FLEMOXIN SOLUTAB tab 1000mg 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).

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

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.

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

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.

Pharmacodynamics

Flemoxin Solutab 250 mg No. 20 dispersible tablet.

Instructions for medical use of the drug Flemoxin Solutab® Trade name Flemoxin Solutab® International nonproprietary name Amoxicillin Dosage form Dispersible tablets 125 mg, 250 mg, 500 mg, 1000 mg Composition One tablet contains the active substance: amoxicillin in the form of amoxicillin trihydrate 125 mg, 250 mg , 500 mg, 1000 mg excipients: dispersible cellulose, microcrystalline cellulose, crospovidone, vanillin, tangerine flavor, lemon flavor, saccharin, magnesium stearate. Description Tablets from white to light yellow, oval in shape with the company logo and digital designation on one side (125 mg - “231”, 250 mg - “232”, 500 mg - “234”, 1000 mg - “236”) and take risks on the other side. Pharmacotherapeutic group Antimicrobial drugs for systemic use. Beta-lactam antibacterial drugs. Broad-spectrum penicillins. Amoxicillin. ATC code J01СA04 Pharmacological properties Pharmacokinetics Absorption After oral administration, amoxicillin is absorbed quickly and almost completely (about 93%), 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 does not penetrate the blood-brain barrier well; 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. Excretion 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 cases. The half-life of amoxicillin does not change with impaired liver function. 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. Indications for use - respiratory infections - infections of the genitourinary system - infections of the gastrointestinal tract - infections of the skin and soft tissues Method of administration and dosage The drug is used orally before 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) with a pleasant fruity taste. 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 9 years of age are prescribed 500 - 750 mg 2 times / day or 375 (one and a half tablets of 250 mg) - 500 mg 3 times / day . The minimum single dose is 375 mg (one and a half tablets of 250 mg), the maximum daily dose is 1500 mg. Children from 3 to 9 years old are prescribed 375 mg (one and a half tablets of 250 mg) 2 times a day or 250 mg 3 times a day. The minimum single dose is 250 mg, the maximum daily dose is 750 mg. Children aged 1 to 3 years are prescribed 250 mg 2 times a day or 125 mg 3 times a day. The minimum single dose is 125 mg, the maximum daily dose is 500 mg. The daily dose of the drug for children is 30-60 mg/kg/day, divided into 2-3 doses. The minimum single dose is 10 mg/kg, the maximum daily dose is 60 mg/kg. When treating severe infections and diseases such as acute otitis media, a three-time dose is preferable. For chronic diseases, recurrent infections and severe infections, the dose of the drug can be increased: adults are prescribed 750 mg - 1 g 3 times a day, the minimum single dose is 750 mg, the maximum daily dose is 3 g; children 60 mg/kg/day, divided into 3 doses, minimum single dose 20 mg/kg, maximum daily dose 60 mg/kg. For acute uncomplicated gonorrhea, 3 g of the drug is prescribed in 1 dose in combination with 1 g of probenecid. For patients with impaired renal function with a creatinine clearance of 15-40 ml/min, the interval between doses is increased to 12 hours; with CC below 10 ml/min, the dose of the drug is reduced to 15-50%; for anuria - maximum dose 2 g/day. 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. When treating chronic diseases and severe infections, the dose of the drug should be determined by the clinical picture of the disease. The drug must be continued for 48 hours after the symptoms of the disease disappear. Side effects Often - allergic skin reactions (maculopapular rash) Rarely - changes in taste - nausea, vomiting, diarrhea, anal itching - exudative erythema multiforme (Stevens-Johnson syndrome) - pseudomembranous and hemorrhagic colitis Very rarely - interstitial nephritis Possible - agranulocytosis, neutropenia, thrombocytopenia, hemolytic anemia - specific maculopapular rash In some cases - moderate increase in the activity of "liver" transaminases - anaphylactic shock - angioedema Contraindications - hypersensitivity to the drug and other beta-lactam antibiotics - infectious mononucleosis and lymphocytic leukemia Drug interactions Probenecid, phenylbutazone, oxyphenbutazone and To a lesser extent, acetylsalicylic acid, indomethacin and sulfinpyrazole inhibit tubular secretion of penicillins, prolonging plasma half-life and increasing plasma levels. Amoxicillin is used in therapy in combination with probenecid. 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, tetracyclines, macrolides chloramphenicol, sulfonamides). Concomitant use with estrogen-containing oral contraceptives may lead to a decrease in their effectiveness and an increased risk of developing acyclic bleeding. Co-administration with allopurinol increases the frequency of skin reactions. 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. During combination therapy with metronidazole, you should not drink alcohol. Use in pediatrics: Use in children under 1 year of age is not recommended. Children under 9 years of age are not recommended to use the dosage of Flemoxin Solutab® 500 mg and 1000 mg. Pregnancy and lactation. Use during pregnancy is possible after a medical assessment of the risks/benefits of treatment. In small quantities, the drug is excreted in breast milk, which can lead to the development of sensitization phenomena in the child. Effect of the drug on the ability to drive vehicles and other potentially dangerous mechanisms Does not affect Overdose Symptoms: nausea, vomiting, diarrhea; water-electrolyte imbalance. Treatment: gastric lavage, activated carbon, saline laxatives; measures to restore water and electrolyte balance. Release form and packaging 5 tablets each in a blister pack made of polyvinyl chloride film and aluminum foil. 4 contour packages together with instructions for medical use in the state and Russian languages are placed in a cardboard box. Storage conditions Store in a place protected from light, at a temperature not exceeding 25 °C. Keep out of the reach of children! Shelf life: 5 years Do not use after expiration date! Conditions for dispensing from pharmacies By prescription Manufacturer Astellas Pharma Europe B.V., Silviusweg 62, 2333 EE, Leiden, the Netherlands Registration certificate holder Astellas Pharma Europe B.V., Silviusweg 62, 2333 EE, Leiden, the Netherlands Address of the receiving organization on the territory of the Republic of Kazakhstan, claims from consumers regarding product quality. Representative office in the Republic of Kazakhstan. Almaty, Al-Farabi Ave. 15, PFC "Nurly Tau", building 4B. office 20 tel., fax

