How to take Flemoklav Solutab for adults and children? Before or after meals? "Flemoklav Solutab": instructions for use of tablets for children with dosage calculation

In this article you can read the instructions for use of the drug Flemoklav solutab. Reviews of site visitors - consumers of this medicine, as well as the opinions of specialist doctors on the use of the antibiotic Flemoclav Solutab in their practice are presented. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Analogues of Flemoklav Solutab in the presence of existing structural analogues. Use for the treatment of sore throat, herpes and other infectious diseases in adults, children, as well as during pregnancy and lactation. Composition and interaction of the drug with alcohol.

Flemoklav solutab- antibiotic wide range actions; combination drug amoxicillin and clavulanic acid - a beta-lactamase inhibitor. Active against gram-positive and gram-negative microorganisms (including strains producing beta-lactamases).

Amoxicillin is bactericidal and inhibits the synthesis of peptidoglycan in the bacterial cell wall. Clavulanic acid inhibits beta-lactamases types 2, 3, 4 and 5. Not active against type 1 beta-lactamases produced by Enterobacter spp., Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid has a high tropism 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 and expands its spectrum of action.

Flemoklav Solutab is active against aerobic and anaerobic gram-positive bacteria, aerobic and anaerobic gram-negative bacteria.

Compound

Amoxicillin trihydrate (Amoxicillin) + Potassium clavulanate (Clavulanic acid) + excipients.

Pharmacokinetics

Amoxicillin

After oral administration, it is quickly absorbed from the gastrointestinal tract. Absorption of amoxicillin at oral administration is 90-94%. Concomitant food intake does not affect absorption. Amoxicillin crosses the placental barrier and is excreted in small quantities into breast milk. Approximately 60-80% of amoxicillin is excreted through the kidneys during the first 6 hours after taking the drug.

Clavulanic acid

After oral administration, it is quickly absorbed from the gastrointestinal tract. Absolute bioavailability is approximately 60%. Concomitant food intake does not affect absorption. Serum protein binding is 22%. Clavulanic acid penetrates the placental barrier. There is no reliable data on excretion in breast milk. Clavulanic acid undergoes extensive metabolism through hydrolysis and subsequent decarboxylation. Approximately 30-50% of clavulanic acid is excreted through the kidneys during the first 6 hours after taking the drug.

Indications

bacterial infections caused by susceptible pathogens: infections of the lower respiratory tract(bronchitis (acute and exacerbation of chronic), pneumonia, pleural empyema, lung abscess);
infections of the ENT organs (sinusitis, tonsillitis, 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, cellulitis, wound infection);
osteomyelitis;
postoperative infections;
prevention of infections in surgery.

Release forms

Dispersible tablets 125 mg, 250 mg, 500 mg, 625 mg, 875 mg and 1000 mg.

There are no other forms of release, be it syrup, injections in ampoules or capsules.

Instructions for use and dosage

For adults and children over 12 years of age and children under 12 years of age weighing more than 40 kg, Flemoclav Solutab at a dose of 875 mg/125 mg is prescribed 2 times a day (every 12 hours).

Children under 12 years of age weighing less than 40 kg are prescribed Flemoklav Solutab in lower dosages.

For adults and children weighing more than 40 kg, the drug is prescribed 500 mg/125 mg 3 times a day. For severe, chronic, recurrent infections, this dose can be doubled.

The daily dose for children is usually 20-30 mg of amoxicillin and 5-7.5 mg of clavulanic acid per kg of body weight. Possible dosage regimen for children depending on the age and body weight of the child:

age from 3 months to 2 years - body weight from 5 to 12 kg - daily dose of tablet 125 mg/31.25 mg 2 times a day;
age from 2 to 7 years - body weight from 13 to 25 kg - daily dose of tablet 125 mg/31.25 mg 3 times a day;
age from 7 to 12 years - body weight from 25 to 37 kg - daily dose of tablet 250 mg/62.5 mg 3 times a day.

For severe infections, these doses can be doubled (the maximum daily dose is 60 mg amoxicillin and 15 mg clavulanic acid per kg body weight).

The duration of treatment depends on the severity of the infection and should not exceed 14 days unless necessary.

To prevent side effects from the digestive system, it is recommended to take the drug at the beginning of a meal. The tablet is swallowed whole with a glass of water, or dissolved in half a glass of water (minimum 30 ml), stirring thoroughly before use (a suspension is obtained that is convenient for children to take).

Side effect

thrombocytosis, hemolytic anemia, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, anemia;
increase in prothrombin time and bleeding time;
dizziness;
headache;
convulsions;
anxiety;
anxiety;
insomnia;
disturbance of consciousness;
aggressive behavior;
vasculitis;
abdominal pain;
nausea, vomiting;
flatulence;
diarrhea;
pseudomembranous colitis (in case of severe and persistent diarrhea while taking the drug or within 5 weeks after completion of therapy);
intestinal candidiasis;
hemorrhagic colitis;
cholestatic jaundice;
itching, burning and vaginal discharge;
interstitial nephritis;
skin rash and itching;
morbilliform exanthema;
hives;
bullous or exfoliative dermatitis (erythema multiforme exudative, Stevens-Johnson syndrome, toxic epidermal necrolysis);
anaphylactic shock;
drug fever;
eosinophilia;
angioedema (Quincke's edema);
swelling of the larynx;
serum sickness;
hemolytic anemia;
allergic vasculitis;
bacterial or fungal superinfections (with long-term therapy or repeated courses of therapy).

Contraindications

liver dysfunction (including jaundice) with a history of taking amoxicillin/clavulanic acid;
Infectious mononucleosis;
lymphocytic leukemia;
renal failure (glomerular filtration ≤ 30 ml/min) - for dispersible tablets 875 mg/125 mg;
children under 12 years of age weighing less than 40 kg (for dispersible tablets 875 mg/125 mg);
hypersensitivity to amoxicillin, clavulanic acid and other components of the drug;
hypersensitivity to other beta-lactam antibiotics (penicillins and cephalosporins).

Use during pregnancy and breastfeeding

When using Flemoklav Solutab during pregnancy, it was not observed negative influence to the fetus or newborn. The use of the drug in the 2nd and 3rd trimester of pregnancy is possible after a medical assessment of the risk/benefit. In the 1st trimester of pregnancy, the use of Flemoclav Solutab should be avoided (only for dispersible tablets 875 mg/125 mg). Dispersible tablets 125 mg/31.25 mg, 250 mg/62.5 mg, 500 mg/125 mg in the 1st trimester of pregnancy should be prescribed with caution.

Amoxicillin and clavulanic acid penetrate the blood-placental barrier and are excreted in breast milk. It is possible to use the drug during breastfeeding.

If a child develops sensitization, diarrhea or candidiasis of the mucous membranes, breastfeeding should be stopped.

special instructions

When taking Flemoclav Solutab, there is a possibility of cross-resistance and hypersensitivity with other penicillins or cephalosporins.

If anaphylactic reactions develop, the drug should be stopped immediately and appropriate therapy administered: treatment of anaphylactic shock may require urgent administration of epinephrine (adrenaline), glucocorticosteroids (GCS) and elimination of respiratory failure.

Superinfection (eg, candidiasis) may develop, especially in patients with chronic diseases and/or impaired immune system function. If superinfection occurs, the drug is discontinued and/or antibacterial therapy is adjusted accordingly.

Patients with severe gastrointestinal disorders accompanied by vomiting and/or diarrhea, the appointment of Flemoklav Solutab is inappropriate 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 prescribed necessary treatment. 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 in these cases is contraindicated.

If liver function is impaired, the drug should be prescribed with caution and under constant medical supervision. The drug should not be used for more than 14 days without assessing liver function.

In a single study, prophylactic amoxicillin/clavulanate in women with premature rupture of membranes increased the risk of neonatal necrotizing enterocolitis.

While taking the drug, an increase in prothrombin time may be observed. Therefore, Flemoklav Solutab should be prescribed with caution to patients receiving anticoagulant therapy (blood clotting parameters must be monitored).

Due to the high concentration of amoxicillin in the urine, it can be deposited on the walls urinary catheter Therefore, such patients require periodic catheter changes. Forced diuresis accelerates the elimination of amoxicillin and reduces its plasma concentration.

During the period of use of Flemoklav Solutab, non-enzymatic methods for determining glucose in urine, as well as a test for urobilinogen, may give false positive results.

At course treatment it is necessary to monitor the functions of the hematopoietic organs, liver and kidneys.

If seizures occur during therapy, the drug is discontinued.

