Amoxiclav is bactericidal or bacteriostatic. Amoxiclav tablets for children: instructions for use

KNF (medicine included in the Kazakhstan National Formulary of Medicines)

ALO (Included in the List of free outpatient drug supply)

Manufacturer: Lek Pharmaceuticals d.d.

Anatomical-therapeutic-chemical classification: Amoxicillin in combination with beta-lactamase inhibitors

Registration number: No. RK-LS-5 No. 004916

Registration date: 13.12.2016 - 13.12.2021

Limit price: 67.58 KZT

Instructions

• Russian

Tradename

Amoxiclav

International nonproprietary name

Dosage form

Film-coated tablets, 375 mg and 625 mg

Compound

One tablet contains

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

Excipients: colloidal silicon dioxide, crospovidone, croscarmellose sodium, magnesium stearate, talc, microcrystalline cellulose,

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

Description

White or almost white film-coated tablets white, octagonal in shape with a biconvex surface, engraved with “250/125” on one side and “AMC” on the other side (for dosage 250 mg + 125 mg).

White or almost white, film-coated tablets, oval in shape with a biconvex surface (for a dosage of 500 mg + 125 mg).

Pharmacotherapeutic group

Antibacterial drugs for systemic use. Beta-lactam antibacterial drugs - Penicillins. Penicillins in combination with beta-lactamase inhibitors. Clavulanic acid + amoxicillin.

ATX code J01CR02

Pharmacological properties

Pharmacokinetics

Amoxicillin and clavulanic acid are completely soluble in aqueous solution at the pH environment of the body. Both components are well absorbed after oral administration. It is optimal to take amoxicillin/clavulanic acid during or at the beginning of a meal. After oral administration, the bioavailability of amoxicillin and clavulanic acid is approximately 70%. The dynamics of drug concentration in plasma of both components are similar. Maximum serum concentrations are achieved 1 hour after administration.

Serum concentrations of amoxicillin and clavulanic acid when taking the amoxicillin/clavulanic acid combination are similar to those observed when an equivalent dose of amoxicillin and clavulanic acid is taken orally separately.

About 25% of total number clavulanic acid and 18% amoxicillin bind to proteins in blood plasma. Volume of distribution at oral administration the drug is approximately 0.3-0.4 l/kg amoxicillin and 0.2 l/kg clavulanic acid.

After intravenous administration, both amoxicillin and clavulanic acid were found in the gallbladder, fiber abdominal cavity, skin, fat, muscle tissue, synovial and peritoneal fluid, bile and pus. Amoxicillin penetrates poorly into the cerebrospinal fluid.

Amoxicillin and clavulanic acid penetrate the placental barrier. Both components also pass into breast milk.

Amoxicillin is partially excreted in the urine as inactive penicillic acid in amounts equivalent to 10 - 25% of the original dose. Clavulanic acid is metabolized in the body and excreted in urine and feces, as well as carbon dioxide with exhaled air.

The average half-life of amoxicillin/clavulanic acid is approximately 1 hour, and the average total clearance is approximately 25 L/h. Approximately 60 - 70% of amoxicillin and 40 - 65% of clavulanic acid are excreted unchanged in the urine during the first 6 hours after taking a single dose of amoxicillin/clavulanic acid tablets. During various studies, it was found that 50-85% of amoxicillin and 27-60% of clavulanic acid are excreted in the urine within 24 hours. The largest amount of clavulanic acid is excreted during the first 2 hours after use.

Concomitant use of probenecid slows down the release of amoxicillin, but this drug does not affect the excretion of clavulanic acid through the kidneys.

The half-life of amoxicillin is similar in children aged 3 months to 2 years, as well as in older children and adults. When prescribing the drug to very young children (including premature newborns) in the first weeks of life, the drug should not be administered more than twice a day, which is associated with the immaturity of the renal excretion pathway in children. Due to the fact that elderly patients are more likely to suffer from renal dysfunction, the drug should be prescribed with caution to this group of patients, but if necessary, monitoring of renal function should be carried out.

The total plasma clearance of amoxicillin/clavulanic acid decreases in direct proportion to the decrease in renal function. The decrease in clearance of amoxicillin is more pronounced compared to clavulanic acid, since a larger amount of amoxicillin is excreted through the kidneys. Therefore, when prescribing the drug to patients with renal failure, dose adjustment is necessary to prevent excessive accumulation of amoxicillin and maintain the required level of clavulanic acid.

When prescribing the drug to patients with liver failure Care should be taken when choosing the dose and liver function should be regularly monitored.

Pharmacodynamics

Amoxicillin is a semisynthetic penicillin antibiotic (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin binding proteins) involved in the biosynthesis of peptidoglycan, which is an important structural component bacterial cell walls. Inhibition of peptidoglycan synthesis results in weakening of the cell wall, which is usually followed by cell lysis and death.