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 ≤15 ml/min), T1/2 of amoxicillin may increase and reaches 8.5 hours in anuria.

Flemoxin solutab 125 mg n20 dispersible tablets

Latin name

Flemoxin Solutab

Active ingredient: Amoxicillin (Amoxicillin)

Compound

The composition of dispersible (water-soluble) tablets includes amoxicillin in the form of amoxicillin trihydrate, microcrystalline and dispersible cellulose, vanillin, crospovidone, flavors (lemon and tangerine), magnesium stearate, saccharin.

Release form

Flemoxin Solutab dispersible tablets:

125, 250, 500 or 1000 mg package No. 20 (blisters of 5 pcs., 4 blisters per package);

125 mg package No. 14 (blisters of 7 pcs., 2 blisters per package).

The tablets are oval, white or white with a yellowish tint, with a dividing line on one side, and a digital designation (231, 232, 234 and 236) and the manufacturer’s logo on the other.

pharmachologic effect

Antibacterial, bactericidal.

Pharmacodynamics and pharmacokinetics

Amoxicillin is a semisynthetic β-lactam antibiotic of the penicillin group with a wide spectrum of antimicrobial activity.

The bactericidal properties of the drug are due to the ability to suppress transpeptidase, disrupt the production of peptidoglycan (supporting protein of cell walls) during periods of division and growth, and provoke the lysis of microorganisms.

Shows activity against Gram (+) aerobes, including Staphylococcus spp. (with the exception of penicillinase-producing strains) and Streptococcus spp. (including Str.pneumoniae and faecalis); Gram (-) aerobes (gonococci, meningococci, Escherichia coli and Haemophilus influenzae, Proteus mirabilis; certain strains of Klebsiella, Shigella and Salmonella, as well as against H. pylori.

Ineffective against strains of Proteus P. rettgeri and vulgaris (they are indole-positive), serrations, pseudomonads, enterobacteria, Morganella morgani. Mycoplasma, rickettsia and viruses are resistant to amoxicillin.

A feature of the dosage form is that the tablets are easily dispersed in water to form a dispersion. Thanks to this, the drug is quickly and as completely as possible (more than 93% of the dose taken) absorbed from the digestive canal.

Eating does not affect the absorption of the substance. TCmax - ranging from 60 to 120 minutes. When taking dispersible tablets, the plasma concentration of amoxicillin is higher than when taking insoluble forms of the drug. The active substance is resistant to acids.

TCmax when taking 500 mg amoxicillin is 120 minutes. When taking twice as much or half as much of the drug, Cmax also changes by half.

About 20% of the administered amoxicillin dose is bound to plasma proteins. The substance in therapeutically effective concentrations penetrates well into bone tissue, mucous membranes, sputum and intraocular fluid. Its concentration in bile is 2-4 times higher than plasma concentration, in amniotic fluid - from 25 to 30% of plasma concentration in the body of a pregnant woman.

