Flemoclav solutab 125mg+31.25mg 20 pcs. dispersible tablets

Compound

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

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

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

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

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

Microorganisms sensitive to amoxicillin in vitro:

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

Strains in which resistance may develop:

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

Resistant microorganisms:

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

Pharmacokinetics

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

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

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

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

Pharmacological properties of the drug Flemoklav solutab

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

Indications for use

Inflammatory infectious diseases caused by microorganisms sensitive to Flemoclav:

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

Contraindications

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

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

Contraindications to the use of the drug Flemoklav solutab

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

Side effects

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

Flemoclav Solutab, 875 mg+125 mg, dispersible tablets, 14 pcs.

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).

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 pronounced; their intensity can be reduced, 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:

uncommon (≥ 1/1000, <1/100) - itching, burning and vaginal discharge; rarely (>1/10000, <1/1000) - interstitial nephritis.

Instructions for Flemoclav Solutab

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

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

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

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

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

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

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

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

Flemoklav Solutab tablets 875mg/125mg No. 14

A country

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Active substance

Amoxicillin + Clavulanic acid

Compound

dispersed cellulose - 30.4 mg, microcrystalline cellulose - 125.9 mg, crospovidone - 64 mg, vanillin - 1 mg, tangerine flavor - 9 mg, lemon flavor - 11 mg, saccharin - 13 mg, magnesium stearate - 6 mg.

pharmachologic effect

A combination drug of amoxicillin and clavulanic acid, a beta-lactamase inhibitor. It has a bactericidal effect, inhibits the synthesis of the bacterial wall. Active against aerobic gram-positive bacteria (including strains that produce 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.

Indications for use

- bacterial infections 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 organs

Mode of application

Orally, intravenously. Doses are given in terms of amoxicillin. The dosage regimen is set individually depending on the severity and location of the infection and the sensitivity of the pathogen. Children under 12 years of age - in the form of a suspension, syrup or drops for oral administration. A single dose is set depending on age: children under 3 months - 30 mg/kg/day in 2 doses; 3 months and older - for mild infections - 25 mg/kg/day in 2 divided doses or 20 mg/kg/day in 3 divided doses, for severe infections - 45 mg/kg/day in 2 divided doses or 40 mg/kg/day a day in 3 doses. Adults and children over 12 years of age or weighing 40 kg or more: 500 mg 2 times / day or 250 mg 3 times / day. For severe infections and respiratory tract infections - 875 mg 2 times a day or 500 mg 3 times a 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 body. The maximum daily dose of clavulanic acid for adults and children over 12 years of age is 600 mg, for children under 12 years of age - 10 mg/kg body weight. If swallowing is difficult in adults, the use of a suspension is recommended. When preparing suspensions, syrups and drops, water should be used as a solvent. For intravenous administration, adults and adolescents over 12 years of age are administered 1 g (amoxicillin) 3 times a day, if necessary - 4 times a day. The maximum daily dose is 6 g. For children 3 months to 12 years old - 25 mg/kg 3 times a day; in severe cases - 4 times a day; for children up to 3 months: premature and in the perinatal period - 25 mg/kg 2 times a day, in the postperinatal period - 25 mg/kg 3 times a day. Duration of treatment - up to 14 days, acute otitis media - up to 10 days. To prevent postoperative infections during operations lasting less than 1 hour, a dose of 1 g is administered intravenously during induction of anesthesia. For longer operations - 1 g every 6 hours during the day. If the risk of infection is high, administration can be continued for several days. In case of chronic renal failure, the dose and frequency of administration are adjusted depending on the CC: with CC more than 30 ml/min, no dose adjustment is required; with CC 10-30 ml/min: orally - 250-500 mg/day every 12 hours; IV - 1 g, then 500 mg IV; with CC less than 10 ml/min - 1 g, then 500 mg/day IV or 250-500 mg/day orally in one dose. For children, doses should be reduced in the same way. Patients on hemodialysis - 250 mg or 500 mg orally in one dose or 500 mg intravenously, 1 additional dose during dialysis and 1 more dose at the end of the dialysis session. With caution: pregnancy, lactation period. Cases of the development of necrotizing enterocolitis in newborns and in pregnant women with premature rupture of membranes have been identified. Children under 12 years of age - in the form of a suspension, syrup or drops for oral administration. A single dose is set depending on age: children under 3 months - 30 mg/kg/day in 2 doses; 3 months and older - for mild infections - 25 mg/kg/day in 2 divided doses or 20 mg/kg/day in 3 divided doses, for severe infections - 45 mg/kg/day in 2 divided doses or 40 mg/kg/day a day in 3 doses. The maximum daily dose of amoxicillin for children under 12 years of age is 45 mg/kg body weight. The maximum daily dose of clavulanic acid for children under 12 years of age is 10 mg/kg of body weight.

