After Penicillin was discovered, antibiotics became an integral part of the medicine. Every year these drugs will be improved, all new drugs appear, among which amoxiclav. This agent has wide spectrum actions. How to take amoxiclav 875 + 125 adult patients? Under what diseases it is prescribed? Possible side effects and contraindications? All these questions should be disassembled in detail.

The composition of the drug

Amoxiclave refers to the improved antibiotics of the penicillin group. Its main active ingredients are amoxicillin trihydrate and clavulanate (clavulanic acid).

The drug is three forms of production:

• tablets (250 mg; 500 mg; 850 mg);
• powder for the preparation of intravenous mortar;
• powder for the manufacture of a suspension, which is taken orally.

The tablet form may differ in the percentage of amoxicillin. With severe pathologies of bacterial nature, doctors recommend drinking amoxyclav 875 + 125. In addition to active substances, it contains:

• anhydrous colloidal silicon dioxide;
• srospovidonum (crosspovidon);
• magnesium stearate;
• ethylcellulose;
• sodium crossarmellosis (NF);
• titanium dioxide and much more.

Description of pharmacological features

Take amoxiclav 875 + 125 can be exclusively as prescribed by the doctor. Amoxicillin, which is included in its composition, refers to semi-synthetic penicillins, which are able to fight gram-positive and gram-negative microbes. The walls of the cells of the bacteria are destroyed, since the substance disrupts the synthesis of protein. Many microorganisms have a property to resist antibiotics from a group of cephalosporins and penicillins. They produce an enzyme beta lactamase, destroying a lactam ring active substanceThus, the angry, the angry effect of the antibacterial agent.

Scientists were able to protect the drug from such bacteria by adding clavulanic acid into it. This substance is a beta lactamase inhibitor. By its structure, it is akin to Penicillin. This component enhances the amoxicillin effect, thereby expanding its range of application.

Preparations containing such components quickly penetrate into many tissues of the body through blood flow. They have a powerful antibacterial property, destroying aerobic and anaerobic microorganisms.

What diseases use amoxiclav?

Indications for use can be the most diverse:

• The pathology of the upper and lower respiratory tract: otitis in acute and chronic form, sinusitis, sinusitis, tonsil pharyngitis, pneumonia and bronchitis.
• Infectious diseases of the urogenital system (urethritis, cystitis, pyelonephritis).
• Venestic diseases (gonorrhea, chalkroid).
• Pathology bile ducts and bubble (cholecystitis, cholangitis and others).
• Postoperative inflammation.
• Diseases of the skin, joints and bones, as well as soft tissues.

The advantages of the drug should include:

• good tolerance;
• a wide range of applications;
• the absence of toxic and harmful components in the composition of the funds;
• convenient dosage of the drug;
• the medicine is safe for applying elderly patients and young children.

List of contraindications

Despite the positive characteristics of the antibiotic, there are certain contraindications for receiving Amoxiclava 875 + 125:

• intolerance to any component of the drug;
• allergies to antibacterial agents of the penicillin and cephalosporin group;
• pathology of liver and kidneys, in heavy forms.

It is indicated that during the battery period, it is necessary to take the drug with caution. So as not to harm the fruit, any medication Must prescribe a qualified doctor.

Amoxiclav is contraindicated by people suffering from lympholoicosis and infectious mononucleosis.

Dosage and application

Many patients are interested in the question: "How many days to take amoxiclav 875 + 125 and what is the dosage of the drug depending on the age-related indicators?"

In most cases, the course of treatment with antibacterial preparation is 5-7 days. If the disease is prolonged, the doctor can increase the term of treatment for another week.

Little children dosage of amoxiclava are calculated based on body weight indicators. In case of light and middle degrees Severity dosage per day no more than 20 mg / kg weight, with severe degree - no more than 40 mg / kg.

Adults and children who have reached 12 years old, doctors prescribe a reception with a dosage of 500 mg. The medicine needs to drink 30 minutes after meals, every 12 hours. With severe pathologies, the dose can be increased.

Amoxiclav 875 + 125 with angina - very effective. Depending on the variety of the disease, the corresponding dose of the drug is prescribed. In the treatment of catarrhal angina, the doctor may assign tablets of 250 mg of amoxicillin. But to combat purulent infection - an increased dosage (875 mg of active substance) will be required. Take a medicine 2 times a day.

It is important to remember that to assign such a serious antibiotic as amoxyclav, only the attending physician can.

Price of drug

Amoxiclav Kviktab 875 mg +125 mg can be bought almost in any pharmacy. The cost of the medication may vary depending on the region where the patient lives. On average, the price of the medicine is about 400-500 rubles per pack.

Reviews that can be found on the forums have positive. If the patient complies with all prescriptions of the doctor, then there will be no negative consequences after receiving the amoxiclava.

Article Verified
Anna Moschovis - family doctor.

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- The drug, which is prescribed with many infectious diseases, as well as for their prevention. This medicine is an antibiotic, so requires caution in use - it needs to be dried strictly to the appointment of a doctor, observing the last time of treatment.

Amoxiclava includes two main components - amoxicillin and clavulanic acid. Chemically, they do not interact with each other. The main form of release is tablets, but there is amoxiclav in solution for injection (intramuscular and intravenous). The drug relates to antibiotics, a group of protected synthetic penicillins.

Amoxicilline is an antibiotic, a synthetic analogue of penicillin. Its spectrum of action includes staphylococci, streptococci, as well as a number of pathogens of other infections - Cocal, Brucellize, especially dangerous infectionsBut in practice, this effect is quite weak. Amoxicillin is included in the Helicobacter eradication redundant (bacteria, which is the pathogen agent of gastritis and peptic disease stomach).

One of the most important advantages of amoxicillin - low frequency side Effects.

Penicillin and its analogues are considered the safest antibiotics. This is due to the fact that their target is the cell wall of bacteria - completely absent in the cells human organism. The toxicity of this drug for a person is extremely low, so amoxicillin is considered a safe drug.

Nevertheless, it has a significant drawback. A number of bacteria (mainly) forms a penicillinase enzyme, which destroys the antibiotic. Amoxicillin, like other antibiotics penicillin rowis subject to this enzyme. In order to protect the antibiotic from the effects of the enzyme, clavulanic acid is used, more precisely, sodium compound clavulanate. It neutralizes penicillinase, which reduces the risk of bacteria stability, increases the efficiency of the drug. Therefore, the purpose of amoxiclava is preferable compared to unprotected penicillins - amoxicillin, penicillin, and others.

When do the drug prescribe?

The drug is prescribed bacterial infectionswhich are caused by microorganisms sensitive to it. To determine sensitivity, bacteriological analysis is carried out and the test for sensitivity to antibiotics (antibioticogram).

In some cases, severe condition The patient or high risk of complications is permissible to assign amoxyclave until the results of analysis are obtained. At the same time, the material for the study must be taken before the course of treatment.

Infections under which amoxiclav are prescribed:

• Diseases of ENT organs.
• Respiratory infections.
• Urinary and sex infections.
• Inflammation in the oral cavity, odontogenic infections.
• Skin infectious diseases.
• Wound infections, including animal bites.
• Bacterial diseases of bone tissue.
• Infections of biliary tract.

Also, amoxiclav can be prescribed after surgical interventions to prevent infectious complications, as well as in injuries, if they are infected (ground or other substances are contaminated). With human bites and animals, this agent is effectively against an infection that dwells in the oral cavity.

In case of non-hospital infections, amoxiclav is most often ineffective, since hospital microorganisms are most often resistant to the most frequently used antibiotics, including various types of penicillins.

How to take it right?

The drug is produced in several dosage formsoh, and each of them should be taken in accordance with the instructions. Tablets are taken inward, the dosage depends on the disease, the patient's body mass, the peculiarities of diseases. For adults, the dosage is usually 250 mg every 8 hours or 500 mg every 12 hours. Teens older than 12 years old or with weight more than 40 kg take medicine adult dosage. With severe dose infections can be increased.

For children under 12 years old, a suspension is preferably prepared from a powder. It is also taken inside, but the dosage of the active substance is lower there, which reduces the risk of side effects, especially allergic reactions. Daily dosage 40mg in 3 reception. The drug is intended for children under 12 years or weighing less than 40 kg.

Injection forms of medicines are designed to treat heavy infectious diseases, accurate dosage The doctor prescribes, and it can vary significantly depending on the state of the patient. Also, they can be prescribed if the oral medication is impossible (severe diseases of the stomach, intestines).