Amoxicillin is destroyed by beta-lactamases produced by resistant bacteria, and therefore 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 expanding its spectrum of activity. Clavulanic acid itself does not have a clinically significant antibacterial effect.

The time it takes to exceed the minimum inhibitory concentration (T > MIC) is considered the main determinant of the effectiveness of amoxicillin.

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

inactivation by bacterial beta-lactamases that are not inhibited by clavulanic acid, including classes B, C and D.

a change in penicillin binding proteins, which reduces the affinity of the antibacterial agent for the target pathogen.

Bacterial impermeability or efflux pump mechanisms (transport systems) can cause or maintain bacterial resistance, especially Gram-negative bacteria.

The MIC breakpoints for amoxicillin/clavulanic acid are those defined by the European Committee on Antimicrobial Susceptibility Testing (EUCAST).

	Limits of detection (µg/ml)
	Sensitive	Moderately resistant	Resistant
Haemophilus influenzae1
Moraxella catarrhalis1
Staphylococcus aureus2
Coagulase-negative staphylococci2
Enterococcus1
Streptococcus A, B, C, G5
Streptococcus pneumoniae3
Enterobacteriaceae5
Gram-negative anaerobes1
Gram-positive anaerobes1
Borderline value without specific connection1

sensitivity, the concentration of clavulanic acid is fixed at 2 mg/l.

3 The control point values ​​in the table are based on the control points

ampicillin.

4 A resistance breakpoint of R > 8 mg/l ensures that all strains with

by resistance mechanisms are reported as resistant.

5 The control point values ​​in the table are based on the control points

benzylpenicillin.

The prevalence of resistance may vary geographically and temporally for selected species, and local information on resistance is desirable, especially when treating severe infections.

Sensitive strains

Enterococcus faecalis Gardnerella vaginalis Staphylococcus aureus (methicillin sensitive) Streptococcus agalacticae Streptococcus pneumoniae Streptococcus pyogenes and other beta-hemolytic streptococci Group Streptococcus viridans Capnocyptophaga spp. Eikenella corrodens Haemophilus influenzae Moraxella catarrhalis Pasteurella multocida Anaerobic microorganisms Bacteroides fragilis Fusobacterium nucleatum Prevotella spp.

Strains for which acquired resistance may cause problems

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 media

exacerbation of chronic bronchitis

bronchopneumonia

• pyelonephritis

  infections of the skin and soft tissues (including cellulitis, animal bites, periodontal abscess, cellulitis maxillofacial area)

  infections of bones and joints (particularly osteomyelitis)

Directions for use and doses

Doses are calculated taking into account the content of amoxicillin/clavulanic acid. When choosing the dose of Amoxiclav® for the treatment of certain infections, the following should be taken into account:

pathogen sensitivity to antibiotics

severity and location of infection

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

It is also necessary to consider other ways of using the drug Amoxiclav®, for example, using higher doses of amoxicillin and/or prescribing amoxicillin and clavulanic acid in different ratios.

The tablets should be taken orally before meals to reduce possible gastrointestinal disturbances and increase the absorption of amoxicillin/clavulanic acid.

Adults and children weighing more than 40 kg

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

The duration of treatment depends on the patient's response. Some infections (such as osteomyelitis) require a longer period of treatment. The maximum duration of therapy should not exceed 14 days.

Maximum daily dose for a dosage of 375 mg is 750 mg amoxicillin/375 mg clavulanic acid, for a dosage of 625 mg is 1500 mg amoxicillin/375 mg clavulanic acid.

Children weighing less than 40 kg should be prescribed the drug in a different dosage form (suspension).

Elderly patients no dose adjustment is required.

For renal failure Dose adjustments are made based on the maximum recommended level of amoxicillin. Dose adjustment is not required when prescribing the drug to patients with creatinine clearance (CrCl) more than 0.5 ml/sec. (30 ml/min.).

Adults and children weighing more than 40 kg

For liver failure should be used with caution. Liver function should be checked regularly.

Side effects

When assessing the frequency of occurrence of different adverse reactions the following gradations were used: “very often” -  1/10, “often” - from  1/100 to  1/10, “infrequently” - from  1/1000 to  1/100, “rarely” - from  1/10000 to  1/1000, “very rare” -  1/10000, unknown (available data are insufficient to make an estimate).

