Many diseases caused by bacilli require treatment with antibiotics. Since their discovery, antibiotics have saved millions of lives. But these medications must be taken with great caution and only with a doctor's prescription. "Flemoklav Solutab" is an effective antibiotic that can cure many diseases.
Composition and release form
"Flemoklav Solutab" are elongated tablets, colored yellow, cream or white and covered with brown dots. The tablet does not have a risk, so it cannot be divided in half, you need to swallow it whole. It quickly dissolves in the oral cavity. Each tablet has the manufacturer’s logo printed on it and is marked “422”.
Types of dosages:
- 125 mg+31.25 mg;
- 250 mg+62.5 mg;
- 500 mg+125 mg;
- 875 mg+125 mg.
The tablets are packaged in bags, blisters or metal drums and placed in a cardboard box.
Each tablet consists of two main active ingredients:
- amoxicillin trihydrate - 291.4 mg;
- potassium clavulanate - 74.5 mg.
This dosage fully corresponds to 62.5 mg of clavulanic acid and 250 mg of amoxicillin base.
The composition of "Flemoclav Solutab" includes auxiliary elements:
- apricot flavor - 4.5 mg;
- Magnesium stearate - 2.5 mg;
- microcrystalline cellulose - 163.6 mg;
- vanillin - 0.5 mg;
- saccharin - 4.5 mg;
- crospovidone - 50 mg.
The drug can also be produced in the form of a syrup or solution for intravenous injections. Sometimes in pharmacies you can see the same medicine under a different name - flemoksiklav.
Flemoklav Solutab tablets 250 mg + 62.5 No. 20
A country
Netherlands
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 + Clavulanic acid
Compound
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.
pharmachologic effect
A combination drug of amoxicillin and clavulanic acid, a beta-lactamase inhibitor. It has a bactericidal effect, inhibits the synthesis of the bacterial wall. Active against aerobic gram-positive bacteria (including strains that produce beta-lactamases): Staphylococcus aureus; aerobic gram-negative bacteria: Enterobacter spp., Escherichia coli, Haemophilus influenzae, Klebsiella spp., Moraxella catarrhalis. The following pathogens are sensitive only in vitro: Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus anthracis, Streptococcus pneumoniae, Streptococcus viridans, Enterococcus faecalis, Corynebacterium spp., Listeria monocytogenes; anaerobic Clostridium spp., Peptococcus spp., Peptostreptococcus spp.; as well as aerobic gram-negative bacteria (including strains producing beta-lactamases): Proteus mirabilis, Proteus vulgaris, Salmonella spp., Shigella spp., Bordetella pertussis, Yersinia enterocolitica, Gardnerella vaginalis, Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus ducreyi, Yersinia multocida ( formerly Pasteurella), Campylobacter jejuni; anaerobic gram-negative bacteria (including beta-lactamase producing strains): Bacteroides spp., including Bacteroides fragilis. Clavulanic acid inhibits types II, III, IV and V beta-lactamases; it is not active against type I beta-lactamases produced by Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid has a high affinity for penicillinases, due to which it forms a stable complex with the enzyme, which prevents the enzymatic degradation of amoxicillin under the influence of beta-lactamases.
Indications for use
- bacterial infections caused by sensitive pathogens: lower respiratory tract infections (bronchitis, pneumonia, pleural empyema, lung abscess); - infections of the ENT organs (sinusitis, tonsillitis, otitis media); - infections of the genitourinary system and organs
Mode of application
Orally, intravenously. Doses are given in terms of amoxicillin. The dosage regimen is set individually depending on the severity and location of the infection and the sensitivity of the pathogen. Children under 12 years of age - in the form of a suspension, syrup or drops for oral administration. A single dose is set depending on age: children under 3 months - 30 mg/kg/day in 2 doses; 3 months and older - for mild infections - 25 mg/kg/day in 2 divided doses or 20 mg/kg/day in 3 divided doses, for severe infections - 45 mg/kg/day in 2 divided doses or 40 mg/kg/day a day in 3 doses. Adults and children over 12 years of age or weighing 40 kg or more: 500 mg 2 times / day or 250 mg 3 times / day. For severe infections and respiratory tract infections - 875 mg 2 times a day or 500 mg 3 times a day. The maximum daily dose of amoxicillin for adults and children over 12 years of age is 6 g, for children under 12 years of age - 45 mg/kg body weight body. The maximum daily dose of clavulanic acid for adults and children over 12 years of age is 600 mg, for children under 12 years of age - 10 mg/kg body weight. If swallowing is difficult in adults, the use of a suspension is recommended. When preparing suspensions, syrups and drops, water should be used as a solvent. For intravenous administration, adults and adolescents over 12 years of age are administered 1 g (amoxicillin) 3 times a day, if necessary - 4 times a day. The maximum daily dose is 6 g. For children 3 months to 12 years old - 25 mg/kg 3 times a day; in severe cases - 4 times a day; for children up to 3 months: premature and in the perinatal period - 25 mg/kg 2 times a day, in the postperinatal period - 25 mg/kg 3 times a day. Duration of treatment - up to 14 days, acute otitis media - up to 10 days. To prevent postoperative infections during operations lasting less than 1 hour, a dose of 1 g is administered intravenously during induction of anesthesia. For longer operations - 1 g every 6 hours during the day. If the risk of infection is high, administration can be continued for several days. In case of chronic renal failure, the dose and frequency of administration are adjusted depending on the CC: with CC more than 30 ml/min, no dose adjustment is required; with CC 10-30 ml/min: orally - 250-500 mg/day every 12 hours; IV - 1 g, then 500 mg IV; with CC less than 10 ml/min - 1 g, then 500 mg/day IV or 250-500 mg/day orally in one dose. For children, doses should be reduced in the same way. Patients on hemodialysis - 250 mg or 500 mg orally in one dose or 500 mg intravenously, 1 additional dose during dialysis and 1 more dose at the end of the dialysis session. With caution: pregnancy, lactation period. Cases of the development of necrotizing enterocolitis in newborns and in pregnant women with premature rupture of membranes have been identified. Children under 12 years of age - in the form of a suspension, syrup or drops for oral administration. A single dose is set depending on age: children under 3 months - 30 mg/kg/day in 2 doses; 3 months and older - for mild infections - 25 mg/kg/day in 2 divided doses or 20 mg/kg/day in 3 divided doses, for severe infections - 45 mg/kg/day in 2 divided doses or 40 mg/kg/day a day in 3 doses. The maximum daily dose of amoxicillin for children under 12 years of age is 45 mg/kg body weight. The maximum daily dose of clavulanic acid for children under 12 years of age is 10 mg/kg of body weight.
Interaction
Antacids, glucosamine, laxatives, aminoglycosides slow down and reduce absorption; ascorbic acid increases absorption. Bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) have an antagonistic effect. Increases the effectiveness of indirect anticoagulants (suppressing intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index). When taking anticoagulants simultaneously, it is necessary to monitor blood clotting indicators. Reduces the effectiveness of oral contraceptives, drugs in the process of metabolism of which PABA is formed, ethinyl estradiol - the risk of developing breakthrough bleeding. Diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration). Allopurinol increases the risk of developing skin rashes.
Side effect
From the digestive system: nausea, vomiting, diarrhea, gastritis, stomatitis, glossitis, increased activity of liver transaminases, in isolated cases - cholestatic jaundice, hepatitis, liver failure (more often in the elderly, men, with long-term therapy), pseudomembranous and hemorrhagic colitis ( can also develop after therapy), enterocolitis, black “hairy” tongue, darkening of tooth enamel. From the hematopoietic organs: reversible increase in prothrombin time and bleeding time, thrombocytopenia, thrombocytosis, eosinophilia, leukopenia, agranulocytosis, hemolytic anemia. From the nervous system: dizziness, headache, hyperactivity, anxiety, behavior change, convulsions. Local reactions: in some cases - phlebitis at the site of intravenous administration. Allergic reactions: urticaria, erythematous rashes, rarely - exudative erythema multiforme, anaphylactic shock, angioedema, extreme rarely - exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), allergic vasculitis, a syndrome similar to serum sickness, acute generalized exanthematous pustulosis. Others: candidiasis, development of superinfection, interstitial nephritis, crystalluria, hematuria.
Contraindications
- hypersensitivity (including to cephalosporins and other beta-lactam antibiotics); — infectious mononucleosis (including with the appearance of a measles-like rash); - phenylketonuria; - a history of episodes of jaundice or impaired liver function as a result of the use of amoxicillin/clavulanic acid; — CC less than 30 ml/min (for tablets 875 mg/125 mg). With caution: pregnancy, lactation, severe liver failure, gastrointestinal diseases (including a history of colitis associated with the use of penicillins), chronic renal failure.
Overdose
Symptoms: dysfunction of the gastrointestinal tract and water-electrolyte balance. Treatment: symptomatic. Hemodialysis is effective.
special instructions
During a course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver and kidneys. In order to reduce the risk of side effects from the gastrointestinal tract, the drug should be taken with meals. Superinfection may develop due to the growth of microflora insensitive to it, which requires a corresponding change in antibacterial therapy .May give false positive results when determining glucose in urine. In this case, it is recommended to use the glucose oxidant method for determining the concentration of glucose in urine. After dilution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen. In patients with hypersensitivity to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible. Cases of development have been identified necrotizing enterocolitis in newborns, in pregnant women with premature rupture of membranes. Since the tablets contain the same amount of clavulanic acid (125 mg), it should be noted that 2 tablets of 250 mg (amoxicillin) are not equivalent to 1 tablet of 500 mg (amoxicillin).
