Flemoksin Solyutab®

General characteristics. Structure:

Active agent: amoxicillin (in the form of trihydrate amoxicillin) - 125 mg, 250 mg, 500 mg, 1000 mg; excipients: the dispersed cellulose, microcrystallic cellulose, кросповидон, vanillin, fragrance tangerine, fragrance lemon, saccharin, magnesium stearate.

Description of a dosage form: the tablets dispersed from white till light yellow color, an oval form with a logo of firm and digital designation on one party and risky, dividing a tablet in half, on other party.
Digital designation: Flemoksin Solyutab (125 mg) - "231"; Flemoksin Solyutab (250 mg) - "232"; Flemoksin Solyutab (500 mg) - "234"; Flemoksin Solyutab (1000 mg) - "236".

Pharmacological properties:

Pharmacodynamics. Flemoksin Solyutab - a bactericidal acid resisting antibiotic of a broad spectrum of activity from group of semi-synthetic penicillin.
Bacillus anthracis, Listeria monocytogenes, Helicobacter pylori is active concerning the gram-positive and gram-negative microorganisms, such as Streptococcus pyogenes, Streptococcus pneumoniae, Clostridium tetani, Clostridium welchii, Neisseria gonorrhoeae, Neisseria meningitidis, Staphylococcus aureus (which are not developing beta lactamelements). Escherichia coli, Proteus mirabilis, Salmonella typhi, Shigella sonnei, Vibrio cholerae is less active concerning Enterococcus faecalis. He is active concerning the microorganisms producing beta lactamelements, Pseudomonas spp., an indole - positive Proteus spp., Serratia spp., Enterobacter spp.

Pharmacokinetics. Absorption
After intake amoxicillin is soaked up quickly and almost completely (about 93%), кислотоустойчив. Meal practically does not exert impact on drug absorption. The maximum concentration of active agent in plasma is observed in 1-2 h. After intake of 500 mg of amoxicillin the maximum concentration of active agent making 5 mkg/ml is noted in a blood plasma in 2 hours. At increase or reduction of a dose of drug twice the maximum concentration in a blood plasma also changes twice.

Distribution
About 20% of amoxicillin contact proteins of plasma. Amoxicillin well gets into mucous membranes, a bone tissue, intraocular liquid and a phlegm in therapeutic effective concentration. Concentration of amoxicillin in bile exceeds its concentration in a blood plasma by 2-4 times. In amniotic liquid and funic vessels concentration of amoxicillin makes 25-30% of its level in a blood plasma of the pregnant woman. Amoxicillin badly gets through GEB; however at an inflammation of a meninx concentration in cerebrospinal fluid makes about 20% of concentration in a blood plasma.

Metabolism
Amoxicillin is partially metabolized in a liver, the majority of its metabolites have no microbiological activity.

Removal
Amoxicillin eliminirutsya preferential by kidneys, about 80% by canalicular excretion, 20% - by means of glomerular filtering. In the absence of a renal failure the elimination half-life of amoxicillin makes 1-1,5 h. At premature, 6 months - 3-4 h are younger than newborns and children.

Pharmacokinetics in special clinical cases
The elimination half-life of amoxicillin does not change at an abnormal liver function. At       a renal failure   (the clearance   of creatinine  <   15   ml/min.),   an elimination half-life of amoxicillin can increase and reaches at an anury of 8,5 h.

Indications to use:

The infectious and inflammatory diseases caused by microorganisms, sensitive to drug:
- infections of a respiratory organs;
- infections of bodies of urinogenital system;
- infections of bodies of a GIT;
- infections of skin and soft tissues.

Route of administration and doses:

Inside (orally)
The dose is established individually, taking into account weight of a course of a disease, age of the patient.  

  In case of  an infectious vospaliteljnykh  of diseases  easy  and  moderately severe use of drug according to the following scheme is recommended: 
To adults and children 10 years are more senior appoint 500-750 mg of 2 times/days or on 375-500 mg of 3 times/days.
To children from 3 to 10 years appoint 375 mg of 2 times/days or on 250 mg of 3 times/days.
To children aged from 1 up to 3 years appoint 250 mg of 2 times/days or on 125 mg of 3 times/days.

The daily dose of drug for children (including children till 1 year) makes 30-60 mg/kg/days, divided into 2-3 receptions.
At treatment of heavy infections, and also at infections with the hardly accessible centers of an infection  (for example,  acute  average  otitis)    triple  administration of drug is preferable.

At  chronic diseases,  recurrent  infections,  infections  of a heavy current the dose of drug can be increased:
the adult appoint 750 mg - 1 g 3 times/days;
to children to 60 mg/kg/days, divided into 3 receptions.

