FLEMOXIN SOLUTAB tab 250mg N20

Composition and release form

Soluble tablets	1 table
amoxicillin (as amoxicillin trihydrate)	125 mg
250 mg
500 mg
1000 mg
excipients: dispersible cellulose; MCC; crospovidone; vanillin; tangerine flavor; lemon flavoring; saccharin; magnesium stearate

5 pcs in blister; there are 4 blisters in a box (125, 250, 500, 1000 mg) or 7 pcs in a blister; There are 2 blisters in a box (125 mg).

Pharmacodynamics

Active against such gram-positive and gram-negative microorganisms as Streptococcus pyogenes, Streptococcus pneumonia, Clostridium tetani, C.welchii, Neisseria gonorrhoeae, Neisseria meningitidis, Staphylococcus aureus (not producing beta-lactamase), Bacillus anthracis, Listeria monocytogenes, Helicobacter pylori. Less active against Enterococcus faecalis, Escherichia coli, Proteus mirabilis, Salmonella typhi, Shigella sonnei, Vibrio cholerae. Not active against microorganisms producing beta-lactamases, Pseudomonas spp., indole-positive Proteus spp., Serratia spp., Enterobacter spp.

Flemoxin solutab tab dispersant. 250 mg 20 pcs

Pharmacodynamics:

Flemoxin Solutab is a bactericidal, acid-resistant, broad-spectrum antibiotic from the group of semisynthetic penicillins. Active against gram-positive and gram-negative microorganisms, such as Streptococcus pyogenes, Streptococcus pneumoniae, Clostridium tetani, Clostridium welchii, Neisseria gonorrhoeae, Neisseria meningitidis, Staphylococcus aureus (not producing beta-lactamase), Bacillus anthracis, Listeria monocytogenes, Helicobacter pylori. Less active against Enterococcus faecalis, Escherichia coli, Proteus mirabilis, Salmonella typhi, Shigella sonnei, Vibrio cholerae. Not active against microorganisms producing beta-lactamases, Pseudomonas spp., indole-positive Proteus spp., Serratia spp., Enterobacter spp.

Pharmacokinetics:

Suction

After oral administration, amoxicillin is absorbed quickly and almost completely (about 93%), and is acid-stable. Food intake has virtually no effect on the absorption of the drug. The maximum concentration of the active substance in plasma is observed after 1-2 hours. After oral administration of 500 mg of amoxicillin, the maximum concentration of the active substance of 5 mcg/ml is observed in the blood plasma after 2 hours. When the dose of the drug is increased or decreased by 2 times, the maximum concentration in the blood plasma also changes by 2 times.

Distribution

About 20% of amoxicillin is bound to plasma proteins. Amoxicillin penetrates well into mucous membranes, bone tissue, intraocular fluid and sputum in therapeutically effective concentrations. The concentration of amoxicillin in bile exceeds its concentration in blood plasma by 2-4 times. In amniotic fluid and umbilical vessels, the concentration of amoxicillin is 25-30% of its level in the blood plasma of a pregnant woman. Amoxicillin penetrates the BBB poorly; however, with inflammation of the meninges, the concentration in the cerebrospinal fluid is about 20% of the concentration in the blood plasma.

Metabolism

Amoxicillin is partially metabolized in the liver; most of its metabolites do not have microbiological activity.

Removal

Amoxicillin is eliminated primarily by the kidneys, about 80% by tubular excretion, 20% by glomerular filtration. In the absence of renal dysfunction, the half-life of amoxicillin is 1-1.5 hours. In premature infants, newborns and children under 6 months. - 3-4 hours

Pharmacokinetics in special clinical situations

The half-life of amoxicillin does not change with impaired liver function. If renal function is impaired (creatinine clearance

Pharmacokinetics

Suction

After oral administration, it is absorbed quickly and almost completely (about 93%), acid-stable. After oral administration at a dose of 500 mg, the Cmax of the active substance in plasma is 5 mcg/ml and is observed in the blood plasma after 2 hours. When the dose of the drug is increased or decreased by 2 times, Cmax in the blood plasma also changes by 2 times. Food intake has virtually no effect on the absorption of the drug.