The duration of the course of treatment is from 5 to 14 days.

Reducing the course can not - this leads to the selection of sustainable bacteria strains. Even if the symptoms of the disease quickly disappeared, the course of treatment must be made to the end. If after 14 days of reception the disease is not cured, this suggests that the drug is ineffective, and it needs to be replaced by more effective tool. As a rule, the replacement occurs earlier.

Who and when is he contraindicated?

The drug often causes hypersensitivity and allergic reactions, especially in children younger agewhich have an immune system formed enough for an adequate response to amoxicillin.

In addition to allergies, the cross-reactions of hypersensitivity on antibiotics of the penicillin row, as well as cephalosporins and other beta lactams are found to amoxiclave.

This is a fairly large and common group of antibiotics, an allergic reaction to one of the drugs in which can mean the presence of hypersensitivity to all related drugs. All similar phenomena in history are contraindications to the use of amoxiclava.

It is also impossible to take it at various lesions of the liver - hepatitis, including medicinal, phenomena of stagnation of bile. These phenomena may be associated with the reception of amoxiclava and have a temporary nature - in this case, it is necessary to stop receiving and replace the drug with an analogue that does not have a hepatotoxic effect.

Third Group of Contraindications - Heavy Pathology immune system, in particular infectious mononucleosis and different kinds leukemia.

In these cases, antibiotics can cause even greater impairment of the immune system and deterioration of the patient's condition.Caution needs to take medicine when renal failure, phenylketonuria in adults. For children under 12 years old, pills are contraindicated, injections are allowed only in severe cases when there is a danger to life.

Can he cause side effects?

Improper use of the drug may cause side effects

Dosage forms that are designed to receive inside, can cause disorders digestive system - Impairment of appetite, pain in the abdomen, diarrhea, nausea, vomiting and any other manifestations of dyspepsia.

If they are so strong that they make it impossible to take the drug, it should be abandoned by amoxiclava and replace it with other means or injection forms.

In turn injection forms These may cause inflammatory reactions at the injection site, the formation of infiltrates under the skin, soreness, swelling and other unpleasant phenomena. It is also possible a dangerous complication - phlebitis (with intravenous administration).

Regardless of the dosage form, allergic reactions are possible, a decrease in the number of leukocytes and a decrease in immunity as a result. To combat this, it is desirable to combine the drug with measures to strengthen immunity - taking vitamins, an increase in the share of fruit in the diet.

Also possible headache, dizziness, cramps, especially in patients with impaired kidney function.

In children, the drug can cause elevated excitability, nervousness, whims. This is a temporary phenomenon that quickly passes. It does not represent the dangers for the health and development of the kid.

Is it possible to take it during pregnancy and gv?

The active substances penetrate the placental barrier and in breast milk, so this drug It is undesirable to take in pregnancy and breastfeeding. Nevertheless, the presence of an unbearable infection in the body of the mother is much more dangerous application Antibiotics. The question of whether it is necessary to take a medicine, only the doctor decides.

Description

Tablets 375 mg: White or almost white octagonal biconvecake tablets, covered with film shell, with engraving 250/125 on one side and AMC on the other side.
Tablets 625 mg: White or almost white oval biconavie pills covered with film shell.

Structure

Each tablet (375 mg) contains 250 mg of amoxicillin in the form of trihydrate and 125 mg of clavulanic acid in the form of a potassium salt - a ratio of 2: 1.
Auxiliary substances: silicon colloidal dioxide, crosspovidone, sodium crossarmellosis, magnesium stearate, talc, microcrystalline cellulose.

Each tablet (625 mg) contains 500 mg of amoxicillin in the form of trihydrate and 125 mg of clavulanic acid in the form of a potassium salt - a ratio of 4: 1.
Auxiliary substances: silicon colloidal dioxide, crosspovidone, sodium crossarmellos, magnesium stearate, microcrystalline cellulose.
Tablet shell: hydroxypropylcellulose, ethyl cellulose, polysorbat, triethyl citrate, titanium dioxide, talc.

Pharmacotherapeutic group

Antibacterial agents for systemic use; Penicillin combinations, including beta-lactamase inhibitors.
ATH code: J01CR02.

Pharmacological properties"Type \u003d" Checkbox "\u003e

Pharmacological properties

Pharmacodynamics
Amoxicillin is a semi-synthetic penicillin, a beta-lactam antibiotic, which inhibits one or more enzyme (often called penicillin-binding protein) in the process of biosynthesis of peptidoglycan - the integral component of the cell wall of bacteria. Inhibition of the synthesis of peptideoglycan leads to the loss of the strength of the cell wall, which usually determines the lysis and death of the cells.
Amoxicillin is destroyed under the action of beta-lactamas produced by resistant bacteria, therefore it is inactive against microorganisms that produce data enzymes.
Clawulanic acid is a beta-lactam, structurally similar to penicillins. It suppresses some beta lactamases and, thus, prevents the inactivation of amoxicillin. By itself, clavulanic acid does not have a clinically useful antibacterial effect.
The time to maintain the concentration above the minimum overwhelming (T\u003e IPC) is recognized as the main determinant of amoxicilline efficiency.
Mechanisms of resistance
There are two main mechanism of the resistance of bacteria to amoxicillin / clavulanic acid:
Inactivation by bacterial beta lactamases, insensitive to the inhibitory effect of clavulanic acid, including beta-lactamases of classes B, C and D;
The change in the penicillin binding proteins, as a result of which the affinity of antibacterial drugs is reduced to target structures.
The impermeability of bacteria or the mechanisms of active transportation of the drug from the bacteria cell can be the direct cause of resistance or to contribute to its occurrence, especially in gram-negative bacteria.

Sensitivity limits
The minimum overwhelming concentrations for amoxicillin / clavulanic acid correspond to the limits of the sensitivity established by the European Antibiotic Sensitivity Evaluation Committee (Eucast)

Microorganism	Sensitivity limits (μg / ml)
	Sensitivity	Intermediate sensitivity	Resistance
Haemophilus influenzae. 1	≤ 1	-	> 1
Moraxella Catarrhalis 1.	≤ 1	-	> 1
Staphylococcus aureus 2.	≤ 2	-	> 2
Coagulatorygable Staphylococcus 2.	≤ 0,25		> 0,25
Enterococcus 2.	≤ 4	8	> 8
Streptococcus A, B, C, G 5	≤ 0,25	-	> 0,25
Streptococcus Pneumoniae 3.	≤ 0,5	1-2	> 2
Enterobacteria 1,4.	-	-	> 8
Gram-negative anaerobes 1.	≤ 4	8	> 8
Gram-positive anaerobes 1.	≤ 4	8	> 8
Nigeon-specific limits 1.	≤ 2	4-8	> 8
1 The obtained values \u200b\u200bcorrespond to the concentrations of amoxicillin. In order to estimate the sensitivity, a fixed concentration of clavulanic acid is used - 2 mg / l. 2 The obtained values \u200b\u200bcorrespond to oxacillin concentrations. 3 The limit values \u200b\u200bin the table are based on the sensitivity to ampicillin. 4 The resistance limit R\u003e 8 mg / l guarantees the antibiotic resistance of all selected strains with resistance mechanisms. 5 The limit values \u200b\u200bin the table are based on the sensitivity to benzylпenicillin.

The prevalence of the resistance of individual species is characterized by geographic and temporal dependence, so prior to the start of therapy, it is advisable to obtain local information on antibiotic resistance, especially in the case of heavy infections. In cases where local antibiotic estimates are questioned by the feasibility of the drug at least in some types of infections, you should contact the appropriate specialists.
Usually sensitive species
Gram-positive aerobes: Enterococcus Faecalis, Gardnerella Vaginalis, Staphylococcus aureus Coagulase-Negative Staphylococci (Methicillin-sensitive strains) £, Streptococcus Agalactiae, Streptococcus Pneumoniae 1, Streptococcus Pyogenes and other beta hemolytic streptococci, group Streptococcus Viridans.
Gram negative aerobes: Capnocytophaga SPP., Eikenella Corrodens, Haemophilus Influenzae 2, Moraxella Catarrhalis, Pasteurella Multocida
Anaerobes: Bacteroides Fragilis, Fusobacterium Nucleatum, Prevotella SPP.
Views with the possible development of acquired resistance
Gram-positive aerobes: Enterococcus Faecium $.
Gram-negative aerobasics: Escherichia Coli, Klebsiella Oxytoca, Klebsiella Pneumoniae, Proteus Mirabilis, Proteus Vulgaris
Views with natural resistance
Gram-negative aerobasics: Acinetobacter Sp., Citrobacter Freundii, Enterobacter Sp., Legionella Pneumophila, Morganella Morganii, Providencia SPP, Pseudomonas Sp., Serratia Sp., Stenotrophomonas Maltophilia
Other microorganisms: Chlamydophyla Pneumoniae, Chlamydophyla Psittaci, Coxiella Burnetti, Mycoplasma Pneumoniae
$ Natural intermediate sensitivity in the absence of the acquired mechanism of resistance.
£ All methicillin-resistant staphylococci is resistant to amoxicillin / clavulanic acid.
1 infections caused by Penicillin-resistant strains of Streptococcus Pneumoniae should not be treated with a given drug form of the drug, if there is a high risk that the proposed pathogens have resistance due to non-beta-lactamase products that are sensitive to inhibition of clavulanic acid, but by changing penicillin binding Proteins (see "Method of Application and Dosage" and "Precautions").
2 In some EU countries, strains with reduced sensitivity occurring with a frequency above 10% are revealed.