It should be taken into account that 1 dispersible tablet 875 mg/125 mg contains 25 mg of potassium.

Drug interactions

When used simultaneously with some bacteriostatic drugs (for example, chloramphenicol, sulfonamides), antagonism with amoxicillin/clavulanic acid was observed.

Flemoklav solutab should not be prescribed simultaneously with disulfiram.

The simultaneous use of drugs that inhibit the renal excretion of amoxicillin (probenecid, phenylbutazone, oxyphenbutazone and, to a lesser extent, acetylsalicylic acid, indomethacin and sulfinpyrazone) increases the concentration and longer presence of amoxicillin in the blood plasma and bile. The excretion of clavulanic acid is not impaired.

When used simultaneously with Flemoklav Solutab, antacids, glucosamine, laxatives, aminoglycosides slow down and reduce the absorption of amoxicillin, ascorbic acid increases the absorption of amoxicillin.

Concomitant use of Flemoclav Solutab with allopurinol may increase the risk of developing a skin rash.

Ethanol (alcohol) reduces the rate of absorption of Amoxicillin in the gastrointestinal tract.

Aminopenicillins may decrease serum concentrations of sulfasalazine.

Amoxicillin reduces the renal clearance of methotrexate, which may lead to an increased risk of toxicity. At simultaneous administration with amoxicillin, monitoring of serum methotrexate concentrations is necessary.

Concomitant use of amoxicillin/clavulanic acid and digoxin may lead to increased absorption of digoxin.

With the simultaneous use of Flemoklav Solutab and indirect anticoagulants, the risk of bleeding may increase.

In rare cases, while taking amoxicillin, a decrease in the effectiveness of oral contraceptives has been observed, so the patient should be advised to use non-hormonal methods of contraception.

Analogs of the drug Flemoklav solutab

Structural analogues of the active substance:

Amovycombe;
Amoxiclav;
Amoxiclav Quiktab;
Amoxicillin + Clavulanic acid Pfizer;
Arlet;
Augmentin;
Bactoclav;
Verklav;
Clamosar;
Liklav;
Honeyclave;
Panclave;
Ranklav;
Rapiklav;
Taromentin;
Fibell;
Ecoclave.

If there are no analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and look at the available analogues for the therapeutic effect.

Its history began in the 60s of the last century, when scientists British company Beecham was the first in the world to obtain the semisynthetic antibiotic Amoxicillin in the laboratory. More than half a century has passed since then, but this drug has not lost its relevance. In addition, based on it, another antibacterial agent was created, which to this day is one of the most popular and effective drugs in the world. We are talking about the seemingly immortal combination of Amoxicillin and Clavulanic acid, which the hero of our story today, Flemoclav Solutab, contains.

Despite the fact that there are several dozen analogs of the original brand drug Augmentin, which was the first to appear in the pharmaceutical world, on the market, Flemoklav Solutab has managed to firmly occupy its niche and firmly “stand on its feet.” What is so unusual about it, how it differs from other generics of the famous antibacterial combination, and why, in fact, it is so popular and indispensable in modern medicine - we will try to answer all these questions honestly and most fully in this article.

And we will begin the story, as has already happened in a series of our popular stories for those who want to immerse themselves in the entertaining world of pharmacology and medicine, from the very beginning - the history of penicillins.

Before you continue reading: If you are looking effective method to get rid of runny nose, pharyngitis, tonsillitis, bronchitis or colds, then be sure to check out Book section of the site after reading this article. This information has helped so many people, we hope it will help you too! So, now back to the article.

The word is penicillin

The creation of a semi-synthetic representative of penicillins was one of the breakthroughs in medicine that made it possible to develop the case quick help for a variety of infections on a wide scale. And, of course, save hundreds of lives.

Let's go back fifty years ago. Benzylpenicillin, discovered in the 40s, has already fulfilled its main mission, appearing exactly when there was a maximum need for it - during the Second World War. However, alas, the clever bacteria were able to quickly “adapt” to unfavorable living conditions in close proximity to penicillins: they “learned” to produce a special enzyme that easily destroyed the beta-lactam ring, which formed the basis of the structural chemical formula of benzylpenicillin. This led to the fact that before effective introduction penicillin was no longer so effective, and sometimes did not lead to results at all. Therefore, scientists zealously began searching for new formulas.

The result of their efforts was the creation first of ampicillin, based on the same structural beta-lactam ring, and a little later - of its derivative, Amoxicillin. The latter was devoid of the significant disadvantages of its predecessor: it had (and has) a much longer half-life, which allows it to be taken two to three times a day, and not four, like Ampicillin. However, as it turned out several years after the discovery of Amoxicillin, addiction to it, just like other penicillins, quickly develops.

And then the same Clavulanic acid came to the rescue, thanks to which the problem of destruction of the beta-lactam ring was successfully solved. It is this that, along with Amoxicillin, that is part of Flemoclav Solutab.

The original antibiotic, containing Amoxicillin and Clavulanic acid, was created in 1979, all in the same company by Beacham. By the way, it was this company that later grew into the world-famous British pharmaceutical giant Glaxo Smith Klein, one of the top corporations in the world.

The brand drug on the basis of which Flemoclav Solutab was created many years later is called Augmentin. It appeared on the market in 1979, and 6 years later the patent for it expired, which gave impetus to companies involved in the production of generics to actively “get involved.” And the result of one of the efforts of generic companies was Flemoclav Solutab.

Flemoklav Solutab: composition and release forms

So, the drug is a dispersible tablet. Flemoklav Solutab is available in several dosages, allowing it to be used to treat children of different ages and adults. The manufacturer of the drug is the famous Japanese company Astellas. Note that this company appeared only in 2005 as a result of the merger of two large corporations Yamanouchi and Fujisawa. Today Astellas is the largest pharmaceutical company countries Rising Sun, which also produces a series of generic drugs Solutab, including the antibiotic Flemoklav.

Dosages for drugs containing a combination of Amoxicillin and Clavulanic acid can be somewhat confusing for buyers who are encountering this complex antibiotic for the first time. For example, the dose of Flemoclav Solutab 500 mg +125 mg may indeed be incomprehensible to an inexperienced consumer. In fact, there is nothing complicated about it.

Components of combination medications, including antibiotics, are included in medications in various dosages. At the same time, for the doctor and the patient himself great value has a dose of each component medicinal substances. There is an unspoken rule in pharmaceuticals: doses in combination drugs are indicated either through a longitudinal line (/) or using a plus sign (+). In the case of Flemoklav Solutab, manufacturers preferred the second option, so you can buy the following dosages of this antibiotic in pharmacy chains:

500 mg+125 mg;
250 mg+62.5 mg;
125 mg+31.25 mg;
875 mg+125 mg.

The first number in the dosage of Flemoclav Solutab means the dose of the antibiotic itself (Amoxicillin), and the second number means the dose of Clavulanic acid.

Of course, the lower the dose of the antibacterial drug, the less “protective” component is required that will counteract the destructive power of bacteria. By the way, it’s time to figure out how Clavulanic acid “works”.

What is the strength, clavulanate?

Clavulanic acid is a drug structurally very similar to penicillin. So close that bacteria that produce the enzyme penicillinase easily mistake it for their target - an antibiotic. This substance, like Amoxicillin, was synthesized by pharmacists of the same British concern Beecham in 1975.

It should be noted that Clavulanic acid itself exhibits extremely insignificant antimicrobial activity, despite the fact that in its structure, as well as in the structure penicillin antibiotics, has a beta-lactam ring. Due to this structural similarity with the antibiotic molecule (in the case of Flemoclav Solutab - Amoxicillin), Clavulanic acid interacts with the enzyme beta-lactamase secreted by some bacteria and “takes the blow.” As a result, the antibiotic Amoxicillin itself remains safe and sound and causes crushing blow against the already disarmed army of bacteria.

For those consumers who are concerned about the origin of drugs, we have somewhat optimistic information about clavulanate: this substance is created by nature itself. Clavulanic acid is synthesized certain type streptomycetes bacteria. And finally one more important point: Does Clavulanic acid in Flemoclav Solutab affect the tolerability of the combined antibiotic?

Unfortunately, it is impossible to say that this drug has no side effects. However, Clavulanic acid is quite well tolerated. Occasionally, its administration in high doses over a long period of time can lead to the development of cholestatic jaundice and even acute hepatitis. However, as a rule, such adverse side effects occur extremely rarely, provided that the treatment regimen recommended by the doctor is followed.

