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
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 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
