Flemoklav solutab - analogues (list), comparison of effectiveness

Flemoklav belongs to the antibacterial agents of the penicillin series. Most people, when they hear a doctor prescribe an antibiotic, panic. Is everything really that serious, and there are no other ways to cope with the disease.

Unfortunately, folk remedies and “light” drugs do not always solve the problem; in some cases, an antibiotic is a salvation from serious complications.

Flemoklav has a wide antibacterial spectrum. The disadvantage of the drug is its high price. In this regard, analogues are selected for the Solutab flemoclav. You can find cheaper analogues among domestic drugs, the price of which will be an order of magnitude lower. In order to choose the right replacement, and not make a mistake with the choice, let's briefly get acquainted with the instructions for the Solutab flemoclav.

Nosological classification (ICD-10)

• H66.9 Otitis media, unspecified
• J01 Acute sinusitis
• J02.9 Acute pharyngitis, unspecified
• J03.9 Acute tonsillitis, unspecified (angina agranulocytic)
• J04 Acute laryngitis and tracheitis
• J06 Acute upper respiratory tract infections of multiple and unspecified localization
• J15.9 Bacterial pneumonia, unspecified
• J31.2 Chronic pharyngitis
• J32.9 Chronic sinusitis, unspecified
• J35.0 Chronic tonsillitis
• J42 Chronic bronchitis, unspecified
• L00-L08 Infections of the skin and subcutaneous tissue
• N15.9 Tubulointerstitial kidney disease, unspecified

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.

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

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

Flemoxin or flemoklav - which is better?

Flemoxin, like flemoklav, is manufactured in the Netherlands, in addition, the drugs have a common manufacturer - Astellas Pharma Europe B.V.
If flemoxin is not suitable for the patient, the pharmacist may offer flemoklav as an analogue. Is it correct? The products under consideration are partial analogues. Flemoxin is a mono drug, it contains only amoxicillin, and flemoklav is a combination of amoxicillin and clavulanic acid. This is an important difference between these funds.

• It should be noted that clavulanic acid enhances the clinical effect, therefore, the therapeutic effect of flemoklav is stronger. Where flemoxin cannot destroy bacteria that produce beta-lactamases, flemoclav is suitable.
• There is also a difference in belonging to the pharmacological group. Flemoklav - penicillins with beta-lactamase inhibitors. Flemoxin is a group of penicillins.

There are no differences between the drugs in terms of release form. Dosages are indicated differently. For example, flemoklav has 250 mg + 62.5 mg, and flemoxin has 250 mg (the dose of each active substance is written separately, 250 mg is amoxicillin, 62.5 mg is clavulanic acid).

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).

Flemoklav Solutab tab. dispers. 500mg+125mg N20

Registration Certificate Holder

ASTELLAS PHARMA EUROPE (Netherlands)

Dosage form

Medicine - Flemoclav Solutab®

Description

Dispersible tablets

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

1 tab.

amoxicillin trihydrate 582.8 mg, which corresponds to the content of amoxicillin base 500 mg potassium clavulanate 148.9 mg, which corresponds to the content of clavulanic acid 125 mg

Excipients

: microcrystalline cellulose - 327.3 mg, crospovidone - 100 mg, vanillin - 1 mg, apricot flavor - 9 mg, saccharin - 9 mg, magnesium stearate - 5 mg.

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

Indications

Treatment of infectious and inflammatory diseases caused by sensitive pathogens: lower respiratory tract infections (bronchitis, pneumonia, pleural empyema, lung abscess); infections of the ENT organs (sinusitis, tonsillitis, otitis media); infections of the genitourinary system and pelvic organs (pyelonephritis, pyelitis, cystitis, urethritis, prostatitis, cervicitis, salpingitis, salpingoophoritis, tubo-ovarian abscess, endometritis, bacterial vaginitis, septic abortion, postpartum sepsis, pelvioperitonitis, chancroid, gonorrhea); infections of the skin and soft tissues (erysipelas, impetigo, secondary infected dermatoses, abscess, cellulitis, wound infection); osteomyelitis; postoperative infections.

Contraindications for use

Hypersensitivity to amoxicillin and other penicillins, clavulanic acid, and other beta-lactam antibiotics (cephalosporins, carbapenems, monobactams); cholestatic jaundice and/or other liver dysfunction caused by a history of amoxicillin/clavulanic acid use; severe renal impairment (creatinine clearance <30 ml/min) (for a dosage form intended for use in children from 3 months to 12 years); children up to 3 months old.

