Registration number:P N016067 / 01-130114
Tradename: Flemoklav Solutab®
Dosage form: dispersible tablets
Composition:
Active ingredient: amoxicillin trihydrate (which corresponds to amoxicillin base) - 145.7 mg (125 mg), 291 mg (250 mg), 528.8 mg (0.5 g); potassium clavulanate (which corresponds to clavulanic acid) 37.2 mg (31.25 mg), 74.5 mg (62.5 mg), 148.9 mg (125 mg).
Excipients: microcrystalline cellulose, crospovidone, vanillin, apricot flavor, saccharin, magnesium stearate.
Description
Elongated tablets from white to yellow with brown dotted spots without risks and marked: "421" - at a dosage of 125 mg + 31.25 mg; "422" - 250 mg + 62.5 mg; "424" - 0.5 g + 125 mg and the company logo.

Pharmacotherapeutic group: antibiotic, polysynthetic penicillin + beta-lactamase inhibitor.

ATX code: .

Pharmacological properties

A broad-spectrum antibiotic, a combined preparation of amoxicillin and clavulanic acid - a beta-lactamase inhibitor. Acts bactericidal, inhibits the synthesis of the bacterial wall. Active against gram-positive and gram-negative microorganisms (including strains that produce beta-lactamases). Clavulanic acid, which is part of the drug, inhibits types II, III, IV and V of beta-lactamases, is inactive against type I 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:
Streptococcus pyogenes, Streptococcus viridans, Streptococcus pneumoniae, Staphylococcus aureus (including beta-lactamase-producing strains), Staphylococcus epidermidis (including beta-lactamase-producing strains), Enterococcus lactamase, Enterococcus Lspp. Faecalis.
Clostridium spp., Peptococcus spp., Peptostreptococcus spp.
Escherichia coli, Klebsiella spp., Proteus mirabilis, Proteus vulgaris, Yersinia enterocolitica, Salmonella spp., Shigella spp., Haemophilus influenzae, Haemophilus ducreyi, Neisseria gonorrhoeae (including the strains of the above bacteria that produce lactic acid dermatitis) 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 strains producing beta-lactamases).

Amoxicillin:
The absolute bioavailability of amoxicillin reaches 94%. Absorption is independent of food intake. The maximum plasma concentration is observed 1-2 hours after taking amoxicillin. After taking a single dose of 500 / 125mg (amoxicillin / clavulanic acid), the average concentration of amoxicillin (after 8 hours) is 0.3mg / l. Serum protein binding is approximately 17-20%. Amoxicillin crosses the placental barrier and in small quantities passes into breast milk.
Amoxicillin is metabolized in the liver (10% of the administered dose), mostly excreted through the kidneys (52 ± 15% of the dose unchanged within 7 hours) and a small amount is excreted in the bile. The serum half-life in patients with normal renal function is approximately 1 hour (0.9-1.2 h), in patients with creatinine clearance within 10-30 ml / min it is 6 hours, and in the case of anuria it ranges between 10 and 15 for hours. The drug is excreted during hemodialysis.
Clavulanic acid:
The absolute bioavailability of clavulanic acid is approximately 60%. Absorption is independent of food intake. The maximum concentration of clavulanic acid in the blood is noted 1-2 hours after ingestion. After taking a single dose of 0.5 g / 125 mg (amoxicillin / clavulanic acid), the average maximum concentration of clavulanic acid reaches 0.08 mg / l after 8 hours. Plasma protein binding is 22%. Clavulanic acid crosses the placental barrier. There are 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). The total clearance is approximately 260 ml / min. The half-life in patients with normal renal function is approximately 1 hour, in patients with creatine clearance of 20-70 ml / min - 2.6 hours, and in anuria - within 3-4 hours. The drug is excreted during hemodialysis.

Indications for use

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
- upper respiratory tract and ENT organs (including otitis media, sinusitis, tonsillitis, pharyngitis);
- lower respiratory tract: chronic bronchitis and its exacerbations, community-acquired pneumonia;
- skin and soft tissues;
- kidneys and lower urinary tract.

Contraindications

Hypersensitivity to amoxicillin, clavulanic acid or other components. Hypersensitivity to other beta-lactam antibiotics such as penicillins and cephalosporins. Jaundice or liver dysfunction with a history of amoxicillin / clavulanate. Patients with infectious mononucleosis or lymphocytic leukemia have an increased risk of exanthema, so amoxicillin / clavulanic acid should not be prescribed for these conditions.

Carefully: severe liver failure, diseases of the gastrointestinal tract (including a history of colitis associated with the use of penicillins), chronic renal failure.

Pregnancy and lactation

No harmful effects of amoxicillin / clavulanate on the fetus and newborns were noted when used by pregnant women. Use in the II and III trimesters of pregnancy is considered safe. During the first trimester, the drug should be administered with caution.
Amoxicillin is excreted in breast milk. There are no data on the excretion of clavulanic acid in breast milk. There was no harmful effect on the child during breastfeeding while taking a combination of amoxicillin and clavulanic acid.

Method of administration and dosage

To prevent dyspeptic symptoms, Flemoklav Solutab® is prescribed at the beginning of a meal. The tablet is swallowed whole with a glass of water, or dissolved 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 without special need.
Adults and children weighing more than 40 kg the drug is prescribed at 0.5 g / 125 mg 3 times / day. For severe, recurrent and chronic infections, these doses can be doubled.
For children aged 3 months to 2 years (with a body weight of about 5-12 kg) the daily dose is 20-30 mg of amoxicillin and 5-7.5 mg of clavulanic acid per kg of body weight. This is usually a dose of 125 / 31.25 mg 2 times / day.
For children aged 2 to 12 (with a body weight of about 13-37 kg) the daily dose is 20-30 mg of amoxicillin and 5-7.5 mg of clavulanic acid per kg of body weight. This is usually a dose of 125 / 31.25 mg 3 times / day for children aged 2 to 7 years (body weight about 13-25 kg) and 250 / 62.5 mg 3 times / day for children aged 7-12 years (weight body about 25-37 kg). In severe infections, these doses can be doubled (the maximum daily dose is 60 mg of amoxicillin and 15 mg of clavulanic acid per kg of body weight).

Patients with impaired renal function
In patients with renal insufficiency, excretion of clavulanic acid and amoxicillin through the kidneys is slow. Depending on the severity of renal failure, the total dose of Flemoklav Solutab® (expressed as a dose of amoxicillin) should not exceed the amounts shown in the table.

Patients with impaired liver function
The combination of amoxicillin / clavulanic acid should be used with caution in patients with liver damage. Liver function must be monitored constantly.