Storage conditions
Room temperature
Dispensing conditions in pharmacies
On prescription
How it affects the body
"Flemoclav Solutab" kills pathogenic bacteria and prevents the synthesis of their cell wall. The medicine helps to successfully fight bacterial infections thanks to its main components. Clavulanic acid inhibits the activity of beta-lactamase types II, III, IV and V (an enzyme that causes bacterial resistance to antibiotics), but is powerless against type I. In addition, clavulanic acid destroys germs and stimulates the body's immune system to protect against harmful bacteria. It effectively fights chlamydia, legionella, streptococci, staphylococci, and gonococci. It is slightly less active against various enterobacteria, as well as Pseudomonas aeruginosa and Haemophilus influenzae. Clavulanic acid is capable of breaking down the walls of gram-positive and gram-negative bacteria.
Amoxicillin is an antibiotic that can destroy various bacteria. It belongs to the group of penicillins, which are beta-lactam antibiotics, and treats all kinds of bacterial diseases.
The medicine affects many bacteria only during experiments, outside a living organism, in vitro.
The drug is quickly absorbed into the gastrointestinal tract. It can be taken every 8 or 12 hours. Its effectiveness is not reduced even if the tablet is taken with food.
Indications for use
Doctors prescribe the antibiotic "Flemoclav Solutab" for many diseases:
- bronchitis;
- tonsillitis;
- inflammation of the middle ear;
- sinusitis;
- pneumonia;
- pleural empyema;
- pharyngitis;
- tracheitis;
- laryngitis;
- osteomyelitis;
- postoperative infection;
- impetigo;
- erysipelas;
- phlegmon;
- dermatoses that have become infected;
- abscesses;
- wound infection;
- many diseases of the genitourinary system (cystitis, pyelonephritis, etc.).
In surgery, Flemoklav Solutab is used for preventive purposes so that patients do not become infected with microbes during and after operations.
Indications of the drug Flemoklav Solutab®
Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
diseases of the upper respiratory tract and ENT organs (including otitis media, sinusitis, tonsillitis, pharyngitis);
lower respiratory tract (including exacerbation of chronic bronchitis, COPD, community-acquired pneumonia);
skin and soft tissue infections;
urinary system (including cystitis, pyelonephritis).
Additionally for tablets 875 mg + 125 mg:
infections of bones and joints (including osteomyelitis);
in obstetrics and gynecology.
Instructions for use
The exact dosage of the drug is prescribed by the doctor for each patient individually.
Children over 12 years of age and adults if they weigh more than 40 kg, take 1 tablet of 500/125 mg three times a day. The dosage can be increased by 2 times.
Children 2–7 years of age who weigh 13–25 kg may take 125/31.25 mg of the medication 3 times daily. Older children 7–12 years old, weighing 25–37 kg, drink 250/62.5 mg three times a day. In severe cases, this dose can be doubled without harm to health.
Maximum doses per 1 kg of weight:
- amoxicillin 60 mg (adults) and 45 mg (children under 12 years of age);
- clavulanic acid 60 mg (over 12 years of age) and 10 mg (children under 12 years of age).
The course of treatment lasts 5–14 days, depending on the severity of the patient’s well-being. With long-term (more than 2 weeks) use, the risk of side effects increases, so the medicine should not be taken for that long. The therapeutic effect is achieved no earlier than 5 days after the start of the course, so Flemoklav Solutab should not be taken for less than 5 days.
Patients with renal failure should drink Flemoklav very carefully. They are allowed to take the drug if the filtration rate in the kidneys is at least 30 ml per minute. Then they are prescribed 875 mg/125 mg of Flemoclav.
It is advisable to take the medicine before meals. The tablet can be dissolved in water or swallowed completely with water.
Contraindications
hypersensitivity to amoxicillin, clavulanic acid and other components of the drug;
hypersensitivity to other beta-lactam antibiotics (penicillins and cephalosporins);
a history of jaundice or liver dysfunction when taking amoxicillin + clavulanic acid;
Infectious mononucleosis;
lymphocytic leukemia
Additionally for tablets 875 mg + 125 mg:
renal failure with glomerular filtration ≤ 30 ml/min;
children under 12 years of age weighing <40 kg.
