Flemoklav solutab with clavulanic acid. Dosage of the drug and features of use

Catad_pgroup Antibiotics penicillins

Flemoclav Solutab - official instructions for use

Registration number:

LSR-000392/09 - 060516

Trade name:

Flemoklav Solutab ®

INN or group name:

amoxicillin + clavulanic acid

Dosage form:

dispersible tablets

Compound:

One tablet contains:

Active ingredient: amoxicillin 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 marks, marked “425” and a graphic part of the company logo. Brown dotted spots are allowed.

Pharmacotherapeutic group:

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

CodeATX:

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 is a beta-lactamase inhibitor, structurally related to penicillins, and 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 drug Flemoklav Solutab protects amoxicillin from destruction by enzymes - beta-lactamases, which allows expanding the antibacterial spectrum of amoxicillin. Below is the activity of the combination of amoxicillin and clavulanic acid in vitro.

Bacteria usually susceptible to the combination of amoxicillin and 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, (sensitive to methicillin).

Gram-positive anaerobes:

Clostridium spp.
Peptococcus niger
Peptostreptococcus magnus
Peptostreptococcus micros
Peptostreptococcus spp.

Gram-negative aerobes:

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

Gram-negative anaerobes:

Bacteroides fragilis
Bacteroides spp.
Capnocytophaga spp.
Eikenella corrodens
Fusobacterium nucleatum
Fusobacterium spp.
Porphyromonas spp.
Prevotella spp.

Others:

Borrelia burgdorferi
Leptospira icterohaemorrhagiae
Treponema pallidum.

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

Gram-negative aerobes:

Escherichia coli 1
Klebsiella oxytoca
Klebsiella pneumoniae 1
Klebsiella spp.
Proteus mirabilis
Proteus vulgaris,
Proteus spp.
Salmonella spp.
Shigella spp.

Gram-positive aerobes:

Corynebacterium spp.
Enterococcus faecium
Streptococcus pneumoniae 1.2

group streptococci Viridans 2

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

Gram-negative aerobes:
Acinetobacter spp.
Citrobacter freundii
Enterobacter spp.
Hafnia alvei
Legionella pneumophila
Morganella morganii
Providencia spp.
Pseudomonas spp.
Serratia spp.
Stenotrophomonas maltophilia
Yersinia enterocolitica.

Others:
Chlamydia pneumoniae
Chlamydia psittaci
Chlamydia spp.
Coxiella burnetii
Mycoplasma spp.

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

2 - strains of these bacterial species do not produce p-lactamases. Sensitivity with amoxicillin monotherapy suggests similar sensitivity to the combination of amoxicillin with clavulanic acid.

Pharmacokinetics

Suction

Both active ingredients of the drug Flemoklav Solutab®, amoxicillin and clavulanic acid, are quickly and completely absorbed from the gastrointestinal tract (GIT) after oral administration. 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 when administered orally reaches 90%, the absolute bioavailability of clavulanic acid averages 60%.

Distribution

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

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

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 sensitization, diarrhea or candidiasis of the oral mucosa, there are no other known negative effects of amoxicillin and clavulanic acid on the health of breastfed infants. Animal reproductive studies have shown that amoxicillin and clavulanic acid cross the placental barrier. However, no negative effects on the fetus were detected.

Metabolism

10-25% of the initial dose of amoxicillin is excreted in the urine in the form of an inactive metabolite (penicillic acid). Clavulanic acid is extensively metabolized 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, as well as with exhaled air in the form of carbon dioxide.

Removal

The total clearance for the 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 drugs”).

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), such as 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, e.g. cystitis, urethritis, pyelonephritis, infections of the female genital tract, usually caused by species of the family Enterobacteriaceae 1 (mostly Escherichiacoli # ), Staphylococcussaprophyticus and species of the genus Enterococcus, A also gonorrhea, caused Neisseria gonorrhoeae#

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

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

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

Other mixed infections (for example, septic abortion, puerperal sepsis, intra-abdominal sepsis) as part of stepwise therapy.

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

The sensitivity of bacteria to the combination of amoxicillin and clavulanic acid varies regionally and over time. Where possible, local sensitivity data should be taken into account. If necessary, microbiological samples should be collected and bacteriological susceptibility testing should be carried out.

CONTRAINDICATIONS

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

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

USE IN PREGNANCY AND BREASTFEEDING

Pregnancy

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

Breastfeeding period

Flemoclav Solutab can be used during breastfeeding. With the exception of the possibility of sensitization, diarrhea or candidiasis of the oral mucosa 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. If adverse effects occur in breastfed children, breastfeeding should be discontinued.

METHOD OF APPLICATION AND DOSES

To prevent dyspeptic symptoms, Flemoclav 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 (minimum 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 reviewing the clinical situation.

