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After penicillin was discovered, antibiotics became an integral part of medicine. Every year these medicines are improved, more and more new drugs appear, including Amoxiclav. This remedy has a wide spectrum of action. How to take Amoxiclav 875+125 for adult patients? For what diseases is it prescribed? Possible side effects and contraindications? All these questions are worth examining in detail.

Composition of the drug

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

The drug comes in three forms of production:

• tablets (250 mg; 500 mg; 850 mg);
• powder for the preparation of intravenous solution;
• powder for making a suspension that is taken orally.

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

• anhydrous colloidal silica;
• сrospovidonum (crospovidone);
• magnesium stearate;
• ethylcellulose;
• croscarmellose sodium (NF);
• titanium dioxide and much more.

Description of pharmacological features

Amoxiclav 875+125 can be taken only as prescribed by a doctor. Amoxicillin, which is part of it, is a semi-synthetic penicillin that can fight gram-positive and gram-negative microbes. The bacterial cell walls are destroyed because the substance disrupts protein synthesis in them. Many microorganisms have the ability to resist antibiotics from the group of cephalosporins and penicillins. They produce the enzyme beta-lactamase, which destroys the lactam ring of the active substance, thus inhibiting the effect of the antibacterial agent.

Scientists were able to protect the drug from the action of such bacteria by adding clavulanic acid to it. This substance is a beta-lactamase inhibitor. In its structure it is related to penicillin. This component enhances the effect of amoxicillin, thereby expanding its range of applications.

Preparations containing such components quickly penetrate many tissues of the body through the bloodstream. They have powerful antibacterial properties, destroying aerobic and anaerobic microorganisms.

For what diseases is Amoxiclav used?

Indications for use can be very diverse:

• Pathologies of the upper and lower respiratory tract: acute and chronic otitis, sinusitis, sinusitis, tonsillopharyngitis, pneumonia and bronchitis.
• Infectious diseases of the genitourinary system (urethritis, cystitis, pyelonephritis).
• Sexually transmitted diseases (gonorrhea, chancroid).
• Pathologies of the bile ducts and bladder (cholecystitis, cholangitis and others).
• Postoperative inflammation.
• Diseases of the skin, joints and bones, as well as soft tissues.

The advantages of the drug include:

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

List of contraindications

Despite the positive characteristics of the antibiotic, there are certain contraindications to taking Amoxiclav 875+125:

• intolerance to any component of the drug;
• allergy to antibacterial agents of the penicillin and cephalosporin group;
• pathologies of the liver and kidneys, in severe forms.

It is indicated that during pregnancy the drug should be taken with caution. To avoid harm to the fetus, any medication must be prescribed by a qualified doctor.

Amoxiclav is contraindicated for people suffering from lymphocytic leukemia and infectious mononucleosis.

Dosage and use of the product

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 age?”

In most cases, the course of treatment with an antibacterial drug is 5-7 days. If the disease is protracted, the doctor may increase the treatment period by another week.

For young children, the dosage of Amoxiclav is calculated based on body weight. For mild to moderate disease, the dosage per day is no more than 20 mg/kg of body weight, for severe disease - no more than 40 mg/kg.

For adults and children over 12 years of age, doctors prescribe the drug with a dosage of 500 mg. The medicine should be taken 30 minutes after meals, every 12 hours. For severe pathologies, the dose may be increased.

Amoxiclav 875+125 for sore throat is very effective. Depending on the type of disease, the appropriate dose of the drug is prescribed. When treating catarrhal tonsillitis, the doctor may prescribe 250 mg amoxicillin tablets. But to combat a purulent infection, an increased dosage will be required (875 mg of the active substance). Take the medicine 2 times a day.

It is important to remember that only the attending physician can prescribe such a serious antibiotic as Amoxiclav.

Drug price

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

The reviews that can be found on the forums are positive. If the patient complies with all the doctor’s instructions, then there will be no negative consequences after taking Amoxiclav.

Article verified
Anna Moschovis is a family doctor.

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Even at the beginning of the last century, the discovery of the first antibacterial and antimicrobial drugs was considered almost a panacea for all ailments, and some scientists publicly announced the advent of an era without diseases in the near future. But over time, health workers began to notice a decrease in the effectiveness of antibacterial drugs against a number of infectious agents.

As a result of numerous laboratory studies and experiments, it turned out that pathogens have the ability at the genetic level to form resistance to the action of medications. To date, some statistical data indicate that the rate of acquisition of resistance in microorganisms exceeds the dynamics of the discovery and synthesis of new, previously unused drugs.

The way out of this situation was the creation of universal drugs by combining antibacterial drugs with special substances - sulbactam, tazobactam and clavuanic acid. This path has allowed us to open new horizons in the problem of overcoming antibiotic resistance.

General principle of operation using the example of a specific drug

A typical representative of combined (protected) drugs is an antibiotic called Amoxiclav, which contains the above-mentioned Clavuanic acid and Amoxicillin, a penicillin-type drug characterized by a wide spectrum of effects. This structure allows the drug to successfully fight pathogens of various ailments, including pathogenic bacteria resistant to semi-synthetic antibiotics. The effect of Amoxiclav on pathogens can be briefly described as follows:

• When Amoxicillin enters the body, it begins to actively suppress the synthesis of cell walls of infectious agents (this principle of action is called bactericidal).
• The effectiveness of the drug is determined by the presence of a β-lactam ring in its structure.
• Microorganisms produce the enzyme beta-lactamase, under the influence of which the molecules (and therefore the penicillin drug itself) are gradually destroyed, and the therapeutic effect is nullified.
• The inhibitor protects the active substance from decay by binding β-lactamases and blocking their activity.
• The result of such joint activity is stopping the progression of the disease and the patient’s recovery.

Absorption and excretion of the drug

Amoxiclav differs from most drugs in its ability to be absorbed in the human body regardless of the time of meal (that is, the medicine can be taken both before and after meals); Moreover, its highest concentration in liquid tissues is observed 60 minutes after consumption.

The antibiotic enters the internal organs evenly. The medicine accumulates in the lungs, in the uterus and its appendages, in the maxillary sinuses (specifically, in their secretions).

It should be noted that when treating lactating women with Amoxiclav, only a small percentage of the active substances of the drug are present in breast milk, therefore some experts recommend not interrupting the process of feeding the child during the period of therapy for the mother.