Side effects

Allergic skin reactions: urticaria, erythematous rash, rarely exudative erythema multiforme, extremely rarely - exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), in some cases there is a so-called "fifth day rash" (koreid exanthema). Reactions depend on the dose of the drug and the condition of the patient.
Digestive system reactions: nausea, vomiting, diarrhea, abnormal liver function, increased activity of "hepatic" transaminases, in isolated cases - cholestatic jaundice, hepatitis, pseudomembranous colitis. An increase in the activity of transaminases (AST and ALT), bilirubin and alkaline phosphatase is usually observed in males and in elderly patients, especially over 65 years of age. To prevent adverse events, the drug is recommended to be taken at the beginning of a meal. The risk of such changes increases when the drug is taken for more than 14 days. These phenomena are very rarely observed in children. The above changes usually appear during treatment or immediately after. Sometimes it can appear several weeks after drug withdrawal. Basically, reactions from the digestive system are transient and insignificant, but sometimes they are pronounced.
Others: candidiasis, development of superinfection, reversible increase in prothrombin time.
The list below shows, in descending order, the possible side effects:

Gastrointestinal tract: nausea, vomiting, diarrhea, abdominal pain
Immune reactions: hives
Skin and soft tissues: exanthema

Blood and lymphatic system: changes in blood composition (leukopenia, thrombocytopenia, hemolytic anemia)
Hepatobiliary system: cholestatic jaundice, hepatitis
The immune system: angioedema, vasculitis
Blood coagulation system: prolongation of prothrombin time
Urinary system: interstitial nephritis

Anaphylactic shock, angioedema, pseudomembranous colitis, erythema multiforme, exfoliative dermatitis

Overdose

Overdose can lead to gastrointestinal symptoms such as nausea, vomiting, and diarrhea, with possible water and electrolyte imbalance.
Treatment
Activated carbon is prescribed. It is necessary to maintain water and electrolyte balances. For seizures, diazepam is prescribed. Other symptoms are treated symptomatically. In cases of severe renal failure, hemodialysis should be performed.

Interaction with other medicinal products

Antacids, glucosamine, laxatives, aminoglycosides slow down and reduce absorption; ascorbic acid enhances absorption.
Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) have a synergistic effect; bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonistic.
Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index). With the simultaneous administration of anticoagulants, it is necessary to monitor the indicators of blood clotting.
Reduces the effectiveness of oral contraceptives, drugs, in the process of metabolism of which para-aminobenzoic acid is formed, ethinyl estradiol - the risk of bleeding "breakthrough".
Diuretics, allopurinol, phenylbutazone, non-steroidal anti-inflammatory drugs 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 administered with disulfiram.
The simultaneous use of amoxicillin and digoxin can lead to an increase in the concentration of digoxin in the blood plasma.

special instructions

When treated with penicillins, patients with hypersensitivity to them may experience anaphylactic reactions. In such cases, Flemoklav Solutab® treatment should be stopped immediately and replaced with another suitable therapy. For the treatment of anaphylactic shock, urgent adrenaline, corticosteroids and the elimination of respiratory distress may be required.
Possibility of cross-resistance and hypersensitivity with other penicillins or cephalosporins exists. As in the case of the use of other broad-spectrum penicillins, superinfections of fungal or bacterial genesis (in particular, candidiasis) may occur, especially in patients with chronic diseases and / or dysfunction of the immune system. In the event of superinfection, the drug should be discontinued and / or appropriate therapy selected.
In patients with impaired renal function, the dose should be selected based on the severity of the condition.
In patients with impaired liver function, the combination of amoxicillin / clavulanic acid should be prescribed with caution and under constant medical supervision. Flemoklav Solutab® should not be used for more than 14 days without liver function assessment.
An increase in prothrombin time is rarely noted. Amoxicillin / clavulanic acid should be used with caution in patients receiving anticoagulation therapy.
Non-enzymatic methods for determining urine sugar, as well as a test for urobilinogen, can give false positive results.
During the course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver and kidneys.

Release form
Dispersible tablets 125 mg + 31.25 mg, or 250 mg + 62.5 mg, or 500 mg + 125 mg. There are 4 tablets (one dosage) in a blister made of polyamide and polyvinyl chloride films, which are laminated on both sides with aluminum foil and polyurethane adhesive. 5 blisters, together with instructions for use, are placed in a cardboard box.

Storage conditions
List B. Store at a temperature not exceeding 25 ° C, out of the reach of children.

Shelf life
3 years. Do not use after the expiration date printed on the package.

Terms of dispensing from pharmacies
by prescription

Registration applicant (owner of RU)

Manufacturer
Astellas Pharma Europe B.V., Hogemaat 2, 7942 JG Meppel, The Netherlands

Pre-packaged and / or packaged
Astellas Pharma Europe B.V., Netherlands
or
CJSC "ORTAT", Russia

Catad_pgroup Antibiotics penicillins

Flemoklav Solutab - instructions for use

Registration number:

LSR-000392/09 - 060516

Tradename:

Flemoklav Solutab ®

INN or grouping name:

amoxicillin + clavulanic acid

Dosage form:

dispersible tablets

Composition:

One tablet contains:

Active substance:amrxicillin trihydrate (which corresponds to amoxicillin base) - 1019.8 mg (875.0 mg); potassium clavulanate (which corresponds to clavulanic acid) -148.9 mg (125 mg).

Excipients:dispersed cellulose - 30.4 mg, microcrystalline cellulose - 125.9 mg, crospovidone - 64.0 mg, vanillin - 1.0 mg, tangerine flavor - 9.0 mg, lemon flavor - 11.0 mg, saccharin - 13, 0 mg, magnesium stearate - 6.0 mg.

Description

Dispersible tablets of oblong shape from white to yellow, without risks, having the marking "425" and the graphic part of the company logo. Brown dotted spots are allowed.

Pharmacotherapeutic group:

Antibiotic - semi-synthetic penicillin + beta-lactamase inhibitor.

ATX Code:

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

Mechanism of action

Amoxicillin is a semisynthetic broad-spectrum antibiotic that is active against many fam-positive and fam-negative microorganisms. At the same time, amoxicillin is susceptible to destruction by beta-lactamases, and therefore the spectrum of activity of amoxicillin does not extend to microorganisms that produce this enzyme. Clavulanic acid, a beta-lactamase inhibitor, structurally related to penicillins, has the ability to inactivate a wide range of beta-lactamases found in microorganisms resistant to penicillins and cephalosporins.

