Flemoklav Solutab - Instructions For Use, Price, Tablets 250 Mg And 500 Mg

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Flemoklav Solutab

Flemoklav Solutab: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Drug interactions
10. 10. Analogs
11. 11. Terms and conditions of storage
12. 12. Terms of dispensing from pharmacies
13. 13. Reviews
14. 14. Price in pharmacies

Latin name: Flemoclav Solutab

ATX code: J01CR02

Active ingredient: amoxicillin + clavulanic acid (amoxicillin + clavulanic acid)

Producer: Astellas Pharma Europe, BV (Netherlands)

Description and photo update: 2019-14-08

Prices in pharmacies: from 122 rubles.

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Flemoklav Solutab is a broad-spectrum penicillin antibiotic with a beta-lactamase inhibitor.

Release form and composition

Dosage form Flemoklav Solutab - dispersible tablets: oblong, from yellow to white with brown splashes, marked "421", "422", "424" or "425" and the company logo, without dividing lines (with the words "421", "422", "424": 4 pcs. In a blister, in a cardboard box 5 blisters; "425": 7 pcs. In a blister, in a cardboard box 2 blisters).

1 tablet contains:

• active ingredients: amoxicillin and clavulanic acid - in tablets with the inscription "421" - 125 mg and 31.25 mg, "422" - 250 mg and 62.5 mg, "424" - 500 mg and 125 mg, "425" - 875 mg and 125 mg, respectively (as amoxicillin trihydrate and potassium clavulanate 145.7 mg and 37.2 mg, 291 mg and 74.5 mg, 528.8 mg and 148.9 mg, 1019.8 mg and 148.9 mg respectively);
• auxiliary components: crospovidone, apricot flavor, microcrystalline cellulose, magnesium stearate, saccharin, vanillin.

Pharmacological properties

Pharmacodynamics

Amoxicillin is a broad-spectrum antibiotic of semi-synthetic origin that is active against many gram-negative and gram-positive microorganisms. However, the substance is capable of being destroyed by beta-lactamases, therefore microorganisms that produce this enzyme are resistant to amoxicillin. Clavulanic acid belongs to beta-lactamase inhibitors and is structurally similar to penicillins, which determines the ability to inactivate a wide range of beta-lactamases found in microorganisms resistant to cephalosporins and penicillins.

Clavulanic acid demonstrates sufficient efficacy against plasmid beta-lactamases, which most often provoke bacterial resistance, but its effectiveness against type 1 chromosomal beta-lactamases, which lack inhibition by clavulanic acid, is minimal. The combination of amoxicillin with clavulanic acid protects it from destruction by beta-lactamase enzymes, which helps to expand the antibacterial spectrum of amoxicillin.

In vitro, the following microorganisms are highly sensitive to the drug:

• gram-negative anaerobes: Prevotella spp., Bacteroides fragilis, Bacteroides spp., Porphyromonas spp., Fusobacterium spp., Fusobacterium nucleatum, Capnocytophaga spp., Eikenella corrodens;
• gram-positive anaerobes: Peptostreptococcus spp., Peptostreptococcus micros, Peptostreptococcus magnus, Peptococcus niger, Clostridium spp.;
• gram-negative aerobes: Vibrio cholerae, Bordetella pertussis, Pasteurella multocida, Haemophilus influenzae, Neisseria gonorrhoeae, Moraxella catarrhalis, Helicobacter pylori;
• gram-positive aerobes: coagulase-negative staphylococci (showing sensitivity to methicillin), Staphylococcus saprophyticus and Staphylococcus aureus (strains sensitive to methicillin), Bacillus anthracis, Streptococcus spp. (other beta-hemolytic streptococci), Streptococcus agalactiae, Streptococcus pyogenes, Enterococcus faecalis, Listeria monocytogenes;
• different: Treponema pallidum, Leptospira icterohaemorrhagiae, Borrelia burgdorferi.

The following microorganisms presumably possess acquired resistance to active components of Flemoklav Solutab:

• gram-positive aerobes: streptococci of the Viridans group, Streptococcus pneumoniae, Enterococcus faecium, Corynebacterium spp.;
• gram-negative aerobes: Shigella spp., Escherichia coli, Salmonella spp., Proteus spp., Proteus vulgaris, Proteus mirabilis, Klebsiella spp., Klebsiella pneumoniae, Klebsiella oxytoca.