But the drug penetrates quite easily through the physiological barrier between the central nervous system and the blood system, which makes it possible to use it as a method of combating meningitis.

Most of the drug is excreted by the kidneys after 2–3 hours; a small percentage is excreted through the intestines. The half-life of both the inhibitor and Amoxicillin averages 75 minutes.

Release form

The pharmaceutical industry produces Amoxiclav in tablet form, as well as in powders for the preparation of injections (intravenous and intramuscular) and suspensions. The most popular medical product is tablets, the line of which is represented by several types with varying amounts of inhibitor and antibiotic in the composition of the drug. The main characteristics of the forms of the medication are presented in the table below.

Type of drug	Compound (in milligrams)		Notes
	inhibitor	antibiotic
Powdered product used in the manufacture of injections,	100	500	Packaged in bottles
Same, 1.2 grams	200	1000
Instant pills Amoxiclav Quiktab	125	500	Ingredients include inactive substances and flavoring.
	125	875
Amoxiclav tablets:	125	875	Packaged in jars or blisters. The color of the pills varies from white to beige-white.
	125	875
	125	500
Amoxiclav (Forte)	62,5	250	Crystalline substance for preparing a suspension. The number of components is indicated in 5 ml of liquid.
Amoxiclav 125	31,5	125	Same

It should be remembered that using any form of the drug without first consulting a doctor is prohibited.

Side effects, contraindications

According to the instructions for use, the use of Amoxiclav in treatment regimens must be carried out under the strict supervision of a doctor in pregnant women, as well as in cases where the patient has:

• allergic manifestations to medications of the cephalosporin and penicillin groups, as well as to representatives of a number of carbapenems;
• disorders of the kidneys and liver;

It is prohibited to use the drug for treatment:

The main manifestations of the drug’s side effects on the body are:

1. Disruption of the gastrointestinal tract, expressed in periodic attacks of nausea, as well as flatulence, vomiting and diarrhea.
2. Changes in blood hemogram data (including anemia and thrombocytopenia).
3. Development of allergic reactions on the skin.

According to generalized data from studies, in isolated cases, the use of Amoxiclav caused headaches, behavioral disturbances, hepatitis, fever, candidiasis of the female genital organs, thrush of the oral mucosa, and convulsions in patients. The above signs of the negative effects of the components of the drug disappeared after discontinuation of the drug.

With rapid infusion of the drug (intravenous injections), phlebitis may occur.

In case of overdose, symptomatic therapy is performed, hemodialysis is allowed.

It is strictly forbidden to consume ethanol during treatment with Amoxiclav, since alcohol, even in minimal quantities, can cause extremely serious consequences. In addition, tetracyclines, macrolides and sulfonamides should not be taken in parallel with the described combination medication.

Application area

The unique combination of components of a highly effective drug allows it to successfully fight the following diseases:

• bronchitis and pneumonia of various origins;
• meningitis;
• intestinal infections (including salmonellosis and dysentery);
• endocarditis;
• osteomyelitis.

In addition to the above diseases, Amoxiclav is recommended to suppress pathogenic conditions of the following body systems:

• genitourinary (cystitis, pyelonephritis);
• bile duct (cholecystitis).

The medication prevents the development of inflammation after surgical procedures, helps eliminate diseases localized in the genitals (prostatitis, salpingoophoritis), ENT organs (otitis media, tonsillitis), and relieves infections of soft tissues and skin (abscesses, erysipelas).

This activity of the drug is explained by the wide range of its effects.

Anaerobes and aerobes (both gram-negative and gram-positive), including streptococci, listeria, salmonella, shigella, echinococcus and a number of other microorganisms, are sensitive to the influence of Amoxiclav.

A complete list of indications for use is contained in the annotation for the drug.

Amoxiclav dosing: instructions

The annotation for the medication states that the amount of the drug is calculated according to individual schemes, depending on the form of the disease, the weight and age of the patient, and the presence of chronic ailments.

The basic principles of dosing tablets and powder for injection solutions are given in the table below:

Type of medicine	Patient age	Recommended usage	Antibiotic quantity	Notes
Pills	Up to 12 years old.	3	The daily dose is 40 mg per 1 kilogram of body weight.	It is preferable to use a suspension.
	Children from 12 years of age and adults, as well as small patients weighing over 40 kg.	2	1 tablet Amoxiclav 625 (500).	The disease is of moderate severity.
		2	One tablet of Amoxiclav 875 (1000).	Respiratory tract infections, complex forms of diseases.
Powder for injection	Infants up to 3 months	2	30 mg/kg body weight	If the child weighs less than 4 kg.
		3	Same	Body weight over four kilograms.
	From 3 months	3	Same	For severe illnesses - 4 times a day.
	Adults and teenagers (over 12 years old), as well as children weighing more than 40 kg	3	1.2 g each	During the treatment of life-threatening illnesses, the interval between injections is reduced.

For preventive purposes, 1.2 grams of Amoxiclav is used once, an hour before the start of surgery, with the operation lasting up to two hours.

In the treatment of serious diseases, two-stage therapy is allowed, i.e. injections are replaced with tablet forms of the medication if the patient’s general condition improves.

The average duration of the drug course is from 5 days to 2 weeks.

Suspension: preparation and use

The antibiotic Amoxiclav for young children is prescribed mainly in the form of suspensions, since not all children know how to swallow tablet forms of medications.

It is not difficult to prepare the suspension: you need to add boiled water and cooled to room temperature into the bottle, and then shake the container several times (until the drug is completely dissolved).

A teaspoon of syrup contains 250 mg of antibiotic. There is also a medicine on sale with a reduced concentration of the active substance, 5 milliliters of which contains 125 milligrams of Amoxiclav.

The prepared solution should be stored in the refrigerator (no more than 14 days).

Scheme for calculating the amount of liquid:

The dosage of the suspension is determined by the doctor taking into account the weight and age of the small patient. For infants less than three months have passed since their birth, the drug is prescribed in the amount of 30 mg/kg of the child’s weight per day, in 2 doses with an interval of 12 hours; babies over 3 months old. for complicated infections - up to 40 mg/kg at intervals of 3 times a day.

The antibiotic in the form of special instant pills is used in pediatrics and in the treatment of adult patients. The tablets have a pleasant fruity taste.

A disease of moderate severity can be treated with Amoxiclav 500; severe diseases require the use of an antibiotic containing 875 units of the active substance. The regimen for using different types of medicine is identical - 1 pill twice a day.