If necessary, it is possible to carry out stepwise therapy (initially, parenteral administration of the drug, followed by switching 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 regimen 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 more than 30 ml/min, and no dosage adjustment is required.

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

Patients with liver dysfunction

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

SIDE EFFECTS

The adverse reactions presented below are listed according to the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows: very 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

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

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

Immune system disorders

Very rare: angioedema, anaphylactic reactions, serum sickness-like syndrome, allergic vasculitis.

Nervous system disorders

Uncommon: dizziness, headache.

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

Gastrointestinal disorders

Adults:

Very common: diarrhea. Common: nausea, vomiting.

Children:

Common: diarrhea, nausea, vomiting.

Whole population:

Nausea was most often associated with the use of high doses of the drug. If, after starting to take the drug, undesirable reactions from the gastrointestinal tract occur, 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.

Disorders of the liver and biliary tract

Uncommon: moderate increase in aspartate aminotransferase and/or alanine aminotransferase (AST and/or ALT) activity. This reaction has been observed in patients receiving beta-lactam antibiotic therapy, 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 concentrations 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 rarely observed in children.

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

Renal and urinary tract disorders

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

OVERDOSE

Symptoms

Gastrointestinal symptoms and water and electrolyte imbalance 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 receiving high doses of the drug (see section "Dosage and Administration" - Patients withrenal dysfunction,"Side effects").

Treatment

Gastrointestinal symptoms - symptomatic therapy, paying special attention to normalizing water and electrolyte balance. Amoxicillin and clavulanic acid can be removed from the bloodstream by hemodialysis.

The results of a prospective study that was conducted in 51 children at a poison control center showed that amoxicillin administered 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 MEDICINES

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

Concomitant use of allopurinol and amoxicillin may increase the risk of allergic skin reactions. Currently, there is no data in the literature on the simultaneous use of a combination of amoxicillin with clavulanic acid and allopurinol. Penicillins can slow down the elimination of methotrexate from the body by inhibiting its tubular secretion, therefore, simultaneous use of the drug Flemoklav Solutab and methotrexate may increase the toxicity of methotrexate. Like other antibacterial drugs, the drug 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 an increase in the international normalized ratio (INR) in patients with the combined use of acenocoumarol or warfarin and amoxicillin. If it is necessary to simultaneously prescribe the drug Flemoklav Solutab® with anticoagulants, prothrombin time or MHO should be carefully monitored when prescribing or discontinuing the drug Flemoklav Solutab; dose adjustment of anticoagulants for oral administration may be required.

In patients receiving mycophenolate mofetil, after starting the combination of amoxicillin and 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 overall changes in mycophenolic acid exposure.

SPECIAL INSTRUCTIONS

Before starting treatment with Flemoclav Solutab®, it is necessary to collect a detailed history regarding 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. If an allergic reaction occurs, treatment with Flemoclav Solutab should be discontinued and appropriate alternative therapy should be initiated. For severe hypersensitivity reactions, the patient should be given epinephrine immediately. Oxygen therapy, intravenous corticosteroids, and airway management, including intubation, may also be required.

If allergic skin reactions occur, treatment with Flemoclav Solutab should be discontinued.

If infectious mononucleosis is suspected, Flemoclav Solutab should not be used, since amoxicillin can cause a measles-like skin rash in patients with this disease, which makes diagnosing the disease difficult.

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

Cases of pseudomembranous colitis have been described when taking antibiotics, the severity of which can vary 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 diarrhea is prolonged or severe and the patient experiences abdominal cramps, treatment should be stopped immediately and the patient should be examined.

In general, the drug Flemoklav Solutab® is well tolerated and has the low toxicity characteristic of all penicillins. During long-term therapy with Flemoclav Solutab®, it is recommended to periodically evaluate renal, liver and hematopoietic function. In patients receiving a combination of amoxicillin and clavulanic acid together with indirect (oral) anticoagulants, an increase in prothrombin time (increase in MHO) has been reported in rare cases. When co-prescribing indirect (oral) anticoagulants with a combination of amoxicillin and clavulanic acid, monitoring of relevant indicators is necessary.

To maintain the desired effect of oral anticoagulants, their dose may need to be adjusted. In patients with reduced diuresis, crystalluria very rarely occurs, mainly during parenteral therapy. During administration of high doses of amoxicillin, it is recommended to take sufficient fluids and maintain adequate diuresis to reduce the likelihood of amoxicillin crystal formation (see section "Overdose").

Taking Flemoklav Solutab® orally leads to a high level of amoxicillin in the urine, which can lead to false-positive results when determining glucose in the urine (for example, Benedict's test, Fehling's test). In this case, it is recommended to use the glucose oxidant method for determining the concentration of glucose in the urine. Clavulanic acid may cause nonspecific binding of immunoglobulin G and albumin to red blood cell membranes, leading to false-positive Coombs test results.