Clavulanic acid is sufficiently effective against plasmid beta-lactamases, which most often cause bacterial resistance, and is not effective against type 1 chromosomal beta-lactamases, which are not inhibited by clavulanic acid. The presence of clavulanic acid in the Flemoklav Solutab preparation protects amoxicillin from destruction by enzymes - beta-lactamases, which makes it possible to expand the antibacterial spectrum of amoxicillin. Below is the activity of the combination of amoxicillin with clavulanic acid in vitro.

Bacteria usually sensitive to the combination of amoxicillin with clavulanic acid

Gram-positive aerobes:

Bacillus anthracis
Enterococcus faecalis
Listeria monocytogenes
Nocardia asteroides
Streptococcus pyogenes 1,2
Streptococcus agalactiae 1.2
Streptococcus spp. (other beta-hemolytic streptococci) 1.2
Staphylococcus aureus(methicillin sensitive) 1
Staphylococcus saprophyticus(methicillin sensitive)

Coagulase-negative staphylococci (methicillin-sensitive).

Gram-positive anaerobes:

Clostridium spp.
Peptococcus niger
Peptostreptococcus magnus
Peptostreptococcus micros
Peptostreptococcusspp.

Gram-negative aerobes:

Bordetella pertussis
Haemophilus influenzae 1
Helicobacter pylori
Moraxella catarrhalis 1
Neisseria gonorrhoeae
Pasteurella multocida
Vibrio cholerae.

Gram-negative anaerobes:

Bacteroides fragilis
Bacteroidesspp.
Capnocytophagaspp.
Eikenella corrodens
Fusobacterium nucleatum
Fusobacteriumspp.
Porphyromonasspp.
Prevotellaspp.

Others:

Borrelia burgdorferi
Leptospira icterohaemorrhagiae
Treponema pallidum.

Bacteria for which acquired resistance to the combination of amoxicillin with clavulanic acid is likely

Gram-negative aerobes:

Escherichia coli 1
Klebsiella oxytoca
Klebsiella pneumoniae 1
Klebsiellaspp.
Proteus mirabilis
Proteus vulgaris,
Proteusspp.
Salmonellaspp.
Shigellaspp.

Gram-positive aerobes:

Corynebacteriumspp.
Enterococcus faecium
Streptococcus pneumoniae 1.2

group streptococci Viridans 2

Bacteria that are naturally resistant to the combination of amoxicillin withclavulanic acid

Gram-negative aerobes:
Acinetobacterspp.
Citrobacter freundii
Enterobacterspp.
Hafnia alvei
Legionella pneumophila
Morganella morganii
Providenciaspp.
Pseudomonasspp.
Serratiaspp.
Stenotrophomonas maltophilia
Yersinia enterocolitica.

Others:
Chlamydia pneumoniae
Chlamydia psittaci
Chlamydiaspp.
Coxiella burnetii
Mycoplasmaspp.

1 - for these types of microorganisms, the clinical efficacy of a combination of amoxicillin with clavulanic acid has been demonstrated in clinical studies.

2 - strains of these types of bacteria do not produce β-lactamase. Sensitivity to amoxicillin monotherapy suggests a similar sensitivity to the combination of amoxicillin with clavulanic acid.

Pharmacokinetics

Suction

Both active ingredients of Flemoklav Solutab®, amoxicillin and clavulanic acid, are rapidly and completely absorbed from the gastrointestinal tract (GIT) after oral administration. The absorption of active substances is optimal if the drug is taken at the beginning of a meal.

After a single dose of Flemoklav Solutab® at a dose of 875/125 mg (amoxicillin / clavulanic acid), the maximum concentration of amoxicillin in the blood plasma is created after 1.5 hours (t max), and is 12 μg / ml (Cmax), clavulanic acid - after 1 hour, amounting to 3 μg / ml. The PFC (area under the pharmacokinetic curve) of amoxicillin and clavulanic acid is 33 μg / l and 6 μg / l, respectively. Absorption of amoxicillin after oral administration reaches 90%, the absolute bioavailability of clavulanic acid averages 60%.

Distribution

As with intravenous administration of a combination of amoxicillin with clavulanic acid, therapeutic concentrations of amoxicillin and clavulanic acid are found in various tissues and interstitial fluid (in the gallbladder, abdominal tissues, skin, adipose and muscle tissues, synovial and peritoneal fluids, bile, purulent discharge) ... Amoxicillin and clavulanic acid have a weak degree of binding to blood plasma proteins. Approximately 17-20% of amoxicillin and 22% of clavulanic acid binds to blood plasma proteins.

In animal studies, no cumulation of the components of the Flemoklav Solutab preparation in any organ was found.

Amoxicillin, like most penicillins, passes into breast milk. Trace amounts of clavulanic acid have also been found in breast milk. With the exception of the possibility of developing sensitization, diarrhea or candidiasis of the oral mucous membranes, no other negative effects of amoxicillin and clavulanic acid on the health of breastfed infants are known. Reproductive studies in animals have shown that amoxicillin and clavulanic acid cross the placental barrier. However, no negative effects on the fetus were found.

Metabolism

10-25% of the initial dose of amoxicillin is excreted in the urine as an inactive metabolite (penicillic acid). Clavulanic acid, undergoes intensive metabolism to 2,5-dihydro-4- (2-hydroxyethyl) -5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-butan-2-one and is excreted by the kidneys , through the gastrointestinal tract, and also with exhaled air in the form of carbon dioxide.

Withdrawal

The total clearance for two active substances is 25 l / h, the half-life (t1 / 2) 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 within the first 6 hours after taking the drug.

Simultaneous administration of probenecid slows down the elimination of amoxicillin, but not clavulanic acid (see section "Interaction with other medicinal products").

INDICATIONS FOR USE

The combination of amoxicillin with clavulanic acid is indicated for the treatment of bacterial infections of the following localizations caused by microorganisms sensitive to the combination of amoxicillin with clavulanic acid:

Upper respiratory tract infections (including ENT infections), eg, recurrent tonsillitis, sinusitis, otitis media, usually caused by Streptococcus pneumoniae, Haemophilus influenzae #, Moraxella catarrhalis # and Streptococcus pyogenes.

Lower respiratory tract infections, such as exacerbations of chronic bronchitis, lobar pneumonia, and bronchopneumonia, usually caused by Streptococcus pneumoniae, Haemophilus influenzae # and Moraxella catarrhalis # .

Genitourinary tract infections such as cystitis, urethritis, pyelonephritis, infections of the female genital tract, usually caused by species of the family Enterobacteriaceae 1 (mainly Escherichiacoli # ), Staphylococcussaprophyticusand species of the genus Enterococcus, andalso gonorrhea caused by Neisseria gonorrhoeae#

Skin and soft tissue infections commonly caused by Staphylococcus aureus # , Streptococcus pyogenes and species of the genus Vasteroides # .