The course of therapy is no more than 14 days.

additional information

Analogues of the drug are Augumentin, Verklav, Toromentin, Medoclav and a number of other drugs. It must be remembered that replacement of Amoxiclav with equivalents is carried out only after consultation with a doctor. You should not self-medicate: like any other antibiotic, this medicine can not only worsen the patient’s general condition, but also lead to the development of severe pathogenic conditions, the occurrence of superinfection (the fight against which will drag on for a long period).

Only a clinic specialist can increase the course of taking Amoxiclav after conducting additional studies of the patient’s kidneys and liver and studying the hemogram.

The antibiotic should be stored away from sunlight, subject to standard conditions: at a humidity level of 50 to 70% and temperatures up to 25 degrees above zero.

It is prohibited to use Amoxiclav after the expiration date.

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Description

375 mg tablets: White or off-white, octagonal, biconvex, film-coated tablets debossed with 250/125 on one side and AMC on the other side.
625 mg tablets: white or almost white, oval, biconvex, film-coated tablets.

Compound

Each tablet (375 mg) contains 250 mg of amoxicillin in the form of trihydrate and 125 mg of clavulanic acid in the form of potassium salt - a ratio of 2:1.
Excipients: colloidal silicon dioxide, crospovidone, croscarmellose sodium, 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 potassium salt - a ratio of 4:1.
Excipients: colloidal silicon dioxide, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose.
Tablet shell: hydroxypropylcellulose, ethylcellulose, polysorbate, triethylcitrate, titanium dioxide, talc.

Pharmacotherapeutic group

Antibacterial agents for systemic use; combinations of penicillins, including beta-lactamase inhibitors.
ATX code: J01CR02.

Pharmacological properties

Pharmacodynamics
Amoxicillin is a semisynthetic penicillin, a beta-lactam antibiotic that inhibits one or more enzymes (often called penicillin binding protein) in the biosynthesis of peptidoglycan, an integral component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to loss of cell wall strength, which usually causes cell lysis and death.
Amoxicillin is destroyed by beta-lactamases produced by resistant bacteria, so it is inactive against microorganisms that produce these enzymes.
Clavulanic acid is a beta-lactam structurally similar to penicillins. It inhibits some beta-lactamases and thereby prevents the inactivation of amoxicillin. Clavulanic acid alone does not have a clinically useful antibacterial effect.
The time to maintain concentrations above the minimum inhibitory concentration (T > MIC) is recognized as the main determinant of the effectiveness of amoxicillin.
Mechanisms of resistance
There are two main mechanisms of bacterial resistance to amoxicillin/clavulanic acid:
inactivation by bacterial beta-lactamases that are insensitive to the inhibitory effect of clavulanic acid, including beta-lactamases of classes B, C and D;
a change in penicillin-binding proteins, as a result of which the affinity of antibacterial drugs for target structures decreases.
Impermeability of bacteria or mechanisms of active drug transport from the bacterial cell can directly cause or contribute to resistance, especially in Gram-negative bacteria.

Sensitivity limits
Minimum inhibitory concentrations for amoxicillin/clavulanic acid correspond to the sensitivity limits established by the European Committee on Antibiotic Susceptibility Assessment (EUCAST)

Microorganism	Limits of detection (µg/ml)
	Sensitivity	Intermediate sensitivity	Resistance
Haemophilus influenzae 1	≤ 1	-	> 1
Moraxella catarrhalis 1	≤ 1	-	> 1
Staphylococcus aureus 2	≤ 2	-	> 2
Coagulase-negative 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
Enterobacteriaceae 1.4	-	-	> 8
Gram-negative anaerobes 1	≤ 4	8	> 8
Gram-positive anaerobes 1	≤ 4	8	> 8
Non-species-specific limits 1	≤ 2	4-8	> 8
1 The obtained values ​​correspond to the concentrations of amoxicillin. To assess sensitivity, a fixed concentration of clavulanic acid is used - 2 mg/l. 2 The obtained values ​​correspond to the concentrations of oxacillin. 3 The limit values ​​in the table are based on ampicillin susceptibility limits. 4 The resistance limit R > 8 mg/l guarantees antibiotic resistance of all isolated strains with resistance mechanisms. 5 The limit values ​​in the table are based on the limits of sensitivity to benzylpenicillin.

The prevalence of resistance of individual species is geographically and temporally dependent, so it is advisable to obtain local information on antibiotic resistance before initiating therapy, especially in the case of severe infections. In cases where local rates of antibiotic resistance call into question the appropriateness of the drug for at least some types of infections, assistance should be sought from 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.
Species with possible development of acquired resistance
Gram-positive aerobes: Enterococcus faecium
Gram-negative aerobes: Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris
Species with natural resistance
Gram-negative aerobes: Acinetobacter sp., Citrobacter freundii, Enterobacter sp., Legionella pneumophila, Morganella morganii, Providencia spp., Pseudomonas sp., Serratia sp., Stenotrophomonas maltophilia
Other microorganisms: Chlamydophila pneumoniae, Chlamydophila psittaci, Coxiella burnetti, Mycoplasma pneumoniae
$ Natural intermediate sensitivity in the absence of an acquired resistance mechanism.
£ All methicillin-resistant staphylococci are resistant to amoxicillin/clavulanic acid.
1 Infections caused by penicillin-resistant strains of Streptococcus pneumoniae should not be treated with this dosage form of the drug if there is a high risk that the suspected pathogens have resistance due not to the production of beta-lactamases sensitive to inhibition of clavulanic acid, but to changes in penicillin-binding proteins (see “Method of administration and dosage” and “Precautions”).
2 In some EU countries, strains with reduced susceptibility have been identified, occurring at frequencies above 10%.