In the UK the Safety Committee medicines, who is also developing schemes regulating how many days antibiotics should be taken, recommends prescribing drugs containing Amoxicillin and Clavulanic acid, that is, in our case - Flemoclav Solutab - for no longer than 14 days. However, in Russian practice Often the course of therapy with protected Amoxicillin is many times longer, and, as a rule, cases of unsatisfactory tolerability requiring discontinuation of the drug, including Flemoclav Solutab dispersible tablets, have not been registered. By the way, the good tolerability and high effect of Flemoclav Solutab are largely due to the advantages of its unique dosage form, which is worth special mention.

What are dispersible tablets?

What medications are domestic consumers accustomed to? Tablets, syrups, suspensions, powders from which medicine is prepared before use - these forms have long been known and do not surprise anyone. But dispersible tablets, in the form of which the hero of our story is produced, remain a mysterious form for many consumers. So, what are Flemoclav Solutab dispersible tablets, and how do they differ from regular tablets for oral administration?

An important difference between the Solutab dosage form is that the active substance in it (Amoxicillin) is enclosed in microspheres - capsules of very small diameter. This protects the antibiotic itself from the inevitably adverse effects of aggressive environments in the body - gastric juice and some enzymes.

Dispersible tablets Flemoklav Solutab easily and quickly dissolve in a minimum volume of water to form a suspension, which must be thoroughly homogenized, that is, stirred, before use.

By the way, the resulting suspension has a pleasant apricot taste due to the addition of the appropriate fragrance, which makes it much easier to take initially bitter antibiotics.

In addition, not all adults are able to swallow quite a lot without problems. large tablet antibiotic. Thus, according to research, almost 30% of Dutch people experience real difficulties when swallowing capsule or tablet dosage forms. Moreover, only 30% report these difficulties to the doctor, and the remaining unconscious majority either takes the medicine irregularly or stops taking it altogether. This leads to the formation resistant strains bacteria and chronic infection, which is subsequently difficult to treat with broad-spectrum antibiotics. But with the advent of Solutab forms, the problem of adults who find it difficult to take sometimes huge tablets for oral administration was solved by itself.

It should be noted that dispersible tablets, including Flemoklav Solutab, are absorbed more completely and much faster in the stomach than traditional ones. By the way, the drug is best absorbed if taken with food.

Therefore, to answer the rather traditional question “How and when is it better to take Flemoklav Solutab?” simple: during breakfast, lunch and dinner, since the drug is usually prescribed three times a day.

A favorable property of Flemoclav Solutab is the fact that the drug does not cumulate, that is, does not accumulate in the body.

Another absolutely positive property of the antibiotic is its gentle effect on the gastrointestinal tract. Due to the fact that the combination of Amoxicillin and Clavulanic acid itself is located inside mini-microspheres, the drug is released only in those parts of the digestive system where they are most completely absorbed - in duodenum and upper section small intestine. Due to this, the residual concentrations of the antibiotic in the intestine are minimal, which ensures the mild effect of the drug and reduces its irritating effect on the intestinal mucosa. Therefore, forms of antibiotics Solutab (for example, Flemoxin - a dispersible form of Amoxicillin, Flemoklav, Unidox - tetracycline Solutab) have a more favorable safety profile and better tolerability than traditional tablets or syrups. The likelihood of developing diarrhea (diarrhea) with these antibiotics is extremely low, even if you do not take medications containing “beneficial” microflora - probiotics.

To complete the picture describing the positive aspects of Flemoclav Solutab, it should be added that the dispersible tablets themselves do not contain sugar, gluten, or common allergens. Therefore, the drug can be taken by people suffering diabetes mellitus, celiac disease and gluten intolerance, as well as allergies.

How does Flemoclav Solutab work?

Well, now, having dealt with the intricacies of the dosage form and dosages of Flemoclav Solutab, let’s proceed to the intricacies of pharmacology. How does this antibiotic work? To find out, you must first refer to the instructions of the main active component drug - Amoxicillin, a derivative of an even earlier antibiotic, Ampicillin. This antibiotic works by inhibiting (blocking) bacterial cell wall synthesis. Simply put, it destroys a major component of the cell wall of gram-positive microorganisms and a minor component of gram-negative microorganisms. This fact explains why beta-lactam antibiotics, including Flemoklav Solutab, do not work powerfully enough against gram-negative microorganisms.

Clavulanic acid, as we have already said, does not have a detrimental effect on bacteria - it only protects the antibiotic itself, Amoxicillin, from destruction by enzymes.

So, what bacteria are sensitive to the action of Flemoclav Solutab? First of all, gram-positive, which include:

enterococci - bacteria that cause some intestinal infections;
streptococci, including rather dangerous beta-hemolytic strains;
staphylococci of various types, including the notorious Staphylococcus aureus;
clostridia, peptococci, peptostreptococci.

In addition, despite the fact that Amoxicillin is much less effective against gram-negative flora, some gram-negative bacteria are still sensitive to the drug. Among them:

bacteroids - causative agents of a number of intestinal infections;
fusobacteria;
Leptospira and some others, rare species microorganisms.

Separately, I would like to list a group of gram-negative bacteria that most likely will not react to Flemoclav Solutab:

coli;
Klebsiella;
Proteus;
salmonella;
shigella (the causative agent of dysentery);
pneumoniae streptococcus and some other types of streptococcus.

Indications for taking Flemoklav Solutab

Yes, but when is Flemoklav Solutab prescribed? A complete list of diseases for which this antibiotic is used may take more than one page - you have seen for yourself how wide the spectrum of its action is. We will try to systematize the pathologies to make it easier to figure out when to use Flemoxin Solutab.

Like any antibiotic, the combination of Amoxicillin and Clavulanic acid is prescribed for diseases caused by bacteria that are sensitive to it. Flemoklav Solutab is prescribed for various pathologies, including:

Upper respiratory tract infections. These infectious diseases include infections of the ear, nose and throat, including tonsillitis (inflammation of the tonsils), pharyngitis (inflammation of the pharynx), as well as inflammation of the middle ear (otitis media), sinusitis and sinusitis. Most of these pathologies are associated with infection with streptococci, Haemophilus influenzae, Moraxella, and streptococcus. This explains the effectiveness of Flemoclav Solutab for purulent, lacunar and other bacterial tonsillitis (also see the article Antibiotics for tonsillitis).
Lower respiratory tract infections , namely, bacterial bronchitis and pneumonia, for which streptococcus pneumoniae, Haemophilus influenzae and Moraxella are most often responsible. By the way, here we should especially highlight the fact that in more than 90% of cases, bronchitis is caused by viruses, and the prescription of antibiotics for it is rather an exception to the rule than an axiom.
Urogenital tract infections , including cystitis (inflammation of the bladder), inflammatory disease urethra (urethritis), kidney (pyelonephritis), some inflammatory gynecological diseases which are caused by bacteria sensitive to Flemoclav Solutab (for example, staphylococci or enterococci). In addition, Amoxicillin with Clavulanic acid has demonstrated effectiveness in uncomplicated gonorrhea, but this fact does not mean that patients can independently begin antibiotic therapy to get rid of the “inconvenient” disease without the help of a specialist.
Skin and soft tissue infections (For example, erysipelas, abscesses and so on). These pathologies are most often caused Staphylococcus aureus, streptococcus and bacteroids sensitive to Flemoclav Solutab.
Bone and joint tissue infections , for example, osteomyelitis, which most often develops due to infection with Staphylococcus aureus. By the way, the instructions for use of Flemoklav Solutab for adults and children emphasize that, if necessary, osteomyelitis can be treated with this antibiotic over long courses.
Dental infectious diseases , including periodontitis (inflammation of the periodontium, which may result in destruction of bone tissue, surrounding the tooth, and ligaments, which leads to severe consequences), maxillary odontogenic sinusitis associated with dental infections in the tissues upper jaw and so on.
Other infectious diseases , including postpartum sepsis (blood poisoning) and other severe infections (as part of complex antibiotic therapy).

When we say “antibiotic”, we mean “doctor”

Right after detailed description diseases for which Flemoclav Solutab is prescribed, I would like to draw the special attention of readers to the fact that all this information is not at all intended for self-medication. Even if you suddenly think that you are confident in the diagnosis and do not particularly need to consult a doctor, do not delude yourself - the doctor must take into account too many nuances when prescribing an antibacterial drug. Let's give a simple example. About 90% of cases of tonsillitis are associated not with a bacterial, but with a viral infection. This means that if you have a sore throat, antibiotics will most likely not only not help with treatment, but will also do harm, since they will only contribute to the development of new flora that is resistant to antibiotics.