Bone and joint infections, such as osteomyelitis, usually caused by Staphylococcus aureus # , if necessary, it is possible to carry out long-term therapy.

Odonogenic infections, eg periodontitis, odontogenic maxillary sinusitis, severe dental abscesses with spreading cellulitis.

Other mixed infections (eg, septic abortion, postpartum sepsis, intra-abdominal sepsis) as part of sequential therapy.

Some representatives of this genus of microorganisms produce beta-lactamase, which makes them insensitive to amoxicillin (see also the section "Pharmacological properties"). Infections caused by microorganisms sensitive to amoxicillin can be treated with Flemoklav Solutab, since amoxicillin is one of its active ingredients. Flemoklav Solutab is also indicated for the treatment of mixed infections caused by microorganisms sensitive to amoxicillin, as well as by microorganisms producing beta-lactamase, sensitive to the combination of amoxicillin with clavulanic acid.

The sensitivity of bacteria to the combination of amoxicillin with clavulanic acid varies by region and over time. Where possible, local sensitivity data should be taken into account. If necessary, collect microbiological samples and test for bacteriological sensitivity.

CONTRAINDICATIONS

• A history of hypersensitivity to amoxicillin, clavulanic acid, other components of the drug, beta-lactam antibiotics (eg, penicillins, cephalosporins);
• previous episodes of jaundice or impaired liver function when using a combination of amoxicillin with clavulanic acid in history;
• children under 12 years of age or body weight less than 40 kg;
• impaired renal function (creatinine clearance< 30 мл/мин).

Carefully:severe liver failure, diseases of the gastrointestinal tract (including a history of colitis associated with the use of penicillins), chronic renal failure.

APPLICATION DURING PREGNANCY AND DURING BREASTFEEDING

Pregnancy

In studies of reproductive function in animals, oral and parenteral administration of the drug amoxicillin + clavulanic acid did not cause teratogenic effects. In a single study in women with premature rupture of the membranes, it was found that prophylactic drug therapy may be associated with an increased risk of necrotizing enterocolitis in newborns. Like all medicines, Flemoklav Solutab is not recommended for use during pregnancy, except in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding period

Flemoklav Solutab can be used during breastfeeding. With the exception of the possibility of developing sensitization, diarrhea or candidiasis of the oral mucous membranes associated with the penetration of trace amounts of the active ingredients of this drug into breast milk, no other adverse effects were observed in breastfed children. In the event of adverse effects in breastfed babies, breastfeeding should be discontinued.

METHOD OF APPLICATION AND DOSE

To prevent dyspeptic symptoms, Flemoklav Solutab® is prescribed at the beginning of a meal. The tablet is swallowed whole with a glass of water, or dissolved in half a glass of water (at least 30 ml), stirring thoroughly before use.

For oral administration.

The dosage regimen is set individually depending on the age, body weight, kidney function of the patient, as well as the severity of the infection.

Treatment should not continue for more than 14 days without revising the clinical situation.

If necessary, it is possible to carry out stepwise therapy (first, parenteral administration of the drug, followed by a transition to oral administration).

Adults and children 12 years and older or weighing 40 kg or more

1 tablet 875 mg / 125 mg 2 times a day.

Special patient groups

Children under 12 years of age weighing less than 40 kg

Elderly patients

No dosage adjustment is required. In elderly patients with impaired renal function, the dose should be adjusted as indicated below for adults with impaired renal function.

Patients with impaired renal function

Tablets 875 mg / 125 mg should be used only in patients with creatinine clearance greater than 30 ml / min, and no dosage adjustment is required.

In most cases, parenteral therapy should be preferred whenever possible. In patients with impaired renal function, convulsions may occur (see the section "Side effects", "Overdose").

Patients with impaired liver function

Treatment is carried out with caution; liver function is monitored regularly. There is insufficient data to change the dosage regimen recommendation in these patients.

SIDE EFFECTS

The adverse reactions presented below are listed in accordance with the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows: often(>1/10), often(>1/100, <1/10), infrequently(>1/1000, <1/100), rarely(>1/10 000, <1/1000), very rarely(<1/10 000). Категории частоты были сформированы на основании клинических исследований препарата и пострегистрационного наблюдения.

Frequency of occurrence of adverse reactions

Rarely: reversible leukopenia (including neutropenia), reversible thrombocytopenia.

Very rare: reversible agranulocytosis and reversible hemolytic anemia, prolonged bleeding time and prothrombin time, anemia, eosinophilia, thrombocytosis.

Immune system disorders

Very rare: angioedema, anaphylactic reactions, a syndrome similar to serum sickness, allergic vasculitis.

Nervous system disorders

Uncommon: dizziness, headache.

Very rare: reversible hyperactivity, seizures. Convulsions can occur in patients with impaired renal function, as well as in those who receive high doses of the drug (see section "Dosage and Administration" - Patients with impaired renal function,"Overdose"). Insomnia, agitation, anxiety, behavior change.

Gastrointestinal disorders

Adults:

Very common: diarrhea. Often: nausea, vomiting.

Children:

Often: diarrhea, nausea, vomiting.

Whole population:

Nausea was most commonly associated with high doses of the drug. If, after the start of taking the drug, there are undesirable reactions from the gastrointestinal tract, they can be eliminated by taking Flemoklav Solutab at the beginning of a meal.

Uncommon: indigestion.

Very rare: antibiotic-associated colitis (including pseudomembranous colitis and hemorrhagic colitis) (see section "Special instructions"), black "hairy" tongue, gastritis, stomatitis.

Liver and biliary tract disorders

Uncommon: Moderate increase in the activity of aspartate aminotransferase and / or alanine aminotransferase (ACT and / or ALT). This reaction is observed in patients receiving therapy with beta-lactam antibiotics, but its clinical significance is unknown.

Very rare: hepatitis and cholestatic jaundice. These reactions are observed in patients receiving therapy with penicillin antibiotics and cephalosporins. Increased concentration of bilirubin and alkaline phosphatase.

Adverse reactions from the liver were observed mainly in men and elderly patients and may be associated with long-term therapy. These adverse reactions are very rare in children.

The listed signs and symptoms usually occur during or immediately after the end of therapy, however in some cases they may not appear for several weeks after the end of therapy. Adverse reactions are usually reversible. Adverse reactions from the liver can be severe, in extremely rare cases, deaths have been reported. In almost all cases, these were persons with serious comorbidities or patients receiving simultaneously potentially hepatotoxic drugs.