Pharmacokinetics
Amoxicillin and clavulanic acid are completely soluble in water at physiological pH levels. Both components are quickly and well absorbed after taking the drug orally. Their absorption is improved if the drug is taken immediately before meals. When taken orally, the bioavailability of amoxicillin and clavulanic acid reaches approximately 70%. The plasma concentration profiles of both components are similar, with the time to peak concentration (Tmax) for each substance being approximately one hour.
When groups of healthy volunteers took the 875 mg/125 mg combination tablet twice daily on an empty stomach, maximum serum concentrations (C max) were 11.64 ± 2.78 mcg/mL for amoxicillin and 2.18 ± 0.99 µg/ml for clavulanic acid. Time to maximum serum concentration (Tmax) 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 T1/2 values ​​were 1.19 ± 0.21 hours for amoxicillin and 0.96 ± 0.12 hours for clavulanic acid.
Serum concentrations of amoxicillin and clavulanic acid achieved by oral administration of the combination product are similar to those obtained by oral administration of equivalent doses of amoxicillin or clavulanic acid alone.
About 25% of the total plasma clavulanic acid content and 18% of the total plasma amoxicillin content is in a protein-bound state. The apparent volume of distribution 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 gallbladder, abdominal wall tissue, skin, adipose tissue, muscle tissue, synovial and peritoneal fluids, bile and pus. Amoxicillin penetrates into the cerebrospinal fluid only to a small extent.
Amoxicillin, like most penicillins, passes into breast milk.
Trace amounts of clavulanic acid are also detected in breast milk (see Pregnancy and Breastfeeding).
Both amoxicillin and clavulanic acid cross the placental barrier.
Amoxicillin is partially excreted in the urine in the form of inactive penicillic acid in volumes equivalent to no more than 10-25% of the original dose. Clavulanic acid is intensively metabolized in the human body, excreted in urine and feces, and also in the form of carbon dioxide in exhaled air.
The main route of elimination of amoxicillin is the kidneys, while clavulanic acid is eliminated from the body through renal and extrarenal mechanisms.
The amoxicillin/clavulanic acid combination has an average elimination half-life of approximately one hour and an average total clearance of approximately 25 L/h in healthy individuals. Approximately 60-70% of amoxicillin and approximately 40-65% of clavulanic acid are excreted unchanged in the urine in the first 6 hours after a single dose of amoxicillin/clavulanic acid 250 mg/125 mg or 500 mg/125 mg tablets. The urinary excretion rate over a 24-hour period is 50-85% for amoxicillin and 27-60% for clavulanic acid. The maximum amount of clavulanic acid is excreted in the first two hours after taking the drug.
Age
The half-life of amoxicillin is similar in children aged three months to two years, older children and adults. For elderly people, the dose is selected with caution due to the possible decrease in renal function and, if necessary, renal function is regularly checked.
Floor
The pharmacokinetics of amoxicillin or clavulanic acid does not depend on the gender of the patient.
Renal dysfunction
The total plasma clearance of amoxicillin and clavulanic acid decreases in proportion to the decrease in renal function. The decrease in clearance is more pronounced for amoxicillin than for clavulanic acid, since the proportion of amoxicillin excreted by the kidneys is higher. In renal failure, doses are adjusted to avoid excessive accumulation of amoxicillin while maintaining adequate clavulanic acid levels (see Dosage and Administration).
Liver failure
In patients with liver failure, the drug is prescribed with caution and liver function is regularly monitored.

Indications for use

Amoxiclav is intended for the treatment of the following infections caused by strains sensitive to the amoxicillin/clavulanic acid combination:
Acute bacterial sinusitis (adequately diagnosed);
Acute otitis media;
Exacerbation of chronic bronchitis (adequately diagnosed);
Community-acquired pneumonia;
Cystitis;
Pyelonephritis;
Infections of the skin and soft tissues, in particular inflammation of the subcutaneous tissue, animal bites, severe dental abscesses with widespread phlegmon;
Infections of bones and joints, in particular osteomyelitis.
Official guidelines on the appropriate use of antibacterial drugs should be considered.

Contraindications

Hypersensitivity to the active or excipients of the drug, as well as to any penicillins.
History of severe immediate hypersensitivity reactions (eg, anaphylaxis) to other beta-lactam drugs (eg, cephalosporins, carbapenems or monobactams).
History of jaundice or other liver damage associated with amoxicillin/clavulanic acid use.

Directions for use and dosage

Doses reflect the content of amoxicillin and clavulanic acid.
When choosing a dose for the treatment of specific infections, the following factors are taken into account:
suspected pathogens and their possible susceptibility to antibacterial drugs;
severity and location of infection;
age, weight and kidney function as follows.
The use of other dosage forms of the drug (for example, with higher doses of amoxicillin and/or with a different amoxicillin/clavulanic acid dose ratio) is considered as needed.
When taking Amoxiclav 375 mg tablets at the recommended doses below, adults and children weighing ≥ 40 kg will receive a total daily dose of 750 mg amoxicillin/375 mg clavulanic acid.
When taking Amoxiclav 625 mg tablets at the recommended doses below, adults and children weighing ≥ 40 kg will receive a total daily dose of 1500 mg amoxicillin/375 mg clavulanic acid.
Overweight children< 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 a higher daily dose of amoxicillin is required, it is recommended to select a different dosage form of the drug to avoid taking excessively high daily doses of clavulanic acid.
The duration of treatment should not exceed 14 days without review (see information on long-term therapy in the "Precautions" section).
Adults and children weighing ≥ 40 kg
One 375 mg tablet or one 625 mg tablet three times a day.
Overweight children< 40 кг
Amoxiclav, 375 mg film-coated tablets, are not recommended for use in overweight children< 40 кг.
Dose from 20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day, divided into three doses.
The table below shows the dose (mg/kg body weight) in children weighing 25 to 40 kg after taking one 625 mg tablet.

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

For the treatment of children under six years of age or weighing 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 is 625 mg tablets taken 2 times a day.
There are no clinical data on the use of dosage forms of the drug with a 4:1 ratio of active components in doses above 40 mg/10 mg/kg/day for the treatment of children under two years of age.
Elderly patients
No dose adjustment is required.
Patients with impaired renal function
The dose is adjusted based on the maximum recommended dose of amoxicillin.
Patients with creatinine clearance more than 30 ml/min do not require dose adjustment.
Adults and children weighing ≥40 kg
Overweight children<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 liver dysfunction
Use with caution. Monitor liver function regularly (see “Contraindications” and “Precautions”).

Mode of application
For oral administration. Take immediately before meals to minimize possible gastrointestinal side effects.
Treatment can be started with the parenteral form of the drug, following the instructions attached to it, and continued with the dosage form for oral administration.