Carefully

Liver dysfunction, kidney dysfunction..

pharmachologic effect

A combination drug of amoxicillin and clavulanic acid, a beta-lactamase inhibitor. It has a bactericidal effect and inhibits the synthesis of the bacterial wall. Active against aerobic gram-positive bacteria (including strains producing beta-lactamases): Staphylococcus aureus; aerobic gram-negative bacteria: Enterobacter spp., Escherichia coli, Haemophilus influenzae, Klebsiella spp., Moraxella catarrhalis. The following pathogens are sensitive only in vitro: Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus anthracis, Streptococcus pneumoniae, Streptococcus viridans, Enterococcus faecalis, Corynebacterium spp., Listeria monocytogenes; anaerobic Clostridium spp., Peptococcus spp., Peptostreptococcus spp.; as well as aerobic gram-negative bacteria (including strains producing beta-lactamases): Proteus mirabilis, Proteus vulgaris, Salmonella spp., Shigella spp., Bordetella pertussis, Yersinia enterocolitica, Gardnerella vaginalis, Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus ducreyi, Yersinia multocida ( formerly Pasteurella), Campylobacter jejuni; anaerobic gram-negative bacteria (including beta-lactamase producing strains): Bacteroides spp., including Bacteroides fragilis.

Clavulanic acid inhibits types II, III, IV and V beta-lactamases; it is not active against type I beta-lactamases produced by 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 beta-lactamases.

Drug interactions

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

Bacteriostatic antibiotics (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) have an antagonistic effect.

When combined with rifampicin, a mutual weakening of the antibacterial effect is observed.

Increases the effectiveness of indirect anticoagulants (suppressing 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 in the process of metabolism of which PABA is formed, ethinyl estradiol - the risk of developing 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).

Concomitant use with methotrexate increases the toxicity of methotrexate.

Allopurinol increases the risk of developing skin rashes.

Concomitant use with probenecid is not recommended. Probenecid reduces the tubular secretion of amoxicillin. When used together, it is possible to increase and prolong the blood concentration of amoxicillin, but not clavulanic acid.

Concomitant use with disulfiram should be avoided.

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

Dosage regimen

Doses are given in terms of amoxicillin. The dosage regimen is set individually depending on the patient’s age, the severity and location of the infection, and the sensitivity of the pathogen.

Children under 12 years of age: 20-40 mg/kg/day in 2-3 doses.

Adults and children over 12 years of age or weighing 40 kg or more: 250-500 mg 2-3 times / day or 875 mg 2 times / day.

The maximum daily dose of amoxicillin for adults and children over 12 years of age is 6 g, for children under 12 years of age - 45 mg/kg body weight.

Side effect

From the digestive system: nausea, vomiting, diarrhea, gastritis, stomatitis, glossitis, increased activity of liver transaminases, in isolated cases - cholestatic jaundice, hepatitis, liver failure (more often in the elderly, men, with long-term therapy), pseudomembranous and hemorrhagic colitis ( can also develop after therapy), enterocolitis, black “hairy” tongue, darkening of tooth enamel. From the hematopoietic organs: reversible increase in prothrombin time and bleeding time, thrombocytopenia, thrombocytosis, eosinophilia, leukopenia, agranulocytosis, hemolytic anemia. From the nervous system: dizziness, headache, hyperactivity, anxiety, behavior changes, convulsions.

From the urinary system: interstitial nephritis, crystalluria, hematuria. Allergic reactions: urticaria, erythematous rashes, rarely - erythema multiforme exudative, anaphylactic shock, angioedema, extremely rarely - exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), allergic vasculitis, a syndrome similar to serum sickness, acute generalized exanthematous pustulosis . Other: candidiasis, development of superinfection.

special instructions

The use of this combination is not recommended if infectious mononucleosis is suspected.

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

In order to reduce the risk of side effects from the gastrointestinal tract, the drug should be taken with meals. It is possible that superinfection may develop due to the growth of microflora that is insensitive to it, which requires a corresponding change in antibacterial therapy. May give false positive results when determining glucose in urine. In this case, it is recommended to use the glucose oxidant method for determining the concentration of glucose in the urine. In patients who are hypersensitive to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - With caution. Restrictions when breastfeeding - With caution. Use with caution during pregnancy and lactation (breastfeeding).

Use for renal impairment

Restrictions for impaired renal function - With caution. In case of chronic renal failure, the dose and frequency of administration are adjusted depending on the QC.

Use for liver dysfunction

Restrictions for liver dysfunction - With caution.

Contraindicated in patients with episodes of jaundice or impaired liver function due to a history of amoxicillin/clavulanic acid use.

With caution: severe liver failure

Use in elderly patients

Restrictions for elderly patients - Use with caution.

Use in children

Restrictions for children - With caution. Used in children over 3 months according to indications and in dosage forms appropriate for age.

Pharmacokinetics

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

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.

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 when administered orally 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, T1/2 amoxicillin - 1.1 hours, clavulanic acid - 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 (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

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 weighing <40 kg.

Carefully:

severe liver failure;

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

chronic renal failure.