Pharmacokinetics
Amoxicillin and clavulanic acid are completely dissolved in water under physiological pH. Both components are quickly and well absorbed after taking the drug inside. Their absorption improves if taking the drug immediately before meals. When taking inside, the bioavailability of amoxicillin and clavulanic acid reaches approximately 70%. The concentration profiles of both plasma components are similar, the time to achieve peak concentration (T max) for each substance is about one hour.
When groups of healthy volunteers received an empty stomach combined drug in the form of tablets 875 mg / 125 mg, maximum serum concentrations (C max) were 11.64 ± 2.78 μg / ml for amoxicillin and 2.18 ± 0.99 μg / ml for clavulanic acid. The time of achieving the maximum serum concentration (T max) was 1.5 hours (range 1.0-2.5) for amoxicillin and 1.25 hours (range 1.0-2.0) for clavulanic acid. The average values \u200b\u200bof the indicator T 1/2 were 1.19 ± 0.21 h for amoxicillin and 0.96 ± 0.12 h for clavulanic acid.
The concentrations of amoxicillin and serum clavulanic acid achieved when taken inside combined drugare similar to concentrations obtained as a result of intake of equivalent doses of amoxicillin or clavulanic acid separately.
About 25% of the total content of clavulanic acid in plasma and 18% of the total content of amoxicillin in the plasma is in the associated protein state. The apparent distribution volume is about 0.3-0.4 l / kg for amoxicillin and about 0.2 l / kg for clavulanic acid.
After intravenous administration Amoxicillin and clavulanic acid are found in the bile bubble, the tissues of the abdominal wall, skin, adipose tissue, muscle tissue, synovial and peritoneal liquids, bile and row. Amoxicillin only enters the cerebrospinal fluid to a slight degree.
Amoxicillin, like most penicillins, enters breast milk.
Track number of clavulanic acid are also defined in breast milk (See "Pregnancy and Breastfeeding").
Both amoxicillin, and clavulanic acid penetrate the placental barrier.
Amoxicillin is partially removed with the urine in the form of inactive penicillic acid in volumes equivalent to no more than 10-25% of the initial dose. Clawulanic acid is intensively metabolized in the human body, is excreted with urine and feces, as well as in the form carbon dioxide with exhaled air.
The main way of removing amoxicillin are kidneys, while clavulanic acid is derived from the body with the help of renal and abandoned mechanisms.
The combination of amoxicillin / clavulanic acid is characterized by the average half-life of about one hour and the average common clearance of about 25 l / h in healthy individuals. Approximately 60-70% of amoxicillin and approximately 40-65% of clavulanic acid is removed unchanged with urine in the first 6 hours after one-time reception of amoxicillin pills / clavulanic acid 250 mg / 125 mg or 500 mg / 125 mg. The level of removal with urine within 24-hour period is 50-85% for amoxicillin and 27-60% for clavulanic acid. The maximum number of clavulanic acid is excreted in the first two hours after the drug is taking.
Age
The half-life of amoxicillin in children aged three months to two years, older children and adults are similar. To the elderly, the dose is selected with caution due to the possible reduction of the kidney function and, if necessary, regularly check the work of the kidneys.
Floor
Amoxicillin pharmacokinetics or clavulanic acid does not depend on the floor of the patient.
Violation of kidney function
The total plasma clearance of amoxicillin and clavulanic acid decreases in proportion to a decrease in the renal function. The decrease in clearance is more pronounced for amoxicillin than for clavulanic acid, as the proportion of amoxicillin derived by the kidney is higher. In renal failure, the dose is chosen in such a way as to avoid excessive accumulation of amoxicillin when maintaining adequate levels of clavulanic acid (see "Method of Application and Dosage").
Liver failure
Patients with hepatic insufficiency The drug is prescribed with caution and regularly control the liver function.

Indications for use

Amoxiclav is designed to treat the following infections caused by amoxicillin sensitive combination / clavulanic acid strains:
Acute bacterial sinusitis (adequately diagnosed);
Acute middle otitis;
Exacerbation chronic bronchitis (adequately diagnosed);
Complete pneumonia;
Cystitis;
Pyelonephritis;
Skin and soft tissue infections, in particular inflammation of subcutaneous tissue, animal bites, severe dental abscesses with a common phlegmon;
Infections of bones and joints, in particular osteomyelitis.
Official guidelines for the proper use of antibacterial drugs should be taken into account.

Contraindications

Increased sensitivity to the active or auxiliary substances of the drug, as well as to any penicillins.
Severe reactions of increased sensitivity of immediate type (for example, anaphylaxis) to other beta-lactam preparations (eg, cephalosporins, carbapenes or monobactams) in history.
Jaundice or other liver damage against the background of the use of amoxicillin / clavulanic acid in history.

Method of application and dosage

Doses reflect the content of amoxicillin and clavulanic acid.
When choosing a dose for the treatment of specific infections, the following factors take into account:
alleged pathogens and their possible susceptibility to antibacterial drugs;
the severity and localization of infection;
age, weight and kidney function, as indicated below.
The use of other drug forms of the drug (for example, with higher doses of amoxicillin and (or) with another ratio of amoxicillin / clavulanic acid doses) is considered as needed.
When receiving amoxiclava 375 mg tablets in the doses recommended, adults and children with a body weight ≥ 40 kg will receive a common daose dose of 750 mg of amoxicillin / 375 mg of clavulanic acid.
When receiving amoxiclava 625 mg tablets in the doses recommended below, adults and children with a body weight ≥ 40 kg will receive a common daily dose of 1500 mg of amoxicillin / 375 mg of clavulanic acid.
Children with body weight< 40 кг будут получать дозу от 20 мг/5 мг/кг/сутки до 60 мг/15 мг/кг/сутки, при этом максимальная суточная доза составит 2400 мг амоксициллина/600 мг клавулановой кислоты.
If necessary in higher daily dose Amoxicillin It is recommended to choose another drug form of the drug to avoid reception of excessively high daily doses of clavulanic acid.
The duration of treatment should not exceed 14 days without revision (see information on long-term therapy in the section "Precautions").
Adults and children with body weight ≥ 40 kg
One tablet 375 mg or one tablet 625 mg three times a day.
Children with body weight< 40 кг
Amoxiclav, tablets of 375 mg, coated with film shell, are not recommended for use in children with body weight< 40 кг.
Dose from 20 mg / 5 mg / kg / day to 60 mg / 15 mg / kg / day, divided into three receptions.
The table below reflects the dose (mg / kg of body weight) in children with a body weight from 25 to 40 kg after receiving one tablet 625 mg.

Body weight (kg)	40	35	30	25	Recommended single dose (mg / kg body weight)
Amoxicillin (mg / kg body weight) after a single reception of one tablet 625 mg	12.5	14.3	16.7	20.0	6.67 – 20
Clawulanic acid (mg / kg body weight) after a single reception of one tablet 625 mg)	3.1	3.6	4.2	5.0	1.67 – 5

For the treatment of children under the age of six years or with a mass of body less than 25 kg, it is preferable to use a suspension.
For the treatment of children from 6 to 12 years old, the optimal dosage form are 625 mg tablets, taken 2 times a day.
Clinical data on the use of drug forms of the drug with a relationship active ingredients 4: 1 in doses above 40 mg / 10 mg / kg / day for the treatment of children under the age of two years.
Elderly patients
Dose correction is not required.
Patients with impaired kidney function
The dose is adjusted based on the maximum recommended dose of amoxicillin.
Patients with creatinine clearance more than 30 ml / min. Dose correction is not required.
Adults and children with body weight ≥ 40 kg
Children with body weight<40 кг
In children with body weight< 40 кг с клиренсом креатинина менее 30 мл/мин применение Амоксиклава с соотношением амоксициллина и клавулановой кислоты 2:1 не рекомендуется из-за отсутствия возможности корректировки дозы. У таких пациентов рекомендуется применение форм Амоксиклава с соотношением амоксициллина и клавулановой кислоты 4:1.
Patients with impaired liver function
Apply with caution. Regularly monitor the function of the liver (see "Contraindications" and "Precautions").