Particularly dangerous is unauthorized treatment of sexually transmitted infections and genitourinary tract infections, which very easily turn into chronic form with incorrect antibiotic therapy. It is worth treating cystitis in a woman who has “caught” this quite common female disease, for a shorter period of time than necessary, and the inflammation will “go underground”: the bacteria will only stop active activity, hiding for a while, to soon become active again and cause a new wave of cystitis. And then it is much more difficult to cope with it, since microorganisms may already have time to develop resistance to the antibiotic.

In addition, along with the very likely development of resistance to the action of an antibacterial agent, drugs in this group can lead to the development of antibiotic-associated diarrhea. Other side effects are possible when using Flemoklav Solutab, and we will dwell on them in more detail.

Flemoklav Solutab: side effects according to instructions

On the one hand, adverse events associated with taking antibiotics, and, in particular, Flemoklav Solutab, are described in detail in the instructions for use, but on the other hand, the untrained reader requires an additional, deeper explanation of this section. This is necessary so that the consumer has a fairly clear understanding of what undesirable effects antibiotic therapy can lead to, but at the same time in no case develops a fear of the antibiotic, because of which patients can voluntarily stop treatment. In order to reduce the intensity of passions, we will categorize side effects, as pharmacologists usually do:

very common side effects that occur in more than one in ten patients;
frequent effects develop in 1–10% of cases;
when they talk about the infrequent development of adverse events, they mean that they occur in 0.1–1% of patients;
rare side effects are reported in 0.01–0.1% of cases;
and very rare side effects are said to occur when they develop in less than one patient out of 10,000.

Well, now let’s figure out when and what you can expect when using Flemoclav Solutab.

Often while taking this antibiotic develops antibiotic-associated diarrhea . Let’s immediately explain its cause: it is not associated with the appearance of so-called dysbiosis and other diseases that are not even listed in international disease codes, and, therefore, practically do not exist in nature. This really common side effect is due to the fact that while taking penicillin antibiotics, intestinal motility may increase, which leads to diarrhea. As a rule, these troubles go away on their own after discontinuation of the drug and in most cases do not require additional therapy. Sometimes, if diarrhea really causes inconvenience or threatens dehydration, you can stop it with the help of a symptomatic drug - Loperamide (2 capsules immediately and one capsule after each subsequent loose stool). However, we note that you should not abuse Loperamide or its analogues (Imodium, Lopedium and others).

Often When treated with Flemoklav Solutab, nausea may occur, which also does not require discontinuation of the drug. To make you feel better, you can accompany your antibiotic intake with the additional use of Metoclopramide (Cerucal) or Domperidone, which also somewhat reduces nausea.

Another common side effect is candidiasis of the skin or mucous membranes. It is due to the fact that Flemoklav Solutab still contributes to some shift in the standard microbiocenosis. The causative agents of candidiasis, candida fungi, which live in the human body and normally belong to the opportunistic flora, in such conditions can begin to multiply intensively, which leads to the development of candidiasis. Most often it manifests itself on the mucous membranes (in women, on the vaginal mucosa, as well as the oral mucosa) and is “popularly” called thrush. It is quite simple to combat this phenomenon: almost any antifungal drug, for example, Fluconazole (tablets or capsules for oral administration), Itraconazole and others effectively deal with candida.

Infrequent in the instructions for use of Flemoclav Solutab they are named the following types adverse events:

rash, itching, or hives;
dizziness and headache.

The remaining side effects are classified as rare and very rare, that is, they develop in almost isolated cases. These include changes in the blood picture, allergic manifestations, agitation or anxiety, digestive disorders, gastritis, and so on. Let us emphasize once again that all these “passions” are classified as rare, sometimes only in isolated cases.

Let's talk about contraindications

We cannot ignore the fact that there are a number of contraindications to taking Flemoclav Solutab.

First of all, the drug should not be taken by those who are allergic to Amoxicillin or Clavulanic acid. Flemoklav Solutab is not suitable for patients who are sensitive to fruit fragrances (in our case, apricot). If you have ever developed an allergy to any penicillin antibiotics or cephalosporins that have cross-sensitivity with penicillins, you are strictly contraindicated from taking Flemoclav Solutab and other analogues of Amoxicillin and Clavulanic acid.

It is also necessary to refuse treatment with Flemoclav for those patients who have developed jaundice or liver failure against the background of previous doses of analogues of this drug.

In addition, doctors prescribe this antibiotic with particular caution to patients with diseases of the gastrointestinal tract and kidney pathologies.

Flemoklav Solutab during pregnancy and lactation

The use of antibiotics during pregnancy has always raised a lot of questions both among doctors and pregnant women themselves. In the case of the combination of Amoxicillin and Clavulanic acid, fortunately, there are slightly fewer questions than usual. Many clinical studies have proven that Flemoclav Solutab (or rather, its active ingredients) do not cause a teratogenic effect in animals. Thus, despite the fact that the instructions for Flemoklav indicate that the drug is not recommended for use during pregnancy if the benefit to the mother is lower than the risk to the child, in obstetric practice the drug is prescribed quite often. There are known cases of long-term use of the drug by pregnant women, for example, against the background of recurrent pyelonephritis throughout the second and third trimester of pregnancy, while both the pregnancy itself and the child developed normally while taking Flemoclav Solutab.

As for breastfeeding, everything is even simpler: the annotation for the antibiotic states that it can be used by women who are breastfeeding.

Thus, the combination of Amoxicillin and Clavulanic acid, for example, Flemoklav Solutab, can be classified as one of the few antibiotics that are successfully used to treat both pregnant and lactating women.

About dosages

Finally, we come to the most detailed part of our story, describing the dosages of Flemoclav Solutab. It should be noted right away that both the exact dose and duration of the course of antibiotic therapy depend on the severity and type of disease, age, weight of the patient, general condition his health and therefore are selected directly by the attending physician. The instructions indicate that in order to reduce gastrointestinal side effects, Flemoklav Solutab is best taken before meals. In this case, the tablet can be swallowed whole with a glass of water, or dissolved in 30 ml of water (or more, if it is more convenient for the patient).

The average dosages of Flemoclav Solutab are:

For adults and children over 12 years of age (body weight over 40 kg) - 500+125 mg three times a day. In more severe cases(usually in adult practice) a higher dose is prescribed, 875+125 mg twice a day (morning and evening).
Children aged 2–12 years should receive a lower dose of antibiotic, which is calculated based on the child's weight. It usually ranges from 20+5 mg to 60+15 mg per kilogram of weight per day. Usually this dosage is divided into three doses.

We select a medicine by price: cheaper analogues of Flemoklav Solutab

And finally, let's list economical analogues of the antibiotic. Considering its unique dosage form, we can say that they simply do not exist - almost all analogues of Amoxicillin and Clavulanic acid are produced in the traditional dosage form of tablets or children's powders, from which a suspension is prepared before use. These include:

Augmentin is an original British drug produced by Glaxo, which has a very wide range of dosages, allowing you to choose a medicine regardless of age;
Amoxiclav is a high-quality Slovak analogue of Flemoklav Solutab, which, by the way, is also available in a dispersible form called Amoxiclas Quiktab. True, this analogue cannot be called cheaper than Flemoklav Solutab;
Ecoclave is a Russian adult and pediatric form of antibiotic that has a reasonable price;
Medoclav - tablets for adults produced in Cyprus, Medokemi company and many other drugs.

Another common consumer question should be answered: what is the difference between Flemoxin and Flemoclav Solutab? The difference is significant: Flemoxin contains only Amoxicillin, while Flemoklav contains a combination of Amoxicillin and Clavulanic acid.

To summarize, we note once again that there are practically no cheaper analogues of the drug Flemoklav Solutab as a product produced in the form of dispersible tablets. But it can be replaced with regular tablets for oral administration, however, it is better to do this with the permission of the attending physician, who must keep under control the entire process of antibiotic therapy: from the start to the complete victory over the infection.

Before using FLEMOCLAV SOLUTAB you should consult your doctor. These instructions for use are for informational purposes only. For more complete information, please refer to the manufacturer's instructions.

Clinical and pharmacological group

06.007 (Broad-spectrum penicillin antibiotic with beta-lactamase inhibitor)

Release form, composition and packaging

Dispersible tablets, oblong, white to yellow color with brown dotted spots, without marks, marked “421” and the company logo.

Dispersible tablets are oblong, from white to yellow in color with brown dotted spots, without marks, marked “422” and the company logo.

Excipients: microcrystalline cellulose, crospovidone, vanillin, apricot flavor, saccharin, magnesium stearate.