Precautionary measures

Before prescribing the drug, a detailed history should be obtained regarding previous hypersensitivity reactions to penicillins, cephalosporins or other β-lactam antibiotics.
There have been reports of serious hypersensitivity reactions, sometimes fatal, (including anaphylactoid and severe cutaneous adverse reactions) in patients receiving penicillin therapy. The risk of such reactions is highest in patients with a history of hypersensitivity reactions to penicillins. If an allergic reaction occurs, it is necessary to stop treatment with Amoxiclav and begin alternative therapy.
In cases of proven susceptibility of infectious agents to amoxicillin, a switch from Amoxiclav to amoxicillin is considered in accordance with official guidelines.
This dosage form of the drug is not suitable for use if there is a high risk that the suspected pathogens have resistance due not to the production of beta-lactamases sensitive to the inhibition of clavulanic acid, but to changes in penicillin-binding proteins (including resistant S. pneumoniae).
In patients with impaired renal function or receiving high-dose therapy, seizures may develop (see “Side effects”).
Therapy with Amoxiclav should be avoided if infectious mononucleosis is suspected, since in patients with this disease amoxicillin can cause a skin rash, which makes diagnosing the disease difficult.
Concomitant use of allopurinol during treatment with amoxicillin may increase the likelihood of allergic skin reactions.
Long-term treatment with Amoxiclav sometimes leads to excessive growth of insensitive microflora.
The appearance at the beginning of treatment of febrile generalized erythema with fever and the formation of pustules at the beginning of therapy is a potential symptom of acute generalized exanthemal pustulosis (AGEP). This reaction requires discontinuation of treatment with Amoxiclav and is a contraindication for any subsequent prescriptions of amoxicillin.
Amoxiclav should be prescribed with caution to patients with impaired liver function.
Drug-induced liver failure has been reported predominantly in males and elderly patients and may be associated with long-term therapy. These phenomena were very rarely observed in children. In all populations, signs and symptoms usually occur during or shortly after treatment, but in some cases become apparent only several weeks after treatment has stopped. Usually they are reversible. Liver failure can be severe and, in extremely rare cases, fatal. It is almost always observed in patients with a serious underlying disease or concomitantly taking drugs with a known potential for liver damage.
Antibiotic-induced colitis occurs with almost all antibacterial drugs and can range in severity from mild to life-threatening. Therefore, it is important to recognize this diagnosis in patients with diarrhea during or after taking any antibiotic. In case of colitis caused by an antibiotic, Amoxiclav should be stopped immediately, a doctor should be consulted, and appropriate therapy should be started. In this situation, the use of drugs that inhibit peristalsis is contraindicated.
During long-term therapy, periodic assessment of the functions of various organ systems, including the kidneys, liver and hematopoietic organs, is recommended.
In rare cases, while taking the drug, an increase in prothrombin time was observed. When using Amoxiclav and anticoagulants simultaneously, it is necessary to regularly monitor the relevant indicators. Dosage adjustments of oral anticoagulants may be necessary to achieve the desired level of anticoagulation.
In patients with renal insufficiency, the dose should be adjusted depending on the degree of insufficiency.
In patients with reduced diuresis, crystalluria very rarely occurs, mainly during parenteral therapy. During administration of high doses of amoxicillin, it is recommended to take sufficient fluids and maintain adequate diuresis to reduce the likelihood of amoxicillin-associated crystalluria. In patients with a catheter installed in the bladder, it is necessary to regularly monitor its patency.
If it is necessary to assess urine glucose levels during treatment with amoxicillin, enzymatic methods with glucose oxidase should be used, since non-enzymatic methods sometimes give false-positive results.
The presence of clavulanic acid in Amoxiclav may cause nonspecific binding of IgG and albumin to red blood cell membranes, which may lead to false positive Coombs test results.
There have been cases of positive enzyme immunoassay (ELISA) results for Aspergillus in patients receiving the drug, in whom the absence of caused Aspergillus infections. Cross-reactions have been observed with non-Aspergillus polysaccharides and polyfuranoses in the ELISA test for Aspergillus. Positive test results in patients taking Amoxiclav should be interpreted with caution and confirmed by other diagnostic methods.

Use during pregnancy and lactation

Limited data on the use of the drug during pregnancy do not indicate an increased risk of congenital anomalies. In women with premature premature rupture of membranes, prophylactic treatment with amoxicillin/clavulanic acid was potentially associated with an increased risk of necrotizing enterocolitis in newborns. The use of the drug should be avoided during pregnancy unless the doctor considers treatment necessary.
Both active ingredients are excreted into breast milk (there are no data on the effect of clavulanic acid on breastfed children).
Breastfed babies may develop diarrhea and fungal infections
mucous membranes, which may require stopping breastfeeding. The possibility of sensitization should be considered. Therapy with the drug during breastfeeding is possible only after assessing the balance of benefits and risks by the attending physician.
Impact on the ability to drive vehicles and operate machinery
Undesirable effects may develop (for example, allergic reactions, dizziness, convulsions), potentially affecting the performance of these functions.

Drug interactions and other types of interactions:

Oral anticoagulants
Cases of increased international normalized ratio (INR) have been described in patients receiving maintenance therapy with acenocoumarol or warfarin during a prescribed course of amoxicillin. If co-administration of drugs is necessary, carefully monitor the prothrombin time or INR at the beginning and after discontinuation of treatment with amoxicillin. Dose adjustment of oral anticoagulants may be required.
Methotrexate
Penicillins may decrease the excretion of methotrexate, which may result in increased toxicity.
Probenecid
It is not recommended to use probenecid simultaneously, which reduces the secretion of amoxicillin by the renal tubules. The simultaneous use of probenecid with Amoxiclav can lead to an increase and longer maintenance of the level of amoxicillin (but not clavulanic acid) in the blood.
Mycophenolate mofetil
In patients taking mycophenolate mofetil, after starting oral amoxicillin and clavulanic acid, there was an approximately 50% decrease in the concentration of the active metabolite, mycophenolic acid (MPA), before taking the next dose of mycophenolate mofetil. Such a change in the concentration of MPA before taking the next dose may not indicate a change in the overall exposure of MPA. Therefore, in the absence of clinical signs of graft dysfunction, there is usually no need to change the dose of mycophenolate mofetil. However, careful medical supervision is necessary during such combination therapy and for some time after the end of antibiotic therapy.