Distribution

Plasma protein binding is about 20%. Amoxicillin penetrates well into mucous membranes, bone tissue, intraocular fluid and sputum in therapeutically effective concentrations. The concentration of amoxicillin in bile exceeds its concentration in blood plasma by 2–4 times. In amniotic fluid and umbilical vessels, the concentration of amoxicillin is 25–30% of its level in the blood plasma of a pregnant woman.

It penetrates poorly through the BBB, but during inflammation of the meninges, the concentration in the cerebrospinal fluid is about 20% of the concentration in the blood plasma.

Metabolism

Partially metabolized, most of its metabolites are inactive against microorganisms.

Removal

It is eliminated primarily by the kidneys, about 80% by tubular excretion, 20% by glomerular filtration. In the absence of renal dysfunction, T1/2 is 1–1.5 hours. In premature infants, newborns and children under 6 months—3–4 hours.

Pharmacokinetics in special clinical cases.

T1/2 of amoxicillin does not change with impaired liver function.

If renal function is impaired (Cl creatinine ≤15 ml/min), T1/2 of amoxicillin may increase and reaches 8.5 hours in anuria.

Flemoxin solutab 250 mg 20 pcs. dispersible tablets

pharmachologic effect

A bactericidal, acid-resistant, broad-spectrum antibiotic from the group of semisynthetic penicillins.

Composition and release form Flemoxin solutab 250 mg 20 pcs. dispersible tablets

Soluble tablets - 1 tablet:

active ingredients: amoxicillin (in the form of amoxicillin trihydrate) - 125/250/500/1000 mg;
excipients: dispersible cellulose; MCC; crospovidone; vanillin; tangerine flavor; lemon flavoring; saccharin; magnesium stearate.

There are 5 pcs in a blister; there are 4 blisters in a box (125, 250, 500, 1000 mg) or 7 pcs in a blister; There are 2 blisters in a box (125 mg).

Description of the dosage form

Dispersible tablets are white to light yellow in color, oval in shape with the company logo and digital designation on one side and a score dividing the tablet in half on the other side.

Digital designation:

Flemoxin Solutab® (125 mg) - “231”;
Flemoxin Solutab® (250 mg) - “232”;
Flemoxin Solutab® (500 mg) - “234”;
Flemoxin Solutab® (1000 mg) - “236”.

Characteristic

A bactericidal, acid-resistant, broad-spectrum antibiotic from the group of semisynthetic penicillins.

Directions for use and doses

Inside.

Adults and children over 10 years old - 500-750 mg 2 times a day or 375-500 mg (up to 1 g for severe infections) 3 times a day (maximum daily dose - 6 g), children from 3 to 10 years - 375 mg 2 times or 250 mg 3 times a day, up to 1 year - 125 mg 2 times or 100 mg 3 times a day.

The daily dose for children is 30 mg/kg (up to 60 mg/kg), frequency of administration is 2–3 times.

For acute gonorrhea - 3 g once in combination with 1 g probenecid (repeated administration is recommended for women).

For patients with creatinine Cl below 10 ml/min, the dose is reduced by 15–50%; for anuria, the dose should not exceed 2 g per day.

The average course is 5–7 days (for streptococcal infections - at least 10 days).

Pharmacodynamics

Pharmacokinetics

Suction

Distribution

Plasma protein binding is about 20%. Amoxicillin penetrates well into mucous membranes, bone tissue, intraocular fluid and sputum in therapeutically effective concentrations. The concentration of amoxicillin in bile exceeds its concentration in blood plasma by 2-4 times. In amniotic fluid and umbilical vessels, the concentration of amoxicillin is 25-30% of its level in the blood plasma of a pregnant woman. It penetrates poorly through the BBB, but during inflammation of the meninges, the concentration in the cerebrospinal fluid is about 20% of the concentration in the blood plasma.

Metabolism

Partially metabolized, most of its metabolites are inactive against microorganisms.