One dispersible tablet Flemoklav Solutab® 875/125 mg contains 0.64 mmol (25 mg) 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.

Drug abuse and dependence

There was no drug dependence, addiction, or euphoric reactions associated with the use of the drug Flemoclav Solutab.

INFLUENCE ON THE ABILITY TO DRIVE VEHICLES,MECHANISMS

No studies have been conducted to study the effect on the ability to drive vehicles and operate machinery. Since the drug may cause side effects (for example, allergic reactions, dizziness, convulsions) (see section "Side Effects"), patients should be warned about precautions when driving or working with moving machinery.

RELEASE FORM

Dispersible tablets 875 mg + 125 mg. 7 tablets in a blister, 2 blisters along 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.

Best before date

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

CONDITIONS OF VACATION FROM PHARMACIES

According to the recipe.

OWNER OF REGISTRATION CERTIFICATES

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., the Netherlands or ORTAT CJSC, 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.

Trade name: Flemoklav Solutab ®

Dosage form: dispersible tablets

Compound
Active substance: 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
Tablets of oblong shape from white to yellow with brown dotted spots without marks 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 company logo.

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

Pharmacological properties
Pharmacodynamics
A broad-spectrum antibiotic, a combination drug of amoxicillin and clavulanic acid, a beta-lactamase inhibitor. It has a bactericidal effect and inhibits the synthesis of the bacterial wall. Active against 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 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 beta-lactamases and expands its spectrum of action.

Flemoklav Solutab ® is active against:
Aerobic gram-positive bacteria: Streptococcus pyogenes, Streptococcus viridans, Streptococcus pneumoniae, Staphylococcus aureus (including beta-lactamase-producing strains), Staphylococcus epidermidis (including beta-lactamase-producing strains) 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 ducreyi, Neisseria gonorrhoeae (including strains of the above bacteria that produce beta-lactamases), Neisseria meningitides, 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. The maximum plasma concentration is observed 1-2 hours after taking amoxicillin. After taking a single dose of 500/125 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 crosses the placental barrier and passes into breast milk in small quantities.

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 hours), in patients with creatinine clearance in the range of 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 eliminated by 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 observed 1-2 hours after administration. 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 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). 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 20 - 70 ml/min - 2.6 hours, and in anuria - within 3-4 hours. The drug is eliminated by 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 genitourinary tract.

Contraindications
Hypersensitivity to amoxicillin, clavulanic acid or other components. Hypersensitivity to other beta-lactam antibiotics such as penicillins and cephalosporins. History of jaundice or liver dysfunction while taking amoxicillin/clavulanate. Patients with infectious mononucleosis or lymphocytic leukemia have an increased risk of exanthema, so amoxicillin/clavulanic acid should not be prescribed in the presence of these diseases.

With caution: severe liver failure, gastrointestinal diseases (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 or newborns were observed when used by pregnant women. Use in the second and third trimesters of pregnancy is considered safe. During the first trimester, the drug should be prescribed with caution.

Amoxicillin is excreted in breast milk. There is no data on the excretion of clavulanic acid in breast milk. There were no harmful effects on the baby during breastfeeding while taking a combination of amoxicillin and clavulanic acid.

Directions for use and doses
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 (minimum 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.

Adults and children weighing more than 40 kg the drug is prescribed at 0.5 g/125 mg 3 times a 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 approximately 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 usually amounts to a dose of 125/31.25 mg 2 times a day.

For children aged 2 to 12 years(with a body weight of approximately 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 usually amounts to 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 (body weight body about 25-37 kg). 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).

Patients with impaired renal function
In patients with renal failure, the 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 presented in the table:

Patients with liver dysfunction
The combination of amoxicillin/clavulanic acid should be administered with caution to patients with liver damage. Liver function should be constantly monitored.

Side effects
Allergic skin reactions: urticaria, erythematous rashes, rarely - exudative erythema multiforme, extremely rarely - exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), in some cases the so-called “fifth day rash” (measles exanthema) appears. Reactions depend on the dose of the drug and the patient's condition.

Reactions from the digestive system: nausea, vomiting, diarrhea, impaired liver function, increased activity of “liver” 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 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. 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.

Others: candidiasis, development of superinfection, reversible increase in prothrombin time.

The following list shows, in descending order, possible side effects:
Often
Gastrointestinal tract: nausea, vomiting, diarrhea, abdominal pain
Immune reactions: hives
Leather and soft tissue: exanthema

Rarely
Blood and lymphatic system: changes in blood composition (leukopenia, thrombocytopenia, hemolytic anemia)
Hepato-biliary system: cholestatic jaundice, hepatitis
Immune system: angioedema, vasculitis
Blood coagulation system: prolongation of prothrombin time
Urinary system: interstitial nephritis

Isolated cases
Anaphylactic shock, angioedema, pseudomembranous colitis, erythema multiforme, exfoliative dermatitis.