Carefully:
severe liver failure;
gastrointestinal diseases (including a history of colitis associated with the use of penicillins);
chronic renal failure.
Contraindications and side effects
It is forbidden to take Flemoklav to patients suffering from the following diseases:
- phenylketonuria;
- mononucleosis of infectious origin;
- liver dysfunction caused by antibiotics;
- individual intolerance;
- the kidney filtration rate is less than 30 ml per minute.
This drug is prescribed very carefully and only as a last resort in the following cases:
- chronic renal failure;
- allergy;
- penicillin-induced colitis;
- asthma;
- severe liver failure;
- pregnancy and lactation.
The doctor finds out in advance whether the patient is allergic to antibiotics of this class.
Flemoclav can cause many side effects:
- stomatitis;
- disorders and inflammations in the gastrointestinal tract (stomach, intestines, etc.);
- glossitis;
- jaundice, hepatitis, liver failure;
- increased levels of eosinophils and agranulocytes in the blood;
- decreased platelet and leukocyte counts;
- hemolytic anemia;
- anxiety;
- headache;
- convulsions;
- dizziness;
- hives;
- erythema;
- anaphylactic shock;
- a condition similar to serum syndrome;
- vasculitis;
- angioedema;
- dermatitis;
- pustulosis;
- nephritis;
- superinfection;
- blood in urine.
In order not to worsen the patient’s well-being, all recommendations and prescriptions of the attending physician must be strictly followed.
special instructions
If anaphylactic reactions occur, treatment should be stopped immediately and replaced with another appropriate therapy.
To recover from a state of anaphylactic shock, urgent administration of adrenaline, corticosteroids and elimination of respiratory failure may be required.
There is a possibility of cross-resistance and hypersensitivity to other penicillins or cephalosporins. As with the use of other broad-spectrum penicillins, superinfections of fungal or bacterial origin (in particular candidiasis) may occur, especially in patients with chronic diseases and/or impaired immune system function. If superinfection occurs, the drug is discontinued and/or appropriate therapy is selected.
For patients with severe gastrointestinal disorders accompanied by vomiting and/or diarrhea, the administration of Flemoclav Solutab® is not advisable until the above symptoms are eliminated, because Possible disruption of drug absorption from the gastrointestinal tract.
The appearance of severe and persistent diarrhea may be associated with the development of pseudomembranous colitis, in which case the drug is discontinued and the necessary treatment is prescribed. In case of development of hemorrhagic colitis, immediate discontinuation of the drug and corrective therapy are also necessary. The use of drugs that weaken intestinal motility is contraindicated in these cases.
In a single study, prophylactic amoxicillin/clavulanate in women with premature rupture of membranes increased the risk of neonatal necrotizing enterocolitis.
Flemoclav Solutab® at a dose of 875 mg + 125 mg can be prescribed only if the glomerular filtration rate is >30 ml/min.
Due to the high concentration of amoxicillin in the urine, it can be deposited on the walls of the urinary catheter, so such patients require periodic catheter changes. Forced diuresis accelerates the elimination of amoxicillin and reduces its plasma concentration.
If seizures occur during therapy, the drug is discontinued. One dispersible tablet Flemoclav Solutab® 875 mg + 125 mg contains 25 mg of potassium.
In patients with impaired renal function, the dose must be adjusted based on the severity of the condition.
In patients with impaired liver function, the amoxicillin/clavulanic acid combination should be administered with caution and under constant medical supervision. Flemoklav Solutab® should not be used for more than 14 days without assessing liver function.
Amoxicillin/clavulanic acid should be administered with caution to patients receiving anticoagulant therapy.
Non-enzymatic methods for determining urine sugar, as well as the urobilinogen test, can give false positive results.
During a course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver and kidneys.
Overdose symptoms
Exceeding the prescribed dose can cause the following unpleasant conditions:
- vomit;
- nausea;
- diarrhea;
- thirst;
- convulsions.
Patients take activated charcoal and other medications to relieve symptoms. If convulsions occur, the patient is prescribed diazepam. If the patient suffers from a severe form of renal failure, he is referred for hemodialysis.
Interaction with other drugs
You should not take Flemoklav Solutab together with other antibiotics, as well as Disulfiram and chemotherapy drugs.
A skin rash appears if the antibiotic is taken together with Allopurinol.
Kidney complications can occur when Flemoklav is combined with Methotrexate, vitamin C, phenylbutazone, oxyphenbutazone, indomethacin, sulfinpyrazone and probenecid.
Bleeding may occur due to the combination of an antibiotic with anticoagulants.
The effect of taking hormonal contraceptives is reduced due to their combination with Flemoklav.
Thanks to Flemoklav, Digoxin is absorbed faster in the intestine.