4 things. - blisters (5) - cardboard packs.

Dispersible tablets are oblong, from white to yellow in color with brown dotted spots, without marks, marked “424” and the company logo.

Excipients: microcrystalline cellulose, crospovidone, vanillin, apricot flavor, saccharin, magnesium stearate.

4 things. - blisters (5) - cardboard packs.

Dispersible tablets, oblong, from white to yellow, without marks, marked “425” and a graphic part of the company logo; brown dotted spots are allowed.

Excipients: dispersed cellulose, microcrystalline cellulose, crospovidone, vanillin, tangerine flavor, lemon flavor, saccharin, magnesium stearate.

7 pcs. - blisters (2) - cardboard packs.

pharmachologic effect

Broad-spectrum antibiotic; a combination drug of amoxicillin and clavulanic acid, a β-lactamase inhibitor. Active against gram-positive and gram-negative microorganisms (including strains producing β-lactamases).

Amoxicillin is bactericidal and inhibits the synthesis of peptidoglycan in the bacterial cell wall. Clavulanic acid inhibits β-lactamases types II, III, IV and V. Not active against type I β-lactamases produced by Enterobacter spp., 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 β-lactamases and expands its spectrum of action.

Flemoclav Solutab® is active against aerobic gram-positive bacteria: Streptococcus spp., Staphylococcus spp. (except methicillin-resistant strains), Enterococcus spp., Corynebacterium spp., Bacillus anthracis, Listeria monocytogenes; anaerobic gram-positive bacteria: Clostridium spp. (except Clostridium difficile), Peptococcus spp., Peptostreptococcus spp.; aerobic gram-negative bacteria: Escherichia coli, Klebsiella spp., Proteus spp., Yersinia enterocolitica, Salmonella spp., Shigella spp., Haemophilus influenzae, Haemophilus ducreyi, Neisseria gonorrhoeae, Neisseria meningitidis, Bordetella pertussis, Moraxella catarrhalis, Gardnerella vaginalis, Brucella spp., Pasteurella multocida, Vibrio cholerae, Helicobacter pylori; anaerobic gram-negative bacteria: Bacteroides spp., including Bacteroides fragilis, Fusobacterium spp.

Pharmacokinetics

Amoxicillin

Suction

After oral administration, it is quickly absorbed from the gastrointestinal tract. Absorption of amoxicillin after oral administration is 90-94%. Absolute bioavailability reaches 94%. Concomitant food intake does not affect absorption.

Cmax in blood plasma is achieved 1-2 hours after administration. After taking a single dose of 500 mg/125 mg (amoxicillin/clavulanic acid), the average concentration of amoxicillin (after 8 hours) is 0.3 mg/l.

After a single dose of 875 mg/125 mg (amoxicillin/clavulanic acid), the Cmax of amoxicillin in blood plasma is 12 mcg/ml.

Distribution

After a single dose of 875 mg/125 mg (amoxicillin/clavulanic acid), the AUC of amoxicillin is 33 mcg x h/l. Serum protein binding is approximately 17-20%.

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

Metabolism

A small part of amoxicillin is metabolized by hydrolysis of the beta-lactam ring to inactive metabolites (the main ones are penicillic and penamaldic acids).

Removal

Approximately 60-80% of amoxicillin is excreted through the kidneys during the first 6 hours after taking the drug. T1/2 is 0.9-1.2 hours.

In case of impaired renal function (creatinine clearance within 10-30 ml/min), T1/2 is 6 hours, and in the case of anuria it ranges between 10 and 15 hours. It is excreted by hemodialysis.

Clavulanic acid

Suction

After oral administration, it is quickly absorbed from the gastrointestinal tract. Absolute bioavailability is approximately 60%. Concomitant food intake does not affect absorption. Cmax in blood plasma is achieved approximately 1-2 hours after administration. After taking a single dose of 500/125 mg (amoxicillin/clavulanic acid), the average concentration of clavulanic acid reaches 0.08 mg/l (after 8 hours).

After a single dose of 875 mg/125 mg (in blood plasma is 3 mcg/ml.

Distribution

Following a single dose of 875 mg/125 mg (amoxicillin/clavulanic acid), the AUC of clavulanic acid is 6 mcg x h/L.

Serum protein binding is 22%. Clavulanic acid penetrates the placental barrier. There is no reliable data on excretion in breast milk.

Metabolism

Clavulanic acid undergoes extensive metabolism through hydrolysis and subsequent decarboxylation.

Removal

Approximately 30-50% of clavulanic acid is excreted through the kidneys during the first 6 hours after taking the drug. T1/2 is approximately 1 hour.

The total clearance for amoxicillin and clavulanic acid is 25 l/h.

Pharmacokinetics in special clinical situations

In case of impaired renal function (creatinine clearance from 20 to 70 ml/min), T1/2 is 2.6 hours, and in case of anuria it ranges from 3-4 hours. It is excreted by hemodialysis.

FLEMOCLAV SOLUTAB: DOSAGE

For adults and children over 12 years of age and children under 12 years of age weighing more than 40 kg, Flemoclav Solutab® at a dose of 875 mg/125 mg is prescribed 2 times a day (every 12 hours).

Children under 12 years of age weighing less than 40 kg are prescribed Flemoclav.

For adults and children weighing more than 40 kg, the drug is prescribed 500 mg/125 mg 3 times a day. For severe, chronic, recurrent infections, this dose can be doubled.

A possible dosage regimen for children is presented in the table. The daily dose is usually 20-30 mg of amoxicillin and 5-7.5 mg of clavulanic acid per kg of body weight.

For severe infections, these doses can be doubled (the maximum daily dose is 60 mg amoxicillin and 15 mg clavulanic acid per kg body weight).

The duration of treatment depends on the severity of the infection and should not exceed 14 days unless necessary.

Flemoclav Solutab® at a dose of 875 mg/125 mg can only be used if the glomerular filtration rate is more than 30 ml/min. In this case, no dose adjustment is required.

In case of liver dysfunction, the drug should be prescribed with caution. It is necessary to monitor liver function.

Age
Body mass
Daily dose
from 3 months to 2 years
from 5 to 12 kg
tablets 125 mg/31.25 mg 2 times/day
from 2 to 7 years
from 13 to 25 kg
tablets 125 mg/31.25 mg 3 times/day
from 7 to 12 years
from 25 to 37 kg
tablets 250 mg/62.5 mg 3 times/day
Glomerular filtration rate
Adults
Children
10-30 ml/min
500 mg 2 times/day
15 mg/kg 2 times/day
less than 10 ml/min
500 mg/day
15 mg/kg/day
hemodialysis

Overdose

Symptoms: nausea, vomiting, diarrhea with possible disturbances in water and electrolyte balance.

Treatment: activated carbon and osmodiuretics are prescribed, it is necessary to maintain water and electrolyte balance, and symptomatic therapy is carried out. For convulsions, diazepam is prescribed. At renal failure severe cases undergo hemodialysis.

Drug interactions

When used simultaneously with some bacteriostatic drugs (for example, chloramphenicol, sulfonamides), antagonism with amoxicillin/clavulanic acid in vitro was observed.

Amoxicillin/clavulanic acid should not be co-administered with disulfiram.

When used simultaneously with Flemoklav Solutab®, antacids, glucosamine, laxatives, aminoglycosides slow down and reduce the absorption of amoxicillin, while ascorbic acid increases the absorption of amoxicillin.

Concomitant use of Flemoclav Solutab® with allopurinol may increase the risk of developing a skin rash.

Aminopenicillins may decrease serum concentrations of sulfasalazine.

Amoxicillin reduces the renal clearance of methotrexate, which may lead to an increased risk of toxicity. When taken concomitantly with amoxicillin, monitoring of the concentration of methotrexate in the blood serum is necessary.

Concomitant use of amoxicillin/clavulanic acid and digoxin may lead to increased absorption of digoxin.

With the simultaneous use of Flemoclav Solutab® and indirect anticoagulants, the risk of bleeding may increase.

In rare cases, while taking amoxicillin, a decrease in the effectiveness of oral contraceptives has been observed, so the patient should be advised to use non-hormonal methods of contraception.

Pregnancy and lactation

When using Flemoklav Solutab® during pregnancy, no negative effects on the fetus or newborn were noted. The use of the drug in the second and third trimester of pregnancy is possible after a medical assessment of the risk/benefit. In the first trimester of pregnancy, the use of Flemoclav Solutab® should be avoided (only for dispersible tablets 875 mg/125 mg). Dispersible tablets 125 mg/31.25 mg, 250 mg/62.5 mg, 500 mg/125 mg in the first trimester of pregnancy should be prescribed with caution.

