Flemoclav Solutab

Flemoclav Solutab (amoxicillin trihydrate + potassium clavulanate) is an antibiotic with a wide therapeutic range, including amoxicillin and designed to protect it from the damaging effect of beta-lactamase potassium clavulanate.

The principle of the drug is based on the introduction of an active substance into a microbial cell, followed by blocking synthesis of a special compound (peptidoglycan), responsible for the construction of cell membranes. As a result of the deficiency of this compound, the growth and development of the microbial cell stops and it dies.

Bactericidal action Flemoclave Solutab extends to most strains of pathogenic microflora, including gram-positive and gram-negative anaerobic and aerobic microorganisms.

Clinical and pharmacological group

Antibacterial preparation.

Terms of sale from pharmacies

Can buyby prescription.

Price

Approximate prices for Flemoclav Solutab in pharmacies, depending on the dosage:

Flemoclav Solutab 125 mg + 31.25 mg (20 packs included in the package) - 304-325 rubles;

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Flemoclav Solutab 250 mg + 62.5 mg (20 packs included in the package) - 426-437 rubles;
Flemoclav Solutab 500 mg + 125 mg (20 packs included in the package) - 398-456 rubles;
Flemoclav Solutab 875 mg + 125 mg (pack of 14 pieces) - 430-493 rubles.

Composition and form of release

Medicinal form Flemoklava Solutab - tablets are dispersible: oblong form, from yellow to white with brown impregnations, with the marking "421", "422", "424" or "425" and the company logo, without separating risks (with the inscription "421", "422", "424": 4 pcs. in a blister, in a cardboard bundle of five blisters; «425»: 7 pcs. Each. in a blister, in a cardboard bundle 2 blisters).

Tablets Flemoklav Solutab can be produced in four different dosages:

clavulanic acid (potassium clavulanate) - 31.25 mg, amoxicillin (amoxicillin trihydrate) -125 mg;
clavulanic acid (potassium clavulanate) - 62.5 mg, amoxicillin (amoxicillin trihydrate) 250 mg;
clavulanic acid (potassium clavulanate) 125 mg, amoxicillin (amoxicillin trihydrate) 500 mg;
clavulanic acid (potassium clavulanate) 125 mg, amoxicillin (amoxicillin trihydrate) 875 mg.

Excipients are: dispersed cellulose, MCC, vanillin, crospovidone, mandarin flavor, lemon flavor, saccharin, magnesium stearate.

Pharmacological effect

Flemoclav Solutab is a combined preparation of amoxicillin and clavulanic acid. It acts bactericidal, inhibits the synthesis of the bacterial wall.

It is active against aerobic Gram-positive bacteria: 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-lactamase): 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: Bacteroides spp., including Bacteroides fragilis.

Clavulanic acid inhibits II, III, IV and V types of beta-lactamases, is not active against type I beta-lactamases produced by Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. It has high tropicity to penicillinases, forms a stable complex with the enzyme, prevents enzymatic degradation of amoxicillin under the influence of beta-lactamases.

Indications for use

What helps? Flemoclav Solutab is used in the treatment of infectious and inflammatory diseases that are caused by microorganisms sensitive to the action of the drug:

gonorrhea, which is caused by Neisseria gonorrhoeae;
infectious diseases of soft tissues and skin;
odontogenic infections (maxillary sinusitis, severe dental abscesses with spreading cellulitis, periodontitis);
infection of the ENT organs and upper respiratory tract (sinusitis, otitis media, recurrent tonsillitis);
infectious diseases of the lower respiratory tract (bronchopneumonia, lobar pneumonia, chronic bronchitis in the acute stage);
urinary tract infections (urethritis, pyelonephritis, cystitis, infectious diseases of female genital organs);
infections of joints and bones that are caused by Staphylococcus aureus and require long-term therapy (only for tablets at a dose of 875/125 mg);
stepwise therapy of other mixed infections (postpartum and intra-abdominal sepsis, septic abortion) (only for tablets at a dose of 875/125 mg).

Contraindications

Severe liver damage after taking the drug in the past.
Lymphocytic leukemia.
Infectious mononucleosis.
Renal failure (filtration below 30 ml per minute) - for tablets 875/125 mg.
Age less than 12 years and weight up to 40 kg - for tablets 875/125 mg.
Hypersensitivity to the components of the drug and any beta-lactam antibiotics (cephalosporins and penicillins).

With caution use the drug in severe forms of hepatic and renal failure, diseases of the digestive system.