Natural resistance to the combination of amoxicillin with clavulanic acid is demonstrated by the following microorganisms:

• gram-negative aerobes: Yersinia enterocolitica, Acinetobacter spp., Stenotrophomonas maltophilia, Citrobacter freundii, Serratia spp., Enterobacter spp., Pseudomonas spp., Hafnia alvei, Providencia spp., Morganella pneumophila, Legionella pneumophilia;
• others: Mycoplasma spp., Chlamydia spp., Chlamydia psittaci, Chlamydia pneumoniae, Coxiella burnetii.

Pharmacokinetics

Both amoxicillin and clavulanic acid are rapidly and completely absorbed from the gastrointestinal tract after oral administration. The value of absorption of active ingredients is optimal if the antibiotic 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 level of amoxicillin in blood plasma is 12 μg / ml and is reached after 1.5 hours. For clavulanic acid, the same characteristics are 3 μg / ml and 1 hour, respectively. The area under the concentration-time pharmacokinetic curve for clavulanic acid and amoxicillin is 6 μg / h / l and 33 μg / h / l, respectively. The degree of absorption of amoxicillin when taken orally reaches 90%, and the absolute bioavailability of clavulanic acid is approximately 60%.

Both with oral administration and with intravenous administration of Flemoklav Solutab, the therapeutic concentrations of amoxicillin and clavulanic acid are determined in the interstitial fluid and various tissues (in purulent discharge, bile, peritoneal and synovial fluids, muscle and adipose tissues, gallbladder, abdominal tissues, skin). Amoxicillin and clavulanic acid are slightly associated with blood plasma proteins (for amoxicillin, this figure is 17-20%, for clavulanic acid - 22%).

Studies on animals have not revealed a tendency towards the accumulation of the active components of the drug in any organs.

Amoxicillin is determined in breast milk, and trace concentrations of clavulanic acid are also found in it. At the moment, no other negative effects of amoxicillin and clavulanic acid on the health of newborns fed with breast milk have been identified, with the exception of an increased risk of developing candidiasis of the oral mucous membranes, diarrhea or sensitization of the body. In studies of the reproductive function of animals, it was shown that the active components of Flemoklav Solutab penetrate the placental barrier, but the negative effect on the fetus was not confirmed.

10-25% of the dose of amoxicillin taken is excreted through the kidneys in the form of penicillic acid, a metabolite that does not have pharmacological activity. Clavulanic acid is extensively metabolized to 1-amino-4-hydroxy-butan-2-one and 2,5-dihydro-4- (2-hydroxyethyl) -5-oxo-1H-pyrrole-3-carboxylic acid and is excreted through the gastrointestinal tract, with urine, as well as with exhaled air in the form of carbon dioxide.

The total clearance for amoxicillin and clavulanic acid is 25 l / h, the half-life of amoxicillin is 1.1 hours, and clavulanic acid is 0.9 hours. Approximately 30-50% of clavulanic acid and 60-80% of amoxicillin are excreted in the urine during the first 6 hours after taking Flemoklav Solutab.

Taking the drug in combination with probenecid reduces the rate of elimination of amoxicillin, but not clavulanic acid.

Indications for use

According to the instructions, Flemoklav Solutab is indicated for the treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

• infections of the ear, throat, nose, and upper respiratory tract (including sinusitis, otitis media, pharyngitis, tonsillitis);
• lower respiratory tract infections [including community-acquired pneumonia, exacerbation of chronic bronchitis, chronic obstructive pulmonary disease (COPD)];
• infections of soft tissues and skin;
• infectious pathologies of joints and bones;
• cystitis, pyelonephritis and other infections of the kidneys and urinary tract.

In addition, Flemoklav Solutab tablets at a dose of 875 mg / 125 mg are prescribed for osteomyelitis, infections in gynecology and obstetrics.

Contraindications

• jaundice and other liver dysfunctions while taking amoxicillin / clavulanic acid in history;
• Infectious mononucleosis;
• lymphocytic leukemia;
• hypersensitivity to penicillins and cephalosporins;
• individual intolerance to the components of the drug.

In addition, contraindications for the use of tablets Flemoklav Solutab 875 mg / 125 mg:

• renal failure (glomerular filtration rate 30 ml / min or less);
• age up to 12 years with a body weight of less than 40 kg.

Care must be taken when prescribing the drug to patients with severe hepatic impairment, diseases of the gastrointestinal tract (GIT) (including colitis with a history of penicillins), chronic renal failure.

The use of Flemoklav Solutab during pregnancy is possible if, according to the doctor's opinion, the expected benefit from treatment for the mother outweighs the risk to the fetus.