Removal

It is eliminated primarily by the kidneys, about 80% by tubular excretion, 20% by glomerular filtration. In the absence of renal dysfunction, T1/2 is 1-1.5 hours. In premature infants, newborns and children under 6 months - 3-4 hours. Pharmacokinetics in special clinical cases. T1/2 of amoxicillin does not change with impaired liver function. If renal function is impaired (Cl creatinine

Indications for use Flemoxin solutab 250 mg 20 pcs. dispersible tablets

Infections of the respiratory tract and ENT organs (bronchitis, pneumonia, tonsillitis, acute otitis media, pharyngitis, sinusitis), genitourinary system (urethritis, cystitis, pyelonephritis, endometritis, uncomplicated gonorrhea), skin and soft tissues, gastrointestinal tract (peritonitis, enterocolitis, cholecystitis , cholangitis, typhoid fever);
leptospirosis, listeriosis, meningitis, Lyme disease (borreliosis), prevention of endocarditis and surgical infection;
combination therapy of gastritis and peptic ulcer (in combination with metronidazole), sepsis (in combination with aminoglycosides).

Contraindications

Hypersensitivity (including to other penicillins, cephalosporins, carbapenems), allergic diathesis, bronchial asthma, hay fever, infectious mononucleosis, lymphocytic leukemia, history of gastrointestinal diseases (especially colitis associated with the use of antibiotics).

Application of Flemoxin solutab 250 mg 20 pcs. dispersible tablets during pregnancy and breastfeeding

During pregnancy and lactation, it is used for health reasons, taking into account the expected effect for the mother and the potential risk for the fetus or child. During the course, breastfeeding is excluded.

special instructions

Hypersensitivity reactions

Before starting treatment with amoxicillin, you should pay attention to the presence of hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam antibiotics in the anamnesis (see sections “Contraindications” and “Side effects”).

Severe and sometimes fatal hypersensitivity reactions (including anaphylactic reactions and severe skin reactions) have been reported in patients receiving penicillin therapy. The development of these reactions is more likely in people with a history of hypersensitivity to penicillins and in people with atopy. If an allergic reaction occurs, discontinue treatment with amoxicillin and institute appropriate alternative treatment.

Acute coronary syndrome associated with hypersensitivity (Kounis syndrome)

In rare cases, hypersensitivity reactions (acute coronary syndrome associated with hypersensitivity) have been reported during treatment with amoxicillin. If this reaction occurs, amoxicillin should be discontinued and appropriate treatment should be prescribed.

Insensitive microorganisms

For some types of infections, before prescribing amoxicillin, it is necessary to first establish the pathogen and its sensitivity to the drug, or make sure that the pathogen is likely to be treatable with amoxicillin. This particularly applies to patients with urinary tract infections and severe ear, nose and throat infections.

Convulsions

Convulsions may occur in patients with renal failure, in patients receiving high doses of the drug, as well as in patients with predisposing factors - a history of seizures, treatment for epilepsy or meningitis, etc.

Kidney failure

In patients with renal insufficiency, the dose should be adjusted according to the degree of renal insufficiency (see section "Dosage and Administration").

Skin reactions

The occurrence of generalized erythema with fever, accompanied by pustules, at the initial stage of treatment may be a symptom of OHEP (see section “Side effects”). In this case, amoxicillin should be discontinued, and its subsequent use will be contraindicated in any situation.

The use of amoxicillin should be avoided in patients who are suspected of having infectious mononucleosis, since a measles-like rash (exanthema) may occur due to the use of amoxicillin for this disease.

Jarisch-Herxheimer reaction

The Jarisch-Herxheimer reaction has been observed following the use of amoxicillin in patients with Lyme disease. This reaction is associated with the bactericidal effect of amoxicillin on the causative agent of Lyme disease, the spirochete Borrelia burgdorferi. Patients should be advised that this reaction is a common side effect of antibiotic treatment for Lyme disease and usually goes away on its own.

Excessive growth of non-susceptible microorganisms

Long-term use of the drug can sometimes lead to excessive growth of microorganisms that are not sensitive to amoxicillin (superinfection).

When using almost all antibacterial drugs, the development of colitis associated with taking antibiotics is possible. Its severity can range from mild to severe (life-threatening). Therefore, it is important to consider the possibility of this diagnosis in patients who develop diarrhea during or after antibiotic use. If diarrhea develops, the patient should immediately stop taking amoxicillin, consult a doctor and begin appropriate treatment. Medicines that inhibit peristalsis are contraindicated in this situation.

Long-term treatment

During long-term therapy, it is necessary to periodically monitor the function of the hematopoietic organs, kidneys and liver. Increased activity of liver enzymes and changes in the number of blood cells were reported.