Overdose
Overdose may result in gastrointestinal symptoms such as nausea, vomiting and diarrhea with possible fluid and electrolyte imbalance.

Treatment
Activated carbon is prescribed. It is necessary to maintain water and electrolyte balances. For convulsions, diazepam is prescribed. Other symptoms are treated symptomatically. In case of severe renal failure, hemodialysis should be performed.

Interaction with other drugs
Antacids, glucosamine, laxatives, aminoglycosides slow down and reduce absorption; ascorbic acid increases 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 intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index). When taking anticoagulants simultaneously, it is necessary to monitor blood clotting indicators.
Reduces the effectiveness of oral contraceptives, drugs, during the metabolism of which para-aminobenzoic acid is formed, ethinyl estradiol - the risk of developing breakthrough bleeding.

Diuretics, allopurinol, phenylbutazone, non-steroidal anti-inflammatory drugs and other drugs that block tubular secretion increase the concentration of amoxicillin (clavulanic acid is eliminated 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.

Special instructions
When treated with penicillins, anaphylactic reactions may occur in patients with hypersensitivity to them. Treatment with Flemoklav Solutab ® in such cases should be stopped immediately and replaced with other appropriate therapy. Treatment of anaphylactic shock may require urgent administration of epinephrine, corticosteroids and management of respiratory failure.

There is a possibility of cross-resistance and hypersensitivity with 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.

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.

An increase in prothrombin time is rarely observed. Amoxicillin/clavulanic acid should be administered with caution to patients receiving anticoagulation therapy.

Non-enzymatic methods for determining urine sugar, as well as the urobilinogen test, can give false positive results.

Release form
Dispersible tablets: 125 mg + 31.25 mg, or 250 mg + 62.5 mg, or 500 mg + 125 mg. 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 along 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.

Best before date
3 years. Do not use after the expiration date stated on the package.

Conditions for dispensing from pharmacies
by doctor's prescription

Manufacturer
Astellas Pharma Europe B.V., The Netherlands Elisabethof 19, Laiderdorp

Packaged and/or packaged:
Astellas Pharma Europe B.V., Netherlands
Or: ORTAT CJSC, Russia

Quality claims are accepted by the representative office in Moscow.
Moscow Representative Office:
109147 Moscow, Marksistskaya st. 16 “Mosalarko Plaza-1” business center, 3rd floor.

Flemoklav Solutab is an antibacterial substance with a broad spectrum of action. The medicine is actively used in otolaryngology.

It can be prescribed for the treatment and prevention of respiratory tract pathologies. The medication is effective for otitis media, tonsillitis, sinusitis and other ailments.

In this article we will look at why doctors prescribe Flemoclav Solutab, including instructions for use, analogues and prices for this drug in pharmacies. Real REVIEWS of people who have already used Flemoclav Solutab can be read in the comments.

Composition and release form

Flemoclav Solutab is available in the form of dispersible tablets. The drug is sold in blisters (4 and 7 tablets each), placed in cardboard packages of 2 and 5 pcs.

1 tablet contains active substances (respectively):

• Amoxicillin – 125/250/500/875 mg (in the form of amoxicillin trihydrate – 145.7/291/528.8/1019.8 mg);
• Clavulanic acid – 31.25/62.5/125/125 mg (in the form of potassium clavulanate – 37.2/74.5/148.9/148.9 mg).

Clinical and pharmacological group: broad-spectrum penicillin antibiotic with beta-lactamase inhibitor.

Indications for use

Flemoklav Solutab is prescribed for the treatment of infectious and inflammatory diseases caused by microorganisms sensitive to its action, such as:

1. Infections of soft tissues and skin.
2. Urinary tract and kidney infections (including pyelonephritis, cystitis).
3. Infections of the ENT organs, upper and lower respiratory tract (including otitis media, pharyngitis, tonsillitis, sinusitis, COPD, chronic bronchitis in the acute stage, community-acquired pneumonia).

Additionally, Flemoklav Solutab 875 mg/125 mg is used for infections in gynecology and obstetrics, as well as in the treatment of infections of joints and bones, including osteomyelitis.

Pharmacological action

Flemoclav Solutab is a broad-spectrum antibiotic active against gram-positive and gram-negative microorganisms, including bacteria that produce beta-lactamases.

• Amoxicillin is a beta-lactam antibiotic of the penicillin group. Amoxicillin disrupts the integrity of the cell membrane of bacteria, resulting in the death of the microorganism. Amoxicillin is inactivated by beta-lactamases, therefore, when used alone, it is inactive against strains that produce beta-lactamases.
• Clavulanic acid – has a slight antimicrobial effect. Clavulanic acid inactivates beta-lactamases of staphylococci and gram-negative bacteria.

