Amoxiclav 2X is shown for treatment of the bacterial infections caused by microorganisms, sensitive to drug:

to

• sharp bacterial sinusitis (confirmed)
with
• sharp average otitis,
• confirmed exacerbation of chronic bronchitis;
• community-acquired pneumonia
• cystitis;
• pyelonephritis;
• an infection of leather and soft tissues, including cellulitis, stings of animals, heavy dentoalveolyarn abscesses with widespread cellulitis;
• an infection of bones and joints, including osteomyelitis.

Structure

active ingredients: amoxicillin, clavulanic acid;

1 tablet contains 500 mg of amoxicillin in the form of trihydrate and 125 mg of clavulanic acid in the form of potassium salt;

Excipients: silicon dioxide colloidal, krospovidon, sodium of a kroskarmelloz, magnesium stearate, cellulose microcrystalline

cover: hydroksipropilmetiltsellyuloza, ethyl cellulose, polysorbate, triethyl citrate, talc, titan dioxide (E 171).

Amoxicillin represents semi-synthetic penicillin (beta laktamnye antibiotics) which inhibits one or several enzymes (which are often called penitsillinsvyazyvayushchy proteins) in the course of biosynthetic metabolism of a bacterial peptidoglikan that is the integral structural component of a cell wall of bacteria. Leads inhibition of synthesis of a peptidoglikan to weakening of a cell wall, lysis and death of cages is a consequence of what.

Amoksitsillin is sensitive

to splitting beta laktamaz, produced by resistant bacteria, therefore, the range of activity of amoxicillin as monotherapy does not include organisms which produce these enzymes.

Clavulanic acid is beta lactams, structurally related with penicillin. It disconnects some enzymes beta lactamelements, thereby preventing an amoxicillin inactivation. Clavulanic acid in the form of monotherapy does not render clinically useful antibacterial effect.

Contraindication

Hypersensitivity to medicine components, to any of antibakterilny means of group of penicillin.

Existence in the anamnesis of heavy reactions of hypersensitivity (including. An anaphylaxis), the agents connected with application of others beta laktamnykh (including. Cephalosporins, karbapenem or monobaktamama).

Existence in the anamnesis of jaundice or the dysfunction of a liver connected with use of amoxicillin / clavulanate.

Route of administration and doses

Drug should be used according to official recommendations about antibiotic treatment and data local sensitivity to an antibiotic. The sensitivity to amoxicillin / clavulanate differs in different regions and can change over time. In case of need it is necessary to address data on local sensitivity and if necessary to carry out microbiological definition and the sensitivity test. Range of the offered doses depends on the expected pathogens and their sensitivity to antibacterial drugs, disease severity and localization of an infection, age, body weight and function of kidneys of the patient.

For adults and children with body weight ≥ 40 kg the daily dose makes 1500 mg of amoxicillin / 375 mg of clavulanic acid (3 tablets) when assigning as shown below.

For children of 6 years with the body weight from 25 to 40 kg the maximum daily dose makes 2400 mg of amoxicillin / 600 mg of clavulanic acid (4 tablets) when assigning as shown below.

If for treatment needs to appoint by

high doses of amoxicillin, it is necessary to apply other forms of medicine to avoid purpose of excess high doses of clavulanic acid.

Duration of treatment is determined by the doctor on clinical by the response of the patient to treatment. Some infections (for example, osteomyelitis) demand long-term treatment.

Adults and children with body weight ≥ 40 kg 1 tablet of 500 mg / 125 mg 3 times a day.

Children aged from 6 years with the body weight from 25 to 40 kg the dose from 20 mg / 5 mg/kg/days up to 60 mg / 15 mg/kg/days divided into 3 receptions.

As a tablet cannot be shared, to children with body weight less than 25 kg, it is not necessary to appoint this form of medicine.

Children aged from 6 years with the body weight from 25 to 40 kg. As the tablet cannot be divided, to children 6 years with the body weight from 25 to 40 kg with clearance of creatinine less than 30 ml/min. are more senior or to the children who are on a hemodialysis not to appoint this form of medicine.

should swallow of the Tablet entirely, without chewing. For optimum absorption and reduction of possible side effects from a digestive tract medicine should be accepted at the beginning of meal.

Duration of treatment is defined by the doctor individually. It is not necessary to continue treatment more than 14 days without assessment of a condition of the patient.