Anticoagulants

Rare cases of increased prothrombin time have been reported in patients receiving amoxicillin. When prescribing the drug simultaneously with anticoagulants, appropriate monitoring should be carried out, and the dose of oral anticoagulants may need to be adjusted to maintain the required level of blood clotting.

Crystalluria

In patients with reduced diuresis, crystalluria was very rarely observed, mainly during parenteral therapy. When using high doses of amoxicillin, it is recommended to maintain adequate fluid intake and diuresis to reduce the likelihood of developing crystalluria associated with amoxicillin use. In patients with a catheterized bladder, catheter patency should be checked regularly.

Impact on diagnostic tests

Increased levels of amoxicillin in serum and urine may interfere with some laboratory tests. Due to high concentrations of amoxicillin in urine, chemical methods often give false-positive results.

When determining glucose in urine during treatment with amoxicillin, it is recommended to use enzymatic glucose oxidase tests.

The use of amoxicillin may affect the results of the quantitative determination of estradiol in urine in pregnant women.

Impact on the ability to drive vehicles and operate machinery

Studies of the effect of amoxicillin on the ability to drive vehicles or operate other machinery have not been conducted. However, side effects may occur (for example, allergic reactions, dizziness, convulsions) that affect the ability to drive vehicles or use other machinery.

Overdose

Symptoms: nausea, vomiting, diarrhea, water and electrolyte imbalance.

Treatment: gastric lavage, administration of activated carbon, saline laxatives, correction of water and electrolyte balance.

Side effects Flemoxin solutab 250 mg 20 pcs. dispersible tablets

Nausea, vomiting, diarrhea, pain in the anus, stomatitis, glossitis;
agitation, anxiety, insomnia, confusion, behavior changes, headache, dizziness, convulsive reactions;
difficulty breathing, tachycardia;
joint pain;
interstitial nephritis;
dysbacteriosis, superinfection, oral or vaginal candidiasis, pseudomembranous or hemorrhagic colitis;
moderate increase in the level of transaminases in the blood, transient anemia, thrombocytopenic purpura, eosinophilia, leukopenia, neutropenia and agranulocytosis;
allergic reactions: exfoliative dermatitis, exudative erythema multiforme, Stevens-Johnson syndrome, anaphylactic shock, maculopapular rash, itching, urticaria, Quincke's edema, reactions similar to serum sickness.

Drug interactions

Bactericidal antibiotics (including aminoglycosides, cephalosporins, vancomycin, rifampicin) have a synergistic effect when taken simultaneously; antagonism is possible when taken with some bacteriostatic drugs (for example, chloramphenicol, sulfonamides).

Concomitant use with estrogen-containing oral contraceptives may lead to a decrease in their effectiveness and an increased risk of breakthrough bleeding).

Concomitant administration with allopurinol does not increase the frequency of skin reactions, unlike the combination of allopurinol with ampicillin.

Side effects

From the gastrointestinal tract: rarely - changes in taste, nausea, vomiting, diarrhea; in some cases - a moderate increase in the activity of liver transaminases; extremely rarely - pseudomembranous and hemorrhagic colitis.

From the urinary system: extremely rarely - the development of interstitial nephritis.

From the hematopoietic system: agranulocytosis, neutropenia, thrombocytopenia, hemolytic anemia are possible, but they are also extremely rare.

Side effects from the nervous system when using amoxicillin in the dosage form of dispersible tablets have not been registered.

Allergic reactions: skin reactions, mainly in the form of a specific maculopapular rash; rarely - exudative erythema multiforme (Stevens-Johnson syndrome); in some cases - anaphylactic shock, angioedema.

Flemoxin Solutab soluble tablets 250 mg No. 20

A country

Netherlands, Russia
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.

Active substance

Amoxicillin

Compound

1 tablet contains: amoxicillin trihydrate 291.4 mg, potassium clavulanate 74.5 mg.
Excipients: microcrystalline cellulose - 163.6 mg, crospovidone - 50 mg, vanillin - 0.5 mg, apricot flavor - 4.5 mg, saccharin - 4.5 mg, magnesium stearate - 2.5 mg. Dispersible tablets are oblong in shape, from white to yellow in color with brown dotted spots, without marks and marked “422” and the company logo.

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 strains producing beta-lactamases): 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 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, phlegmon, wound infection); — osteomyelitis; — postoperative infections; — prevention of infections in surgery.