Amoxicillin in combination with clavulanic acid has a significantly wider spectrum of action than with monotherapy.

Instructions for use

According to the instructions for use, to reduce the risk of side effects from the digestive system, Flemoclav Solutab is recommended to be taken immediately before meals. The tablet must be swallowed whole with water, or dissolved in 50 ml of water, stirring completely before use.

• tablets 875 mg/125 mg: one tablet 2 times a day (every 12 hours);
• tablets 500 mg/125 mg: one tablet 3 times a day (every 8 hours). For the treatment of chronic, recurrent, severe infections, this dose can be doubled.

Only a doctor can prescribe the exact dosage for a child. The average dosage for children is as follows:

• 7–12 years (25–37 kg): at a dose of 250 mg/62.5 mg – one tablet 3 times a day;
• 2–7 years (13–25 kg): at a dose of 125 mg/31.25 mg – one tablet 3 times a day;
• 3 months – 2 years (5–12 kg): at a dose of 125 mg/31.25 mg – one tablet 2 times a day.

The duration of treatment is no more than 14 days. If longer-term use of the drug is necessary, consult a doctor.

Contraindications

The drug should not be used in the following cases:

• lymphocytic leukemia;
• renal failure;
• liver dysfunction;
• infectious mononucleosis;
• breastfeeding period;
• hypersensitivity to the components of the drug;
• diseases of the digestive tract, accompanied by vomiting and chronic diarrhea.

Contraindicated in children under 12 years of age weighing less than 40 kg (for dispersible tablets 875 mg/125 mg);

Side effects

The antibiotic is usually well tolerated by patients. However, the development of undesirable reactions is still possible. The most common side effects are:

1. Nausea;
2. Vomiting;
3. Abdominal pain;
4. Diarrhea;
5. Flatulence;
6. Dry mouth;
7. Dyspepsia;
8. Colitis pseudomembranous;
9. Change in taste;
10. Elevated levels of liver enzymes;
11. Skin rashes and itching;
12. Changing the shade of tooth enamel.

Allergic reactions include morbilliform exanthema, urticaria, dermatitis (exfoliative and bullous), Stevens-Johnson syndrome, eosinophilia, hemolytic anemia, angioedema, allergic vasculitis.

Pregnancy and lactation

When using Flemoclav Solutab during pregnancy, no negative effects on the fetus or newborn were noted. The use of the drug in the second and third trimesters 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.

When breastfeeding, Flemoklav Solutab is allowed as prescribed by a doctor, although the components of the drug pass into breast milk. If negative phenomena develop in a child (allergies, candidiasis or diarrhea), breastfeeding should be stopped.

Analogues of 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.

Attention: the use of analogues must be agreed with the attending physician.

Prices

The average price of the drug differs depending on the form of release:

• Dispersible tablets 125 mg + 31.25 mg 20 pcs – 320 rubles.
• Dispersible tablets 500mg+125mg 20 pcs – 400 rubles.
• Dispersible tablets 250 mg + 62.5 mg 20 pcs – 428 rubles.
• Dispersible tablets 875mg+125mg 14 pcs – 445 rubles.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Flemoxin Solutab Otofa ear drops: instructions, reviews, analogues Macmiror tablets and suppositories: instructions, reviews, analogues

When choosing an antibiotic to help eliminate an infectious disease, preference is given to agents that act on many types of bacteria. One of these drugs is Flemoklav Solutab.

Release form and composition

The medicine is presented in dispersible tablets, that is, it can dissolve when mixed with water, forming a suspension, which is why the word “solutab” is present in the name of the medicine. The drug is produced in the Netherlands in four different dosages:

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

The first digit in the indicated dosage of the medication is the amount of amoxicillin, presented in the form of trihydrate. The second number is the amount of clavulanic acid, which is contained in the drug in the form of potassium clavulanate.

In addition to these main components, the medication contains crospovidone, saccharin, MCC, magnesium stearate, apricot flavor and vanillin. The auxiliary components of tablets with a dosage of 875 mg + 125 mg are slightly different - dispersed cellulose is added to them, and instead of apricot flavoring, this medicine contains lemon and tangerine flavors.

In appearance, all variants of “Flemoclav Solutab” are similar to each other, since they are oblong oval tablets of white or yellowish color, the structure of which contains brown inclusions. There are no marks on the surface of the tablet, that is, its division into parts is not provided, however, there is a logo of the manufacturing company and a three-digit number that differs for tablets of different dosages (for example, on a drug with 125 mg of amoxicillin you can see the number 421).