Amoxicillin passes through the BBB poorly, but in case of inflammation of the meninges, its concentration in the cerebrospinal fluid is about 1/5 of the plasma concentration.

The substance is partially metabolized; most metabolic products are inactive against pathogenic microflora.

Excretion is carried out by the kidneys. In patients with healthy kidneys, T1/2 - from 60 to 90 minutes, in children under six months of age (including premature babies and newborns) - from 3 to 4 hours. If liver function is impaired, the indicator does not change; if kidney function is impaired, it can increase to 8.5 hours (this is T1/2 of amoxicillin for anuria).

Indications for use

- bacterial infections of the external respiratory system (angina, pneumonia, bronchitis, pharyngitis, sinusitis, acute inflammation of the middle ear), genitourinary system (pyelonephritis, pyelitis, cystitis, urethritis, cervicitis, endometritis), skin and/or soft tissues (impetigo, erysipelas, secondary infected dermatoses), digestive system organs and abdominal infections (angiocholitis, peritonitis, typhoid fever, cholecystitis, salmonellosis, dysentery, salmonella carriage), if they are caused by bacteria sensitive to Flemoxin.

Flemoxin - what is it used for in pediatrics?

Flemoxin Solutab is the drug of the penicillin group most commonly used in pediatric practice. Most often it is prescribed for bacterial infections of the respiratory system.

Practical experience proves the high effectiveness of Flemoxin for sinusitis, acute non-purulent otitis, bronchitis, bronchopneumonia, tonsillitis, and sore throat.

The drug is safe, well tolerated by young patients of any age and, just as important when it comes to treating children, has excellent organoleptic properties.

Contraindications

Flemoxin is not prescribed for hypersensitivity to amoxicillin, other β-lactams or auxiliary components of the tablets.

Relative contraindications for the antibiotic Flemoxin Solutab:

lymphocytic leukemia;

Infectious mononucleosis;

renal failure;

history of gastrointestinal pathology (especially colitis associated with the use of antibiotics);

pregnancy;

lactation;

breastfeeding period;

polyvalent hypersensitivity to chemicals foreign to the body (xenobiotics).

Side effects

Side effects appear as:

nausea, changes in taste, diarrhea, vomiting, moderate increases in liver enzyme activity (sometimes), hemorrhagic and pseudomembranous colitis (extremely rare);

interstitial nephritis (extremely rare);

hemolytic anemia, neutropenia, agranulocytosis, thrombocytopenia.

When using the drug in the form of dispersible tablets, no adverse effects from the nervous system were observed.

The use of the drug may be accompanied by the development of hypersensitivity reactions, which are expressed in the form of a rash (mainly specific maculopapular), exudative erythema multiforme (rarely), angioedema and anaphylactic shock (in exceptional cases).

Instructions for use

How should adults take Flemoxin tablets?

The drug is taken orally, without reference to the time of meal.

The tablet can be dissolved in 20 ml of water to obtain a syrup or in 100 ml of water to obtain a suspension; it can be swallowed whole or taken in crushed form.

For mild and moderately severe infections, 250 mg tablets are taken in 2-3 pieces. 2 times a day, 500 mg tablets - 1-1.5 pcs. 2 r./day, 1000 mg tablets - half 3 r./day.

When treating severe diseases, as well as infections with hard-to-reach foci, it is preferable to take the drug three times a day.

The daily dose of antibiotic for severe infections, relapses and chronic pathologies is 1.5-2 tablets. 500 mg 3 times/day.

For acute gonorrhea without complications, a single dose of Flemoxin with Probenecid is indicated (dose, 3 and 1 g, respectively).

For severe infections and chronic pathologies, the treatment regimen is selected taking into account the characteristics of the clinical picture of the disease.

In case of kidney damage, in which the Clcr value is in the range from 15 to 40 ml/min, the interval between tablet doses should be increased to 12 hours. If Clcr does not exceed 10 ml/min, the dosage of amoxicillin should be reduced by 15-50%. For anuria, the highest daily dose of amoxicillin is 2 g.

How should children take Flemoxin tablets?

Children's Flemoxin is a tablet with a dosage of amoxicillin of 125 and 250 mg. The instructions for children indicate that it is more convenient for a younger child to give a syrup or suspension; older children can swallow the tablet whole or after chewing it.