Mode of application

Inside, 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 / day or 500 mg 3 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. 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 suspension, syrup and drops, water should be used as a solvent. When administered intravenously, 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 under 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 may 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 additional dose at the end of the dialysis session.

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 changes, 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, 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, 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. Use during pregnancy and lactation With caution: pregnancy, lactation. Cases of the development of necrotizing enterocolitis in newborns and in pregnant women with premature rupture of membranes have been identified.

Use in children 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 body weight.

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. 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. After dilution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen. In patients who are hypersensitive to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible. Cases of the development of necrotizing enterocolitis in newborns and in pregnant women with premature rupture of membranes have been identified. 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).

Storage conditions

Room temperature

Dispensing conditions in pharmacies

On prescription

Interaction

Probenecid, phenylbutazone, oxyphenbutazone, and to a lesser extent acetylsalicylic acid and sulfinpyrazone, inhibit the tubular secretion of penicillins, which leads to an increase in the half-life and an increase in the concentration of amoxicillin in the blood plasma. Bactericidal antibiotics (including aminoglycosides, cephalosporins, vancomycin, rifampicin) have a synergistic effect when taken simultaneously; antagonism is possible when taken with some bacteriostatic drugs (for example, chloramphenicol, sulfonamides). Concomitant use with estrogen-containing oral contraceptives may lead to a decrease in their effectiveness and an increased risk of breakthrough bleeding). Concomitant administration with allopurinol does not increase the frequency of skin reactions, unlike the combination of allopurinol with ampicillin.

Flemoxin Solutab dispersible tablets 250 mg No. 20

Compound

Active substance: amoxicillin - 250 mg. Excipients: lemon flavor - 2.8 mg, tangerine flavor - 2.3 mg, vanillin - 0.26 mg, crospovidone - 12.6 mg, magnesium stearate - 1.5 mg, saccharin - 3.3 mg, dispersible cellulose - 8.7 mg, microcrystalline cellulose - 12.6 mg.

Pharmacokinetics

When taken orally, amoxicillin is quickly and completely absorbed from the gastrointestinal tract and is not destroyed in the acidic environment of the stomach. Cmax of amoxicillin in blood plasma is achieved after 1-2 hours. When the dose is doubled, the concentration also increases by 2 times. In the presence of food in the stomach does not reduce total absorption. With intravenous, intramuscular and oral administration, similar concentrations of amoxicillin are achieved in the blood.

The binding of amoxicillin to plasma proteins is about 20%.

Widely distributed in tissues and body fluids. High concentrations of amoxicillin in the liver have been reported.

T1/2 from plasma is 1-1.5 hours. About 60% of the dose taken orally is excreted unchanged in the urine by glomerular filtration and tubular secretion; at a dose of 250 mg, the concentration of amoxicillin in the urine is more than 300 mcg/ml. A certain amount of amoxicillin is detected in feces.

In newborns and the elderly, T1/2 may be longer.

In case of renal failure, T1/2 can be 7-20 hours.

In small quantities, amoxicillin penetrates the BBB during inflammation of the pia mater.

Amoxicillin is removed by hemodialysis.

Indications for use

Infectious and inflammatory diseases caused by microorganisms sensitive to amoxicillin: respiratory infections;
infections of the genitourinary system; infections of the gastrointestinal tract (GIT); skin and soft tissue infections. For use in combination with metronidazole: chronic gastritis in the acute phase, peptic ulcer of the stomach and duodenum in the acute phase, associated with Helicobacter pylori.

Contraindications

Infectious mononucleosis, lymphocytic leukemia, severe gastrointestinal infections accompanied by diarrhea or vomiting, respiratory viral infections, allergic diathesis, bronchial asthma, hay fever, hypersensitivity to penicillins and/or cephalosporins.

For use in combination with metronidazole: diseases of the nervous system; hematopoietic disorders, lymphocytic leukemia, infectious mononucleosis; hypersensitivity to nitroimidazole derivatives.

For use in combination with clavulanic acid: a history of liver dysfunction and jaundice associated with taking amoxicillin in combination with clavulanic acid.

Directions for use and doses

Inside (orally).

