occur, such as:

  • headache,
  • dizziness,
  • allergic reactions (very rare),
  • vomit,
  • nausea,
  • diarrhea,
  • flatulence
  • dry mouth,
  • distortion of taste sensations.

If any of the above signs of side effects occur, you should stop using it and consult a doctor.

Side effects

The drug "Flemoklav Solutab" is attractive because it has significantly fewer side effects than its other analogues. But the drug still has side effects, and they must be taken into account when using it.

Side effects of the drug, depending on the frequency of occurrence, can be divided into:

  • frequent cases (diarrhea, abdominal pain, nausea, vomiting, urticaria),
  • rare cases (cholestatic jaundice, hepatitis, leukopenia, hemolytic anemia, vasculitis, angioedema, interstitial nephritis),
  • isolated cases (pseudomembrial colitis, erythema multiforme, anaphylactic shock, exfoliative dermatitis).

If these signs of a side effect of the drug appear, you should immediately stop using it and consult your doctor.

Patients who are quite skeptical about taking antibiotics nevertheless listened to the doctor’s advice and underwent a course of treatment for pneumonia using the drug “Flemoclav Solutab”. The results pleasantly surprised them, since no side effects appeared during the treatment process. Surprisingly, you can simply dissolve the antibiotic in water and drink it.

Use of the drug during pregnancy

The components of the drug, as a rule, do not have a negative effect on the development of the fetus. "Flemoklav Solutab" can be prescribed to pregnant women, but only after carefully weighing all the possible risks and benefits of such treatment.

In the first three months of pregnancy, it is usually recommended to use alternative remedies that are safer for the body. During lactation it is recommended not to treat with this antibiotic. If use cannot be avoided, doctors advise temporarily stopping breastfeeding for the period of treatment.

In the case of a medicine for adults, the package contains: 2 blisters with the drug "Flemoclav Solutab", instructions. For children (reviews are usually positive) there is a specially developed antibiotic with the required dosage.

How to properly store Flemoclav Solutab?

The manufacturer recommends storing the drug for no more than three years from the date of manufacture. The antibiotic should be stored out of the reach of children at a temperature not exceeding + 25 degrees Celsius. Usually, some marbling and small brown spots on the surface of the tablets are acceptable.

"Flemoklav Solutab 250" for children: reviews of the drug

As a rule, the drug is taken by swallowing and drinking water. It is much easier to give Flemoclav Solutab to children in the form of a suspension. The dosage is indicated by the attending physician. The finished suspension is usually stored in a cold and dark place for no more than a day.

Flemoclav Solutab 250 is also perfect for children. The antibiotic "Flemoklav Solutab" has very different reviews, because each patient has his own characteristics of the body. Parents are often frightened by possible side effects, which, by the way, occur extremely rarely. But all this once again suggests the need to consult a doctor.

Children suffering from diseases of the gastrointestinal tract can also be prescribed Flemoclav Solutab. Instructions for use, reviews of those who have used the drug - all this should be thoroughly studied by parents.

"Flemoklav Solutab": analogues, reviews

The antibiotic has a number of equally effective analogue agents, such as:

  • "Amovicombe"
  • "Amoxiclav"
  • "Bactoclav"
  • "Medoclav"
  • "Panklav"
  • "Ranklav" and others.

Reviews about the drug "Flemoklav Solutab" are quite different, because it is a broad-spectrum antibiotic. Before use, you can independently analyze the impressions of other patients and, based on them, weigh the pros and cons.

Most people who take Flemoclav Solutab leave quite positive reviews. This is especially true for the treatment of diseases of the ENT organs, as well as the upper and lower respiratory tract. The drug has a positive effect on any inflammatory diseases in a short time.

In general, reviews about the drug "Flemoclav Solutab" are quite loyal. Many people are attracted by the relatively small number of side effects, as well as the ability to use the drug during pregnancy and lactation.