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)
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  • 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

 Flemoklav Soljutab

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

Match code ATC 4th level:
  •  Flemoklav Soljutab
 Augmentin
  •  Flemoklav Soljutab
 Ampisid
  •  Flemoklav Soljutab
 Amoxil 625 K
  •  Flemoklav Soljutab
 Sultasin
  •  Flemoklav Soljutab
 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.

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