Mode of application
For receiving inside. Take directly before meals to minimize possible side effects from the gastrointestinal tract.
Treatment can be started with the parenteral form of the drug, following the instructions of the instructions attached to it, and continue the dosage form for intake.

Precautions

Before appointment of the drug, it is necessary to collect a detailed history regarding the preceding reactions of hypersensitivity to penicillins, cephalosporins or other β-lactam antibiotics.
Reports were obtained about the development of serious hypersensitivity reactions, sometimes with death, (including anaphylactoid and heavy skinless unwanted reactions) in patients receiving penicilline therapy. The risk of such reactions is the highest in patients with a history of hypersensitivity reactions on penicillins. In the event of an allergic reaction, it is necessary to stop the treatment with amoxyclava and begin alternative therapy.
In cases of proven susceptibility of causative agents of infection to amoxicillin, the transition from amoxiclava to amoxicillin in accordance with official manuals is considered.
This dosage form of the drug is unsuitable for use, if there is a high risk that the alleged pathogens have resistance due to non-beta-lactamase products that are sensitive to inhibition of clavulanic acid, but by changing penicillin-binding proteins (including resistant S. Pneumoniae.).
In patients with impaired renal function or receiving highly visible therapy, the convulsion is possible (see "Sidey").
Amoxiclave therapy should be avoided by suspected infectious mononucleosis, since patients with this disease amoxicillin may cause skin rash, which makes it difficult to diagnose the disease.
The simultaneous use of allopurinol during the treatment of amoxicillin may increase the likelihood of allergic skin reactions.
Long-term treatment by amoxiclave sometimes leads to an excessive increase in insensitive microflora.
The appearance at the beginning of the treatment of feverish generalized erythema with fever and formation of the emasculation at the beginning of therapy is a potential symptom of acute generalized testing Pustulose (OGP). This reaction requires cessation of amoxiclave treatment and is a contraindication for any subsequent impositions of amoxicillin.
Caution is prescribed amoxiclav patients with impaired liver function.
The liver failure caused by the use of the drug was primarily noted in men and elderly patients and can be associated with long therapy. These phenomena were very rarely marked in children. In all populations, signs and symptoms usually arise during or shortly after treatment, but in some cases become apparent only a few weeks after the cessation of treatment. Usually they are reversible. Hepatic insufficiency can be severe and, in extremely rare cases, end with a fatal outcome. It is almost always observed in patients with a serious main disease or simultaneously receiving drugs with pre-known potential impact on the liver.
The colitis caused by the intake of antibiotics is manifested by the use of almost all antibacterial drugs and may differ in seriousness from moderate to threatening life. In this regard, it is important to recognize this diagnosis in patients with diarrhea, during or after receiving any antibiotic. When the antibiotic caused by an antibiotic, the reception of amoxiclava must be immediately discontinued, a doctor consultation must be carried out, and the appropriate therapy has begun. In this situation, the reception of funds depressing peristaltics are contraindicated.
During long-term therapy, it is recommended a periodic assessment of the functions of various organ systems, including kidneys, liver and blood formation organs.
In rare cases, against the background of drug intake, prothrombin time elongation was noted. With the simultaneous use of amoxiclava and anticoagulants, it is necessary to carry out regular control of the corresponding indicators. It may be necessary to correct the dose of oral anticoagulants to achieve the desired level of anticoagulation.
In patients with renal failure, the dose must be adjusted depending on the degree of failure.
Patients with reduced diuresis very rarely arises crystalluria, mainly in parenteral therapy. During the introduction of high doses of amoxicillin, it is recommended to make a sufficient amount of fluid and maintain adequate diuresis to reduce the likelihood of amoxicillin-associated crystalluria. In patients with a catheter installed in the bladder, be sure to regularly control its permeability.
If it is necessary to estimate the level of glucose in the urine during the treatment, amoxicillin should be enjoyed by enzymatic methods with glucose oxidase, since non-enzyme methods sometimes provide false-positive results.
The presence of clavulanic acid in amoxiclave may cause non-specific binding of IgG and albumin membranes of erythrocytes, which can lead to false positive results of Cumbac sample.
There were cases of positive results of immunoassay analysis (ELISA) on Aspergillus.in patients who received the drug, which subsequently defined the absence of caused Aspergillus.infections. Cross reactions with non-surgilation polysaccharides and polyfuranoses were noted within the framework of the IFA test on Aspergillus.. Positive results of analyzes in patients taking amoxiclav should be interpreted with caution and confirmed by other diagnostic methods.

Application during pregnancy and lactation

Limited data on the use of the drug during pregnancy does not indicate an increased risk of congenital anomalies. In women with early premature rupture of the fetal shells, a potential connection of prophylactic treatment with amoxicillin / clavulanic acid with an increased risk of necrotic enterocolitis in newborns was revealed. The use of the drug during pregnancy should be avoided if the doctor does not consider treatment necessary.
Both actors are released into breast milk (data on the effect of clavulanic acid on breastfeeding children).
Children on breastfeeding may develop diarrhea and fungal infections
mucous membranes, which may require cessation of breastfeeding. It should be taken into account the possibility of sensitization. Therapy with the drug during the period of breastfeeding is possible only after estimating the benefit ratio and the attending physician.
Impact on the ability to manage motor vehicles and working with mechanisms
It is possible to develop undesirable effects (for example, allergic reactions, dizziness, seizures), potentially affecting the functions of these functions.

Medicinal interactions and other types of interactions:

Oral anticoagulants
Cases of increasing the international normalized relationship (many) in patients receiving supporting therapy by the Acecimocymarol or Warfarin on the background of the appointed courage of amoxicillin are described. If necessary, the simultaneous purpose of the drugs carefully control the prothrombin time or many at the beginning and after the cessation of the treatment of amoxicillin. Correction of doses of oral anticoagulants may be required.
Methotrexat
Penicillins can reduce the excretion of methotrexate, which can lead to an increase in toxicity.
Samples
It is not recommended to use simultaneously a probe, which reduces the secretion of amoxicillin by renal tubules. The simultaneous use of an amoxiclave probamacide can lead to an increase and to a longer maintenance of amoxicilline level (but not clavulanic acid) in the blood.
Mikophenolate Mofetil
In patients receiving mikophenolate mofetyl, after the beginning of the use of oral administration of amoxicillin and clavulanic acid, an approximately 50% decrease in the concentration of active metabolite - mycophenolic acid (IFC) was observed - before taking the next dose of mofetila mikophenolate. Such a change in the concentration of IFC before taking the next dose may not indicate the change in the overall exposure of the IFC. In this regard, in the absence of clinical signs of the transplant dysfunction, it is usually no need to change the dose of mikophenolate mofetila. Nevertheless, during such combined therapy and some time after the end of antibiotic therapy, careful medical observation is necessary.

Overdose

It is possible to develop gastrointestinal symptoms, as well as a violation of the water and electrolyte balance. There were cases of amoxicillin-associated crystaluria, sometimes leading to renal failure.
In patients with impaired renal function or the resulting therapy in high doses, convulsions may develop.
Amoxicillin is deposited in urinary catheters, mainly after intravenous introduction of large doses. It is necessary to regularly monitor the passability of catheters.
As for gastrointestinal symptoms, symptomatic treatment can be carried out, along with the restoration of the water and electrolyte balance.
Amoxicillin and potassium clavulanate can be derived from the body by hemodialysis.

Side effect

Storage conditions

Store in a dry place at a temperature not higher than 25 ° C. Keep out of the reach of children.
Invested in a bottle of a red desiccant insembly.

Shelf life

2 years.
Do not use the expiration date specified on the package.

Conditions of vacation

Jobs only on the doctor's prescription.