Skin and subcutaneous tissue disorders

Uncommon: rash, itching, urticaria.

Rare: erythema multiforme.

Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis.

Kidney and urinary tract disorders

Very rare: interstitial nephritis, crystalluria (see section "Overdose"), hematuria.

OVERDOSE

Symptoms

Symptoms from the gastrointestinal tract and imbalance in water and electrolyte balance may occur. Amoxicillin crystalluria has been described, in some cases leading to the development of renal failure (see section "Special instructions and precautions"). Convulsions may occur in patients with impaired renal function, as well as in those who receive high doses of the drug (see section "Dosage and Administration" - Patients withimpaired renal function,"Side effects").

Treatment

Symptoms from the gastrointestinal tract - symptomatic therapy, with special attention to the normalization of water and electrolyte balance. Amoxicillin and clavulanic acid can be removed from the bloodstream by hemodialysis.

The results of a prospective study, which was conducted with the participation of 51 children in a poison control center, showed that the administration of amoxicillin at a dose of less than 250 mg / kg did not lead to significant clinical symptoms and did not require gastric lavage.

INTERACTIONS WITH OTHER MEDICINAL PRODUCTS

The simultaneous use of Flemoklav Solutab® and probenecid is not recommended. Probenecid reduces the tubular secretion of amoxicillin, and therefore the simultaneous use of Flemoklav Solutab® and probenecid can lead to an increase and persistence in the blood of the concentration of amoxicillin, but not clavulanic acid.

The simultaneous use of allopurinol and amoxicillin may increase the risk of allergic skin reactions. There are currently no data in the literature on the simultaneous use of a combination of amoxicillin with clavulanic acid and allopurinol. Penicillins are able to slow down the excretion of methotrexate from the body by inhibiting its tubular secretion, therefore, the simultaneous use of Flemoklav Solutab and methotrexate may increase the toxicity of methotrexate. Like other antibacterial drugs, Flemoklav Solutab® can affect the intestinal microflora, leading to a decrease in the absorption of estrogens from the gastrointestinal tract and a decrease in the effectiveness of combined oral contraceptives.

The literature describes rare cases of increased international normalized ratio (MHO) in patients with the combined use of acenocoumarol or warfarin and amoxicillin. If it is necessary to simultaneously prescribe Flemoklav Solutab® with anticoagulants, the prothrombin time or MHO should be carefully monitored when prescribing or discontinuing Flemoklav Solutab, the dose of anticoagulants for oral administration may need to be adjusted.

In patients receiving mycophenolate mofetil, after the start of the combination of amoxicillin with clavulanic acid, a decrease in the concentration of the active metabolite, mycophenolic acid, was observed before taking the next dose of the drug by approximately 50%. Changes in this concentration may not accurately reflect general changes in mycophenolic acid exposure.

SPECIAL INSTRUCTIONS

Before starting treatment with Flemoklav Solutab®, it is necessary to collect a detailed history of previous hypersensitivity reactions to penicillins, cephalosporins or other substances that cause an allergic reaction in the patient. Serious, and sometimes fatal, hypersensitivity reactions (anaphylactic reactions) to penicillins have been described. The risk of such reactions is highest in patients with a history of hypersensitivity reactions to penicillins. In case of an allergic reaction, it is necessary to stop treatment with Flemoklav Solutab and start an appropriate alternative therapy. In severe hypersensitivity reactions, epinephrine should be administered promptly to the patient. Oxygen therapy, intravenous glucocorticosteroids, and airway management, including intubation, may also be required.

In case of skin allergic reactions, treatment with Flemoklav Solutab should be discontinued.

In case of suspicion of infectious mononucleosis, the drug Flemoklav Solutab should not be used, since in patients with this disease, amoxicillin can cause a measles-like skin rash, which makes it difficult to diagnose the disease.

Long-term treatment with Flemoklav Solutab can lead to excessive reproduction of insensitive microorganisms.

Cases of pseudomembranous colitis with antibiotics have been described, the severity of which can range from mild to life-threatening. Therefore, it is important to consider the possibility of developing pseudomembranous colitis in patients with diarrhea during or after antibiotic use. If the diarrhea is prolonged or severe and the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient should be examined.

In general, Flemoklav Solutab® is well tolerated and has low toxicity characteristic of all penicillins. During long-term therapy with Flemoklav Solutab®, it is recommended to periodically assess the function of the kidneys, liver and hematopoiesis. In patients who received a combination of amoxicillin with clavulanic acid in conjunction with indirect (oral) anticoagulants, in rare cases, an increase in prothrombin time (increased MHO) was reported. With the joint appointment of indirect (oral) anticoagulants with a combination of amoxicillin with clavulanic acid, it is necessary to control the corresponding indicators.

Dose adjustments may be required to maintain the desired effect of oral anticoagulants. Crystalluria is very rare in patients with reduced diuresis, mainly with parenteral therapy. During the administration of high doses of amoxicillin, it is recommended to take a sufficient amount of fluid and maintain adequate diuresis to reduce the likelihood of amoxicillin crystals forming (see the Overdose section).

Taking Flemoklav Solutab® orally leads to a high content of amoxicillin in the urine, which can lead to false positive results in the determination of glucose in the urine (for example, Benedict's test, Fehling's test). In this case, it is recommended to use the glucose oxidative method for determining the concentration of glucose in urine. Clavulanic acid can cause non-specific binding of immunoglobulin G and albumin to erythrocyte membranes, which leads to false positive Coombs test results.

One dispersible tablet Flemoklav Solutab® 875/125 mg contains 0.64 mmol (25 mg) of potassium. Potassium intake of more than 1 mmol per day requires special attention in patients with reduced renal function and in those on a controlled potassium diet.

Abuse and drug dependence

There were no drug dependence, addiction and euphoric reactions associated with the use of the drug Flemoklav Solutab.

IMPACT ON ABILITY TO DRIVE VEHICLES,MECHANISMS

There have been no studies examining the effect on the ability to drive vehicles and work with mechanisms. Since the drug can cause side effects (for example, allergic reactions, dizziness, convulsions) (see section "Side effects"), patients should be warned about the precautions when driving or working with moving machinery.

RELEASE FORM

Dispersible tablets 875 mg + 125 mg. 7 tablets in a blister, 2 blisters together with instructions for use are placed in a cardboard box.

STORAGE CONDITIONS

Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Shelf life

2 years. Do not use after the expiration date printed on the package.

TERMS OF RELEASE FROM PHARMACIES

On prescription.