Overdose

Gastrointestinal symptoms may develop, as well as water and electrolyte imbalance. Cases of amoxicillin-associated crystalluria, sometimes leading to renal failure, have been observed.
Patients with impaired renal function or those receiving high-dose therapy may develop seizures.
Amoxicillin precipitates in urinary catheters, mainly after intravenous administration of large doses. It is necessary to regularly monitor the patency of catheters.
For gastrointestinal symptoms, symptomatic treatment can be carried out, along with restoration of water and electrolyte balance.
Amoxicillin and potassium clavulanate can be eliminated from the body by hemodialysis.

Side effect

Storage conditions

Store in a dry place at a temperature not exceeding 25 °C. Keep out of the reach of children.
The red desiccant included in the bottle is inedible.

Best before date

2 years.
Do not use after the expiration date stated on the package.

Vacation conditions

Dispensed only with a doctor's prescription.

Manufacturer
Lek d.d.,
Verovskova 57, Ljubljana, Slovenia

– a drug that is prescribed for many infectious diseases, as well as for their prevention. This medicine is an antibiotic, and therefore requires caution in use - it must be taken strictly as prescribed by the doctor, observing the prescribed duration of the course of treatment.

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

Amoxicillin 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 - whooping cough, brucellosis, especially dangerous infections, but in practice this effect is quite weak. Amoxicillin is included in the reserve regimen for the eradication of Helicobacter (a bacterium that is the causative agent of gastritis and gastric ulcers).

One of the important advantages of amoxicillin is the low incidence of side effects.

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

However, it has a significant drawback. A number of bacteria (mostly) produce the enzyme penicillinase, which destroys the antibiotic. Amoxicillin, like other penicillin antibiotics, is susceptible to the action of this enzyme. In order to protect the antibiotic from the effects of the enzyme, clavulanic acid, or more precisely, the sodium compound clavulanate, is used. It neutralizes penicillinase, which reduces the risk of bacterial resistance and increases the effectiveness of the drug. Therefore, the appointment of Amoxiclav is preferable compared to unprotected penicillins - amoxicillin, penicillin, and others.

When is the drug prescribed?

The drug is prescribed for bacterial infections caused by microorganisms sensitive to it. To determine sensitivity, a bacteriological analysis and an antibiotic sensitivity test (antibioticogram) are performed.

In some cases, if the patient’s condition is serious or there is a high risk of complications, it is permissible to prescribe Amoxiclav until the test results are received. In this case, the material for research must be taken before the start of treatment.

Infections for which Amoxiclav is prescribed:

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

Amoxiclav can also be prescribed after surgical interventions to prevent infectious complications, as well as for injuries if they have been infected (contaminated with soil or other substances). For human and animal bites, this remedy is effective against infections in the oral cavity.

For nosocomial infections, Amoxiclav is most often ineffective, since hospital microorganisms are most often resistant to the most commonly used antibiotics, including various types of penicillins.

How to take it correctly?

The drug is available in several dosage forms, and each of them should be taken in accordance with the instructions. The tablets are taken orally, the dosage depends on the disease, the patient’s body weight, and the characteristics of the disease. For adults, the dosage is usually 250 mg every 8 hours or 500 mg every 12 hours. Adolescents over 12 years of age or weighing more than 40 kg take the medicine at the adult dosage. For severe infections, the dose may be increased.

For children under 12 years of age, a suspension made from powder is preferred. It is also taken orally, but the dosage of the active substance is lower, which reduces the risk of side effects, especially allergic reactions. Daily dosage 40 mg in 3 divided doses. The drug is intended for children under 12 years of age or weighing less than 40 kg.

Injectable forms of the drug are intended for the treatment of severe infectious diseases; the exact dosage is prescribed by the doctor, and it can vary significantly depending on the patient’s condition. They can also be prescribed if oral administration of the medicine is impossible (severe diseases of the stomach, intestines).

The duration of treatment ranges from 5 to 14 days.

It is impossible to shorten the course - this leads to the selection of resistant strains of bacteria. Even if the symptoms of the disease quickly disappear, the course of treatment must be completed. If after 14 days of use the disease is not cured, this indicates that the drug is ineffective and needs to be replaced with a more effective drug. As a rule, replacement occurs earlier.

To whom and when is it contraindicated?

The drug quite often causes hypersensitivity and allergic reactions, especially in young children whose immune system is not yet sufficiently developed to adequately respond to amoxicillin.

In addition to allergies to Amoxiclav itself, cross-hypersensitivity reactions to penicillin antibiotics, as well as cephalosporins and other beta-lactams, occur.

This is a fairly large and common group of antibiotics, an allergic reaction to one of the drugs in which may mean the presence of hypersensitivity to all related drugs. All such phenomena in the anamnesis are contraindications to the use of Amoxiclav.

Also, it should not be taken for various liver lesions - hepatitis, including drug-induced, bile stagnation. These phenomena may be associated with taking Amoxiclav and be temporary; in this case, it is necessary to stop taking the drug and replace the drug with an analogue that does not have a hepatotoxic effect.

The third group of contraindications are severe pathologies of the immune system, in particular infectious mononucleosis and various types of leukemia.

In these cases, taking antibiotics can further deteriorate the immune system and worsen the patient's condition.You should take the medicine with caution in case of renal failure and phenylketonuria in adults. Tablets are contraindicated for children under 12 years of age; injections are allowed only in severe cases when there is a danger to life.

Can it cause side effects?

Improper use of the drug may cause side effects

Dosage forms that are intended for oral administration can cause disruption of the digestive system - loss of appetite, abdominal pain, diarrhea, nausea, vomiting and any other manifestations of dyspepsia.

If they are so strong that they make it impossible to take the drug, you should discard Amoxiclav and replace it with other drugs or injectable forms.

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

Regardless of the dosage form, allergic reactions, a decrease in the number of leukocytes and a decrease in immunity as a consequence are possible. To combat this, it is advisable to combine the drug with measures to strengthen the immune system - taking vitamins, increasing the proportion of fruits in the diet.

Headache, dizziness, and convulsions are also possible, especially in patients with impaired renal function.

In children, the drug can cause increased excitability, nervousness, and moodiness. This is a temporary phenomenon that goes away fairly quickly. It does not pose a danger to the health and development of the baby.

Can it be taken during pregnancy and breastfeeding?

The active substances penetrate the placental barrier and into breast milk, so this drug is not advisable to take during pregnancy and breastfeeding. However, the presence of an untreated infection in the mother’s body is much more dangerous than the use of antibiotics. The question of whether you need to take the medicine is decided only by your doctor.