Amoxicillin and clavulanic acid penetrate the blood-placental barrier and are excreted in breast milk. It is possible to use the drug during the period.

If a child develops sensitization, diarrhea or candidiasis of the mucous membranes, breastfeeding should be stopped.

FLEMOCLAV SOLUTAB: SIDE EFFECTS

The incidence of adverse events was classified as follows: often (≥1/100,

From the hematopoietic system: rarely - thrombocytosis, hemolytic anemia; very rarely - leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, anemia. These adverse reactions are reversible and disappear after discontinuation of therapy.

From the coagulation system: very rarely - an increase in prothrombin time and bleeding time. These adverse reactions are reversible and disappear after discontinuation of therapy.

From the outside nervous system: rarely - dizziness, headache, convulsions (in case of impaired renal function or drug overdose); very rarely - hyperactivity, restlessness, anxiety, insomnia, impaired consciousness, aggressive behavior.

From the outside of cardio-vascular system: rarely - vasculitis.

From the digestive system: often - abdominal pain, nausea (more often in case of overdose), vomiting, flatulence, diarrhea (generally, reactions from the digestive system are transient and rarely pronounced; their intensity can be reduced by taking the drug at the beginning of treatment food); pseudomembranous colitis (in case of severe and persistent diarrhea while taking the drug or within 5 weeks after completion of therapy), in most cases caused by Clostridium difficile; rarely - intestinal candidiasis, hemorrhagic colitis, discoloration of the surface layer of tooth enamel.

From the liver: often - a slight increase in the activity of liver enzymes; rarely - hepatitis and cholestatic jaundice. Symptoms of liver dysfunction occur during treatment or immediately after stopping therapy, but in some cases they may appear several weeks after stopping the drug; more often observed in men and patients over 60 years of age; observed very rarely in children (

From the genitourinary system: infrequently - itching, burning and vaginal discharge; rarely - interstitial nephritis.

Allergic reactions: often - skin rash and itching; morbilliform exanthema, appearing 5-11 days after the start of therapy. The appearance of urticaria immediately after starting to take the drug with high degree is likely a manifestation of an allergic reaction and requires discontinuation of the drug. Rarely - bullous or exfoliative dermatitis (erythema multiforme exudative, Stevens-Johnson syndrome, toxic epidermal necrolysis), anaphylactic shock, drug fever, eosinophilia, angioedema (Quincke's edema), laryngeal edema, serum sickness, hemolytic anemia, allergic vasculitis, interstitial nephritis .

Other: uncommon - bacterial or fungal superinfections (with long-term therapy or repeated courses of therapy).

Storage conditions and periods

List B. The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life - 3 years. The shelf life of dispersible tablets 875 mg/125 mg is 2 years.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

infections upper sections respiratory tract and ENT organs (incl.
otitis media,
sinusitis,
tonsillitis,
pharyngitis);
lower respiratory tract infections (incl.
exacerbation chronic bronchitis,
COPD,
community-acquired pneumonia);
infections of bones and joints,
incl.
osteomyelitis (only for tablets 875 mg/125 mg);
infections in obstetrics and gynecology (only for tablets 875 mg/125 mg);
skin and soft tissue infections;
kidney infections and urinary tract(incl.
cystitis,
pyelonephritis).

Contraindications

liver dysfunction (incl.
jaundice) with a history of taking amoxicillin/clavulanic acid;
Infectious mononucleosis;
lymphocytic leukemia;
renal failure (glomerular filtration ≤ 30 ml/min) - for dispersible tablets 875 mg/125 mg;
children under 12 years of age weighing less than 40 kg (for dispersible tablets 875 mg/125 mg);
hypersensitivity to amoxicillin,
clavulanic acid and other components of the drug;
hypersensitivity to other beta-lactam antibiotics (penicillins and cephalosporins).

The drug should be prescribed with caution in severe liver failure, chronic renal failure, gastrointestinal diseases (including a history of colitis associated with the use of penicillins).

special instructions

When taking Flemoclav Solutab®, there is a possibility of cross-resistance and hypersensitivity with other penicillins or cephalosporins.

If anaphylactic reactions develop, the drug should be stopped immediately and appropriate therapy administered: treatment of anaphylactic shock may require urgent administration of epinephrine (adrenaline), corticosteroids and elimination of respiratory failure.

Superinfection (for example, candidiasis) may develop, especially in patients with chronic diseases and/or impaired immune system function. If superinfection occurs, the drug is discontinued and/or antibacterial therapy is adjusted accordingly.

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 in these cases is contraindicated.

If liver function is impaired, the drug should be prescribed with caution and under constant medical supervision. The drug should not be used for more than 14 days without assessing liver function.

In a single study, prophylactic amoxicillin/clavulanate in women with premature rupture of membranes increased the risk of neonatal necrotizing enterocolitis.

While taking the drug, an increase in prothrombin time may be observed. Therefore, Flemoklav Solutab® should be prescribed with caution to patients receiving anticoagulant therapy (blood clotting parameters must be monitored).

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.

During the period of use of Flemoclav Solutab®, non-enzymatic methods for determining glucose in urine, as well as a test for urobilinogen, may give false positive results.

During a course of treatment, it is necessary to monitor the functions of the hematopoietic organs, liver and kidneys.

If seizures occur during therapy, the drug is discontinued.

It should be taken into account that 1 dispersible tablet 875 mg/125 mg contains 25 mg of potassium.

Use for renal impairment

The drug should be prescribed with caution in chronic renal failure.

If renal function is impaired, the excretion of clavulanic acid and amoxicillin by the kidneys slows down. Depending on the severity of renal failure, the dose of Flemoclav Solutab® (calculated as amoxicillin) should not exceed that presented in the table.

Creatinine clearance
Adults
Children
10-30 ml/min
500 mg 2 times/day
15 mg/kg 2 times/day
less than 10 ml/min
500 mg/day
15 mg/kg/day
hemodialysis
500 mg/day and 500 mg during and after dialysis
15 mg/kg/day and 15 mg/kg during and after dialysis

Use for liver dysfunction

The drug should be prescribed with caution in severe liver failure.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Registration numbers

tab. dispersible 875 mg+125 mg: 14 pcs. LSR-000392/09 (2026-01-09 – 0000-00-00) tab. dispersible 250 mg+62.5 mg: 20 pcs. P N016067/01 (2017-11-09 – 0000-00-00) tab. dispersible 500 mg+125 mg: 20 pcs. P N016067/01 (2017-11-09 – 0000-00-00) tab. dispersible 125 mg+31.25 mg: 20 pcs. P N016067/01 (2017-11-09 – 0000-00-00)

Composition and release form

4 pcs in blister; There are 5 blisters in a cardboard pack.

7 pcs in blister; There are 2 blisters in a cardboard pack.

Description of the dosage form

Tablets of oblong shape from white to yellow with brown dotted spots, without marks, marked: “421” - at a dosage of 125 mg + 31.25 mg; “422” - 250 mg + 62.5 mg; “424” - 500 mg + 125 mg; “425” - 875 mg + 125 mg and a graphic part of the company logo.

Characteristic

A combination drug containing semisynthetic penicillin and a beta-lactamase inhibitor.

pharmachologic effect

Pharmacological action - broad spectrum antibacterial.

Pharmacodynamics

It has a bactericidal effect and inhibits the synthesis of the bacterial wall. Active against gram-positive and gram-negative microorganisms (including strains producing beta-lactamases). Clavulanic acid, which is part of the drug, suppresses types II, III, IV and V beta-lactamases, and is inactive against type I beta-lactamases produced Enterobacter spp., Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid has a high tropism 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 and expands its spectrum of action.

Flemoklav is active in relation to:

Aerobic gram-positive bacteria Streptococcus pyogenes, Streptococcus viridans, Streptococcus pneumoniae, Staphylococcus aureus(including strains producing beta-lactamases), Staphylococcus epidermidis(including strains producing beta-lactamases) Enterococcus faecalis, Corynebacterium spp., Bacillus anthracis, Listeria monocytogenes;

Anaerobic gram-positive bacteria Clostridium spp., Peptococcus spp., Peptostreptococcus spp.