Structural analogues - list

In fact, any antibiotic is an analogue of flemoclav. There are simply analogues in structure or therapeutic effect. Important points in choosing an analogue are price, country of manufacture and diagnosis. We present to your attention a list of the most popular flemoclav analogues:

• ecoclave;
• foraklav;
• panclave;
• amoxiclav;
• augmentin;
• fibell;
• honeyclave;
• quicktab;
• arlet;
• Verklav;
• flemoxin
• other.

Ecoclave

Country of origin: Russia. The drug is completely identical to flemoklav. There are differences in the auxiliary composition, the list of indications is somewhat wider. Tablets 500 mg + 125 mg No. 15 cost about 300 rubles.

Adverse reactions and contraindications largely coincide with flemoklav.

Foraklav

Manufacturer – India. The drug is a structural analogue of flemoklav, but is available in the form of a solution for intravenous administration. Vials of 500 mg + 100 mg and 1000 mg + 200 mg are available.

• The product belongs to semi-synthetic antibiotics, supplemented with a beta-lactamase inhibitor.
• Foraklav is prescribed for severe infection. Widely used for erysipelas, septicemia, meningitis, shigellosis, salmonellosis, paratyphoid fever, typhoid fever, and other dangerous infections. The downside is a large number of contraindications and side effects.

The price and supplies need to be clarified in the pharmacy chain; at the moment there is no information.

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 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.

Tablets 875 mg + 125 mg

Infections: uncommon (≥1/1000, <1/100) - bacterial or fungal superinfections (with long-term therapy or repeated courses of therapy).

From the blood system and hematopoietic organs: rarely (≥1/10000, <1/1000) - thrombocytosis, hemolytic anemia; very rarely (<1/10000) - leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, anemia, increased PT and bleeding time. These adverse reactions are reversible and disappear after discontinuation of therapy.

Allergic reactions: often (≥1/100, <1/10) - skin rashes 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 (≥1/10000, <1/1000) - bullous or exfoliative dermatitis (erythema multiforme exudative, Stevens-Johnson syndrome, toxic epidermal necrolysis), anaphylactic shock; other allergic reactions - drug fever, eosinophilia, angioedema (Quincke's edema), laryngeal edema, serum sickness, hemolytic anemia, allergic vasculitis, interstitial nephritis.

From the nervous system: rarely (≥1/10000, <1/1000) - dizziness, headache, convulsions (in case of impaired renal function or drug overdose); very rarely (<1/10000) - hyperactivity, restlessness (anxiety), insomnia, impaired consciousness, aggressive behavior.

From the cardiovascular system: rarely (≥1/10000, <1/1000) - vasculitis.

Reactions from the digestive system: often (≥1/100, <1/10) - abdominal pain, nausea (more often with overdose), vomiting, flatulence, diarrhea (generally reactions from the digestive system are transient and rarely severe ; their intensity can be reduced by taking the drug at the beginning of a meal); pseudomembranous colitis (in case of severe and persistent diarrhea while taking the drug or within 5 weeks after completion of therapy) in most cases is caused by toxin-producing strains of Clostridium difficile; rarely (≥ 1/10000, <1/1000) - intestinal candidiasis, hemorrhagic colitis, discoloration of the surface layer of tooth enamel.

From the hepatobiliary system: often (≥ 1/100, <1/10) - a slight increase in the activity of liver enzymes; rarely (≥1/10000, <1/1000) - 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; in children - very rarely (<1/10000). The risk of adverse reactions increases when using the drug for more than 14 days. Liver dysfunction, usually reversible, is sometimes severe and can be fatal in very rare cases (<1/10,000) and only in patients with severe comorbidities or when concomitantly taking potentially hepatotoxic drugs.

From the genitourinary system: infrequently (≥ 1/1000, <1/100) - itching, burning and vaginal discharge; rarely (>1/10000, <1/1000) - interstitial nephritis.

