Description overdue on 05/30/2014
- Latin name: Flemoslav Solutab
- ATC code: J01CR02
- Active substance: Amoxicillin + Clavulanic acid (Amoxicillin + Clavulanic acid)
- Manufacturer: Astellas Pharma Europe, B.V. (Netherlands)
- Composition
- Product form
- Pharmacological action
- Pharmacodynamics and pharmacokinetics
- Indications
- Contraindications
- Side effects
- Instructions on Flemoklav Soljutab
- Overdose
- Cooperation
- Terms of sale
- Storage conditions
- Shelf life
- Cautions
- Analogs
- Flemoklav Soljutab children
- With alcohol
- During pregnancy (and lactation)
- Reviews
- Price, where to buy
Composition
Tablets Flemoklav Soljutab can be produced in four different dosages:
- clavulanic acid (potassium clavulanate) - 31, 25 mg, amoxicillin (amoxicillin trihydrate) -125 Mg;
- clavulanic acid (potassium clavulanate) - 62 5 mg amoxicillin (amoxicillin trihydrate) - 250 mg;
- clavulanic acid (potassium clavulanate) - 125 mg amoxicillin (amoxicillin trihydrate) - 500 mg;
- clavulanic acid (potassium clavulanate) - 125 mg amoxicillin (amoxicillin trihydrate) - 875 mg.
Auxiliaries are: cellulose dispersed, MCC, vanillin, Valium, tangerine flavor, lemon flavor, saccharin, magnesium stearate .
Product form
Tablets white or straw-colored, oblong, engraved with " 425 "And the image of the company logo; possible presence of single brown spots.
7 tablets antibiotic Flemoklav Soljutab total weight of 1,000 mg of active substances ( Amoxicillin 875 mg plus clavulanic acid 125 mg) was enclosed in the blister of the blister 2 on paper packaging.
Tablets of other dosages are enclosed in blisters of 4 pieces, 5 of the blister pack in the paper.
Pharmacological action
This medicine has antibacterial action.
Pharmacodynamics and pharmacokinetics
Pharmacodynamics
Flemoklav Soljutab - it antibiotic with a wide spectrum of action includes clavulanic acid and Amoxicillin .
The drug is active against gram-negative and gram-positive bacteria (including species synthesize Beta-lactamase ) Inhibits the synthesis of peptidoglycan (part of the cell wall of microorganisms).
Clavulanic acid inhibits 5, 4, 3 and 2 types Beta-lactamase and inactive with respect to type 1 Beta-lactamase , Sinteziruemyh Enterobacter spp., Pseudomonas aeruginosa, Acinetobacter spp . It forms a complex with the protein and prevents denaturation of the enzyme Amoxicillin under influence Beta-lactamase , Thus broadening the spectrum of action Flemoklav Soljutab.
Sensitive in vitro to amoxicillin microorganisms:
- Gram-positive aerobic bacteria - Enterococcus faecalis, Nocardia asteroids, Bacillus anthracis, Gardnerella vaginalis, Streptococcus pneumoniae, Listeria monocytogenes, Streptococcus pyogenes and certain other beta-hemolytic strains Streptococcus , Metitsilenchuvstvitelnye strains Staphylococcus saprophyticus, Staphylococcus aureus, coagulase-negative staphylococci;
- Gram-negative aerobic bacteria - Haemophilus influenza, Bordetella pertussis, Helicobacter pylori, Haemophilus parainfluenzae, Asteurella multocida, Moraxella catarrhalis, PVibrio cholera ;
- Gram-positive anaerobic bacteria - some species Clostridium, Peptostreptococcus micros, Peptostreptococcus magnus, Peptococcus niger Some species Peptostreptococcus ;
- anaerobic gram-negative bacteria - some species Bacteroides, Capnocytophaga, Eikenella corrodens, Fusobacterium, Porphyromonas, Prevotella ;
- Others: Leptospirosa ictterohaemorrhagiae, Treponema pallidum.
Strains in which the possible emergence of resistance:
- Gram-negative aerobic bacteria - Klesiella pneumonia, Escherichia coli , kinds Klebsiella, Proteus vulgaris, Proteus mirabilis , kinds Proteus , kinds Salmonell a, kind of Shigella;
- Gram-positive aerobic bacteria - Enterococcus faecium , kinds Corynebacterium .
Resistant organisms:
- Gram-negative aerobic bacteria - Citrobacter freundii , kinds Acinetobacter , kinds Enterobacter , kinds Providencia , kinds Serratia , kinds Pseudomonas, Hafnia alvei, Morganella morganii, Legionella pneumophila, Stenotrophomas maltophilia;
- other - types Chlamydia, Coxiella burnetti , kinds Mycoplasma.