REGISTRATION CERTIFICATE OWNER

Astellas Pharma Europe B.V.
Silviusweg 62, 2333 BE Leiden, The Netherlands

MANUFACTURER

Astellas Pharma Europe B.V.,
Hogemaat 2, 7942 JG Meppel, The Netherlands

PACKED AND / OR PACKED

Astellas Pharma Europe B.V., Netherlands or CJSC ORTAT, Russia

Quality claims are accepted by the Representative Office of the Private Limited Liability Company Astellas Pharma Europe B.V. (Netherlands) in Moscow at the address:

109147 Moscow, Marksistskaya st., 16, "Mosalarko Plaza-1" business center, floor 3.

The page provides instructions for use Flemoklava solutab... It is available in various dosage forms of the drug (tablets 125 mg, 250 mg, 500 mg, 875 mg and 1000 mg dispersible), and also has a number of analogues. This annotation has been checked by specialists. Leave your feedback on the use of Flemoklav Solutab, which will help other site visitors. The drug is used for various diseases (tonsillitis, bronchitis, sinusitis, otitis media and other infectious diseases). The tool has a number of side effects and interactions with other substances. Doses of the drug differ for adults and children. There are restrictions on the use of the medication during pregnancy and during lactation. Treatment with Flemoklav Solutab can only be prescribed by a qualified doctor. The duration of therapy can vary and depends on the specific disease.

Instructions for use and dosage

Adults and children over 12 years old and children under 12 years old with a body weight of over 40 kg Flemoklav Solutab at a dose of 875 mg / 125 mg is prescribed 2 times a day (every 12 hours).

For children under 12 years old with a body weight of less than 40 kg, Flemoklav Solutab is prescribed 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 dosing 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 a 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 a 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 a tablet 250 mg / 62.5 mg 3 times a day.

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

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

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

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.

Composition

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

Flemoklav solutab - broad spectrum antibiotic; a combined preparation of amoxicillin and clavulanic acid - a beta-lactamase inhibitor. Active against gram-positive and gram-negative microorganisms (including strains producing beta-lactamases).

Amoxicillin acts bactericidal, inhibits the synthesis of peptidoglycan of the bacterial cell wall. Clavulanic acid inhibits beta-lactamase types 2, 3, 4 and 5. Inactive 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.

Pharmacokinetics

Amoxicillin

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

Clavulanic acid

After oral administration, it is rapidly absorbed from the gastrointestinal tract. The absolute bioavailability is approximately 60%. Concomitant food intake does not affect absorption. Serum protein binding is 22%. Clavulanic acid crosses the placental barrier. There are no reliable data on excretion in breast milk. Clavulanic acid is extensively metabolized by 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 sensitive pathogens: lower respiratory tract infections (bronchitis (acute and chronic exacerbation), pneumonia, pleural empyema, lung abscess);
• eNT infections (sinusitis, tonsillitis, tonsillitis, otitis media);
• infections of the genitourinary system and pelvic organs (pyelonephritis, pyelitis, cystitis, urethritis, prostatitis, cervicitis, salpingitis, salpingo-oophoritis, tubo-ovarian abscess, endometritis, bacterial vaginitis, septic abortion, postpartum sepsis, pelvioperitonitis, soft chancre);
• infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses, abscess, phlegmon, wound infection);
• osteomyelitis;
• postoperative infections;
• prevention of infections in surgery.

Contraindications

• liver dysfunction (including jaundice) with a history of amoxicillin / clavulanic acid;
• infectious mononucleosis;
• lymphocytic leukemia;
• renal failure (glomerular filtration less than 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).

special instructions

When taking Flemoklav 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 should be carried out: for the treatment of anaphylactic shock, urgent administration of epinephrine (adrenaline), glucocorticosteroids (GCS) and elimination of respiratory failure may be required.

Superinfection (eg, candidiasis) may develop, especially in patients with chronic diseases and / or impaired immune system function. In the event of superinfection, the drug should be canceled and / or the antibiotic therapy is changed accordingly.

For 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 a violation of the absorption of the drug from the gastrointestinal tract is possible.

The appearance of severe and persistent diarrhea may be associated with the development of pseudomembranous colitis, in which case the drug is canceled and the necessary treatment is prescribed. In case of development of hemorrhagic colitis, immediate withdrawal of the drug and corrective therapy are also necessary. The use of drugs that weaken intestinal peristalsis in these cases is contraindicated.

In case of impaired liver function, the drug should be prescribed with caution and under constant medical supervision. Do not use the drug for more than 14 days without assessing liver function.

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

While taking the drug, there may be an increase in prothrombin time. Therefore, Flemoklav Solutab should be prescribed with caution to patients receiving anticoagulant therapy (it is necessary to monitor blood clotting indicators).

Due to the high concentration of amoxicillin in the urine, it can deposit on the walls of the urinary catheter, therefore, such patients need periodic catheter changes. Forced diuresis accelerates the excretion of amoxicillin and reduces its concentration in plasma.

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

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

In case of seizures during therapy, the drug is canceled.

It should be borne in mind that 1 dispersible tablet 875 mg / 125 mg contains 25 mg of potassium.

Side effect

• thrombocytosis, hemolytic anemia, leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, anemia;
• increased prothrombin time and bleeding time;
• dizziness;
• headache;
• convulsions;
• anxiety;
• anxiety;
• insomnia;
• violation 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;
• bark-like exanthema;
• hives;
• bullous or exfoliative dermatitis (exudative erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• anaphylactic shock;
• drug fever;
• eosinophilia;
• angioneurotic edema (Quincke's edema);
• laryngeal edema;
• serum sickness;
• hemolytic anemia;
• allergic vasculitis;
• bacterial or fungal superinfections (with prolonged therapy or repeated courses of therapy).

Drug interactions

With simultaneous use with some bacteriostatic drugs (for example, chloramphenicol, sulfonamides), antagonism with amoxicillin / clavulanic acid was noted.

Flemoklav Solutab should not be administered concomitantly with disulfiram.

Concomitant 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 a longer stay 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.

The simultaneous use of Flemoklav Solutab with allopurinol may increase the risk of developing skin rashes.

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

Aminopenicillins can reduce the serum sulfasalazine concentration.

Amoxicillin reduces the renal clearance of methotrexate, which may increase the risk of its toxic effect. When taken simultaneously with amoxicillin, it is necessary to monitor the concentration of methotrexate in the blood serum.

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

With the simultaneous use of Flemoklav Solutab and indirect anticoagulants, an increase in the risk of bleeding is possible.