Amoxiclav
Buy Amoxiclav in pharmacies

DOSAGE FORMS
film-coated tablets 875mg/125mg
film-coated tablets 875mg+125mg

MANUFACTURERS
Lek d.d. (Slovenia)

GROUP
Combined antimicrobial agents

COMPOUND
Active ingredients: 875 mg of amoxicillin in the form of trihydrate and 125 mg of clavulanic acid in the form of potassium salt.

INTERNATIONAL NON-PROPENTED NAME
Amoxicillin+Clavulanic acid

SYNONYMS
Amoxiclav Quiktab, Arlet, Augmentin, Augmentin EU, Augmentin SR, Klamosar, Medoclav, Panclave, Ranklav, Rapiclav, Sinulox, Sinulox RTU, Flemoclav Solutab, Ecoclave

PHARMACHOLOGIC EFFECT
The drug is a combination of amoxicillin and clavulanic acid. Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthesis pathway of peptidoglycan, an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to a loss of cell wall strength, which usually causes lysis and death of microbial cells. Amoxicillin is destroyed by the action of beta-lactamases produced by resistant bacteria, so the spectrum of activity of amoxicillin alone does not include microorganisms that produce these enzymes. Clavulanic acid is a beta-lactam structurally related to penicillins. It inhibits some beta-lactamases, thereby preventing the inactivation of amoxicillin and broadens its spectrum of activity to include bacteria usually resistant to amoxicillin, as well as other penicillins and cephalosporins. Clavulanic acid itself does not have a clinically significant antibacterial effect. The drug has a bactericidal effect in vivo on the following microorganisms: Gram-positive aerobes. Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes. Gram-negative aerobes. Enterobacter spp, Escherichia coli, Haemophilus influenza, Klebsiella species, Moraxella catarrhalis (Branhamella catarrhalis). The drug has a bactericidal effect in vitro on the following microorganisms (however, the clinical dependence is still unknown). Gram-positive aerobes. BacilHs anthracis. Species of the genus Corynebacterium, Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Nocardia asteroids, Coagulase-negative staphylococci (including Staphylococcus epidermidis) Streptococcus agalaciiae. Other species of the genus Streptococcus Streptococcus viridians. Gram-positive anaerobes. Species of the genus Clostridium, Species of the genus Peptococcus, Species of the genus Peptostreptococcus. Gram-negative 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. Species of the genus Bacteroides (including Bacteroides fragilis), Species of the genus Fusobacterium. Other: Borrella burgdorferi, Chlamydia spp. , Leptospira icterohaemorrhagiae, Treponema pallidum. Some strains of these bacterial species produce beta-lactamases, which contributes to their insensitivity to amoxicillin monotherapy. Pharmacokinetics. The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar. Amoxicillin and clavulanic acid are highly soluble in aqueous solutions with a physiological pH value and, after taking the drug orally, they are quickly and completely absorbed from the gastrointestinal tract (GIT). Absorption of the active substances amoxicillin and clavulanic acid is optimal if taken at the beginning of a meal. The bioavailability of amoxicillin and clavulanic acid after oral administration is about 70%. Peak plasma concentrations are reached approximately 1 hour after administration. The maximum concentration values ​​for amoxicillin (depending on the dose) are 3-12 μg/ml, for clavulanic acid - about 2 μg/ml. When using the drug, plasma concentrations of amoxicillin/clavulanic acid are similar to those when taking corresponding doses of amoxicillin or clavulanic acid orally in equivalent doses. Both components are characterized by a good volume of distribution in various organs, tissues and fluids of the body (including the lungs, abdominal organs; adipose, bone and muscle tissues; pleural, synovial and peritoneal fluids; skin, bile, urine, purulent discharge, sputum, interstitial fluid). Plasma protein binding is moderate: 25% for clavulanic acid and 18% for amoxicillin. The volume of distribution is approximately 0.3-0.4 l/kg for amoxicillin and approximately 0.2 l/kg for clavulanic acid. Amoxicillin and clavulanic acid do not penetrate the blood-brain barrier when the meninges are not inflamed. Amoxicillin (like most penicillins) is excreted in breast milk. Trace amounts of clavulanic acid are also found in breast milk. Amoxicillin and clavulanic acid penetrate the placental barrier. Amoxicillin is eliminated primarily by the kidneys, while clavulanic acid is eliminated through both renal and extrarenal mechanisms. After a single oral dose of one tablet of 250 mg/125 mg or 500 mg/125 mg, approximately 60-70% of amoxicillin and 40-65% of clavulanic acid are excreted unchanged in the urine during the first 6 hours. About 10-25% of the initial dose of amoxicillin is excreted in the urine as inactive penicillic acid. Clavulanic acid in the human body undergoes intensive metabolism with the formation of 2,5-dihydro-4-(2-hydroxyethyl)-5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-butan-2-one and is excreted in urine and feces. The average half-life of amoxicillin/clavulanic acid is approximately one hour, and the average total clearance is approximately 25 L/h in healthy patients. Various studies have found that urinary excretion of amoxicillin within 24 hours is approximately 50-85%, and that of clavulanic acid is 27-60%. The largest amount of clavulanic acid is excreted during the first 2 hours after administration. Patients with impaired liver function. In patients with severe renal impairment, the half-life increases to 7.5 hours for amoxicillin and to 4.5 hours for clavulanic acid. For patients with impaired liver function, the dose of the drug should be selected with caution, and constant monitoring of the condition of the liver is necessary. Both components are removed by hemodialysis and minor amounts by peritoneal dialysis.

INDICATIONS FOR USE
Infections caused by sensitive strains of microorganisms: infections of the upper respiratory tract and ENT organs (including acute and chronic sinusitis, acute and chronic otitis media, retropharyngeal abscess, tonsillitis, pharyngitis); lower respiratory tract infections (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; infections of bone and connective tissue; biliary tract infections (cholecystitis, cholangitis); odontogenic infections.

CONTRAINDICATIONS
Hypersensitivity to the components of the drug; history of hypersensitivity to penicillins, cephalosporins and other beta-lactam antibiotics, cholestatic jaundice and/or other liver dysfunction caused by a history of taking amoxicillin/clavulanic acid; infectious mononucleosis and lymphocytic leukemia.