Pharmacokinetics
After penetration of the drug dose 875/125 mg ( Amoxicillin / clavulanic acid ) Concentration in the intestine Amoxicillin in the blood reaches a maximum after 90 minutes, clavulanic acid - After 60 minutes.
Bioavailability Amoxicillin Orally about 90% absorption of clavulanic acid up to 60%.
Approximately 20% Amoxicillin and 21% clavulanic acid form bonds with the blood. The half-life Amoxicillin - 1 hour, clavulanic acid - 50 minutes. Approximately 70% Amoxicillin and 40% clavulanic acid excreted by the kidneys in the first 5, 5 hours.
Therapeutic concentrations of both compounds can be achieved in the gall bladder, abdominal cavity, muscle, skin, bile, peritoneal and synovial fluids, pus.
Indications
Infectious diseases of inflammatory nature, caused by susceptible microorganisms to Flemoklav:
- infection of upper respiratory tract and respiratory tract ( COPD . exacerbation of chronic bronchitis, otitis media, tonsillitis, pharyngitis, sinusitis, community-acquired pneumonia );
- gynecological infections;
- infections of joints and bones, including osteomyelitis ;
- soft tissue infections and skin;
- infections of the genitourinary system ( cystitis . pyelonephritis ).
Contraindications
- Severe liver damage after taking the drug in the past.
- Lymphocytic leukemia .
- Kissing disease .
- Renal failure (filtration below 30 ml per minute) - for tablets 875/125 mg.
- Age less than 12 years old and weighing up to 40 kg - for tablets 875/125 mg.
- Hypersensitivity to the drug and any beta-lactam antibiotics (penicillins and cephalosporins).
With careful use of the drug in severe forms of liver and kidney failure, diseases of the digestive system.
Side effects
- From the nervous system: in less than 0, 001% - headache, convulsions (with an overdose of a drug); in less than 0, 0001% - anxiety, hyperactivity, impaired consciousness, insomnia, anxiety, aggressive behavior.
- Hematopoietic system - hemolytic anemia . thrombocytosis ; less than 0, 0001% - granulocytopenia, leukopenia, thrombocytopenia, pancytopenia Increase in clotting time.
- For part of the digestive system: less than 0, 1% - nausea, abdominal pain, diarrhea . vomiting . pseudomembranous colitis ; less than 0 001% - hemorrhagic colitis . intestinal candidiasis , Discoloration of tooth enamel.
- From the vessel: less than 0 001% - vasculitis .
- Liver: less than 0, 1% - increase in activity transaminases ; less than 0 001% - jaundice and hepatitis .
- On the part of the urinary tract: in less than 0, 01% - burning, itching and vaginal discharge; less than 0 001% - jade .
- Allergic reactions: less than 0, 1% - hives Itching; less than 0 001% - dermatitis . anaphylactic shock . angioedema . serum sickness .
- Others: less than 0, 01% - superimposed infection bacterial or fungal origin (with frequent and prolonged treatment drug).
Instructions on Flemoklav Soljutab
Instructions for use Flemoklav Soljutab recommends adults, children under 12 years of age and for children under twelve years of age with a weight of over 40 kilograms to take the antibiotic at a dose of 875 +125 mg (total dose of active substances - 1000 mg) twice daily (chronic, severe, recurrent infections increase the dose twice).
Children under 12 years of age and weighing less than 40 kilograms of the drug is prescribed in weaker doses (250 mg plus Flemoklav 62, 5 mg and 500 mg plus Flemoklav 125 mg).
Adults and children weighing 40 kilograms recommend Flemoklav Soljutab 500mg + 125mg three times a day.
The daily dose for children under 12 years of age and weighing up to 40 kg is 5 mg clavulanic acid and 25 mg Amoxicillin per kilogram body weight.
In severe infectious and inflammatory diseases, these doses can be doubled, however, it does not exceed a dose of 60 mg Amoxicillin and 15 mg clavulanic acid per kilogram body weight per day.
The duration of treatment should not exceed two weeks.
In patients with concomitant renal failure Flemoklav Solutab 875 mg / 125 mg may be used, if renal filtration rate of more than 30 ml per minute.
To reduce the risk of side effects from the digestive organs is recommended to take the drug just before eating. Tablets should be swallowed whole with water or dissolving it in 50 ml of water, fully stirred before use.
Overdose
The phenomena of overdose are usually limited to the intestinal symptoms such as nausea and diarrhea .
Less frequently when using large doses of the drug may occur convulsions . coma, hemolysis, renal failure .
Treatment. Receiving Activated Carbon and osmodiuretikov . Maintenance of water and mineral balance. Seizures arrest diazepam . In the event of severe violations of the kidney is necessary to conduct Hemodialysis . The rest of the treatment is symptomatic.
Cooperation
Other antibiotics. Flemoklav Soljutab should not be used in conjunction with bacteriostatic drugs / chemotherapy / disulfiram / antibiotics ( chloramphenicol . macrolides . tetracycline . sulfonamides ).