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

Analogs of the drug Flemoklav Solutab

Structural analogues for the active substance:

• Amovikomb;
• Amoxiclav;
• Amoxiclav Kviktab;
• Amoxicillin + Pfizer Clavulanic Acid;
• Arlet;
• Augmentin;
• Bactoclav;
• Verclave;
• Klamosar;
• Lyclavus;
• Medoclav;
• Panklave;
• Ranklove;
• Rapiklav;
• Taromentin;
• Fibell;
• Ecoclave.

Application during pregnancy and lactation

When using Flemoklav Solutab during pregnancy, its negative effect on the fetus or newborn was not noted. The use of the drug in the 2nd and 3rd trimester of pregnancy is possible after a medical risk / benefit assessment. In the 1st trimester of pregnancy, the use of Flemoklav 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 administered with caution.

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

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

Antibacterial preparation Flemoklav Solutab ® is a combination drug intended for the treatment of infections caused by gram-positive and gram-negative flora, including pathogenic microorganisms that produce beta-lactamase enzymes (which destroy penicillins and many cephalosporins).

Differs in low toxicity, high efficiency and a wide spectrum of antimicrobial activity.

It belongs to the antibiotics of the penicillin series (a group of inhibitor-protected penicillins), which is a combination of semisynthetic amoxicillin with clavulanic acid (potassium clavulanate) and is available in an easy-to-use form of soluble tablets.

Flemoklav Solutab ® - instructions for use of tablets 500 mg

This drug is a combined semi-synthetic antibiotic from the group of inhibitor-protected penicillins.

The main active ingredient is amoxicillin + clavulanic acid.

- characterized by a pronounced bactericidal effect against most pathogenic microorganisms:

• Gram-positive and gram-negative aerobes Enterococcus faecalis, Gardnerella vaginalis, Streptococcus pyogenes, Nocardia asteroids, Staphylococcus saprophyticus and aureus, Listeria monocytogenes, Helicobacter pylori, Haemophilus influenza and parainfluenza parain
• Anaerobes Peptostreptococcus micros and magnus, Eikenella corrodens, some varieties of fusobacteria, clostridia and peptococci.
• Atypical causative agents of leptospirosis and syphilis.

Potassium clavulanate (or clavulanic acid) in the composition of the medication significantly increases the spectrum of antimicrobial activity of the antibiotic and its resistance by inhibiting beta-lactamases produced by bacteria. The mechanism of bactericidal action consists in the introduction of an active substance into the cell and blocking the biosynthesis of peptidoglycan. This compound is necessary for building the cell wall, therefore its lack leads to the death of the microorganism.

Is Flemoklav Solutab an antibiotic or not ®?

Yes, it is an antibiotic of the penicillin group.

Chemical composition

The main component of the drug is amoxicillin, fortified with clavulanic acid.

Synthesized in 1972, amoxicillin exhibited much greater acid resistance and bactericidal activity than, however, it was also destroyed by beta-lactamases. It is absorbed by the body almost completely (by 94%), quickly distributed, excreted mainly by the kidneys.

The problem of the destruction of the antibiotic by beta-lactamases was solved by adding clavulanic acid, a powerful inhibitor of destructive enzymes. Due to the additional beta-lactam ring, the drug acquired increased stability and a wider spectrum of antimicrobial action. The bioavailability of potassium clavulanate is about 60%, like the main component, it does not depend on the presence of food in the stomach.

Release form

The drug is produced in tablet form by the pharmaceutical company Astellas ® from the Netherlands. The tablets are white (sometimes with brown blotches), large, oblong, without risks. They dissolve in water, that is, they are dispersed, they are digitally marked on one of the sides. The numbers indicate dosage options, of which this drug has four:

• "421" - tablets contain 125 mg of amoxicillin and 31.25 mg of clavulanic acid;
• "422" - 250 and 62.5 active components, respectively;
• "424" - 500 and 125 milligrams;
• "425" - 875 and 125 (this option is also called Flemoklav Solutab ® 1000 - according to the sum of the number of main ingredients).

Packing photo Flemoklav ® 875 mg + 125 mg from Astellas ®

Forming aids are microcrystalline cellulose, crospovidone, magnesium stearate, saccharin, vanillin, and apricot flavor. Tablets are packed in foil blisters of 5 pieces, a total of 20 tabs in the package. An exception is the option marked with the number "425" - there are 2 blisters in a cardboard box, 7 tablets each.

What Flemoklav Solutab ® helps with

An antibiotic resistant to the destructive effects of beta-lactamases is widely used to treat inflammatory processes of various localization. Easy-to-use dissolving tablets are prescribed in case of bacterial infections of all parts of the respiratory tract (both lower and upper), ENT organs. The drug is especially effective for purulent sinusitis - inflammation of the paranasal sinuses. It is also effective for pharyngitis, otitis media, bronchitis, pneumonia, etc.

This drug is also used in urology for antibiotic therapy of pyelonephritis and cystitis. In gynecology, Flemoklav ® is indicated for infection of female reproductive organs with bacteria sensitive to the drug. Effective for purulent inflammation of the musculoskeletal system (muscles, joints, bones) and skin.

It is prescribed for both adults and children due to its low toxicity, however, the characteristics of the dosage form do not allow giving it to babies under 2 years old. In these cases, it is recommended to use chemical analogs produced in the form of powders for the manufacture of suspensions.

Flemoklav ® indications

Antibiotic Flemoklav Solutab ®, according to the instructions, should be used in case of the following diseases:

• inflammation of the mucous membranes of the paranasal paranasal sinuses (sinusitis) - sinusitis, frontal sinusitis, sphenoiditis, etc.;
• otitis media;
• tonsillitis (sore throat) and pharyngitis;
• bronchitis;
• community-acquired pneumonia;
• genitourinary (including gynecological) infections - cystitis, pyelonephritis and others;
• purulent lesions of the skin, muscles and bones (osteomyelitis, purulent arthritis);
• abscesses, phlegmon;
• peritonitis;
• septic complications.

Contraindications to the appointment of funds

Since the drug is low-toxic, the list of strict contraindications includes only liver dysfunction caused by Flemoklav ® in the past, mononucleosis, body weight less than 13 kg, lymphocytic leukemia and individual hypersensitivity to beta-lactams. Also, tablets are not used in the treatment of children under 12 years of age and those with severe kidney failure.

Flemoklav Solutab ® during lactation and pregnancy

When prescribing an antibiotic to pregnant women in clinical practice, no teratogenic effect was revealed, despite the fact that amoxicillin and potassium clavulanate penetrate well through the hematoplacental barrier. The active substances do not affect the fetus, no congenital pathologies have been recorded.