Aerobic gram-negative bacteria Escherichia coli, Klebsiella spp., Proteus mirabilis, Proteus vulgaris, Yersinia enterocolitica, Salmonella spp., Shigella spp., Haemophilus influenzae, Haemophilus duсreyi, Neisseria gonorrhoeae(including strains of the above bacteria that produce beta-lactamases), Neisseria meningitidis, Bordetella pertussis, Gardnerella vaginalis, Brucella spp., Branhamella catarrhalis, Pasteurella multocida, Campylobacter jejuni, Vibrio cholerae, Moraxella catarrhalis, Helicobacter pylori;

Anaerobic gram-negative bacteria Bacteroides spp., including Bacteroides fragilis(including beta-lactamase producing strains).

Pharmacokinetics

Amoxicillin. The absolute bioavailability of amoxicillin reaches 94%. Absorption is independent of food intake. Cmax in plasma is observed 1–2 hours after taking amoxicillin. After taking a single dose of 500 mg + 125 mg (amoxicillin + clavulanic acid), the average concentration of amoxicillin (after 8 hours) is 0.3 mg/l. Serum protein binding is approximately 17–20%. Amoxicillin penetrates the placental barrier and in small quantities into breast milk.

Amoxicillin is metabolized in the liver (10% of the administered dose). For the most part excreted through the kidneys (52±15)% of the dose (unchanged within 7 hours) and in small quantities with bile. T1/2 from blood serum in patients with normal renal function is approximately 1 hour (0.9–1.2 hours), in patients with creatinine Cl in the range of 10–30 ml/min it is 6 hours, and in case of anuria it fluctuates within the range between 10 and 15 hours. Excreted during hemodialysis.

Clavulanic acid. The absolute bioavailability of clavulanic acid is approximately 60%. Absorption is independent of food intake. Cmax of clavulanic acid in the blood is observed 1–2 hours after administration. After taking amoxicillin with clavulanic acid in a single dose of 500 mg + 125 mg, the average Cmax of clavulanic acid (0.08 mg/l) is achieved after 8 hours. Plasma protein binding is 22%. Clavulanic acid penetrates the placental barrier. There is no reliable data on penetration into breast milk.

Clavulanate is metabolized in the liver (50–70%) and about 40% is excreted through the kidneys (18–38% unchanged). Total Cl is approximately 260 ml/min. T1/2 in patients with normal renal function is approximately 1 hour, in patients with creatinine Cl 20-70 ml/min - 2.6 hours, and with anuria - within 3-4 hours. Eliminated by hemodialysis.

Tablets 875 mg + 125 mg

After a single dose of Flemoklav Solutab ® at a dose of 875 mg + 125 mg (amoxicillin + clavulanic acid), the Cmax of amoxicillin in the blood plasma is created after 1.5 hours and is 12 μg/ml, clavulanic acid - after 1 hour, amounting to 3 μg/ml . The AUC of amoxicillin and clavulanic acid is 33 mcg h/l and 6 mcg h/l, respectively. Absorption of amoxicillin when administered orally reaches 90%, the absolute bioavailability of clavulanic acid averages 60%.

Approximately 17–20% of amoxicillin and 22% of clavulanic acid are bound to plasma proteins. The total Cl for the two active substances is 25 l/h, half-life of amoxicillin is 1.1 hours, clavulanic acid is 0.9 hours. Approximately 60–80% of amoxicillin and 30–50% of clavulanic acid are excreted through the kidneys during the first 6 hours after taking the drug. Amoxicillin is excreted predominantly unchanged, a small part is metabolized by hydrolysis of the beta-lactam ring to inactive metabolites (the main ones are penicillic and penamaldic acids). Clavulanic acid undergoes extensive metabolism through hydrolysis and subsequent decarboxylation.

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).

infections of bones and joints (including osteomyelitis);

in obstetrics and gynecology.

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 with body weight

Carefully:

severe liver failure;

gastrointestinal diseases (including a history of colitis associated with the use of penicillins);

chronic renal failure.

Use during pregnancy and breastfeeding

There were no adverse effects of amoxicillin/clavulanate on the fetus or newborns when used by pregnant women. Use in the second and third trimesters of pregnancy is possible after a medical assessment of the risks/benefits of treatment. In the first trimester, the use of the drug should be avoided.

Both components of the drug penetrate the hematoplacental barrier and are excreted into breast milk. It is possible to use the drug during breastfeeding.

If a child develops sensitization, diarrhea or candidiasis of the mucous membranes, breastfeeding should be stopped.

Side effects

Tablets 125 mg + 31.25 mg; 250 mg + 62.5 mg; 500 mg + 125 mg

Allergic skin reactions: urticaria, exanthema; erythematous rashes, rarely - exudative erythema multiforme, extremely rarely - exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), erythema multiforme. Reactions depend on the dose of the drug and the patient's condition.

From the gastrointestinal tract: nausea, vomiting, diarrhea, abdominal pain; impaired liver function, increased activity of liver transaminases, in isolated cases - pseudomembranous colitis.

An increase in the activity of transaminases (AST and ALT), bilirubin and alkaline phosphatase is usually observed in males and elderly patients, especially over 65 years of age. These phenomena are very rarely observed in children. The above changes usually appear during treatment or immediately after. Sometimes they may appear several weeks after stopping the drug. Basically, reactions from the digestive system are transient and minor, but sometimes they are pronounced. To prevent side effects, it is recommended to take the drug at the beginning of a meal. The risk of such changes increases when taking the drug for more than 14 days.

From the blood system and lymphatic system: rarely - changes in blood composition (leukopenia, thrombocytopenia, hemolytic anemia); prolongation of prothrombin time (reversible).

rarely - cholestatic jaundice, hepatitis.

From the immune system: rarely - angioedema, vasculitis.

From the urinary system: interstitial nephritis.

Others: candidiasis, development of superinfection. In isolated cases - anaphylactic shock.

Tablets 875 mg + 125 mg

Infections: infrequently (?1/1000,

From the blood system and hematopoietic organs: rarely (?1/10000, PT and bleeding time. These adverse reactions are reversible and disappear after cessation of therapy.

Allergic reactions: often (?1/100, From the nervous system: rarely (?1/10000,

From the cardiovascular system: rarely (?1/10000,

Reactions from the digestive system: often (?1/100, weeks after completion of therapy) in most cases caused by toxin-producing strains Clostridium difficile; rare (? 1/10000,

From the hepatobiliary system: often (? 1/100,

From the genitourinary system: infrequently (? 1/1000, 1/10000,

Interaction

Tablets 125 mg + 31.25 mg; 250 mg + 62.5 mg; 500 mg + 125 mg

Antacids, glucosamine, laxatives, aminoglycosides slow down and reduce absorption; ascorbic acid - increases.

Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) have a synergistic effect; bacteriostatic antimicrobial agents (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonistic.

Increases the effectiveness of indirect anticoagulants (suppresses intestinal microflora, reduces the synthesis of vitamin K and prothrombin index). When taking anticoagulants simultaneously, it is necessary to monitor blood clotting indicators.

Reduces the effectiveness of oral contraceptives, drugs, during the metabolism of which para-aminobenzoic acid and ethinyl estradiol are formed (risk of 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.

Amoxicillin should not be given with disulfiram.

The simultaneous use of amoxicillin and digoxin may lead to an increase in the concentration of digoxin in the blood plasma.

Tablets 875 mg + 125 mg

Other antimicrobial drugs. At joint use with some bacteriostatic drugs (for example, chloramphenicol, sulfonamides, etc.), antagonism with amoxicillin/clavulanic acid was observed in vitro.

Disulfiram. Amoxicillin/clavulanic acid should not be used concomitantly with disulfiram.

Medicines that inhibit the renal excretion of amoxicillin. Concomitant use of probenecid, phenylbutazone, oxyphenbutazone and, to a lesser extent, acetylsalicylic acid, indomethacin and sulfinpyrazone helps to increase the concentration and longer presence of amoxicillin in the blood plasma and bile. The excretion of clavulanic acid is not impaired.

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

Allopurinol. Prescription of allopurinol and amoxicillin may increase the risk of developing skin rash.

Sulfasalazine. Aminopenicillins may decrease serum concentrations of sulfasalazine.

Methotrexate. Amoxicillin reduces the renal clearance of methotrexate, which may lead to an increased risk of toxicity. When taken concomitantly with amoxicillin, monitoring of the concentration of methotrexate in the blood serum is necessary.

Digoxin. While taking amoxicillin/clavulanic acid, digoxin absorption may be increased.

Anticoagulants. When taken simultaneously with indirect anticoagulants, the risk of bleeding may increase.

Hormonal contraceptives. In rare cases, while taking amoxicillin, a decrease in the effectiveness of oral contraceptives has been observed, so patients should be advised to use non-hormonal methods of contraception.