In the first trimester of pregnancy, the drug is taken with caution, you should avoid taking 875 mg / 125 mg tablets.

During the period of breastfeeding, Flemoklav Solutab can be used, but since the active components of the tablets are excreted in breast milk, there is a risk of developing sensitization, candidiasis of the mucous membranes or diarrhea in the child. If the child develops symptoms of these disorders, breastfeeding should be discontinued.

Instructions for the use of Flemoklav Solutab: method and dosage

The tablets are taken orally before meals, swallowing whole and drinking 200 ml of water or dissolving in 100 ml of water and stirring thoroughly before taking.

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

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

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

Recommended dosage for children:

• 7-12 years old (25-37 kg): Flemoklav Solutab 250 mg + 62.5 mg - one tablet 3 times a day;
• 2-7 years (13-25 kg): drug 125 mg + 31.25 mg - one tablet 3 times a day;
• 3 months - 2 years (5-12 kg): tablets 125 mg + 31.25 mg - one each. 2 times a day.

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

The duration of treatment is no more than 14 days. If you need a longer use of the drug, you should consult a doctor.

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

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

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

Side effects

• 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 - itchy skin, rash, measles-like exanthema (manifests itself after 5-11 days of admission), 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,
• on the part of the hematopoietic system: rarely - hemolytic anemia, thrombocytosis; very rarely - anemia, leukopenia, thrombocytopenia, granulocytopenia, pancytopenia (reactions are reversible);
• on the part of the coagulation system: very rarely - an increase in bleeding time and prothrombin time (reactions are reversible);
• on the part of the cardiovascular system: rarely - vasculitis;
• from the nervous system: rarely - headache, dizziness, convulsions; very rarely - insomnia, hyperactivity, anxiety, anxiety, aggressive behavior, impaired consciousness;
• 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 for more than 14 days; violations, as a rule, are reversible, but in very rare cases they can be severe, and in patients with severe concomitant pathologies or when the drug is combined with potentially hepatotoxic drugs, it is possible death);
• from the genitourinary system: infrequently - burning and vaginal discharge, itching; rarely - interstitial nephritis;
• others: infrequently - against the background of prolonged use or repeated courses of therapy, fungal or bacterial superinfections may develop.

Overdose

An overdose of Flemoklav Solutab can manifest itself as violations of the water-electrolyte balance and the appearance of symptoms from the gastrointestinal tract. Sometimes it is accompanied by amoxicillin crystalluria, in some cases provoking the development of renal failure.

Patients with kidney dysfunction, as well as those taking extremely high doses of the drug, may develop seizures.

As a treatment, symptomatic therapy is recommended, and special attention should be paid to the normalization of the water-electrolyte balance. Amoxicillin and clavulanic acid can be removed from the systemic circulation by hemodialysis.

The results of a study at a poison control center, in which 51 children participated, proved that the intake of amoxicillin in the body at a dose of less than 250 mg / kg did not lead to the appearance of clinically significant symptoms and did not require gastric lavage.

special instructions

There is a risk of developing cross-resistance and hypersensitivity with the simultaneous use of Flemoklav Solutab with other antibiotics of the penicillin or cephalosporin series.

If an anaphylactic reaction develops, taking the pills should be immediately discontinued and seek appropriate medical attention. The patient may need the introduction of adrenaline (epinephrine), glucocorticosteroids (GCS), urgent restoration of respiratory function.

To reduce the intensity of side effects from the digestive system, Flemoklav Solutab is recommended to be taken before meals.

The appearance of urticaria in the first days of treatment with a high degree of probability may indicate an allergic reaction to the drug, therefore, its cancellation is required.

It is inappropriate to prescribe Flemoklav Solutab during a period of severe gastrointestinal upset accompanied by vomiting and / or diarrhea, since the absorption of the drug from the gastrointestinal tract will be impaired.

With the development of superinfection, it is necessary to accordingly revise antibiotic therapy or cancel the drug.

In the case of the development of hemorrhagic colitis or pseudomembranous colitis, a symptom of which may be the appearance of persistent severe diarrhea, it is recommended to stop the use of Flemoklav Solutab and prescribe the necessary corrective therapy to the patient. In these cases, drugs that weaken the intestinal motility cannot be used.

Patients with impaired liver function should be provided with constant medical supervision. You should not take tablets for more than 14 days without assessing the functional state of the liver.

Symptoms of a functional disorder of the liver can appear both during treatment and after discontinuation of the drug, immediately or after several weeks. Most often they occur in patients over the age of 60 and men, very rarely in children.