All types of medicine, except for the drug with the highest dosage, are packaged in blisters of 4 pieces and sold in boxes of 20 tablets. As for “Flemoklav” containing amoxicillin at a dose of 875 mg, such tablets are sold 14 pieces per pack and 7 pieces in one blister.

Operating principle

Amoxicillin, which is one of the main components of Flemoklav, is a penicillin antibiotic. It has a fairly wide range of bactericidal (bacteria-destroying) effects on microbes that cause infections of the respiratory tract, kidneys and other organs.

The presence of another active ingredient (clavulanic acid) in the tablets helps amoxicillin avoid destruction by beta-lactamases, enzymes produced by some strains of bacteria. Thanks to the combination with such an acid, the medication is effective against various types of staphylococci, enterococci, listeria, bacteroides, clostridia, Escherichia, Proteus, streptococci and other pathogens.

Indications

In addition, tablets with a dosage of 875 mg + 125 mg are prescribed for bacterial damage to joints and bones, as well as for gynecological infections.

At what age is it prescribed?

According to the instructions for the tablets, they can be given from 3 months of age. Use in children in the first months of life is also possible, but only for serious indications and under the supervision of a doctor. Babies who are already three months old are also given medicine only as prescribed by the doctor.

Tablets with the highest dose of amoxicillin are contraindicated before the age of 12, since the amount of antibiotic in such a drug (875 mg + 125 mg) is only suitable for patients weighing more than 40 kg.

Contraindications

The medication is not used in children with hypersensitivity to any of the components of the tablets, as well as allergies to other penicillin or cephalosporin antibacterial drugs. It should also not be given to patients who have had liver dysfunction or jaundice in the past while being treated with a combination of amoxicillin and clavulanic acid.

"Flemoclav" is not used for lymphocytic leukemia and infectious mononucleosis, as well as for influenza and other viral infections. The highest dosage tablets are contraindicated in cases of severe renal impairment.

If the patient has any disease of the gastrointestinal tract, kidneys or liver, the question of taking Flemoklav should be decided by the attending physician on an individual basis.

Side effects

Taking Flemoklav Solutab can sometimes cause an allergic skin reaction or negative gastrointestinal symptoms, such as vomiting or abdominal pain. In some patients, the tablets have a negative effect on the liver or hematopoiesis. In addition, the medication can cause the development of candidiasis or superinfection.

Instructions for use

To prevent the negative effect of Flemoklav Solutab on the stomach and intestines, taking the tablet is recommended immediately before meals. If a child can swallow it, it is advised not to chew the drug, but to immediately drink it with water. However, the most common “children’s” way of taking the medicine is to dissolve it in water (30-100 ml).

After thorough stirring, the resulting syrup is given to the patient in a dose appropriate for age and weight. If the child’s age is from 3 months to 12 years, then per 1 kilogram of body weight of such a patient, 20-30 mg of amoxicillin is required, and clavulanic acid is required from 5 to 7.5 mg. Often the drug is prescribed in the following dosages:

• a child weighing 5-12 kg (under two years) – 125 mg + 31.25 mg twice a day;
• for a patient whose weight is from 13 to 25 kg (aged 2-7 years) - three times a day, 125 mg + 31.25 mg;
• a child who weighs 25-37 kg (usually 7-12 years old) - 250 mg + 62.5 mg three times a day;
• for a patient weighing more than 40 kg - three times a day, 500 mg + 125 mg, or twice a day, a dosage of 875 mg + 125 mg.

If the infection is severe, the indicated dosages can be doubled, but the child should not receive more than 60 mg of amoxicillin per day per kilogram of his weight, and for clavulanic acid the limit is considered to be a dose of 15 mg/kg.

The duration of use of Flemoklav should be determined taking into account the severity of the disease, but usually the course of therapy does not exceed two weeks.

Overdose

If a child accidentally takes Flemoklav in a much higher dose than the doctor prescribed, this will lead to vomiting, diarrhea or severe nausea, which in severe poisoning can lead to dehydration and electrolyte imbalance. In such a situation, you need to give the child activated charcoal and a rehydration solution, and then consult a doctor.

You should not combine Flemoklav with anticoagulants, diuretics, digoxin, methotrexate and some other medications that can be seen in the instructions for the tablets.

Terms of sale

"Flemoklav Solutab" is a prescription drug, so a doctor's examination is required before purchasing tablets. The cost of the drug depends on the dosage of its active substances. For example, for a pack of tablets containing 125 mg of amoxicillin, you need to pay from 260 to 300 rubles, and a package of medicine containing 250 mg of amoxicillin in each tablet costs approximately 400 rubles.

Storage conditions

The shelf life of dispersible tablets, with the exception of the drug with a dosage of 875 mg + 125 mg, is 3 years, but the drug with the highest dose of active substances is good for 2 years from the date of manufacture. It is recommended to store the medication at temperatures up to +25 degrees, choosing a dry place inaccessible to children.