Treatment can be begun with

with parenteral administration, and then to continue oral administration.

Feature of application

Use during pregnancy or feeding by a breast

Pregnancy. Reproductive researches on animals of oral and parenteral forms of medicine did not find any teratogenic action. During one research with participation of women with a premature rupture of covers of a fruit reported that preventive use of medicine can be connected with increase in risk of a necrotizing coloenteritis at newborns. As well as at use of other medicines, it is necessary to avoid use of medicine during pregnancy, especially in the first trimester, except cases when, according to the doctor, such application is necessary.

feeding Period breast . Both active components of medicine are excreted in breast milk (there is no information on influence of clavulanic acid on the baby who is on breastfeeding). Respectively, at the baby who is on breastfeeding the appearance of diarrhea and fungal infection of mucous membranes is possible therefore feeding by a breast should be stopped. It is necessary to consider possibility of allergic reactions. Drug during feeding by a breast can be used only when, according to the doctor, the advantage of application prevails risk.

Children

in it to a dosage children can use Drug aged from 6 years with body weight not less than 25 kg.

Ability to influence speed of response at control of motor transport or other mechanisms

Researches on ability of medicine to influence speed of response at control of motor transport or other mechanisms was not carried out. However there can be side reactions (for example, allergic reactions, dizziness, spasms) which can affect ability to drive the car or other mechanisms.

Overdose

Symptoms. symptoms of disorders of digestive tract and violation of balance of liquid and electrolytes Can be observed. The crystalluria connected with intake of amoxicillin that in some cases led to a renal failure was observed.

At patients with renal failures and at the patients accepting high doses of medicine the developing of spasms is possible

.

to

It was reported about amoxicillin precipitation in bladder catheters, mainly after introduction in high doses. It is regularly necessary to check passability of catheters (see the Section "Features of Application").

Treatment. from digestive tract can treat symptomatically, paying attention to balance of liquids / electrolytes.

Amoksitsillin / clavulanic acid can be removed with

from a blood-groove by means of a hemodialysis.

Side reactions Most often reported

to

about such side reactions on medicine as diarrhea, nausea and vomiting.

Interaction with other medicines and other types of interactions

Anticoagulants for oral administration.

Anticoagulants to oral administration and antibiotics of a penicillinic row widely apply

in practice in the absence of messages about interaction. However cases of increase in the international coefficient of normalization at the patients accepting atsenokumarol or warfarin and to what the course of treatment was prescribed by amoxicillin are described. If the concomitant use of medicines is necessary, it is necessary to control carefully the prothrombin ratio or the international coefficient of normalization at addition or the termination of intake of amoxicillin. Besides, dose adjustment of anticoagulants for oral administration can be required (see the Sections "Features of Application" and "Side reactions").

Simultaneous application of a probenetsid is not recommended to

. Probenetsid reduces renal canalicular secretion of amoxicillin. Simultaneous application of a probenetsid can lead to increase in level and duration of finding of amoxicillin (but not clavulanic acid) in blood.

Simultaneous use of Allopyrinolum during treatment by amoxicillin can increase the probability of allergic reactions. sup do not have data on simultaneous use of Allopyrinolum and ^{Amoxiclav ® 2X.}

As well as other antibiotics, ^{Amoxiclav ®} 2X can influence intestines flora that leads to reduction of a reabsorption of estrogen and decrease in efficiency of the combined oral contraceptives.

^{Amoxiclav ®} 2X should not be applied together with bacteriostatic chemotherapeutic means / antibiotics (chloramphenicol, macroleads, tetracyclines or streptocides) as in vitro at such combinations was observed antagonistic effect.

Methotrexate. Penicillin can reduce removal of a methotrexate that causes potential increase in toxicity.

Mofetil's

mikofenolat. At patients who are treated a mofetila mikofenolaty after the beginning of use of oral amoxicillin with clavulanic acid the predozova concentration of an active metabolite of IFC approximately can decrease by 50%. This change of predozovy level can correspond to change of the general exposure of IFC not completely. Thus, change in a dosage of a mofetil of the mikofenolat usually is not required if there is no clinical confirmation of dysfunction of a transplant. However fixed observation is necessary during combined use and for some time after antibiotic treatment.

Storage conditions

to Store

at a temperature not above 25 °C in original packing.

to Store

out of children's reach.

Expiration date - 2 years.