Instructions for use

Flemoxin for children over 10 years of age is similar to the instructions for adults: for mild and moderately severe infections, the child is given 3-4 tablets. 125 mg 3 times/day.

Flemoxin Solutab for children over 3 years of age is prescribed to take 3 tablets. 125 mg 2 times/day. or 2 tablets. 125 mg 3 times/day.

For children under 3 years of age, according to the instructions for use, Flemoxin Solutab 125 mg, two tablets given 2 times a day. or one 3 rubles/day.

The dosage of Flemoxin Solutab for children, which contains 250 mg of amoxicillin, is as follows:

2-3 tab. 2 rubles/day — patients over 10 years of age;

1 tab. 3 rubles/day — patients 3-10 years old;

1 tab. 2 rubles/day or 0.5 tab. 3 rubles/day - patients under three years of age.

The daily dose of Flemoxin Solutab for children of all age groups (including children of the first year of life) is from 30 to 60 mg/kg, divided into 2 or 3 doses. If the disease is severe or the pathological focus is difficult to reach, it is preferable to take the drug 3 times a day.

For severe infections (including those with hard-to-reach lesions), the recommended dose of antibiotic is 60 mg/kg/day, divided into three doses.

Duration of treatment

The duration of the course for mild and moderately severe infections is from 5 days to 1 week. If the causative agent of the infection is Str. pyogenes, treatment lasts at least 10 days.

For severe infections, medication should be continued for 48 hours after symptoms disappear.

Antibiotic Flemoxin Solutab for sore throat

Sore throat is a common acute infectious disease, the local manifestations of which are damage to the tonsils (mainly the first and second tonsils). The most common causative agents of sore throat are B-hemolytic streptococci of group A. Staphylococci provoke it much less often.

Untreated or undertreated tonsillitis is complicated by paratonsillitis, nephritis, myocarditis, paratonsillar abscess, and tonsillogenic sepsis.

Given the bacterial nature of the disease, timely use of antibiotics is very important. If in case of catarrhal tonsillitis, in some cases, local antibiotics are enough for the patient, then in case of follicular and lacunar tonsillitis, the doctor must prescribe systemic drugs.

Research results and practical experience have shown that the most effective remedies for angina are drugs of the penicillin group.

The advantages of Flemoxin over analogues are:

unique dosage form (Solyutab);

the presence of tablets with a “children’s” dosage of the active substance;

the possibility of using the drug without being tied to the time of meals.

For adults with sore throat, it is recommended to take the drug 2 times a day. 500-700 mg each. For angina in children, children's Flemoxin Solutab is used - tablets with a minimum dosage of the active substance. The dose is selected by the doctor depending on the patient’s age and the characteristics of the disease.

After the symptoms of sore throat are relieved (body temperature decreases, pustules on the tonsils disappear, sore throat goes away, the condition of the lymph nodes normalizes), taking Flemoxin should be continued for at least two more days.

If treatment is stopped immediately, the risk of disease recurrence is high. Moreover, the symptoms may appear with a vengeance.

Use of the drug for sinusitis

Sinusitis is an inflammation of the paranasal sinuses.

The use of an antibiotic for sinusitis is advisable if the disease is caused by bacteria sensitive to its action. When associated with a viral or fungal infection, as well as allergic sinusitis, antibiotic therapy is not only ineffective, but can also aggravate the course of the disease.

Acute bacterial sinusitis manifests itself first:

hyperthermia (febrile temperature or higher);

violation of nasal respiration and phonation;

soreness and swelling of the skin in the projection of the maxillary cavities;

decreased sense of smell;

the presence of pain radiating to different parts of the face (the pain gradually loses its specific location);

symptoms of general intoxication (sleep disturbances, headache, joint pain, etc.);

the characteristic color of the pathological secretion discharged from the sinuses (its color in bacterial infections usually varies from yellow to dark green).

The selection of an antibiotic is carried out taking into account:

the results of a microbiological study of biomaterial taken from the paranasal sinuses and a rapid test for staining of the pathogen using the Gram method;

characteristics of the patient’s body;

possible allergic reactions to the drug;

presence of concomitant diseases.

If the cause of the disease is staphylococci, streptococci or Haemophilus influenzae, it is considered most preferable to prescribe drugs of the penicillin group to the patient.

The use of amoxicillin for bacterial sinusitis (including complicated forms of the disease) gives a pronounced positive effect already in the first 7 days of treatment: the patient’s symptoms of intoxication and pain in the paranasal sinuses decrease/disappear, the temperature decreases and nasal breathing becomes easier.