Flemoklav Solutab Tablets, 14 pcs., 875+125 mg+mg

Side effect

Infections: Uncommon (≥ 1/1000, less than 1/100): bacterial or fungal superinfections (with long-term therapy or repeated courses of therapy). From the blood system and hematopoietic organs: Rarely (≥ 1/10000, less than 1/1000): thrombocytosis, hemolytic anemia. Very rare (less than 1/10000): leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, anemia, increased prothrombin time and bleeding time. These adverse reactions are reversible and disappear after discontinuation of therapy. Allergic reactions: Often (≥ 1/100, less than 1/10): skin rashes 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 (≥1/10000, less than 1/1000); bullous or exfoliative dermatitis (erythema multiforme exudative, Stevens-Johnson syndrome, toxic epidermal necrolysis), anaphylactic shock; other allergic reactions - drug fever, eosinophilia, angioedema (Quincke's edema), laryngeal edema, serum sickness, hemolytic anemia, allergic vasculitis, interstitial nephritis. From the nervous system: Rarely (≥1/10000, less than 1/1000): dizziness, headache, convulsions (in case of impaired renal function or drug overdose). Very rare (less than 1/10000): hyperactivity, restlessness (anxiety), insomnia, impaired consciousness, aggressive behavior. From the cardiovascular system: Rarely (≥1/10000, less than 1/1000): vasculitis. Reactions from the digestive system: Often (≥1/100. less than 1/10): abdominal pain, nausea (more often with overdose), vomiting, flatulence, diarrhea (generally, reactions from the digestive system are transient and rarely occur pronounced; their intensity can be reduced by taking the drug at the beginning of a meal); pseudomembranous colitis (in case of severe and persistent diarrhea while taking the drug or within 5 weeks after completion of therapy), in most cases is caused by toxin-producing strains of Clostridium difficile. Rarely (≥1/10000, less than 1/1000): intestinal candidiasis, hemorrhagic colitis, discoloration of the surface layer of tooth enamel. From the hepatobiliary system: Often (≥1/100, less than 1/10): slight increase in the activity of liver enzymes. Rarely (≥1/10000, less than 1/1000): 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 (less than 1/10,000). The risk of adverse reactions increases when using the drug for more than 14 days. Liver dysfunction is usually reversible, but can sometimes be severe and in very rare cases (less than 1/10,000) (only in patients with severe concomitant diseases or while taking potentially hepatotoxic drugs) can be fatal. From the genitourinary system: Uncommon (≥ 1/1000, less than 1/100): itching, burning and vaginal discharge; Rarely (≥1/10000, less than 1/1000): interstitial nephritis.

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.

Instructions for use FLEMOCLAV SOLUTAB®

In patients with hypersensitivity to penicillins, anaphylactic reactions may occur (more often in the presence of a history of hypersensitivity).

Treatment with Flemoclav Solutab® in such cases should be stopped immediately and replaced with other appropriate therapy. Treatment of anaphylactic shock may require urgent administration of adrenaline, corticosteroids and elimination of respiratory failure.

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

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, since absorption of the drug from the gastrointestinal tract may be impaired.

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.

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

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 longer than 14 days without assessing liver function. With long-term use of the drug, it is necessary to regularly monitor peripheral blood parameters, kidney and liver function.

While taking the drug, an increase in prothrombin time is sometimes observed, so in patients receiving anticoagulants in combination with amoxicillin/clavulanic acid, this indicator must be regularly 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.

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

If seizures occur during therapy, the drug is discontinued.

One dispersible tablet Flemoklav Solutab® 875 mg/125 mg contains 25 mg of potassium.

Impact on the ability to drive vehicles and operate machinery

Studies of the effect of taking the drug on the ability to drive a car and work with moving mechanisms have not been conducted. However, the possibility of undesirable effects (allergic reactions, dizziness, convulsions) may affect the ability to drive vehicles and operate machinery.

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:

Table

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

Instructions for use - briefly

The main active ingredients are amoxicillin trihydrate and potassium clavulanate. Tablets are available in different dosages. The maximum dose of flemoklav solutab is 1000 mg, represented by amoxicillin and clavulanic acid (875 mg/125 mg), respectively.

The drug is prescribed for infectious processes in:

• otolaryngology,
• pulmonology,
• urology,
• gynecology,
• dermatovenerology,
• other medical practices.

Contraindications are intolerance to the flemoclav composition, lymphocytic leukemia, severe liver pathologies, mononucleosis, and children under 2 years of age.

For patients aged 12 years or more, the drug is often recommended at a dose of 500/125 mg three times a day. For young children, the dose is selected depending on weight.

Flemoclav is used during pregnancy. The first trimester of pregnancy is considered the most vulnerable, so taking any medications before the 12th week of gestation is not recommended.

Flemoklav solutab is produced in the Netherlands, the price for a package of tablets No. 20 (500 mg/125 mg) is 420 rubles.

Analogs are selected based on active ingredients, i.e. they must match, or have a therapeutic effect. Let's consider both.

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.

Flemoclav or amoxiclav - which is better?

The drugs have the same composition, which means that their therapeutic effect is the same. The difference parameters include the composition of the auxiliary components, the release form, the manufacturer, and the degree of purification of the product. For example, Flemoxin Solutab has dispersible tablets that dissolve well in water. They are easier for the patient to swallow, and absorption of this form of the substance is better.

• In most cases, the doctor chooses the drug, not forgetting to agree on the possibility of purchasing this or that drug with the patient.
• Amoxiclav is not much cheaper, about 50 rubles.

According to statistical data on the trade turnover of medicines, it is noted that the number of sales of flemoklav is greater than that of amoxiclav. Often this picture is influenced by the marketing capabilities of pharmaceutical companies. The more advertising, the more successfully medicines are sold.