In this medical article you can familiarize yourself with the drug Flemoklav. The instructions for use will explain in what cases the tablets can be taken, what the medicine helps with, what are the indications for use, contraindications and side effects. The annotation presents the forms of release of the drug and its composition.

In the article, doctors and consumers can only leave real reviews about Flemoklav, from which you can find out whether the medicine helped in the treatment of sore throat, herpes and other infectious diseases in adults and children, for which it is also prescribed. The instructions list analogues of Flemoclav, prices of the drug in pharmacies, as well as its use during pregnancy.

A broad-spectrum penicillin antibiotic with a beta-lactamase inhibitor is Flemoklav Solutab. Instructions for use prescribe taking dispersible tablets 125 mg, 250 mg, 500 mg, 875 mg and 1000 mg for infectious pathologies.

Release form and composition

The drug Flemoklav Solutab is available in the form of white oblong dispersible tablets in blisters of 4 pieces (5) in a cardboard box with a detailed annotation attached.

Each tablet of the drug contains active ingredients - clavulanic acid. Depending on the content of active ingredients in the drug, tablets are available in dosages of 125 mg, 250 mg, 500 mg, 875 mg and 1000 mg.

The auxiliary components in the tablet are: povidone, microcrystalline cellulose, magnesium stearate, flavoring (vanilla, apricot, lemon, tangerine), saccharin, dispersed cellulose.

Pharmacological action

Flemoklav Solutab is a combination drug of amoxicillin and clavulanic acid. It has a bactericidal effect and inhibits the synthesis of the bacterial wall. Active against aerobic gram-positive bacteria: Staphylococcus aureus; aerobic gram-negative bacteria: Enterobacter spp., Escherichia coli, Haemophilus influenzae, Klebsiella spp., Moraxella catarrhalis.

The following pathogens are sensitive only in vitro: Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus anthracis, Streptococcus pneumoniae, Streptococcus viridans, Enterococcus faecalis, Corynebacterium spp., Listeria monocytogenes; anaerobic Clostridium spp., Peptococcus spp., Peptostreptococcus spp.

Aerobic gram-negative bacteria (including beta-lactamase producing strains): Proteus mirabilis, Proteus vulgaris, Salmonella spp., Shigella spp., Bordetella pertussis, Yersinia enterocolitica, Gardnerella vaginalis, Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus ducreyi, Yersinia multocida (formerly Pasteurella ), Campylobacter jejuni; anaerobic gram-negative bacteria: Bacteroides spp., including Bacteroides fragilis.

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

Indications for use

What does Flemoklav Solutab help with? Tablets are prescribed for infectious diseases of an inflammatory nature caused by microorganisms sensitive to Flemoclav:

• infections of joints and bones, including osteomyelitis;
• infections of the ENT organs and respiratory tract (COPD, exacerbation of chronic bronchitis, otitis media, tonsillitis, pharyngitis, sinusitis, community-acquired pneumonia);
• infections of the genitourinary system (cystitis, pyelonephritis);
• gynecological infections;
• infections of soft tissues and skin.

Instructions for use

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

Contraindications

The drug can be taken only after consulting a doctor and undergoing tests. Self-administration of drug tablets without examination can blur the clinical picture of the disease and make it difficult to make a correct diagnosis.

Flemoklav Solutab tablets have the following contraindications for use:

• pregnancy in the 1st trimester;
• individual intolerance to the components of the drug;
• age of children under 12 years (for tablets with a dosage of 1000 mg);
• infectious mononucleosis;
• acute renal failure;
• severe liver diseases accompanied by dysfunction of the organ;
• kidney disease with organ dysfunction;
• history of severe adverse reactions to penicillins.

With particular caution, the drug should be prescribed to pregnant women, nursing mothers, and people with gastrointestinal diseases.

Side effects

• from the hematopoietic system: rarely - hemolytic anemia, thrombocytosis; very rarely - anemia, leukopenia, thrombocytopenia, granulocytopenia, pancytopenia (reactions are reversible);
• from the digestive system: often - nausea, vomiting, abdominal pain, flatulence, diarrhea, pseudomembranous colitis; rarely – hemorrhagic colitis, intestinal candidiasis, discoloration of the upper layer of tooth enamel; allergic reactions: often - skin itching, rash, measles-like exanthema (appears after 5-11 days of use), urticaria; rarely - drug fever, exfoliative or bullous dermatitis (Stevens-Johnson syndrome, exudative erythema multiforme, toxic epidermal necrolysis), eosinophilia, anaphylactic shock, laryngeal edema, Quincke's edema, hemolytic anemia, serum sickness, interstitial nephritis, allergic vasculitis;
• from the cardiovascular system: rarely – vasculitis;
• from the liver: often – a slight increase in the activity of liver enzymes; rarely - cholestatic jaundice, hepatitis (the risk increases with a duration of therapy of more than 14 days; disorders are usually reversible, but in very rare cases they can be severe, and in patients with severe concomitant pathologies or when combining the drug with potentially hepatotoxic drugs death);
• from the nervous system: rarely – headache, dizziness, convulsions; very rarely - insomnia, hyperactivity, anxiety, restlessness, aggressive behavior, impaired consciousness;
• from the genitourinary system: infrequently – burning and vaginal discharge, itching; rarely – interstitial nephritis; other: infrequently - against the background of long-term use or repeated courses of therapy, fungal or bacterial superinfections may develop;
• from the coagulation system: very rarely - an increase in bleeding time and prothrombin time (reactions are reversible).