The dose is set individually, taking into account the severity of the disease and the patient’s age. In the case of infectious and inflammatory diseases of mild to moderate severity, it is recommended to use the drug according to the following scheme: adults and children over 10 years of age are prescribed 500-750 mg 2 times a day or 375-500 mg 3 times a day.

Children from 3 to 10 years old are prescribed 375 mg 2 times a day or 250 mg 3 times a day.

Children aged 1 to 3 years are prescribed 250 mg 2 times a day or 125 mg 3 times a day. The daily dose of the drug for children (including children under 1 year old) is 30-60 mg/kg/day, divided into 2-3 doses.

When treating severe infections, as well as for infections with hard-to-reach foci of infection (for example, acute otitis media), a three-time dose of the drug is preferable.

For chronic diseases, recurrent infections, severe infections, the dose of the drug can be increased: adults are prescribed 750 mg - 1 g 3 times a day; children up to 60 mg/kg/day, divided into 3 doses.

For acute uncomplicated gonorrhea in adults, 3 g of the drug is prescribed in 1 dose in combination with 1 g of probenecid.

For patients with impaired renal function with creatinine clearance below 10 ml/min, the dose of the drug is reduced by 15-50%.

The drug is prescribed before, during or after meals. The tablet can be swallowed whole, divided into pieces or chewed with a glass of water, and can also be diluted in water to form a syrup (20 ml) or suspension (100 ml), which has a pleasant fruity taste.

In case of mild to moderate infections, the drug is taken for 5-7 days. However, for infections caused by Streptococcus pyogenes, the duration of treatment should be at least 10 days.

The drug must be continued for 48 hours after the symptoms of the disease disappear.

Storage conditions

Store out of the reach of children at a temperature not exceeding 25°C.

Best before date

5 years. Do not use the drug after the expiration date indicated on the package.

special instructions

Use with caution in patients prone to allergic reactions.

Amoxicillin in combination with metronidazole is not recommended for use in patients under 18 years of age; should not be used for liver diseases.

During combination therapy with metronidazole, it is not recommended to drink alcohol.

Description

A broad-spectrum penicillin antibiotic that is destroyed by penicillinase.

Dosage form

Dispersible tablets are white to light yellow in color, oval in shape with the company logo and the digital designation “232” on one side and a score dividing the tablet in half on the other side.

Use in children

Use in children is possible according to the dosage regimen.

Amoxicillin in combination with metronidazole is not recommended for use in patients under 18 years of age.

Pharmacodynamics

An antibiotic from the group of semisynthetic penicillins with a broad spectrum of action. It is a 4-hydroxyl analogue of ampicillin. Has a bactericidal effect. Active against aerobic gram-positive bacteria: Staphylococcus spp. (except for penicillinase-producing strains), Streptococcus spp.; aerobic gram-negative bacteria: Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Shigella spp., Salmonella spp., Klebsiella spp.

Microorganisms that produce penicillinase are resistant to amoxicillin.

In combination with metronidazole, it is active against Helicobacter pylori. Amoxicillin is believed to inhibit the development of Helicobacter pylori resistance to metronidazole.

Cross-resistance exists between amoxicillin and ampicillin.

The spectrum of antibacterial action expands with the simultaneous use of amoxicillin and the beta-lactamase inhibitor clavulanic acid. This combination increases the activity of amoxicillin against Bacteroides spp., Legionella spp., Nocardia spp., Pseudomonas (Burkholderia) pseudomallei. However, Pseudomonas aeruginosa, Serratia marcescens and many other gram-negative bacteria remain resistant.

Side effects

Allergic reactions: urticaria, erythema, Quincke's edema, rhinitis, conjunctivitis; rarely - fever, joint pain, eosinophilia; in isolated cases - anaphylactic shock.

Effects associated with chemotherapy: superinfections may develop (especially in patients with chronic diseases or reduced body resistance).

With long-term use in high doses: dizziness, ataxia, confusion, depression, peripheral neuropathies, convulsions.

Mainly when used in combination with metronidazole: nausea, vomiting, anorexia, diarrhea, constipation, epigastric pain, glossitis, stomatitis; rarely - hepatitis, pseudomembranous colitis, allergic reactions (urticaria, angioedema), interstitial nephritis, hematopoietic disorders.

Mainly when used in combination with clavulanic acid: cholestatic jaundice, hepatitis; rarely - erythema multiforme, toxic epidermal necrolysis, exfoliative dermatitis.