Maximum caution when using should be observed in the first trimester (during this period, the appropriateness of treatment and potential risks should be strictly evaluated by a doctor). It is necessary to use the medicine strictly according to the recommendation of a therapist or other specialist.

It is also possible to prescribe Flemoklav Solutab® for HS: both components penetrate into breast milk in large enough volumes, but they do not harm the child. In the course of clinical studies, no negative effects of the antibiotic on the microflora and the general condition of infants were recorded. However, if the newborn has hypersensitivity and diarrhea, mucosal candidiasis or allergic reactions occurs, breastfeeding should be suspended for the duration of the mother's treatment. At the same time, it is advisable to express milk so that lactation does not stop.

Flemoklav Solutab ®: dosage regimen and dosage

Tablets can be taken in two ways: by dissolving beforehand in half a glass of clean water, or simply by swallowing and drinking. This should be done immediately before eating, since dispersible dosage forms can irritate the gastric mucosa. The presence of food in the digestive tract does not affect the absorption and bioavailability of clavulanic acid and amoxicillin.

Therapeutic doses and the optimal dosage schedule are determined by the attending physician (self-medication is unacceptable) in accordance with the severity of the course and the nature of the disease itself.

Doses are calculated using amoxicillin.

Usually, the medicine is prescribed as follows:

• adult patients and children who have reached the age of twelve are recommended to take either 500 mg every 8 hours (that is, three times a day), or 875 milligrams of the active substance with an interval of 12 hours. In the case of recurrent and particularly severe chronic diseases, the daily dose may be increased. Assign 875-1000 mg of amoxicillin three times a day.
• For children under the age of twelve, Flemoklav Solutab ® is provided at 125 mg, that is, in a lower dosage. Tablets with an antibiotic content of 250 and 500 mg are also used if the infection is severe. Starting from the age of two, the daily dose should be calculated according to his body weight - 20-30 mg for each kilogram of weight. On average, this is 125 mg three times a day for a child from 2 to 7 years old and 250 milligrams in the same way for children aged 7 to 12.
• Tablets containing 875 mg of the active ingredient are not prescribed for persons with renal insufficiency and a glomerular filtration rate of less than 30 ml per minute. In this case, the dose is usually halved.

Careful use requires the treatment of patients with severe liver dysfunction.Constant monitoring of the patient's condition and control of analyzes are mandatory.

The duration of antibiotic therapy under any circumstances should not exceed 2 weeks.

Exceeding the recommended doses is fraught with dyspeptic disorders. The patient develops nausea, vomiting, and diarrhea. The latter can be severe and lead to dehydration. An overdose is treated symptomatically with the use of enterosorbent (activated carbon) and the restoration of the water-electrolyte balance. When a convulsive symptom appears, Diazepam is prescribed, and renal failure requires hemodialysis.

Flemoklav Solutab ®: overdose and side effects

Amoxicillin in combination with potassium clavulanate rarely has a negative effect on the patient's body, since penicillin antibiotics are generally low toxic. However, in clinical trials and post-marketing independent studies, the following responses to the drug from internal organs and systems were identified:

• Digestive tract and liver. Epigastric pain, stool disturbances (diarrhea), vomiting and nausea are uncommon. Even less often, liver dysfunction in the form of jaundice was noted, and the development of pseudomembranous colitis was observed in isolated cases. As a rule, digestive problems do not occur if you take the drug as recommended by the instructions - before eating.
• The immune system. Rarely (less than one case in every thousand), allergic reactions such as exanthema and urticaria can occur. Malignant and erythema multiforme, vasculitis, angioedema, and exfoliative dermatitis are even less common.
• Urinary organs. Development of interstitial nephritis is possible.

Other side effects include candidiasis characteristic of antibiotic therapy, provoked by the activation of the opportunistic microflora of the mucous membranes. There is also the possibility of superinfection and anaphylactic shock.

The listed negative reactions of the body are typical for the drug in a dosage of 125 to 500 mg. An increased dose (tablets labeled "425") can cause rare additional side effects: reversible hematopoiesis disorders (hemolytic anemia), more severe allergies, headache and seizures, increased anxiety, insomnia, increased activity of liver enzymes.

Flemoklav and Amoxiclav ®: what's the difference?

The drug Amoxiclav ®, produced by the pharmaceutical company Lek (Slovenia), also belongs to the group of inhibitor-protected semi-synthetic penicillins.

The main active ingredient is the antibiotic amoxicillin in the form of trihydrate, an inhibitor protected by clavulanic acid. That is, this drug is a complete chemical analogue of Flemoklav ® and is sold in pharmacy chains at similar prices.

The differences between these two antibacterial agents lie in the variety of dosage forms of the Slovenian version and some features of the component composition. Amoxiclav ® is produced both in the form of dispersible and conventional tablets, as well as in the form of a powder for suspensions and a solution for parenteral use.

Film-coated tablets contain different doses of the antibiotic (from 250 to 875 mg), but the amount of potassium clavulanate is always the same - 125 milligrams. The dispersible variety Amoxiclav-Kviktab ® is characterized by the same. The powder contains the same active ingredients in different doses.

The many dosage forms significantly expand the scope of the antibiotic. Abdominal infections, chancre and gonorrhea have been added to the list of indications. In addition, the drug solution is used as a prophylactic agent for surgical interventions. Age restrictions are also removed: a parenteral drug can be prescribed from the first days of a child's life, and in the form of a suspension - from 2 months.

Dispersible tablets 14 pieces per pack

pharmachologic effect

Broad-spectrum antibiotic; a combined preparation of amoxicillin and clavulanic acid - a β-lactamase inhibitor.

Amoxicillin acts bactericidal, inhibits the synthesis of peptidoglycan of the bacterial cell wall. Active against gram-positive and gram-negative microorganisms (including strains that produce many plasmid and some chromosomal β-lactamases).

Clavulanic acid, which is part of the drug, inhibits type II, III, IV and V β-lactamases, is inactive against type I β-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 β-lactamases and expands its spectrum of action.

Indication for use

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

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

Method of administration and dosage

Adults and children over 12 years old and children under 12 years old weighing more than 40 kg Flemoklav Solutab at a dose of 875 mg / 125 mg is prescribed 2 times / day (every 12 hours).

For children under 12 years old with a body weight of less than 40 kg, Flemoklav Solutab is prescribed in lower dosages.

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

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

To prevent the appearance of side effects from the digestive system, the drug is recommended to be taken at the beginning of a meal. The tablet is swallowed whole with a glass of water, or dissolved in half a glass of water (at least 30 ml), stirring thoroughly before use.

Contraindications

• liver dysfunction (including jaundice) with a history of 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).

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C.