Interaction

Antacids, glucosamine, laxatives, aminoglycosides slow down and reduce absorption; ascorbic acid increases absorption. Bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) have an antagonistic effect. 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). Allopurinol increases the risk of developing skin rashes.

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 change, convulsions. Local reactions: in some cases - phlebitis at the site of intravenous administration. Allergic reactions: urticaria, erythematous rashes, rarely - exudative erythema multiforme, anaphylactic shock, angioedema, extreme rarely - exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), allergic vasculitis, a syndrome similar to serum sickness, acute generalized exanthematous pustulosis. Others: candidiasis, development of superinfection, interstitial nephritis, crystalluria, hematuria.

Contraindications

- hypersensitivity (including to cephalosporins and other beta-lactam antibiotics); — infectious mononucleosis (including with the appearance of a measles-like rash); - phenylketonuria; - a history of episodes of jaundice or impaired liver function as a result of the use of amoxicillin/clavulanic acid; — CC less than 30 ml/min (for tablets 875 mg/125 mg). With caution: pregnancy, lactation, severe liver failure, gastrointestinal diseases (including a history of colitis associated with the use of penicillins), chronic renal failure.

Overdose

Symptoms: dysfunction of the gastrointestinal tract and water-electrolyte balance. Treatment: symptomatic. Hemodialysis is effective.

special instructions

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. Superinfection may develop due to the growth of microflora 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 urine. After dilution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen. In patients with hypersensitivity to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible. Cases of development have been identified necrotizing enterocolitis in newborns, in pregnant women with premature rupture of membranes. Since the tablets contain the same amount of clavulanic acid (125 mg), it should be noted that 2 tablets of 250 mg (amoxicillin) are not equivalent to 1 tablet of 500 mg (amoxicillin).

Dispensing conditions in pharmacies

On prescription

Overdose

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

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

Treatment of overdose

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

Interaction

Other antibiotics

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

Drugs that inhibit the excretion of amoxicillin by the kidneys

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

Allopurinol

Use with amoxicillin increases the risk of skin rash.

Methotrexate

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

Digoxin

Flemoklav Solutab increases the absorption of Digoxin in the intestine.

Anticoagulants

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

Hormonal contraceptives

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

Interactions of the drug Flemoklav solutab

Antacids, glucosamine, laxatives, aminoglycosides slow down and reduce, and ascorbic acid increases the absorption of the drug components. Flemoklav Solutab should not be prescribed simultaneously with bacteriostatic drugs (tetracyclines, macrolides or chloramphenicol), especially in acute infections. A synergistic effect is possible when administered simultaneously with aminoglycosides, cephalosporins, cycloserine, rifampicin, vancomycin. Medicines that inhibit the release of amoxicillin (probenecid, phenylbutazone, oxyphenbutazone and, to a lesser extent, acetylsalicylic acid, indomethacin and sulfinpyrazone) contribute to a longer presence of amoxicillin in the blood plasma. Flemoklav Solutab is not used in combination with probenecid. The use of allopurinol and amoxicillin increases the risk of rash. Amoxicillin is prescribed with caution in combination with disulfiram. The combined use of amoxicillin and digoxin causes an increase in the level of digoxin in the blood plasma. The drug reduces the effectiveness of oral contraceptives. Diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion increase the concentration of amoxicillin in the blood. When used simultaneously with anticoagulants, medical supervision of the patient is necessary, since this increases the prothrombin time.

special instructions

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

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

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

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

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

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

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

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

If seizures , treatment with the drug is discontinued.