Children, pregnancy and breastfeeding

The maximum daily dosage for children should not exceed 15 mg of clavulanic acid and 60 mg of amoxicillin per kilogram of weight. Reports of side effects are generally not typical for reviews from children.

When using Flemoclav Solutab during pregnancy, no negative effects on the fetus or newborn were noted. 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 the drug, there is a risk of cross-resistance and hypersensitivity with other cephalosporins or penicillins. Superinfection (for example, candidiasis) may occur, especially in people with functional disorders and/or chronic diseases of the immune system.

If superinfection develops, Flemoklav Solutab should be stopped and/or antibacterial treatment should be changed accordingly. If anaphylactic reactions occur, the drug should be discontinued and appropriate treatment should be carried out: for the treatment of anaphylactic shock, urgent administration of GCS, epinephrine (adrenaline) and elimination of respiratory failure are necessary.

The appearance of persistent and severe diarrhea may be due to the development of pseudomembranous colitis. In this case, Flemoklav Solutab is canceled and the necessary therapy is prescribed. In case of hemorrhagic colitis, immediate discontinuation of the medication and corrective treatment are also required.

In these cases, the use of drugs that weaken intestinal motility is contraindicated. In case of functional liver disorders, the drug must be prescribed with extreme caution and under constant medical supervision. Without assessing the condition of the organ, it is not recommended to take tablets for more than 14 days.

While taking Flemoclav Solutab, an increase in prothrombin time may be observed. In this regard, the drug should be prescribed with extreme caution to people undergoing treatment with anticoagulants (blood clotting indicators must be monitored).

For patients with severe gastrointestinal disorders, which are accompanied by diarrhea and/or vomiting, the administration of the drug is not advisable (until the above symptoms are eliminated). If convulsions occur during therapy, stop taking the drug.

During the period of use of Flemoklav Solutab, the test for urobilinogen, as well as non-enzymatic methods for determining the glucose content in urine, may give false positive results. Due to the high content of amoxicillin in the urine, it can accumulate on the walls of the urinary catheter. Therefore, such patients require periodic change of urinary devices.

Drug interactions

• Methotrexate. Taking amoxicillin reduces the excretion of methotrexate by the kidneys, so toxic effects may occur. It is necessary to monitor the level of the latter in the blood.
• Other antibiotics. Flemoklav Solutab should not be used together with bacteriostatic drugs/chemotherapy/disulfiram/antibiotics (chloramphenicol, macrolides, tetracycline, sulfonamides).
• Anticoagulants. Combining the drug with indirect anticoagulants may increase the risk of bleeding.
• Hormonal contraceptives. Amoxicycline in rare cases may inhibit the effects of oral contraceptives.
• Drugs that inhibit the excretion of amoxicillin by the kidneys. Concomitant use with phenylbutazone, probenecid, oxyphenbutazone, indomethacin, acetylsalicylic acid and sulfinpyrazone may cause an increase in the concentration of amoxicillin in the blood and bile. The excretion of clavulanic acid in such cases does not change.
• Digoxin. Flemoklav Solutab increases the absorption of digoxin in the intestine.
• Allopurinol. Its use with amoxicillin increases the risk of skin rash.

Analogues of the drug Flemoklav Solutab

Analogues are determined by structure:

1. Liklav.
2. Fibell.
3. Panclave.
4. Verklav.
5. Bactoclav.
6. Amoxiclav Quiktab.
7. Rapiklav.
8. Clamosar.
9. Ecoclave.
10. Ranklav.
11. Honeyclave.
12. Amoxicillin + Clavulanic acid Pfizer.
13. Amoxiclav.
14. Taromentin.
15. Arlet.
16. Amovycombe.

Vacation conditions and price

The average cost of Flemoklav Solutab (dispersible tablets 500 mg + 125 mg No. 20) in Moscow is 395 rubles. Available without a prescription.

Store at a temperature not exceeding 25 C. Keep away from children. Shelf life – 3 years (for tablets 875 mg/125 mg – 2 years).