The effectiveness of Flemoxin Solutab is explained by the fact that this drug:

affects a large number of strains of infectious agents;

quickly and in high concentrations absorbed from the digestive tract;

resistant to gastric juice;

Available in an easy-to-use form.

Overdose

Symptoms

overdose of Flemoxin Solutab: nausea, diarrhea, vomiting, water-salt imbalance.

Treatment:

gastric lavage, prescribing enterosorbents, saline laxatives, taking measures aimed at correcting the balance of water and electrolytes.

Interaction

Phenylbutazone, probenecid, oxyphenbutazone and, to a slightly lesser extent, sulfinpyrazone and ASA inhibit the secretion of penicillin antibiotics, which leads to an increase in T1/2 and an increase in the plasma concentration of amoxicillin.

Bactericidal antibiotics (including rifampicin, vancomycin, cephalosporins and aminoglycosides) have a synergistic effect when used in combination with Flemoxin.

When taken simultaneously with certain bacteriostatic agents (sulfonamides, chloramphenicol, etc.), antagonism is possible.

Use with estrogen-containing oral contraceptives may reduce the effectiveness of the latter and increase the risk of recurrent bleeding.

Use in combination with allopurine, unlike the combination of Ampicillin with allopurine, does not increase the frequency of skin reactions.

Terms of sale

On prescription.

Storage conditions

Store at temperatures below 25°C.

Best before date

Five years.

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®

Hypersensitivity reactions

Acute coronary syndrome associated with hypersensitivity (Kounis syndrome)

Insensitive microorganisms

Convulsions

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

Jarisch-Herxheimer reaction

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).

Long-term treatment

Anticoagulants

Crystalluria

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.

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.

Contraindications and side effects

Particular sensitivity to amoxicillin and the components of the drug is an obstacle to the use of Flemoxin. It is also contraindicated for:

Infectious mononucleosis.
Kidney failure.
Lymphocytic leukemia.
Severe pathologies of the gastrointestinal tract, especially with colitis caused by the use of antibiotics.
Pregnancy (possibly with caution as prescribed by a doctor).
Viral infections.
Bronchial asthma.

Use during lactation is allowed with caution.

The use of Flemoxin may cause undesirable effects, such as:

Attacks of nausea.
The appearance of diarrhea.
Hemorrhagic colitis.
Interstitial nephritis.
Neutropenia, thrombocytopenia.
An allergic reaction in the form of a rash, and in rare cases, anaphylactic shock or angioedema.

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

Flemoxin solutab

® (lat.
Flemoxin Solutab
®) is an antibiotic of the penicillin class. The active ingredient is amoxicillin.

Dosage forms of flemoxin solyutab

Flemoxin Solutab is available in the form of dispersible (soluble) tablets containing 125, 250, 500 or 1000 mg of amoxicillin (as amoxicillin trihydrate). Tablets are white to light yellow in color, oval in shape, from white to light yellow in color with the company logo and digital designation on one side and a score dividing the tablet in half on the other side. The number on the tablet indicates the content of amoxicillin:

“231” - tablet contains 125 mg of amoxicillin
“232” - tablet contains 250 mg of amoxicillin
“234” - tablet contains 500 mg of amoxicillin
“236” - tablet contains 1000 mg of amoxicillin

Indications for use of flemoxin solyutab

Flemoxin solutab is used in the treatment of infectious and inflammatory diseases caused by microbes sensitive to flemoxin solutab, including:

infectious diseases of the respiratory system
infectious diseases of the genitourinary system
infectious diseases of the skin and soft tissues
infectious diseases of the gastrointestinal tract, including Helicobacter pylori
-associated gastric and duodenal ulcers, atrophic gastritis, MAL Tomas.

Flemoxin solutab in gastroenterology

Gastroenterologists most often use flemoxin solutab as one of the antibiotics as part of complex therapy for the eradication of Helicobacter pylori
.
Flemoxin solutab is not used in the eradication of Helicobacter pylori
outside of special regimens, without drugs that reduce gastric acidity.
The dosage and procedure for taking Flemoxin Solutab depends on the eradication “scheme” used (see the article “Amoxicillin” or “Standards for the diagnosis and treatment of acid-dependent and Helicobacter pylori-associated diseases (fourth Moscow agreement)”) Flemoxin Solutab is also not used in any form for treatment of gastric and duodenal ulcers or gastritis in the absence of Helicobacter pylori
.