Intended use for pregnancy and lactation

In the first trimester of pregnancy, the preparation Flemoklav soluteba is contraindicated, since at this stage all organs and systems of the fetus are formed and laid, and the effect of drugs on the maternal organism can lead to failure of this delicate process, respectively, the formation of anomalies and congenital malformations.

The use of the drug in the second and third trimesters of pregnancy is possible according to the indications. Before appointing tablets to a future mother, the doctor carefully assesses the balance of risks and benefits. Treatment is carried out in the lowest effective dosage under the supervision of a doctor.

Use of the preparation Flemoclav Solutab during breast-feeding is possible. Despite the fact that the active ingredients are excreted in milk, no negative or toxic effects of the drug on the child's organism were found during the studies.

Application in childhood

In chronic renal insufficiency, dose adjustment and the frequency of administration are carried out depending on the CC: at a QC greater than 30 ml / min, dose adjustment is not required; at CC 10-30 ml / min: inside - 250-500 mg / day every 12 hours; I / O - 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 at one time. For children, the dose should be reduced in the same way. With QC less than 30 ml / min, tablets 875 mg / 125 mg are contraindicated.

Patients on hemodialysis 250 mg or 500 mg orally at one time or 500 mg IV, 1 additional dose during dialysis and 1 additional dose at the end of the dialysis session.

Dosage and route of administration

As indicated in the instructions for use, tablets are taken orally before meals, swallowing whole and washing with 200 ml of water or dissolving in 100 ml of water and thoroughly stirring before taking.

Recommended dosing for adults and children weighing more than 40 kg:

Flemoclav Solutab 875 mg + 125 mg: one tablet 2 times a day (every 12 hours);
Flemoclav Solutab 500 mg + 125 mg: one tablet 3 times a day (every 8 hours). To treat chronic, recurrent, severe infections, you can double this dose.

The daily dose for children under 12 years with a body weight of up to 40 kg is usually prescribed at the rate of 20-30 mg of amoxicillin and 5-7.5 mg of clavulanic acid per 1 kg of the child's weight.

Recommended dosing for children:

7-12 years (25-37 kg): Flemoclav Solutab 250 mg + 62.5 mg - one tablet 3 times a day;
2-7 years (13-25 kg): preparation 125 mg + 31.25 mg - one tablet 3 times a day;
3 months - 2 years (5-12 kg): tablets 125 mg + 31.25 mg - one piece. 2 times a day.

With severe clinical indications, these doses for children can be doubled, provided that the daily dose does not exceed 60 mg of amoxicillin and 15 mg of clavulanic acid per 1 kg of body weight.

Duration of treatment - no more than 14 days. If you need more time, you should consult your doctor.

The dosage regimen of amoxicillin for patients with renal insufficiency is adjusted taking into account GFR:

10-30 ml / min: adults - 500 mg twice a day, children - 15 mg per 1 kg 2 times a day;
less than 10 ml / min: adults - 500 mg per day, children - at a dose of 15 mg per 1 kg per day.

Patients on hemodialysis are recommended to take Flemoklav Solutab in a dose: adults - 500 mg per day and 500 mg during and after dialysis, children - 15 mg per 1 kg of weight per day and 15 mg per kg of weight during and after dialysis.

Adverse Reactions

During the reception of the Flemoclav Solutab tablets, patients with hypersensitivity to the drug may develop side effects:

skin and subcutaneous tissues: infrequently - itching, urticaria, rash; rarely erythema multiforme; very rarely - the development of acute generalized exanthematous pustules, toxic epidermal necrolysis, Stevens-Johnson syndrome, bullous exfoliative dermatitis;
blood and lymphatic systems: rarely - reversible leukopenia (including neutropenia), reversible thrombocytopenia; very rarely - eosinophilia, lengthening prothrombin time, anemia (including reversible hemolytic), reversible agranulocytosis, prolonged bleeding time, thrombocytosis;
nervous system: infrequently - headache, dizziness; very rarely - insomnia, reversible hyperactivity, behavior change, agitation, anxiety, convulsions (with violations of kidney function and taking high doses);
immune system: very rarely - allergic vasculitis, anaphylactic reactions, angioedema, development of a syndrome similar to serum sickness;
kidney and urinary tract: very rarely - crystalluria, hematuria, interstitial nephritis;
parasitic and infectious diseases: often - development of candidiasis of mucous membranes and skin;
liver and biliary tract: infrequent - moderate increase in ALT and / or ACT activity (in patients taking beta-lactam antibiotics of patients); very rarely - cholestatic jaundice and hepatitis (in people taking penicillin antibiotics and cephalosporins), an increase in the concentration of alkaline phosphatase and bilirubin. Side effects from the liver are mainly observed in men and elderly patients and can be associated with long-term treatment. Such reactions in children are very rare. The symptoms listed above are reversible and often develop during or immediately after completion of treatment, but in some cases they may appear within a few weeks after the end of therapy. Side effects from the liver can be quite severe, up to fatal outcomes in extremely rare cases (mostly we are talking about individuals with serious concomitant pathologies or patients taking potentially potentially hepatotoxic drugs in parallel).