Use during pregnancy and breastfeeding

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

If it is necessary to use amoxicillin during pregnancy, the expected benefits of therapy for the mother and the potential risk to the fetus should be carefully weighed.

Use amoxicillin with caution during lactation (breastfeeding).

Interaction

Amoxicillin may reduce the effectiveness of oral contraceptives.
With the simultaneous use of amoxicillin with bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin), synergism appears; with bacteriostatic antibiotics (including macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonism.
Amoxicillin enhances the effect of indirect anticoagulants by suppressing intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index.
Amoxicillin reduces the effect of drugs whose metabolism produces PABA.
Probenecid, diuretics, allopurinol, phenylbutazone, NSAIDs reduce the tubular secretion of amoxicillin, which may be accompanied by an increase in its concentration in the blood plasma.
Antacids, glucosamine, laxatives, aminoglycosides slow down and reduce, and ascorbic acid increases the absorption of amoxicillin.
With the combined use of amoxicillin and clavulanic acid, the pharmacokinetics of both components does not change.

Overdose

Symptoms: dysfunction of the gastrointestinal tract - nausea, vomiting, diarrhea; Vomiting and diarrhea may result in water and electrolyte imbalance.

Treatment: gastric lavage, activated charcoal, saline laxatives are prescribed; measures are taken to restore water and electrolyte balance, hemodialysis.

Impact on the ability to drive vehicles and operate machinery

No adverse effects on the ability to drive or operate machines were reported.

Directions for use and doses

Inside, before, during or after meals. The tablet can be swallowed whole, divided into pieces or chewed with a glass of water or diluted in water to form a syrup (20 ml) or suspension (100 ml).

Adults and children over 10 years of age (for mild to moderate infections) - 500–750 mg 2 times a day or 375–500 mg 3 times a day.

Children from 3 to 10 years old - 375 mg 2 times a day or 250 mg 3 times a day; from 1 year to 3 years - 250 mg 2 times a day or 125 mg 3 times a day. The daily dose for children (including children under 1 year of age) is 30–60 mg/kg/day, divided into 2–3 doses.

When treating severe infections, as well as for infections with hard-to-reach foci (for example, acute otitis media), a three-time dose of the drug is preferable.

For chronic diseases, relapses, severe infections: adults - 0.75–1 g 3 times a day, children - up to 60 mg/kg/day in 3 divided doses.

For acute uncomplicated gonorrhea - 3 g, once, in combination with 1 g probenecid.

For mild to moderate infections, treatment is carried out for 5-7 days, for infections caused by Streptococcus pyogenes - at least 10 days.

When treating chronic diseases and severe infections, the dose of the drug should be determined by the clinical picture of the disease. The drug is continued for 48 hours after the symptoms of the disease disappear.

For patients with creatinine Cl below 10 ml/min, the dose is reduced by 15–50%.

Flemoxin Solutab dispersant tablet 250 mg No. 20

Indications

For use as monotherapy and in combination with clavulanic acid: infectious and inflammatory diseases caused by sensitive microorganisms, incl. bronchitis, pneumonia, tonsillitis, pyelonephritis, urethritis, gastrointestinal infections, gynecological infections, infectious diseases of the skin and soft tissues, listeriosis, leptospirosis, gonorrhea.

For use in combination with metronidazole: chronic gastritis in the acute phase, peptic ulcer of the stomach and duodenum in the acute phase, associated with Helicobacter pylori.

pharmachologic effect

Microorganisms that produce penicillinase are resistant to amoxicillin.

In combination with metronidazole, it is active against Helicobacter pylori. Amoxicillin is believed to inhibit the development of Helicobacter pylori resistance to metronidazole.

Cross-resistance exists between amoxicillin and ampicillin.

Drug interactions

Amoxicillin may reduce the effectiveness of oral contraceptives.

With the simultaneous use of amoxicillin with bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin), synergism appears; with bacteriostatic antibiotics (including macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonism.

Amoxicillin enhances the effect of indirect anticoagulants by suppressing intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index.

Amoxicillin reduces the effect of drugs whose metabolism produces PABA.

Probenecid, diuretics, allopurinol, phenylbutazone, NSAIDs reduce the tubular secretion of amoxicillin, which may be accompanied by an increase in its concentration in the blood plasma.

