Producer: Arterium (Arterium) Ukraine
Code of automatic telephone exchange: J01CR02
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Acting veshchestva:1 a tablet contains trihydrate amoxicillin in terms of amoxicillin 500 mg and mix of potassium of a klavulanataa of microcrystallic cellulose in the ratio (1:1) in terms of clavulanic acid of 125 mg;
auxiliary a veshchestva:kremniya dioxide colloid anhydrous, sodium stearate, cellulose microcrystallic, mix for a covering of "Opadry II White" 33G28707 krakhmalglikolit (type A), magnesium;
structure of a cover: "Opadry II White" 33G28707 (gipromeloz (gidroksipropilmetiltsellyuloz); titanium dioxide (Е 171); lactose, monohydrate; polyethyleneglycol (macrogoal) 3000; triacetin).
Pharmacodynamics. Amoxicillin – a semi-synthetic antibiotic with a wide range of antibacterial activity against many gram-positive and gram-negative microorganisms. Amoxicillin is sensitive to a beta laktamaze and undergoes disintegration under its influence therefore the range of activity of amoxicillin does not include microorganisms which synthesize this enzyme. Clavulanic acid has beta лактамную structure, similar to penicillin, and has properties to inactivate beta лактамазные the enzymes inherent to microorganisms, resistant to beta lactams. In particular, it has the expressed activity rather important from the clinical point of view plasmid beta лактамаз, которыечасто are responsible for emergence of cross resistance to antibiotics. Presence of clavulanic acid as a part of Amoksila-K 625 protects amoxicillin from disintegration under the influence of enzymes beta лактамаз and expands a range of antibacterial effect of amoxicillin, including in it many microorganisms, resistant to amoxicillin and another beta лактамным to antibiotics.
Thus, Amoksil-K 625 has properties of an antibiotic of a broad spectrum of activity and inhibitor beta лактамаз. Amoksil-K 625 has bactericidal effect of rather wide range of microorganisms, including:
gram-positive aerobes: Bacillus anthracis *, types of Corynebacterium, Enterococcus faecalis *, Enterococcus faecium *, Listeria monocytogenes, Nocardiaasteroids, Staphylococcus aureus *, koagulazonegativny staphylococcus (including Staphylococcus epidermidis), Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans;
gram-positive anaerobe bacterias: types of Clostridium, types of Peptococcus, types of Peptostreptococcus;
gram-negative aerobes: Bordetella pertussis, types of Brucella, Escherichia coli *, Gardnerellavaginalis, Haemophilus influenzae *, Helicobacterpylori, types of Klebsiella *, types of Legionella, Moraxella catarrhalis * (Branhamellacatarrhalis), Neisseria gonorrhoeae *, Neisseria meningitidis *, Pasteurella multocida, Proteus mirabilis *, Proteus vulgaris *, types of Salmonella *, types of Shigella *, Vibrio cholerae, Yersiniaenterocolitica;
gram-negative anaerobe bacterias: types of Bacteroides (including Bacteroides fragilis), types of Fusobacterium;
other microorganisms: Borrelia burgdorferi, types of Chlamydia, Leptospira icterohaemorrhagiae, Treponema pallidum.
* - some representatives of these species of bacteria produce beta lactamazu that does them insensitive to monotherapy by amoxicillin.
Pharmacokinetics. Absorption. Both Amoksila-K components 625 (amoxicillin and clavulanic acid) are completely soluble in aqueous solutions at physiological values рН. Both components are well and quickly absorbed at oral administration. Absorption of Amoksila-K 625 improves at its reception at the beginning of food.
Pharmacokinetic parameters of amoxicillin and clavulanic acid are closely connected. The maximum concentration of both components in serum is reached approximately in 1 hour after oral administration of drug. The concentration of amoxicillin in blood serum which is reached at reception of Amoksila-K 625 is similar that which is reached at oral administration of equivalent doses of the amoxicillin.
The accompanying reception of a probenetsid brakes amoxicillin excretion, but does not influence renal excretion of clavulanic acid.
Distribution. At use inside therapeutic concentration of amoxicillin and clavulanic acid are defined in fabrics and intersticial liquid. Therapeutic concentration of both substances reveal in a gall bladder, tissues of an abdominal cavity, skin, fatty and muscular fabrics, and also in synovial and peritoneal liquids, bile and pus. Amoxicillin and clavulanic acid poorly contact proteins; by researches it is established that indicators of linkng with proteins make 25% for clavulanic acid and 18% for amoxicillin of their general concentration in a blood plasma. Cumulation of any of these components in any body is not installed.
Amoxicillin, as well as other penicillin, can come to light in breast milk. Trace amounts of clavulanic acid can be also revealed in breast milk. Amoxicillin and clavulanic acid can get through a placental barrier. However any data on disturbance of fertile function or an adverse effect on a fruit are not revealed.