Directions for use and doses

Inside, at the beginning of a meal (to prevent dyspeptic symptoms), without chewing, with a glass of water or dissolving the tablet in half a glass of water (at least 30 ml), stirring thoroughly before use.

The duration of treatment depends on the severity of the infection and should not exceed 14 days unless absolutely necessary.

For adults and children over 12 years of age, as well as children under 12 years of age weighing more than 40 kg, the drug is prescribed at 500 mg + 125 mg 3 times a day or 875 mg + 125 mg 2 times a day. A single dose is taken at regular intervals. For severe, recurrent and chronic infections, these doses can be doubled.

Children under 12 years of age weighing up to 40 kg are prescribed Flemoklav Solutab ® with lower dosages: 125 mg + 31.25 mg; 250 mg + 62.5 mg; 500 mg + 125 mg.

For children aged 2 to 12 years (body weight approximately 13–37 kg), the daily dose is 20–30 mg/kg amoxicillin and 5–7.5 mg/kg clavulanic acid. This usually amounts to: for children 2–7 years old (body weight about 13–25 kg) - 125 mg + 31.25 mg 3 times a day; for children 7–12 years old (body weight 25–37 kg) - 250 mg + 62.5 mg 3 times a day. For severe infections, these doses can be doubled (maximum daily dose - 60 mg/kg amoxicillin and 15 mg/kg clavulanic acid).

In patients with renal failure, the excretion of clavulanic acid and amoxicillin through the kidneys is slow. Flemoclav Solutab ® at a dose of 875 mg + 125 mg can only be used if the glomerular filtration rate is >30 ml/min. In this case, no dose adjustment is required.

Depending on the severity of renal failure, the total dose of Flemoclav Solutab ® (in doses of 125 mg + 31.25 mg, 250 mg + 62.5 mg, 500 mg + 125 mg), expressed as a dose of amoxicillin, should not exceed the dosages presented in the table:

Amoxicillin with clavulanic acid should be administered with caution to patients with liver damage. Liver function should be constantly monitored.

Overdose

Symptoms: nausea, vomiting and diarrhea with possible violation water and electrolyte balance.

Treatment: appointment activated carbon. Maintaining water and electrolyte balance. Symptomatic therapy. For convulsions, diazepam is prescribed. In case of severe renal failure - hemodialysis.

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 Flemoklav Solutab ® is not advisable until the above symptoms are eliminated, because Possible disruption of drug absorption from the gastrointestinal tract.

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.

If seizures occur during therapy, the drug is discontinued. One dispersible tablet Flemoklav 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.

Storage conditions for the drug Flemoklav Solutab ®

At a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf life of the drug Flemoklav Solutab ®

dispersible tablets 125 mg+31.25 mg - 3 years.

dispersible tablets 250 mg+62.5 mg - 3 years.

dispersible tablets 500 mg+125 mg - 3 years.

dispersible tablets 875 mg+125 mg - 2 years.

Do not use after the expiration date stated on the package.

This drug is a broad-spectrum antibiotic. Has become widespread in medical practice. Loved by doctors and parents for its quick and effective treatment various diseases. Flemoklav Solutab contains amoxicillin and clavulanic acid. This medicine Available in the form of dispersible tablets in dosages of 125 mg, 250 mg, 500 mg and 875 mg. The dosage (given in terms of amoxicillin) when prescribed depends on the age and body weight of each patient (and the severity of the disease).

Flemoklav Solutab (has analogues in composition) is used orally for infections:

respiratory tract (bronchitis, pneumonia, pleural empyema, lung abscess);
ENT organs (sinusitis, tonsillitis, otitis media);
genitourinary system (pyelonephritis, pyelitis, cystitis, urethritis and others);
soft tissues (erysipelas, impetigo, secondary infected dermatoses, abscesses);
joints and bones (including osteomyelitis);
postoperative.

The doctor decides how to take the drug in each individual case.

It is especially important to remember this when the appointment is made to a child.

Application

Flemoklav Solutab tablets are taken immediately before meals, without chewing (whole) and with a whole glass of water. It is better and easier for children to give the drug in the form of a suspension. To do this, the instructions for use recommend thoroughly dissolving the dispersible tablets in water (0.5 cups).

The dosage of Flemoklav Solutab for children under 3 months of age is 20 mg per unit of the child’s weight per day (to be divided into 2 doses). For a child from 3 months to 2 years – 25 mg per unit of weight per day (also in 2 doses).

Children aged 2 to 7 years, weighing 13-25 kg, need to take a single dose of 125 mg (two or three times a day). From 7 to 12 years (weight 25-37 kg) – 1 tablet of 250 mg (or 2 of 125) 2 to 3 times a day. The exact dose is determined by the doctor.

For children over 12 years of age whose weight exceeds 40 kg (and for adults), the dosage of Flemoklav Solutab is 1 tablet of 250 mg (or 2 tablets of 125) three times a day. In severe forms of the disease, it is possible to increase the dose - 1 tablet of 500 mg (2 tablets of 250 or 4 tablets of 125) three times a day.

How to prepare the suspension

Let's calculate the dosage of the suspension for a 2-month-old child weighing about 5 kg. To do this, you will need Flemoklav Solutab dispersible tablet with a dosage of 125 mg and 125 ml of boiled water (strictly at room temperature). Dissolve the tablet in a glass of water, stirring thoroughly.

Since the daily dose for a 2-month-old baby is 20 mg for each unit of weight, then 20 5 = 100.

Therefore, 100 ml of the resulting Flemoclav Solutab solution must be divided into 2 doses (50 ml each) and given to the infant at equal intervals. Use a bottle and a nipple with a large hole for this.

The suspension is stored in a cool, dark place for no more than one day.

Special cases

For patients with renal impairment, the daily dose of Flemoclav Solutab should be less than the values indicated in the table.

In this case, the dosage of Flemoklav Solutab requires adjustment by the attending physician. He also gives recommendations for use and decides how long to use the drug.

Patients with problems with liver function must strictly monitor its functions. Consequently, strict medical supervision is also carried out.

Contraindications

Instructions for use include Flemoclav Solutab as contraindications:

increased sensitivity of the patient to the components of the drug;
hypersensitivity to penicillin and cephalosporin antibiotics;
mononucleosis (infectious);
jaundice or liver dysfunction after taking amoxicillin or clavulanic acid.

Flemoklav Solutab is prescribed with extreme caution to children with diseases of the gastrointestinal tract.

Parents need to remember that a developing child’s body requires careful attention.

By-effect

When using a medication at a dosage of 125 or 250 mg, the child’s body may experience such negative manifestations as:

skin allergy– urticaria, erythematous rashes, exanthema;
gastrointestinal organs – vomiting, nausea, abdominal pain, diarrhea;
blood and lymph– leukopenia, hemolytic anemia, thrombocytopenia;
hepatobiliary system– jaundice (cholestatic), hepatitis;
the immune system– vasculitis, angioedema;
urinary system– interstitial nephritis.

In very rare cases, anaphylactic shock is possible.

It should be noted that all of the listed reactions to the drug Flemoklav Solutab, as a rule, occur immediately during treatment.

However, there is a possibility of their manifestations after some time (about a week).

In any case, parents should immediately notify the attending physician about this and seek advice on the advisability of further use of the medicine.

Overdose

Toxication is possible if the instructions for use of the drug Flemoklav Solutab are not followed and entails nausea, vomiting, and diarrhea.

To eliminate such symptoms, children are advised to urgently lavage the stomach and then take sorbent drugs (activated carbon).

We emphasize once again that the dosage for a child is determined by the doctor depending on weight and age. Parents must strictly adhere to the instructions.

Drug substitutes

Analogs of the drug Flemoklav Solutab are known on the domestic market of medical drugs. : Amoxiclav 2X, Amoxil - K 625, Amoxiclav Quiktab, Augmentin (BD), Augmentin (SR), Baktolkav, Klavam, Clavamitin, Medoclav, Panclave, Rapiclav, Rekut, Trifamox IBL.

All of them have a similar ATC code and active ingredients.

Which of the listed drugs is suitable for a child of different ages, and what dosage is required, is determined only by the attending physician.

Parents should never make this decision on their own. Since each medication requires an individual approach.

Helper in the fight for health

The time has long passed when the use of antibiotics was considered an out-of-the-ordinary event. Modern pharmacology can boast the latest developments in the field of similar medicines.

Flemoklav Solutab and its analogues allow as soon as possible cope with various diseases and their consequences.

The only rule that all patients need to remember is that antibiotics require strict dosage.

And then they will bring only benefits, without any side effects.