Manufacturer
Lek dd,
Verovshkova 57, Ljubljana, Slovenia

Amoxiclav.
Buy amoxiclav in pharmacies

Medicinal forms
Tablets covered with shell 875mg / 125mg
Tablets covered with film shell 875mg + 125mg

Manufacturers
Lek D.D. (Slovenia)

GROUP
Combined antimicrobial means

STRUCTURE
Active substances: 875 mg of amoxicillin in the form of trihydrate and 125 mg of clavulanic acid in the form of a potassium salt.

International non-proprietary name
Amoxicillin + Clawulanic Acid

Synonyms
Amoxiclav Kviktab, Artlet, Augmentin, Augmentin EU, Augmentin Wed, Claimar, Medoclaw, Panklav, Ranklav, Rapiklav, Sinijinoks, Siniwoks RTU, Flemoclav Solutab, Ecoclav

PHARMACHOLOGIC EFFECT
The preparation is a combination of amoxicillin and clavulanic acid. Amoxicillin is a semi-synthetic penicillin (beta-lactam antibiotic) inhibiting one or more enzymes (often denoted by penicillin-binding proteins, PSB) on the path of peptidoglycan biosynthesis, which is the integral structural components of the cell wall of bacteria. Inhibition of the synthesis of peptideoglycan leads to the loss of the strength of the cell wall, which usually determines the lysis and death of cells of microorganisms. Amoxicillin is destroyed by the action of beta-lactamas produced by resistant bacteria, thus, the spectrum of activity of one amoxicillin does not include microorganisms producing these enzymes. Clawulanic acid is a beta-lactam, structurally associated with penicillins. It inhibits some beta lactamases, thereby preventing the inactivation of amoxicillin and expands its spectrum of activity, including bacteria, usually resistant to amoxicillin, as well as other penicillins and cephalosporins. By itself, clavulanic acid does not have a clinically significant antibacterial action. The drug has a bactericidal effect in vivo for the following microorganisms: gram-positive aerobes. Staphylococcus aureus, Streptococcus Pneumoniae, Streptococcus Pyogenes. Gram-negative aerobes. Enterobacter SPP, Escherichia Coli, Haemophilus Influenza, species of Klebsiella, Moraxella Catarrhalis (Branhamella Catarrhalis). The drug has a bactericidal effect in vitro on the following microorganisms (however, clinical dependence is still unknown). Gram-positive aerobes. Bacilhs anthracis. Types of Corynebacterium, Enterococcus Faecalis, Enterococcus Faecium, Listeria Monocytogenes, Nocardia Asteroids, Coagulaso-Negative Staphylococci (including StareLococcus Epidermidis) Streptococcus Agalaciiae. Other species of the genus Streptococcus Streptococcus Viridians. Gram-positive anaerobes. Types of the genus Clostridium, types of Peptococcus genus, species of PepTostReptococcus. Gramountal aerobes. Bordetella pertussis, species of the genus Brucella, Gardnerella vaginalis, Helicobacter pylori, species of the genus Legionella, Neisseria gonorrhoeae, Neisseria meningitides, Pasteurella multocida, Proteus mirabilis, Proteus vulgaris, species of the genus Salmonella, species of the genus Shigella, Vibrio cholerae, Yersinia enterocolitica. Gram-negative anaerobes. Types of Bacteroides (including Bacteroides Fragilis), species of Fusobacterium genus. Others: Borrella Burgdorferi, Chlamydia SPP. , Leptospira Icterohamorrhagiae, Treponema Pallidum. Some strains of these types of bacteria produce beta lactamases, which contribute to their insensitivity to amoxicillin monotherapy. Pharmacokinetics. The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar. Amoxicillin and clavulanic acid are well dissolved in aqueous solutions with the physiological value of the pH and after taking the drug inside quickly and completely absorbed from the gastrointestinal tract (gastrointestinal tract), absorption of amoxicilline active substances and clavulanic acid is optimal in the event of its reception at the beginning of the meal. The bioavailability of amoxicillin and clavulanic acid after intake is about 70%. The peak of plasma concentrations is achieved approximately 1 hour after the reception. The maximum concentration values \u200b\u200bare for amoxicillin (depending on the dose) 3-12 μg / ml, for clavulanic acid - about 2 μg / ml. When the preparation of the concentration of amoxicillin / clavulanic acid concentration in plasma is similar to those in the oral administration of the corresponding doses of amoxicillin or clavulanic acid separately in equivalent doses. Both components are characterized by a good distribution volume in various organs, tissues and liquid media (including in the lungs, abdominal organs; fat, bone and muscular tissues; pleural, synovial and peritoneal fluids; in the skin, bile, urine, purulent separated, sputum, in interstitial fluid). Plasma protein binding moderate: 25% for clavulanic acid and 18% for amoxicillin. The distribution volume is approximately 0.3-0.4 l / kg for amoxicillin and about 0.2 l / kg for clavulanic acid. Amoxicillin and clavulanic acid do not penetrate the hematorecephalic barrier with unrevenched brain shells. Amoxicillin (like most penicillins) stands out with breast milk. In breast milk, trace amounts of clavulanic acid were also found. Amoxicillin and clavulanic acid penetrate the placental barrier. Amoxicillin is derived mainly by the kidneys, whereas clavulanic acid is by both kidney and out-of-current mechanisms. After one-time intake, a single tablet 250 mg / 125 mg or 500 mg / 125 mg approximately 60-70% amoxicillin and 40-65% of clavulanic acid for the first 6 hours is removed with the urine unchanged. About 10-25% of the initial dose of amoxicillin is derived from the urine in the form of inactive penicilloic acid. Clawulanic acid in the human body is subjected to intensive metabolism with the formation of 2.5-dihydro-4- (2-hydroxyethyl) -5-oxo-1H-pyrrol-3-carboxylic acid and 1-amino-4-hydroxy-butane-2-one And excreted with urine and feces. The average half-life of amoxicillin / clavulanic acid is approximately one hour, the average general clearance is approximately 25 l / h in healthy patients. In the course of various studies, it was found that the removal of amoxicillin with urine for 24 hours is approximately 50-85%, clavulanic acid - 27-60%. The largest number of clavulanic acid is displayed within the first 2 hours after the reception. Patients with impaired liver function. In patients with severe renal failure, the half-life increases to 7.5 hours for amoxicillin and up to 4.5 hours for clavulanic acid. For patients with impaired liver function, the dose of the drug should be selected with caution, it is necessary to constant control over the liver condition. Both components are removed by hemodialysis and minor quantities - peritoneal dialysis.

Indications for use
Infections caused by sensitive strains of microorganisms: infections of the upper respiratory tract and ENT organs (incl. Acute and chronic sinusitis, acute and chronic average otitis, cap abscess, tonsillitis, pharyngitis); infections of the lower respiratory tract (including acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia); urinary tract infections; infections in gynecology; Skin and soft tissue infections, as well as wounds from human and animal bites; bone and connective tissue infections; biliary tract infections (cholecystitis, cholangitis); Thindogenous infections.

Contraindications
Increased sensitivity to the components of the drug; Increased sensitivity to penicillins, cephalosporins and other beta-lactam antibiotics, cholestatic jaundice and / or other liver function caused by amoxicillin / clavulanic acid intake in history; Infectious mononucleosis and lympholecosis.

SIDE EFFECT
From the digestive system: loss of appetite, nausea, vomiting, diarrhea, abdominal pain, gastritis, stomatitis, glossitis, black "hairy" language, dental enamel darkening, hemorrhagic colitis (can also develop after therapy), enterocolitis, pseudomambranous colitis, violation The liver functions, an increase in the activity of alanine-one-appicrugations, aspartaminotransferase, alkaline phosphatase and / or level of bilirubin in blood plasma, liver failure (more often in the elderly, men, long therapy), cholestatic jaundice, hepatitis. Allergic reactions: itching, urticaria, erythematous rash, multiform exudative erythema, angioedema edema, anaphylactic shock, allergic vasculitis, exfoliative dermatitis, Stevens-Johnson syndrome, acute generalized examatosis, and serum sickness, toxic epidermal necroliz. From the side of the blood formation system and the lymphatic system: reversible leukopenia "(including neutropenia), platelet singing, hemolytic anemia, reversible increase in prothrombin of time (with co-use with anticoagulants), reversible increase in bleeding time, eosinophilia, pancytopenia, thrombocytosis, agranulocytosis. Parties to the central nervous system: dizziness, headache, convulsions (can manifest itself in patients with impaired kidney function when taking high doses of the drug), hyperactivity. Feeling alarm, insomnia, change behavior, excitement. From the urinary system: interstitial nephritis, crystalluria, hematuria . Other: Candidiasis and other types of superinfection.