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

With the combined use of amoxicillin and clavulanic acid, the pharmacokinetics of both components does not change.

Dosage regimen

Individual. For oral administration, a single dose for adults and children over 10 years of age (with a body weight of more than 40 kg) is 250-500 mg, for severe disease - up to 1 g. For children aged 5-10 years, a single dose is 250 mg; aged 2 to 5 years - 125 mg. The interval between doses is 8 hours. For children weighing less than 40 kg, the daily dose, depending on the indications and clinical situation, can be 20-100 mg/kg in 2-3 doses.

For the treatment of acute uncomplicated gonorrhea - 3 g once (in combination with probenecid). In patients with impaired renal function with CC 10-40 ml/min, the interval between doses should be increased to 12 hours; with CC less than 10 ml/min, the interval between doses should be 24 hours.

For parenteral use in adults, IM - 1 g 2 times a day, IV (with normal renal function) - 2-12 g/day. Children IM - 50 mg/kg/day, single dose - 500 mg, frequency of administration - 2 times/day; IV - 100-200 mg/kg/day. In patients with impaired renal function, the dose and interval between administrations must be adjusted in accordance with CC values.

Contraindications for use

For use in combination with metronidazole: diseases of the nervous system; hematopoietic disorders, lymphocytic leukemia, infectious mononucleosis; hypersensitivity to nitroimidazole derivatives.

For use in combination with clavulanic acid: a history of liver dysfunction and jaundice associated with taking amoxicillin in combination with clavulanic acid.

Use in children

Use in children is possible according to the dosage regimen.

Amoxicillin in combination with metronidazole is not recommended for use in patients under 18 years of age.

Restrictions for children

Contraindicated

Restrictions for elderly patients

No data

Use for liver dysfunction

Amoxicillin in combination with metronidazole should not be used for liver disease.

Restrictions for liver dysfunction

Contraindicated

Use during pregnancy and breastfeeding

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

If it is necessary to use amoxicillin during pregnancy, the expected benefits of therapy for the mother and the potential risk to the fetus should be carefully weighed.

Use amoxicillin with caution during lactation (breastfeeding).

Restrictions when breastfeeding

Use with caution

Restrictions during pregnancy

Use with caution

Use for renal impairment

In patients with impaired renal function, the dose and interval between administrations must be adjusted in accordance with CC values.

Restrictions for impaired renal function

Use with caution

special instructions

Use with caution in patients prone to allergic reactions.

Amoxicillin in combination with metronidazole is not recommended for use in patients under 18 years of age; should not be used for liver diseases.

During combination therapy with metronidazole, it is not recommended to drink alcohol.

Side effect

Allergic reactions:

urticaria, erythema, Quincke's edema, rhinitis, conjunctivitis; rarely - fever, joint pain, eosinophilia; in isolated cases - anaphylactic shock.

Effects associated with chemotherapy:

the development of superinfections is possible (especially in patients with chronic diseases or reduced body resistance).

With long-term use in high doses:

dizziness, ataxia, confusion, depression, peripheral neuropathies, convulsions.

Mainly when used in combination with metronidazole:

nausea, vomiting, anorexia, diarrhea, constipation, epigastric pain, glossitis, stomatitis; rarely - hepatitis, pseudomembranous colitis, allergic reactions (urticaria, angioedema), interstitial nephritis, hematopoietic disorders.

Advantageously when used in combination with clavulanic acid:

cholestatic jaundice, hepatitis; rarely - erythema multiforme, toxic epidermal necrolysis, exfoliative dermatitis.

Possible product names

Flemoxin Solutab dispersant tablet 250 mg No. 20
FLEMOXIN SOLUTAB 250 MG TAB. DISPERS. No. 20
(Flemoxin Solutab) Flemoxin Solutab dispersible tablet 250 mg No. 20

special instructions

A history of erythroderma is not a contraindication for the use of Flemoxin Solutab®.

Cross-resistance with penicillin drugs and cephalosporins is possible.

As with other penicillin drugs, superinfection may develop.

The appearance of severe diarrhea, characteristic of pseudomembranous colitis, is an indication for discontinuation of the drug.

The drug should be prescribed to patients with infectious mononucleosis and lymphocytic leukemia with caution, because there is a high probability of the appearance of exanthema of non-allergic origin.