Also, when taking the preparation Flemoklav Solutab, the following undesirable reactions from the digestive system are observed:

children: often - nausea, diarrhea, vomiting;
adults: very often - diarrhea; often - vomiting, nausea;
common for both categories: often - the appearance of nausea and other reactions from the gastrointestinal tract when taking large doses of the drug (these effects usually disappear when using tablets at the beginning of admission food); infrequently - digestive disorders; very rarely - colitis, induced by antibiotics (including hemorrhagic and pseudomembranous), gastritis, stomatitis, black "hairy" tongue.

Overdose

If there is a significant excess of the recommended dose or a prolonged uncontrolled drug intake, the patient develops signs of an overdose that clinically manifested by an increase in the above-described side effects, a violation of the water-electrolyte balance, indomitable vomiting and diarrhea.

Treatment of an overdose consists of rinsing the stomach, administering activated charcoal and performing symptomatic treatment. With the development of renal failure, the patient undergoes hemodialysis.

special instructions

Before you start using the drug, read the special instructions:

After reconstitution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen.
In course treatment it is necessary to monitor the status of the functions of the organs of hematopoiesis, liver and kidneys.
To reduce the risk of side effects from the gastrointestinal tract, you should take the drug while eating.
It is possible to develop superinfection due to the growth of insensitive microflora, which requires a corresponding change in antibacterial therapy.
Can give false positive results in determining glucose in the urine. In this case, it is recommended to use a glucose oxidant method for determining the concentration of glucose in the urine.
In patients who are hypersensitive to penicillins, there may be cross-allergic reactions with cephalosporin antibiotics.
Cases of development of necrotizing enterocolitis in newborns, in pregnant women with premature rupture of membranes were revealed.
Since the tablets contain the same amount of clavulanic acid (125 mg), it should be noted that 2 tablets of 250 mg (for amoxicillin) are not equivalent to 1 tablet of 500 mg (for amoxicillin).

Compatibility with other drugs

When using the drug, it is necessary to take into account the interaction with other drugs:

Allopurinol increases the risk of skin rash.
Antacids, glucosamine, laxative drugs, aminoglycosides slow down and reduce absorption; ascorbic acid increases absorption.
Diuretics, allopurinol, phenylbutazone, NSAIDs, and others. drugs that block tubular secretion, increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).
Bacteriostatic medicinal products (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) have an antagonistic effect.
Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index). With the simultaneous administration of anticoagulants, it is necessary to monitor blood coagulability.
Reduces the effectiveness of oral contraceptives, drugs, in the process of metabolism which forms PABC, ethinyl estradiol - the risk of bleeding "breakthrough".

Reviews

We offer you to read reviews of people who used Flemoklav Solutab:

Alina. To the child 4 years, the doctor has appointed or nominated "Flemoklav", a dosage 500. A very strong drug, after two days of admission, there were noticeable improvements in the condition, on the 5th day of the reception of the symptoms of the disease was no longer there. Cured quickly. It is convenient that the tablet can be dissolved in water and drunk, for children it is convenient, since the tablet itself is quite large, and it is difficult for the children to swallow it.
Dina. I have several times been treated with a Flemoclav, since I have chronic bronchitis for more than five years. Of course, now I try not to run to the deep stage, when only antibiotics help, but sometimes it happens. With bronchitis fights perfectly. For a week you can practically recover. But there are some "buts." It is really a very strong antibiotic, so it gives side effects to other organs. After taking this medication, I had a disorder, pain in the intestines and kidneys. Then I had to take Essential and Linex for recovery. Recently, I take this drug only as a last resort, when lighter drugs no longer help.

Analogues

Structural analogs for the active substance:

Amovicomb;
Amoxiclav;
Amoksiklav Quiktab;
Amoxicillin + Clavulanic acid Pfizer;
Arlette;
Augmentin;
Bactocklave;
Verklav;
Clamosar;
Liklave;
Médoclase;
Panklav;
Ranklav;
Rapiklav;
Taromentine;
Fibell;
Ecoclave.

Before buying an analogue, consult your doctor.

Shelf life and storage conditions

Keep the tablets in a cool dry place out of the reach of children. The shelf life of the drug is indicated on the packaging and is 3 years from the date of manufacture. Do not use the product with expired shelf life.