Method of administration of Flemoxin Solutab and dose

Flemoxin solutab is taken orally, before, during or after meals, swallowed whole, or divided into parts or chewed, washed down with a glass of water or diluted in water to form a syrup (20 ml) or suspension (100 ml).
For 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 of Flemoxin Solutab for children under 1 year of age is 30–60 mg per kg of weight, divided into 2–3 doses.

When treating severe infections and hard-to-reach lesions, it is advisable to take flemoxin solutab three times a day.

For chronic diseases, relapses, severe infections: adults - 0.75–1 g 3 times a day, children - up to 60 mg per kg per day; The dose calculated in this way is divided into 3 doses.

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

For mild to moderate infections, treatment with flemoxin solutab is 5–7 days, for infections caused by Streptococcus pyogenes

, - at least 10 days.

When treating chronic diseases and severe infections, the dose of Flemoxin Solutab should be determined by the clinical picture of the disease. Flemoxin solutab is continued for two days after the symptoms of the disease disappear.

When creatinine clearance is less than 10 ml per minute, the dose of Flemoxin Solutab is reduced by 15–50%.

Professional medical articles regarding the use of flemoxin solutab in the eradication of Helicobacter pylori

Potapov A.S., Pakhomovskaya N.L., Dublina E.S. and others. Evaluation of the effectiveness and safety of triple eradication therapy for helicobacteriosis in children with the drugs helol, de-nol and flemoxin solutab // Almanac of Clinical Medicine. – 2006. – volume XIV. - With. 87–94.
Samsonov A.A., Maev I.V., Ovchinnikova N.I., Shakh Yu.S., Podgorbunskikh E.I. The effectiveness of using colloidal bismuth subcitrate in Helicobacter pylori eradication therapy regimens for duodenal ulcer // RZHGGK. 2004. No. 4. pp. 30–35.

On the website gastroscan.ru in the literature catalog there is a section “Antibiotics used in the treatment of gastrointestinal diseases”, containing articles on the use of antimicrobial agents in the treatment of diseases of the digestive tract.

Other medicines containing the active ingredient amoxicillin

Amoxicillin, Amoxicillin, Amoxicillin capsules 0.25 g, Amoxicillin DS, Amoxicillin sodium sterile, Amoxicillin Sandoz, Amoxicillin-ratiopharm, Amoxicillin-ratiopharm 250 TC, Amoxicillin powder for suspension 5 g, Amoxicillin tablets, Amoxicillin trihydrate, Amoxicillin trihydrate (P urimox) , Amosin Gonoform, Gramox-D, Grunamox, Danemox, Ospamox, Hiconcil, Ecobol.

general information

According to the pharmacological index, Flemoxin Solutab belongs to the “Penicillin” group, according to the ATC - to the “Broad-spectrum Penicillin” group and has the code “J01CA04 Amoxicillin”.
Flemoxin Solutab is a generic version of amoxicillin and therefore information about its medicinal properties, including: indications for use, dosage regimen, list of microorganisms against which Flemoxin Solutab is active, Flemoxin Solutab in Helicobacter pylori

, antibiotoresistance
of Helicobacter pylori
to flemoxin solutab (amoxicillin), preservation of intestinal microflora during therapy with flemoxin solutab, pharmacokinetics of flemoxin solutab, interaction of flemoxin solutab with other drugs, contraindications when taking flemoxin solutab - see the article “Amoxicillin”.

The manufacturer of Flemoxin Solutab is Astellas Pharma Europe B.V. (Astellas Pharma Europe BV), Holland.

Instructions from the manufacturer (pdf): “Instructions (information for specialists) on the medical use of the drug Flemoxin Solutab.”

Flemoxin solutab has contraindications and application features; before starting therapy, consultation with a specialist is necessary.

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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.

Indications for the use of Flemoxin Solutab

Flemoxin Solutab is widely used in therapeutic and pediatric practice.

Indicated if bacterial sensitivity to amoxicillin is detected in:

Bacterial sore throat, pharyngitis, sinusitis, laryngitis, otitis media, tracheitis.
Infections in the bronchi and pneumonia).
Infection of the urinary organs (cervicitis, urethritis, cystitis, pyelonephritis, endometritis).
Skin infections (dermatoses, erysipelas, impetigo).
Bacterial damage to the digestive organs and peritoneum (salmonellosis, dysentery, typhoid fever).

For exacerbations of chronic gastritis and gastric ulcers caused by bacteria, it is prescribed with metronidazole.

Children are prescribed antibiotics for the same indications as adults.