INTERACTION
Antacids, glucosamine, laxative drugs, aminoglycosides slow down absorption, ascorbic acid - increases absorption. Diuretics, allopurinol, phenylbutazone; Non-steroidal anti-inflammatory drugs and other drugs that block the tubular secretion (probenecide) increase the concentration of amoxicillin (clavulanic acid is output mainly by glomerular filtration). The simultaneous use of the drug and methotrexate increases the toxicity of methotrexate. Appointment together with allopurinol increases the frequency of the examination. Simultaneous use with disulfram should be avoided. Reduces the effectiveness of drugs, in the process of metabolism of which a para-aminobenzoic acid is formed, ethinyl estradiol - the risk of developing bleeding "breakthrough". The literature describes rare cases of increasing the international normalized relationship (MHO) in patients with the joint use of Acentokumarol or Warfarin and Amoxicillin. If it is necessary to simultaneously use with anti-coagulants and protsual time or MHO, it must be carefully made when prescribing or canceling the drug. A combination with rifampicin antagonistic (mutual weakening of the antibacterial effect). The drug should not be applied simultaneously in combination with bacteriostatic antibiotics (macrolides, tetracyclines), sulfonamides due to a possible decrease in the efficiency of the drug. The drug reduces the effectiveness of oral contraceptives.

Method of application and dosage
Inside. The dosing mode is established individually depending on age, body weight, kidney function of the patient, as well as on the severity of infection. The drug is recommended to take at the beginning of a meal for optimal absorption and reducing possible side effects on the part of the digestive system. The course of treatment is 5 - 14 days. The duration of the course of treatment is determined by the attending physician. A course should not last more than 14 days without a re-medical examination. Children under 12 years old. The dose is prescribed depending on the age and mass of the body. Recommended dosing mode: 40 mg / kg / day in 3 reception. Children with a mass mass of 40 kg and more should be prescribed the same doses as adults. For children under the age of 6 years, the reception of the suspension of the drug is more preferable. Adults and children over 12 years old (or more than 40 kg of body weight). The usual dose in the event of a light and medium-free flow of infection is 1 tablet every 12 hours, in the case of severe flow of infection and respiratory tract infections - 1 tablet every 8 hours. Since the pills of the combination of amoxicillin and clavulanic acid 250 mg + 125 mg and 500 mg - 125 mg contain the same number of clavulanic acid -125 mg, then 2 tablets of 250 mg + 125 mg are not critical 1 tablet 500 mg + 125 mg. Dosage in odontogenic infections: 1 tablet every 12 hours for 5 days. Patients with impaired kidney function. Dose correction is based on the maximum recommended dose of amoxicillin and is carried out taking into account the values \u200b\u200bof creatinine clearance (QC). Adults and children over 12 years old (or more than 40 kg of body weight). QC\u003e 30 ml / min: Dose correction is not required. When Anuuria, the interval between dosing should be increased to 48 hours or more. Tablets 875 mg + 125 mg should be used only in patients with QC\u003e 30 ml / min. Patients with impaired liver function. Reception of the drug should be carried out with caution. It is necessary to carry out regular control of the liver function.

OVERDOSE
Messages about the fatal outcome or the occurrence of threatening life of side effects due to the overdose of the drug. In most cases, the symptoms of an overdose include disorders from the gastrointestinal tract (abdominal pain, diarrhea, vomiting). Anxiety is also possible, insomnia, dizziness, in isolated cases - convulsive seizures. In case of overdose, the patient must be under the supervision of the doctor, the treatment is symptomatic. In the case of a recent reception (less than 4 hours), it is necessary to wash the stomach and assign activated coal to reduce suction. Amoxicillin / clavulanic acid is removed by hemodialysis.

SPECIAL INSTRUCTIONS
Carefully. Pseudommbranous colitis in history, diseases of the gastrointestinal tract, liver failure, severe disorders of the kidney function, pregnancy, lactation period, while using anticoagulants simultaneously. Application during pregnancy and in breastfeeding period. During pregnancy and during lactation, the drug is used only if the intended benefit for the mother exceeds the potential risk to the fetus and the child. In case treatment, it is necessary to monitor the state of the function of the blood formation organs, liver, kidneys. In patients with severe disorders, the kidney function requires an adequate dose correction or an increase in the intervals between the dose intake. In order to reduce the risk of developing side effects from the gastrointestinal tract, the drug should be taken during meals. It is possible to develop superinfection due to the growth of microflora insensitive to it, which requires an appropriate change in antibacterial therapy. In patients having increased sensitivity to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible. In women with a premature rupture of the fruit shells, it was found that the prophylactic therapy of amoxicillin + clavulanic acid may be associated with an increase in the risk of developing necrotic colitis in newborns. In patients with reduced diuresis, crystalluria occurs very rarely. During the use of large doses of amoxicillin, it is recommended to make a sufficient amount of fluid and maintain adequate diuresis to reduce the likelihood of amoxicillin crystals. Laboratory tests: High concentrations of amoxicillin give a false-positive reaction to urine glucose when using Benedict reagent or felling solution. It is recommended to use enzymatic reactions with glucosidase. Special precautions in the destruction of an unused drug preparation. There is no need for special precautions when destroying, unused drug. Impact on the ability to manage vehicles and occupations by other activities requiring the concentration of attention and speed of psychomotor reactions. Due to the possibility of developing side effects on the part of the central nervous system, such as: dizziness, headache, convulsions, during treatment, caution should be taken when driven by car and occupations by other activities requiring the focus and speed of psychomotor reactions.

STORAGE CONDITIONS
Store in a dry, inaccessible place at temperatures not higher than 25 C.

Dosage form

Tablets covered with film shell, 375 mg and 625 mg

Structure

One tablet covered with film shell contains

active substances: 250 mg of amoxicillin in the form of amoxicillin trihydrate, 125 mg of acid clavulanation in the form of potassium clavulanate (for dosage 375 mg) or 500 mg of amoxicillin in the form of amoxicillin trihydrate, 125 mg of acid clavulanation in the form of potassium clavulanate (for dosage 625 mg).

auxiliary substances: silicon colloidal dioxide, crosspindon, dried, carboxymethylcellulose sodium cross, dried, magnesium stearate, talc, microcrystalline cellulose, dried.

the composition of the film shell: hydroxypropylcellulose, ethyl cellulose, polysorbate, triethyl citrate, titanium dioxide (E 171), talc.

Description

Tablets coated with a film shell of white or almost white, octagonal shape with a biconnecting surface, with engraving "250/125" on one side and "AMS" on the other side (for dosage 375 mg).

Tablets, coated with a film shell of white or almost white, oval shape with a biconnecting surface (for a dosage of 625 mg).

Pharmacotherapeutic group

Antibacterial drugs for system use. Beta-lactam antibacterial drugs - penicillins. Penicillins in combination with beta lactamase inhibitors. Clawulanic acid + amoxicillin.

ATH code J01CR02.

Pharmacological properties

Pharmacokinetics

Amoxicillin and Clavulanic acid acid are completely dissolved in an aqueous solution at pH of the body. Both components are well absorbed after taking inside. It is optimally taking amoxicillin / acid clavulanone during or at the beginning of meals. After taking inside, the bioavailability of amoxicillin and acid Clavulanova is approximately 70%. The dynamics of the concentration of the drug in the plasma of both components is similar. Maximum serum concentrations are achieved 1 hour after the reception.

The concentrations of amoxicillin and acid Clavulanova in the blood serum when receiving a combination of amoxicillin / acid preparations of Clavulanova are similar to those observed in orally separate reception of the equivalent dose of amoxicillin and acid Clavulanova.

About 25% of the total acid of Clavulanova and 18% amoxicillin binds to proteins in blood plasma. The volume of distribution in oral administration is approximately 0.3-0.4 l / kg of amoxicillin and 0.2 L / kg of acid Clavulanova.

After intravenous administration, both amoxicillin and clavulanic acid were found in the bile bubble, the transshipment of the abdominal cavity, leather, fat, muscle tissue, synovial and peritoneal liquid, bile and row. Amoxicillin does not penetrate the spinal fluid.

Amoxicillin and acid clavulanation penetrate through a placental barrier. Both components also go into breast milk.