Removal. In the main way of removal of amoxicillin, as well as other penicillin, renal excretion whereas removal of clavulanate is carried out also by kidneys and by extrarenal mechanisms is. About 60-70% of amoxicillin and 40-65% of clavulanic acid are allocated with urine in not changed look for the first 6 h after one-time reception of tablets.
Amoxicillin is also partially removed with urine in the form of inactive penitsillovy acid in the quantities equivalent to 10-25% of the accepted dose. Clavulanic acid is considerably metabolized in a human body to 2,5-digidro-4-(2 hydroxyethyl) - 5-oxo-1H-pirol-3-carboxyl acid and 1 - amino - 4 - hydroxy - butane - 2 - it also is allocated with urine and a stake, and also in the form of carbon dioxide with expired air.
The main physical and chemical svoystva:tabletka, film coated, white color, a biconvex form, with risky on the one hand. On a break the kernel of white or almost white color is visible.
Indications to use:
Treatment of the bacterial infections caused by microorganisms of such localization, sensitive to drug:
upper respiratory tract infections (including infections of ENT organs), among them - recurrent tonsillitis, sinusitis, average otitises;
lower respiratory tract infections, including exacerbation of chronic bronchitis, partial (lobar) pneumonia and bronchial pneumonia;
infections of urinogenital system, including cystitis, uretrita, pyelonephritises;
infections of skin and soft tissues, including burns, abscesses, inflammation of hypodermic cellulose, wound fevers;
tooth infections, including dentoalveolyarny abscesses;
infections of bones and joints, including osteomyelites;
other infections, including septic abortion, postnatal sepsis, intraabdominal sepsis.
The infections caused by the microorganisms sensitive to amoxicillin will respond to treatment of Amoksilom-K 625 as it contains amoxicillin. Thus, Amoksilom-K 625 can be treated the multi-infections caused by microorganisms, sensitive to amoxicillin, in combination with 625 microorganisms, sensitive to Amoksilu-K, producing beta lactamazu.
Route of administration and doses:
General recommendations for treatment of infections.
The dose for treatment of infections easy and moderate severity at adults and children is more senior than 12 years: 1 tablet Amoksila-K 625 two times a day.
Dosing at dentoalveolyarny abscesses.
1 tablet 2 times a day for 5 days.
Dosing at a renal failure.
Insufficiency of easy severity
(clearance of creatinine> 30 ml/min.) Any changes дозировання (that is 1 tablet two times a day)
Insufficiency of moderate severity
(clearance of creatinine of 10-30 ml/min.) 1 tablet two times a day
Heavy renal failure (clearance of creatinine <10 ml/min.) No more than 1 tablet each 24 hours
Dosing at a hemodialysis.
1 tablet a day plus on 1 tablet in time and upon termination of dialysis (considering decrease in concentration of amoxicillin and clavulanic acid in serum).
Dosing at an abnormal liver function.
To apply with care; it is necessary to monitor function of a liver through regular periods. Data for the recommendation of dosing are not enough.
Dosing at patients of advanced age.
Dose adjustment with normal function of kidneys is not required from patients of advanced age. If necessary the dose is adjusted depending on function of kidneys.
Whole should swallow of a tablet, without chewing. If it is necessary, the tablet can be broken in half and to swallow halves, without chewing.
For optimum absorption and reduction of possible side effects from a digestive tract drug should be accepted at the beginning of meal.
It is not necessary to continue treatment more than 14 days without assessment of a condition of the patient.
Treatment can be begun parenterally, and then to continue orally.
Features of use:
Before therapy of Amoksilom-K 625neobkhodimo precisely to establish existence at the patient in the anamnesis of hypersensitivity to penicillin, cephalosporins or other allergens.
Serious, sometimes lethal reactions of hypersensitivity (anaphylactoid reactions), developed at patients during therapy by penicillin. Such reactions are more probable at patients with existence of hypersensitivity to penicillin in the anamnesis (see the section "Contraindications").
Amoksil-K it is not necessary to appoint 625 at suspicion to an infectious mononucleosis as at use of amoxicillin at this pathology noted cases of korepodobny rash. Prolonged use of drug can cause the excess growth of the 625th microflora, insensitive to Amoksilu-K.
Occasionally at the patients accepting Amoksil-K 625 and peroral anticoagulants, the lengthening of a prothrombin time (increase in level of the international normalized ratio (INR)) exceeding norm can be observed. At a concomitant use of anticoagulants the corresponding monitoring is necessary. Dose adjustment of peroral anticoagulants can be necessary for support of appropriate level of anti-coagulation.
Amoksil-K 625 it is necessary to apply with care at patients with liver dysfunction. It was reported about changes of hepatic functional tests at some patients who were treated by Amoksilom-K 625 though clinical value of it is not established.