SIDE EFFECT
From the digestive system: loss of appetite, nausea, vomiting, diarrhea, abdominal pain, gastritis, stomatitis, glossitis, black “hairy” tongue, darkening of tooth enamel, hemorrhagic colitis (can also develop after therapy), enterocolitis, pseudomembranous colitis, disorder liver function, increased activity of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and/or plasma bilirubin levels, liver failure (more often in the elderly, men, with long-term therapy), cholestatic jaundice, hepatitis. Allergic reactions: itching, urticaria, erythematous rashes, erythema multiforme exudative, angioedema, anaphylactic shock, allergic vasculitis, exfoliative dermatitis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, a syndrome similar to serum sickness, toxic epidermal necrolysis. From the hematopoietic system and lymphatic system: reversible leukopenia (including neutropenia), platelets, hemolytic anemia, reversible increase in prothrombin over time (when used together with anticoagulants), reversible increase in bleeding time, eosinophilia, pancytopenia, thrombocytosis, agranulocytosis. Parts of the central nervous system: dizziness, headache, convulsions (may occur in patients with impaired renal function when taking high doses of the drug), hyperactivity. Feelings of anxiety, insomnia, behavioral changes, agitation. From the urinary system: interstitial nephritis, crystalluria, hematuria Other: candidiasis and other types of superinfection.

INTERACTION
Antacids, glucosamine, laxatives, aminoglycosides slow down absorption, ascorbic acid increases absorption. Diuretics, allopurinol, phenylbutazone; non-steroidal anti-inflammatory drugs and other drugs that block tubular secretion (probenecid) increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration). The simultaneous use of the drug and methotrexate increases the toxicity of methotrexate. Prescription together with allopurinol increases the incidence of exanthema. Concomitant use with disulfiram should be avoided. Reduces the effectiveness of drugs, during the metabolism of which para-aminobenzoic acid is formed, ethinyl estradiol - the risk of developing “breakthrough” bleeding. The literature describes rare cases of an increase in the international normalized ratio (INR) in patients with the combined use of acenocoumarol or warfarin and amoxicillin. If simultaneous use with anticoagulants and prothrobinated time or MHO is necessary, it must be carefully repeated when prescribing or discontinuing the drug. The combination with rifampicin is antagonistic (mutual weakening of the antibacterial effect). The drug should not be used simultaneously in combination with bacteriostatic antibiotics (macrolides, tetracyclines), sulfonamides due to a possible decrease in the effectiveness of the drug. The drug reduces the effectiveness of oral contraceptives.

METHOD OF APPLICATION AND DOSAGE
Inside. The dosage regimen is set individually depending on the age, body weight, kidney function of the patient, as well as the severity of the infection. It is recommended to take the drug at the beginning of a meal for optimal absorption and to reduce possible side effects from the digestive system. The course of treatment is 5 - 14 days. The duration of treatment is determined by the attending physician. The course should not last more than 14 days without repeated medical examination. Children under 12 years old. The dose is prescribed depending on age and body weight. Recommended dosage regimen: 40 mg/kg/day in 3 divided doses. Children weighing 40 kg or more should be prescribed the same doses as adults. For children under 6 years of age, taking a suspension of the drug is more preferable. Adults and children over 12 years of age (or more than 40 kg body weight). The usual dose in case of mild to moderate infection is 1 tablet every 12 hours, in case of severe infection and respiratory tract infections - 1 tablet every 8 hours. Since amoxicillin and clavulanic acid combination tablets of 250 mg + 125 mg and 500 mg-125 mg contain the same amount of clavulanic acid -125 mg, then 2 tablets of 250 mg + 125 mg are not equivalent to 1 tablet of 500 mg + 125 mg. Dosage for odontogenic infections: 1 tablet every 12 hours for 5 days. Patients with impaired renal function. Dose adjustments are based on the maximum recommended dose of amoxicillin and are based on creatinine clearance (CC) values. Adults and children over 12 years of age (or more than 40 kg body weight). QC > 30 ml/min: no dose adjustment required. For anuria, the interval between dosing should be increased to 48 hours or more. Tablets 875 mg + 125 mg should be used only in patients with CC > 30 ml/min. Patients with impaired liver function. The drug should be taken with caution. It is necessary to regularly monitor liver function.

OVERDOSE
There are no reports of death or life-threatening side effects due to drug overdose. In most cases, symptoms of overdose include gastrointestinal disorders (abdominal pain, diarrhea, vomiting). Anxiety, insomnia, dizziness, and, in isolated cases, seizures are also possible. In case of overdose, the patient should be under medical supervision, treatment is symptomatic. In case of recent use (less than 4 hours), it is necessary to perform gastric lavage and prescribe activated charcoal to reduce absorption. Amoxicillin/clavulanic acid is removed by hemodialysis.

SPECIAL INSTRUCTIONS
Carefully. History of pseudomembranous colitis, diseases of the gastrointestinal tract, liver failure, severe renal dysfunction, pregnancy, lactation, when used simultaneously with anticoagulants. Use during pregnancy and breastfeeding. During pregnancy and lactation, the drug is used only if the expected benefit to the mother outweighs the potential risk to the fetus and child. During a course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver, and kidneys. In patients with severely impaired renal function, adequate dose adjustment or increased intervals between doses is required. In order to reduce the risk of side effects from the gastrointestinal tract, the drug should be taken with meals. It is possible that superinfection may develop due to the growth of microflora that is insensitive to it, which requires a corresponding change in antibacterial therapy. In patients who are hypersensitive to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible. In women with premature rupture of membranes, it was found that prophylactic therapy with amoxicillin + clavulanic acid may be associated with an increased risk of developing necrotizing colitis in the newborn. Crystalluria very rarely occurs in patients with reduced diuresis. During the use of large doses of amoxicillin, it is recommended to take sufficient fluids and maintain adequate diuresis to reduce the likelihood of amoxicillin crystal formation. Laboratory tests: High concentrations of amoxicillin give a false-positive reaction to urine glucose when using Benedict's reagent or Fehling's solution. It is recommended to use enzymatic reactions with glucosidase. Special precautions when disposing of unused medicinal products. There is no need for special precautions when disposing of unused drug. Impact on the ability to drive vehicles and engage in other activities that require concentration and speed of psychomotor reactions. Due to the possibility of developing side effects from the central nervous system, such as dizziness, headache, convulsions, during treatment you should be careful when driving and engaging in other activities that require concentration and speed of psychomotor reactions.

STORAGE CONDITIONS
Store in a dry place, out of reach of children, at a temperature not exceeding 25 C.