Amoxicillin is partially excreted in the urine in the form of inactive penicilloy acid in quantities equivalent to 10 - 25% of the initial dose. Clavulanic acid is metabolized in the body and is derived from urine and feces, as well as in the form of carbon dioxide with exhaled air.

The average half-life of amoxicillin / acid Clavulanova is approximately 1 hour, and the average general clearance of about 25 l / h. Approximately 60 - 70% of amoxicillin and 40-65% of the acid of Clavulanic are derived from the body unchanged with urine for the first 6 hours after receiving a single dose of amoxicilline / acid Tablets Clavulanova. During various studies, it was found that with urine 50-85% of amoxicillin and 27-60% of Clavulanic acid for 24 hours are removed. The greatest amount of acid is derived for the first 2 hours after use.

The simultaneous use of the probenecide slows down the extraction of amoxicillin, but this drug does not affect the removal of the acid of Clavulanova through the kidneys.

The half-life of amoxicillin is similar in children aged 3 months to 2 years, also in older children and adults. When prescribing a medicinal product to very small children (including premature newborn) in the first weeks of life, the drug should not be introduced more often than two times a day, which is associated with the immaturity of the renal route of elimination in children. Due to the fact that the elderly patients are more likely to suffer renal dysfunction, it should be cautious to prescribe the drug to this group of patients, but if necessary, monitoring renal function should be monitored.

Common clearance of amoxicillin / acid Clavulanova in plasma decreases directly in proportion to a decrease in kidney functions. The reduction in amoxicillin clearance is more pronounced compared with acid clavulanaya, as a larger amount of amoxicillin is displayed through the kidneys. Therefore, when prescribing the drug to patients with renal failure, a dose correction is necessary to prevent excessive accumulation of amoxicillin and maintain the necessary acid level of Clavulanova.

When prescribing the drug, patients with hepatic insufficiency should be taken care when choosing a dose and regularly monitor the liver function.

Pharmacodynamics

Amoxicillin is a semi-synthetic antibiotic from the penicillin group (beta-lactam antibiotic), which inhibits one or more enzymes (frequently referred to as binding pepticillin proteins) involved in peptidoglycan biosynthesis, which is an important structural component of the wall of the bacterial cell. Inhibition of the synthesis of peptideoglycan leads to the weakening of the cell wall, which usually follows the cell lysis and its death.

Amoxicillin is destroyed by beta lactamases produced by resistant bacteria, and, therefore, the spectrum of activity of one amoxicillin does not include microorganisms that produce these enzymes.

Clavulanic acid is a beta lactam, structurally connected with penicillins. It inhibits some beta lactamases, thereby preventing the inactivation of amoxicillin and expand its spectrum of activity. By itself, clavulanic acid does not have a clinically significant antibacterial action.

The exceeding time is higher than the minimum overwhelming concentration (T\u003e IPC) is considered the main determinant of amoxicilline efficiency.

The two main mechanisms of resistance to amoxicillin and acid Clavulanova are:

Inactivation by bacterial beta lactamases, which are not suppressed by acid clavulano, including classes in, C and D.

Changes in penicillin binding proteins, which reduces the affinity of the antibacterial agent to the target causative agent.

The impermeability of bacteria or the mechanisms of the effuxe pump (transport systems) can cause or maintain the stability of bacteria, especially gram-negative bacteria.

The Border Values \u200b\u200bof the IPC for Amoxicillin / Acid Clavulanova are those that are identified by the European Committee for Testing Antimicrobial Sensitivity (Eucast).

Strains	Sensitivity limits (μg / ml)
	Sensitive	Moderately resistant	Resistant
Haemophilus influenzae1
Moraxella Catarrhalis1.
Staphylococcus aureus2.
Coagulaguine Staphylococci2.
Streptococcus A, B, C, G5
Streptococcus Pneumoniae3.
Enterobacteriaceae5.
Gram-negative anaerobes1
Gram-positive anaerobes1
Border value without a specific connection1

sensitivity, the concentration of acid clavulano is fixed by 2 mg / l.

3 The values \u200b\u200bof the checkpoints in the table are based on check points

ampicillin.

4 Control point of resistance R\u003e 8 mg / l ensures that all strains with

mechanisms of resistance are communicated as resistant.

5 The values \u200b\u200bof the checkpoints in the table are based on check points

benzylPenicillin.

The predominance of resistance can vary geographically and in time for selected species, and local information on resistance is desirable, especially in the treatment of severe infections.

Sensitive strains

Enterococcus Faecalis, Gardnarella Vaginalis, Staphylococcus aureus (sensitive to meticillina), Streptococcus Agalacticae, Streptococcus Pneumoniae, Streptococcus Pyogenes and other beta hemolytic streptococci, Streptococcus Viridans Group

Capnocyptophaga SPP., Eikenella Corrodens, Haemophilus Influenza, Moraxella Catarrhalis, Pasteurella Multocida

Anaerobic microorganisms

Bacteroides Fragilis, Fusobacterium Nucleatum, Prevotella SPP.

Strains purchased by the resistance of which can cause difficulties

Aerobic gram-positive microorganisms

Enterococcus Faecium.

Aerobic gram-negative microorganisms

Escherichia Coli, Klebsiella Oxytoca, Klebsiella Pneumoniae, Proteus Mirabilis, Proteus Vulgaris

Resistant strains

Aerobic gram-negative microorganisms

Acinetobacter Sp., Citrobacter Freundii, Enterobacter Sp., Legionella Pneumophila, Morganella Morganii, Providencia SPP., Pseudomonas Sp., Serratia Sp., Stenotrophomonas Maltophilia

Other strains

Chlamydophila Pneumoniae, Chlamydophila Psitacci, Coxiella Burnetti, Mycoplasma Pneumoniae

Indications for use

Acute bacterial sinusitis

Acute otitis of the middle ear

The aggravation of chronic bronchitis

Bronchopneumonia

Pyelonephritis

Skin and soft tissue infections (among phlegmon, animal bites, periodontal abscess, phlegmon maxillofacial region)

Infections of bones and joints (in particular osteomyelitis)

Method of application and dose

Doses are calculated taking into account the content of amoxicillin / acid Clavulanova. When choosing a dose of the drug, amoxiclav to treat individual infections should be considered:

Sensitivity of the pathogen to the antibiotic

Severity and Localization of Infection

The age, weight and function of the patient's kidney, as shown below.

It is also necessary to take into account other methods of using the Amoxiclav drug, for example, to use higher doses of amoxicillin and / or assign amoxicillin and acid to clavulan in various ratios.

Tablets should be taken orally before taking food to reduce possible gastrointestinal disorders and increase the absorption of amoxicillin / acid clavulano.

Adults and children with body weight more than 40 kg

Assign 1 tablet 375 mg 3 times a day or 1 tablet 625 mg 2-3 times per day.

The duration of treatment depends on the patient's reaction. Some infections (for example, osteomyelitis) require a longer treatment period. The maximum therapy time should not exceed 14 days.

The maximum daily dose for the dosage of 375 mg is 750 mg of amoxicillin / 375 mg of Clavulanic acid, for dosage 625 mg is 1500 mg of amoxicillin / 375 mg of acid Clavulanova.

Children with body weight below 40 kg should be prescribed a drug in a different dosage form (suspension).

Elderly patients do not need a dose adjustment.

In renal failure, the dose adjustment is performed taking into account the maximum recommended level of amoxicillin. Dose correction is not required when prescribing the drug to patients with creatinine clearance (CRCL) more than 0.5 ml / s. (30 ml / min.).

Adults and children weighing more than 40 kg

With hepatic failure, it should be used with caution. You must regularly check the liver functions.

Side effects

When assessing the frequency of the occurrence of different side effects, such gradations were used: "very often" - ³ 1/10, "often" - from ³ 1/100 to< 1/10, "нечасто" – от ³ 1/1000 до < 1/100, "редко" – от ³ 1/10000 до < 1/1000, "очень редко" – < 1/10000, неизвестно (имеющихся данных недостаточно для выполнения оценки).

Often:

Candidiasis (skin and mucous membranes)

Nausea3

Dizziness, headache

Digestion disorder

Raising AST and / or Alt5

Skin rash7, itching7, urticap7

Transient leukopenia (including neutropenia), thrombocytopenia

Multiform Erythema7.