At acute uncomplicated gonorrhea appoint 3 g of drug in 1 reception in combination with 1 g of a probenetsid.

To patients with a renal failure at clearance of creatinine lower than 10 ml/min. reduce a dose of drug by 15-50%.

Drug is appointed to, in time or after meal. The tablet can be swallowed entirely, to divide into parts or to chew, having washed down with a glass of water, and also it is possible to part in water with formation of syrup (in 20 ml) or the suspensions (in 100 ml) having pleasant fruit taste.

In case of infections easy and moderately severe currents accept drug within 5-7 days. However at the infections caused by Streptococcus pyogenes, duration of treatment has to make not less than 10 days.
At treatment of chronic diseases, infections of a heavy current of a dose of drug have to be defined by a clinical picture of a disease. Administration of drug needs to be continued during 48 h after disappearance of symptoms of a disease.

Features of use:

Existence of an erythrosis in the anamnesis is not a contraindication for Flemoksin's appointment of Solyutab®.

  Cross   stability   with   drugs   of a penicillinic   row  and cephalosporins is possible.
As well as at use of other drugs of a penicillinic row, development of superinfection is possible.
Emergence of the heavy diarrhea characteristic of pseudomembranous colitis is the indication for drug withdrawal.
It is necessary to appoint drug sick with an infectious mononucleosis and a lymphoid leukosis with care since the probability of emergence of a dieback of not allergic genesis is high.
Cross hypersensitivity to drugs of a penicillinic row and cephalosporins is possible.

Side effects:

From a GIT: seldom - taste change, nausea, vomiting, diarrhea; in some cases - moderate increase in activity of "hepatic" transaminases, is extremely rare - pseudomembranous and hemorrhagic colitis.

From an urinary system: extremely seldom - development of intersticial nephrite.

   From   system   of a hemopoiesis;      the agranulocytosis, a neutropenia, thrombocytopenia, hemolitic anemia are possible, but they are observed also extremely seldom.

Side effects from a nervous system when using amoxicillin in a dosage form of a tablet dispersed are not registered.

Allergic reactions: skin reactions , mainly, in the form of specific makulopapulezny rash; seldom - a multiformny exudative erythema (Stephens's syndrome - Johnson);               in some cases acute     anaphylaxis, Quincke's disease.

Interaction with other medicines:

Probenetsid, phenylbutazone, оксифенбутазон, to a lesser extent acetylsalicylic acid and Sulfinpyrazonum slow down canalicular secretion of penicillin that leads to increase in an elimination half-life and increase in concentration of amoxicillin in a blood plasma.
Bactericidal antibiotics (including aminoglycosides, cephalosporins, Vancomycinum, rifampicin) at a concomitant use have sinergidny effect; antagonism at reception with some bacteriostatic drugs is possible (for example, chloramphenicol, streptocides). The concomitant use with estrogensoderzhashchy oral contraceptives can lead to decrease in their efficiency and increase in risk of development of bleedings of "break"). Co-administration with Allopyrinolum does not increase the frequency of skin reactions unlike Allopyrinolum combination to ampicillin.

Contraindications:

   Hypersensitivity   to   drug   and   another   beta лактамным to antibiotics

With care
Polyvalent hypersensitivity to xenobiotics, an infectious mononucleosis, a lymphoid leukosis, gastrointestinal diseases in the anamnesis (especially the colitis connected using antibiotics), a renal failure, pregnancy, the lactation period.

Pregnancy and lactation
Purpose of drug during pregnancy and a lactation is possible if the expected positive take from use of drug exceeds risk of development of side effects. In small amounts amoxicillin is emitted with breast milk that can lead to development of the phenomena of a sensitization in the child.

Overdose:

Symptoms: dysfunction of a GIT - nausea, vomiting, diarrhea; disturbance of water and electrolytic balance can be a consequence of vomiting and diarrhea.
Treatment: appoint a gastric lavage, absorbent carbon, salt purgatives; apply measures to recovery of water and electrolytic balance.

Storage conditions:

List B. To store drug at a temperature not above 25 °C. To store in the places unavailable to children. Period of validity of 5 years. Not to use drug after the expiry date specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Tablets the dispersed 125 mg - on 5 or 7 tablets in the blister from a polyvinyl chloride film and aluminum foil. On 4 or 2 blisters together with the application instruction place in a cardboard pack. Tablets the dispersed 250 mg, 500 mg and 1000 mg - on 5 tablets in the blister manufactured of a polyvinyl chloride film and aluminum foil. On 4 blisters together with the application instruction place in a cardboard pack.