It is necessary to monitor the indicators of blood clotting in patients receiving concomitant anticoagulant therapy, since the action of Flemoklav Solutab can increase the prothrombin time.

Due to the high concentration of amoxicillin in the urine and its possible accumulation on the walls of the urinary catheter, patients need to periodically change catheters. The use of the forced diuresis method will accelerate the excretion of amoxicillin and reduce its concentration in plasma.

During treatment, the use of non-enzymatic methods for determining glucose in urine and the test for urobilinogen can give false positive results.

It should be borne in mind that the potassium content in 1 dispersible tablet 875 mg / 125 mg is 25 mg.

During the course of treatment, careful monitoring of the function of the liver, kidneys, and hematopoietic organs is required.

When the patient develops seizures during therapy, Flemoklav Solutab is canceled.

Influence on the ability to drive vehicles and complex mechanisms

Studies on the effect of the drug on the ability to drive vehicles and perform complex types of work have not been conducted. Since the use of Flemoklav Solutab can cause side effects (for example, dizziness, convulsions, allergic reactions), patients should be aware of the precautions when driving or performing work that requires increased concentration.

Drug interactions

When combined in vitro with some bacteriostatic agents (including sulfonamides, chloramphenicol), antagonism with the drug was noted.

Should not be combined with disulfiram.

With the simultaneous use of Flemoklav Solutaba:

• probenecid, oxyphenbutazone, phenylbutazone, acetylsalicylic acid, sulfinpyrazone, indomethacin - slow down the renal excretion of amoxicillin and cause an increase in the concentration level and a longer stay of amoxicillin in bile and blood plasma (this does not affect the excretion of clavulanic acid);
• antacids, laxatives, glucosamine, aminoglycosides - reduce and slow down the absorption of amoxicillin;
• ascorbic acid - causes an increase in the absorption of amoxicillin;
• allopurinol - the risk of developing a skin rash increases;
• sulfasalazine - can reduce its serum content;
• methotrexate - reduces its renal clearance, the risk of increasing its toxic effect increases;
• digoxin - increases its absorption;
• indirect anticoagulants - may increase the risk of bleeding;
• hormonal oral contraceptives - may be less effective.

Analogs

Analogs of Flemoklav Solutab are: Trifamox IBL, Amoxiclav 2X, Rekut, Augmentin, Augmentin SR, Panklav, Baktoklav, Medoklav, Clavam, Arlet, Ekoklav, Sultasin, Oksamp, Oksamp-Sodium, Amoxil K 625, Ampisid.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 25 ° C.

Shelf life: tablets labeled "421", "422", "424" - 3 years, "425" - 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Flemoklav Solutab

Reviews of Flemoklav Solutab confirm the high effectiveness of the drug and the rapid onset of the therapeutic effect when taken. Children are often prescribed additional therapy to prevent the development of superinfection and dysbiosis. There are reports that patients with sinusitis after starting treatment with Flemoklav Solutab experienced rapid relief of the condition.

Price for Flemoklav Solutab in pharmacies

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

• Flemoklav Solutab 125 mg + 31.25 mg (20 pcs are included in the package) - 304‒325 rubles;
• Flemoklav Solutab 250 mg + 62.5 mg (the package includes 20 pcs.) - 426-437 rubles;
• Flemoklav Solutab 500 mg + 125 mg (20 pcs are included in the package) - 398-456 rubles;
• Flemoklav Solutab 875 mg + 125 mg (14 pcs are included in the package) - 430-493 rubles.

Flemoklav Solutab: prices in online pharmacies

Drug name Price Pharmacy

Flemoklav Solutab 125 mg + 31.25 mg dispersible tablets 20 pcs. 122 RUB Buy

Flemoklav Solutab tablets dispersion 125mg + 31.25mg 20 pcs. 123 r Buy

Flemoklav Solutab 250 mg + 62.5 mg dispersible tablets 20 pcs. 219 r Buy

Flemoklav Solutab tablets dispersion 250mg + 62.5mg 20 pcs. 276 r Buy

Flemoklav Solutab 500 mg + 125 mg dispersible tablets 20 pcs. 341 r Buy

Flemoklav Solutab 875 mg + 125 mg dispersible tablets 14 pcs. 359 r Buy

Flemoklav Solutab tablets dispersion 500mg + 125mg 20 pcs. 415 RUB Buy

Flemoklav Solutab tablets dispersion 875mg + 125mg 14 pcs. 439 r Buy

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Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!