Preparations . inhibiting the excretion of amoxicillin kidney. Simultaneous treatment with phenylbutazone, probenecid, oxyphenbutazone, indomethacin, acetylsalicylic acid and sulfinpyrazone may cause an increased concentration Amoxicillin Blood and bile. Excretion of clavulanic acid in such cases is not changed.
Allopurinol. Its use with amoxicillin povysishaet the risk of skin rash.
Methotrexate. Amoxicillin reduces the excretion by the kidneys Methotrexate Therefore may cause toxic effects. It is necessary to control the blood level of the latter.
Digoxin . Flemoklav Soljutab increases absorption Digoxin in the intestine.
Anticoagulants . The combination of the drug with indirect anticoagulants can cause an increase in the risk of bleeding.
Hormonal contraceptives. Amoxicillin In rare cases, it may inhibit the effects of oral contraceptives .
Terms of sale
In Russia, the drug available without prescription, Ukraine strictly on prescription.
Storage conditions
- Store at temperatures up to 25 ° C. Keep away from children!
- During storage, the tablets can be formed isolated dark spots.
- You may not use the drug after the expiry date (indicated on the package).
Shelf life
24 months.
Cautions
Prior to treatment Flemoklav Soljutab to exclude the presence of allergic reactions in the past to cephalosporins, penicillins or components of the drug.
This drug should not be prescribed if there is a suspicion of kissing disease As using Amoxicillin in this situation reported cases morbilliform rash .
People with severe forms allergies and asthma history should be careful when using the drug.
There is a possibility of cross-resistance and allergic reactions with others cephalosporins or penicillins .
Long-term use of the drug causes and the growth of resistant Flemoklav Soljutab microflora, as well as fungal or bacterial superinfection .
To apply caution in patients with liver disease, there is the risk of jaundice.
Due to the high content Amoxicillin in urine, possibly settling on its walls urinary catheter , So you need to regularly change the catheter.
The appearance at the beginning of therapy generalized erythema Accompanied by fever and pustular rash may be a sign of acute exanthematous pustulosis . In this case, stop taking the drug.
In the case of seizures treatment with overturned.
It should be remembered that one tablet Flemoklav Soljutab 875/125 mg contains as part of 0, 025 grams of potassium.
Analogs Flemoklav Soljutab
Augmentin
Ampisid
Amoxil 625 K
Sultasin
Amoxiclav
Price analogues listed below often is more attractive for patients: Amoxiclav 2X . Augmentin . Augmentin SR, Baktoklav, Clave, Medoklav, Panklav, Rekut, Trifamoks IBL .
What is different from Flemoksin Soljutab Flemoklav Soljutab?
Often heard among patients questions - what is different Flemoksin by Flemoklav? To understand what the difference is easy: Flemoklav unlike flemoksin contains clavulanic acid, which prevents the destruction of molecules of antibiotic bacterial enzymes that better affects many indicators characterizing the effectiveness of the drug.
Is it better or Amoxiclav Flemoklav Soljutab?
Difference Amoksiklava and Flemoklav consists only produced in a variety of dosage forms, it is the latter more, which allows better control employed the dose and reduce side effects. Price range is comparable to both drugs.
Flemoklav Soljutab children
Section " Instructions on Flemoklav Soljutab "Clearly shows how children take this drug. The maximum daily dose for children should not exceed 15 mg clavulanic acid and 60 mg Amoxicillin and per kilogram body weight.
Reports of adverse events in general, are not characteristic for reviews of children. Price low dosages of the drug favorably with prices Flemoklav Soljutab a dose of 875/125 mg.
With alcohol
It is advisable to give up drinking alcohol at the time of treatment.
During pregnancy and lactation
Posts of toxic effects on the fetus or newborn Amoxicillin and clavulanic acid it is noted.
Application after 13 weeks of pregnancy is possible only when prescribed by the attending physician. In the first 12 weeks of pregnancy prescribing dose 875/125 mg.
The active ingredients penetrate placenta and passes into breast milk. It does not prohibit the use of the drug during lactation, but it should be used with caution.
Reviews Flemoklav Soljutab
Reviews Flemoklav show high efficacy and rapid onset of the desired effect from using the drug. Babies often prescribe additional therapy that prevents accession superinfection and Development dysbiosis . Reviews at sinusitis reported rapid onset of relief after the start of use of the drug in most patients.
Price Flemoklav Soljutab
In Russia, the price Flemoklav 1000 mg (875/125 mg) is close to 510 rubles. The price of 250 mg (250 mg ± 62, 5 mg) of the drug is 420 rubles, buy 500 mg tablets will cost 500-640 rubles. In Ukraine, the average price of the drug dosages above 175, 130 and 190 hryvnia, respectively.