Unknown:

Growth of insensitive organisms

Providing agranulocytosis, hemolytic anemia, increase in bleeding time and prothrombin time1

Angioedema edema10, anaphylaxia10, whey-like syndrome10, allergic vasculit10

Transient hyperactivity, cramps2

Antibiotic-associated coliti4, black "Village" language, discoloration of teeth11

Hepatitis6, cholestatic jaundice6

Stevens-Johnson Syndrome7, toxic epidermal necroliz7, bullous exfoliative dermatitis7, acute generalized Exandtematous Pustuez (AGEP) 9

Iterstial nephritis

Crystalluria8.

1 See Special Instructions section.

2 See Special Instructions section.

3 nausea more often when applying higher doses inside. Can be reduced

gastrointestinal reactions, taking amoxicillin / acid clavulano in

the beginning of meals.

4 Including pseudomambranous colitis and hemorrhagic colitis (see Special

instructions).

5 was noted a moderate increase in the level of AST and / or Alt in patients,

taking beta-lactam antibiotics, but the value of these results is not known.

6 These complications were noted when using the drug in combination with others

penicillins and cephalosporins (see Special Instructions).

7 If any skin reaction occurs, treatment should

stop (see Special guidelines).

8 See SPECIAL INSTRUCTIONS.

9 See Contraindication section.

10 See Special Instructions section.

11 were registered very rare cases of discoloration of the surface of the teeth

children. Compliance with the rules of hygiene of the mouth will help prevent it. Cleaning

the teeth removes the drug from the oral cavity.

Contraindications

Hypersensitivity to the active components of drugs from the group

penicillin or any auxiliary component of the drug

Severe hypersensitivity reaction as a history of other beta

lactam preparations (for example, cephalosporins, carbapenes or

monobaktamam)

Cholestatic jaundice or other cases of hepatic insufficiency in history (due to the use of amoxicillin / acid Clavulanova)

Children's age up to 12 years old (weight less than 40 kg)

Medicinal interactions

Oral anticoagulants

Oral anticoagulants and antibiotics of the penicillin group are widely used in practice without messages about interaction. However, in literary sources, an increase in the international normalized relationship in patients who took Acentokumarol or Warfarin together with amoxicillin was noted. If the simultaneous use of drugs is necessary, the prothrombin time should be carefully monitored or an international normalized relationship when appointing and canceling amoxicillin. Moreover, a change in dosage of oral anticoagulants may be required.

Methotrexat

Preparations of the penicillin group can reduce the removal of methotrexate, which causes a potential increase in toxicity.

Samples

It is not recommended simultaneous use of a probe. The probelacide reduces the kidney tubular secretion of amoxicillin. The combined use with the drug amoxiclav can lead to an increase in the levels of amoxicillin in the blood, but not clavulanic acid.

The simultaneous use of allopurinol and amoxiclav can increase the risk of allergic reactions. Data on the simultaneous use of allopurinol and amoxiclav are currently absent.

In patients taking mikophenolate mofetyl, with a combined use with the drug amoxiclav, the concentration of active metabolite of mycophenolic acid at the prescription of the initial dose is reduced by approximately 50%. The change in the level of the initial dose concentration may not correspond to the change in the total concentration of mycophenolic acid.

special instructions

Before starting therapy with amoxicilline / acid Clavulanova, it is necessary to carefully examine the presence of hypersensitivity reactions in penicillins, cephalosporins or other beta-lactam substances.

Serious and sometimes fatal (anaphylactic) hypersensitivity reactions were recorded in patients who received treatment with Penicillin. These reactions are more often found in people with a reaction of hypersensitivity to penicillin and anosnesis. When developing an allergic reaction to amoxicillin / acid, Clavulanova should stop therapy with this drug and go to another alternative treatment.

If the infection has proven to be resistant to amoxicillin, it should be considered the possibility of using amoxicillin / acid Clavulanova instead of amoxicillin.

With a high risk of sustainability of the pathogen to beta-lactam antibiotics, amoxiclav should not be used. It is not recommended to use the drug for the treatment of S. pneumoniae resistant to Penicillin.

In patients with impaired kidney function and taking a high dose of the drug, convulsions may develop.

Amoxicillin / acid should not be prescribed when infectious mononucleosis, as it is possible to appear the cap-like rash (for amoxicillin).

The simultaneous use of allopurinol during the treatment of amoxicillin can increase the likelihood of skin allergic reactions. Data on the simultaneous use of allopurinol and amoxiclav are currently absent.

Prolonged use of the drug may cause excessive growth of insensitive microorganisms.

The appearance at the beginning of the treatment of generalized erythema with pustular rashes and fever can be a symptom of the development of acute generalized examature Pustulusa. In the development of this reaction, it is required to stop the use of the drug amoxiclav and more not to use amoxicillin in the future.

The drug should be caution to prescribe patients with hepatic insufficiency.

Cases of the appearance of violations of the liver function were recorded mainly in men and older patients, quite rarely met in children who took the drug for a long period of time. Signs and symptoms are usually developing during or immediately after the start of treatment, but in some cases they can manifest themselves only a few weeks after the termination of therapy. These symptoms are usually reversible. Complications from the side of the liver can be expressed in severe and in extremely rare cases to flow with fatal. They are almost always developing in patients with serious concomitant diseases or in patients taking other drugs that affect the liver.

The development of antibiotic-associated colitis is characteristic of any antibacterial drugs, including amoxicillin, and may vary by severity from moderate to life-in-law. Therefore, it is important to take into account this diagnosis when prescribing the drug to patients suffering from diarrhea during or after the use of any antibiotics. In the occurrence of antibiotic-associated colitis, the use of the Amoxiclav® drug should be immediately discontinued. After consulting the doctor, appropriate therapy should be appointed. Preparations that reduce peristaltics are contraindicated in this situation.
With long-term therapy, it is recommended to regularly estimate the function of organ systems, including kidneys, liver and hematopoietual function.
It is necessary to adjust the dose of oral anticoagulants to maintain the desired level of blood coagulation.

In patients with impairment of kidney functions, a dose adjustment is required depending on the severity of violations.

In patients with reduced diuresis, crystalluria was very rarely noted, mainly during parenteral therapy. During treatment, the patient is recommended to drink plenty to avoid the possible development of crystalluria. According to the obtained data, amoxicillin is settled in the bladder catheters (mainly during intravenous introduction of large doses), in this case it is necessary to regularly monitor the passability of the catheter.

During treatment with the use of amoxicillin, enzymatic methods of glucose oxidase should be used when analyzes for the presence of glucose in the urine, since when using non-enzymatic methods, false positive results are possible.

The presence of an acid of clavulano in the preparation can lead to non-specific binding of immunoglobulin G and albumin with erythrocyte membranes and false positive results of Cumbac sample.
Data on the positive results of the analysis of BIO-RAD Laboratories Platelia Aspergillus EIA in patients who took amoxicillin / acid clowlane, which were subsequently not infected with Aspergillus infection, but there is no data on cross-reactions using non-Aspergillus polysaccharides and polyfuragoes. Thus, the positive results of analyzes of patients who took amoxicillin / acid clavulano should be interpreted with caution and confirmed by other diagnostic methods.
Pregnancy

Animal research does not indicate direct or indirect harmful effects on pregnancy, the development of embryo / fetus, childbirth or postnatal development.

Currently, there is a limited amount of data on the use of amoxicillin / acid Clavulanova during pregnancy in a person who did not reveal the increased risk of congenital malformations. In a clinical study, women with premature rupture of the fruit shell were registered with the causal relationship between prophylactic treatment using amoxicillin / acid clavulanoic and increased risk of necrotic enterocolitis in a newborn. It is not recommended to use amoxicillin / acid clavulanoy during pregnancy, the use is possible only in the case of the need for the prescription of the doctor.

Lactation

Both active substances are highlighted in breast milk (there are no data on the effect of acid clavulane on breastfeeding). Consequently, in breastfeeding, such symptoms may be the appearance of such symptoms as diarrhea and fungal infections of mucous membranes, in these cases it is necessary to stop breastfeeding. Amoxicillin / acid Clawulanic is allowed to use during breastfeeding only after the benefit / risk assessment by the attending physician.

Features of the influence of the medicinal product on the ability to control the vehicle or potentially hazardous mechanisms

Research on identifying effects affecting the ability to manage the car and technology has not been carried out. However, amoxiclave can cause such side effects as allergic reactions, convulsions that may affect the ability to control the car and moving mechanisms.

Manufacturer

Lek Pharmasyukals D.D., Slovenia

Perzonali 47, Si - 2391 PREVALJE, Slovenia