There are single messages on cholestatic jaundice which can have a heavy current, but usually is reversible. Symptoms and signs can not be shown up to 6 weeks after the end of treatment.
For patients with a renal failure it is necessary to adjust a dose according to extent of disturbance.
At patients with reduced excretion of urine the crystalluria very seldom can be observed, generally at parenteral administration of drug. Therefore for decrease in risk of emergence of a crystalluria it is recommended by high doses of drug to provide during treatment adequate balance between the drunk liquid and the emitted urine (see the section "Overdose").
Ability to influence speed of response at control of motor transport or work with other mechanisms.
The negative impact on ability to drive the car and other mechanisms was not observed, but it is necessary to consider probability of such side effect as dizziness.
Interaction with other medicines and other types of interactions. Simultaneous use of a probenetsid is not recommended. Probenetsid reduces renal canalicular secretion of amoxicillin. Its simultaneous use with Amoksilom-K 625 can lead to increase in level of amoxicillin in blood throughout a long time, at the same time does not exert impact on clavulanic acid level.
Simultaneous use of Allopyrinolum during treatment by amoxicillin can increase probability of development of skin and allergic reactions. There are no data on the combined use of Amoksila-K 625i Allopyrinolum.
As well as other antibiotics, Amoksil-K 625mozhet to influence an indestinal flora that leads to decrease in a reabsorption of estrogen and decrease in efficiency of the combined peroral contraceptive means.
There are separate messages on increase in the INR level at patients who are treated atsenokumaroly or warfarin and accept amoxicillin. If such use is necessary, it is necessary to control carefully a prothrombin time or the INR level with addition or the termination of treatment of Amoksilom-K 625.
Side effects were classified by bodies and systems and for the frequency of their emergence. On the frequency of emergence are divided into such categories: very often (≥1/10), it is frequent (≥1/100 and <1/100), infrequently (≥1/1 000 and <1/100), is rare (≥1/10000 and <1/1 000), is very rare (<1/10 000).
Infections and invasions:
often – candidiasis of skin and mucous membranes.
Circulatory and lymphatic systems:
very seldom – a reversible hyperactivity and convulsions (convulsions can arise at patients with a renal failure or at the patients receiving drug in high doses).
very often – diarrhea;
Nausea is associated with high doses of drug more often. The above-stated symptoms from a digestive tract can be reduced at administration of drug at the beginning of meal;
infrequently – digestion disturbances;
infrequently – moderate increase in level of nuclear heating plant and/or ALT was defined at patients who were treated by antibiotics of group of beta lactams, however clinical value of it is not established;
very seldom – hepatitises and cholestatic jaundice. Such phenomena arose at use of other penicillin or cephalosporins. Hepatitises arose, generally at men and patients of advanced age, their emergence can be connected with long treatment by drug.
At children such manifestations arose very seldom.
Signs and symptoms arise in time or right after treatment, however in certain cases can be shown in several weeks after the treatment termination. These phenomena are usually reversible. Extremely seldom (than 1 message approximately on 4 million appointments is more rare) lethal outcomes which always occur at patients with a serious basic disease or at a concomitant use of the drugs exerting a negative impact on a liver take place.
Skin and hypodermic fabrics:
seldom – a polymorphic erythema;
very seldom – Stephens's syndrome - Johnson, a toxic epidermal necrolysis, violent exfoliative dermatitis and acute generalized exanthematous пустулез.
In case of any allergic dermatitis treatment needs to be stopped.
Kidneys and urinary system:
Hypersensitivity to beta lactams, that is to penicillin and cephalosporins. Existence in the anamnesis of jaundice or dysfunction of the liver tied using Amoksila-K 625.
The overdose can be followed by symptoms from a digestive tract and disturbance of water and electrolytic balance. These phenomena treat symptomatic, paying attention to correction of water and electrolytic balance. It was reported about crystalluria cases which in some cases can lead to a renal failure.
Use during pregnancy or feeding by a breast.
Pregnancy (category B). It is necessary to avoid use of Amoksila-K 625 during pregnancy, especially in the I trimester, except those cases when the advantage of use of drug exceeds potential risk for a fruit.
Feeding period breast. Amoksil-K 625 it is possible to apply during feeding by a breast. Excepting the risk of development of hypersensitivity connected with allocation of trace quantities of Amoksila-K 625 in breast milk, any harmful effects on the child who is on breastfeeding it is not revealed.
This dosing of the tablets Amoksila-K 625ne is recommended to apply at children aged up to 12 years.
Period of validity 1 year. To store in original packaging at a temperature not over 25 ºС. To store in the place, unavailable to children.
According to the recipe
Packaging on 7 tablets in the blister; 2 blisters in a pack.