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

Special instructions for the use of the drug Flemoklav solutab

Elderly patients do not require dosage adjustment. The drug is prescribed with caution to patients with impaired liver function. Liver function must be constantly monitored. There is a possibility of developing cross-resistance of microorganisms to other penicillins or cephalosporins. As with other broad-spectrum penicillins, superinfections may occur, especially in patients with chronic diseases and/or immune system dysfunction. For persistent diarrhea, possible pseudomembranous and hemorrhagic colitis, appropriate measures should be taken. The use of antiperistaltic agents is contraindicated. In patients with impaired renal function, the dose of the drug must be selected taking into account 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. Flemoclav Solutab should not be used for more than 14 days without assessing liver function. An increase in prothrombin time is rarely noted. Amoxicillin/clavulanic acid should be administered with caution to patients receiving anticoagulants. It is necessary to consider the possibility of developing fungal or bacterial superinfection during therapy. If superinfection develops, stop taking the drug and prescribe appropriate therapy. Due to the high concentration of amoxicillin in the urine, it can settle on the walls of the urinary catheter, so such patients need to change the catheter promptly. Forced diuresis accelerates the elimination of amoxicillin and reduces its serum concentration. Non-enzymatic methods for determining blood glucose, as well as the urobilinogen test, may give false positive results. If seizures occur during therapy, stop taking the drug. One dispersed tablet Flemoklav Solutab 875/125 mg contains 25 mg of potassium. During pregnancy and breastfeeding. When using the combination of amoxicillin/clavulanic acid during pregnancy, no negative effects on the fetus or newborn were observed. In a single study, prophylactic amoxicillin/clavulanic acid in women with premature rupture of membranes increased the risk of necrotizing enterocolitis in the newborn. Use in the second and third trimester of pregnancy is possible after a doctor has assessed the benefit/risk ratio of treatment. During the first trimester of pregnancy, the combination of amoxicillin/clavulanic acid at a dose of 875/125 mg should be avoided. Both components of the drug penetrate the placental barrier and are excreted into breast milk (there is no data on the effect of clavulanic acid on a breastfed baby). It is possible to use the drug during breastfeeding. However, if the child develops diarrhea or a fungal infection of the mucous membranes, breastfeeding must be stopped. It is also necessary to take into account the possibility of sensitization of the child by the components of the drug during breastfeeding. There were no negative effects on the ability to drive vehicles or operate potentially dangerous machinery.

Analogues of Flemoklav Solutab

Level 4 ATX code matches:
Arlet

Ecoclave

Panclave

Amoxiclav

Oxamp-Sodium

Oxamp

Amoxicillin + Clavulanic acid

Augmentin

Ampisid

Amoxil K 625

Sultasin

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

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

What is the difference between Flemoxin Solutab and Flemoklav Solutab?

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

Which is better: Amoxiclav or Flemoklav Solutab?

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

Price Flemoklav Solutab

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

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

Pharmacy Dialogue

• Flemoclav Solutab tablets 250 mg + 62.5 No. 20Astellas Pharma
  RUB 285 order

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Pharmacy24

• Flemoclav Solutab 125 mg/31.25 mg No. 20 tablets Astellas Pharma Europe B.V., Netherlands
  85 UAH.order
• Flemoklav Solutab 250 mg/62.5 mg N20 tablets Astellas Pharma Europe B.V., Netherlands

  101 UAH order

• Flemoklav Solutab 500 mg/125 mg N20 tablets Astellas Pharma Europe B.V., Netherlands

  129 UAH order

PaniPharmacy

• Flemoclav solutab tablet 500/125 mg No. 20 Australia, Astellas Pharma Europe B.V. Leiderdorp

  189 UAH order

• Flemoklav tablets Flemoklav solutab, tablet. dispers. 500mg/125mg No. 20 Netherlands, Astellas Pharma Europe

  136 UAH order

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

  91 UAH order

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

  108 UAH order

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