Often:

Often:

candidiasis (skin and mucous membranes)

Infrequently:

dizziness, headache

indigestion

increased AST and/or ALT5 levels

skin rash 7, itching7, urticaria7

Rarely:

transient leukopenia (including neutropenia), thrombocytopenia

erythema multiforme7

Unknown:

growth of insensitive organisms

transient agranulocytosis, hemolytic anemia, increased bleeding time and prothrombin time1

angioedema10, anaphylaxis10, serum-like syndrome10, allergic vasculitis10

transient hyperactivity, seizures2

antibiotic-associated colitis4, black “villous” tongue, tooth discoloration11

hepatitis6, cholestatic jaundice6

Stevens-Johnson syndrome7, toxic epidermal necrolysis7, bullous exfoliative dermatitis 7, acute generalized exanthematous pustulosis (AGEP)9

interstitial nephritis

crystalluria8

1 see section Special instructions.

2 see section Special instructions.

3 Nausea is more common with higher oral doses. Can be reduced

gastrointestinal reactions while taking amoxicillin/clavulanic acid

the beginning of a meal.

4 Including pseudomembranous colitis and hemorrhagic colitis (see section Special

instructions).

5 Moderate increases in AST and/or ALT levels have been noted in patients

taking beta-lactam antibiotics, but the significance of these results is unknown.

6 These complications have been noted when using the drug in combination with other

penicillins and cephalosporins (see section Special instructions).

7 If any hypersensitivity skin reaction occurs, treatment should be

stop (see section Special instructions).

8 see section Special instructions.

9 see section Contraindications.

10 see section Special instructions.

11 Very rare cases of discoloration of the surface of teeth have been reported in

children. Practicing good oral hygiene will help prevent this. Cleaning

teeth removes the drug from oral cavity.

Contraindications

hypersensitivity to the active components of drugs from the group

penicillin or any auxiliary component of the drug

history of severe hypersensitivity reaction to other beta-

lactam drugs (for example, cephalosporins, carbapenems or

monobactam)

Cholestatic jaundice or other cases of liver failure

history (in connection with the use of amoxicillin/clavulanic acid)

children under 12 years of age (weight less than 40 kg)

Drug interactions

Oral anticoagulants

Oral anticoagulants and penicillin antibiotics are widely used in practice without reports of interaction. However, the literature has noted an increase in the international normalized ratio in patients taking acenocoumarol or warfarin together with amoxicillin. If concomitant use of drugs is necessary, the prothrombin time or international normalized ratio should be carefully monitored when amoxicillin is instituted and discontinued. Moreover, changes in the dosage of oral anticoagulants may be required.

Methotrexate

Penicillin-type drugs may reduce the elimination of methotrexate, causing a potential increase in toxicity.

Probenecid

Concomitant use of probenecid is not recommended. Probenecid reduces the renal tubular secretion of amoxicillin. Concomitant use with Amoxiclav® may increase blood levels of amoxicillin, but not clavulanic acid.

The simultaneous use of allopurinol and Amoxiclav® may increase the risk of allergic reactions. There are currently no data on the simultaneous use of allopurinol and Amoxiclav®.

In patients taking mycophenolate mofetil, joint use with the drug Amoxiclav ® the concentration of the active metabolite of mycophenolic acid when prescribing the initial dose is reduced by approximately 50%. The change in the initial dose concentration level may not correspond to the change in the total concentration of mycophenolic acid.

special instructions

Before initiating amoxicillin/clavulanic acid therapy, it is necessary to carefully evaluate the patient for hypersensitivity reactions to penicillins, cephalosporins, or other beta-lactam substances.

Serious and sometimes fatal (anaphylactic) hypersensitivity reactions have been reported in patients treated with penicillin. These reactions are more common in people with a penicillin hypersensitivity reaction and a history of atopy. During development allergic reaction for amoxicillin/clavulanic acid, discontinue therapy with this drug and switch to another alternative treatment.

If the infection is resistant to amoxicillin, the use of amoxicillin/clavulanic acid instead of amoxicillin should be considered.

At high risk If the pathogen is resistant to beta-lactam antibiotics, Amoxiclav should not be used. It is not recommended to use the drug for the treatment of penicillin-resistant S. pneumoniae.

Patients with impaired renal function and taking a high dose of the drug may develop seizures.

Amoxicillin/clavulanic acid should not be prescribed for infectious mononucleosis, as a morbilliform rash may occur (to amoxicillin).

Concomitant use of allopurinol during treatment with amoxicillin may increase the likelihood of developing allergic skin reactions. There are currently no data on the simultaneous use of allopurinol and Amoxiclav®.

Long-term use of the drug may cause excessive growth of insensitive microorganisms.

The appearance at the beginning of treatment of generalized erythema with pustular rashes and fever may be a symptom of the development of acute generalized exanthematous pustulosis. If this reaction develops, you must stop using the drug Amoxiclav® and no longer use amoxicillin in the future.

The drug should be prescribed with caution to patients with liver failure.

Cases of liver dysfunction were reported mainly in men and elderly patients, and were quite rare in children who took the drug for a long period of time. Signs and symptoms usually develop during or immediately after starting treatment, but in some cases may not appear until several weeks after stopping therapy. These symptoms are usually reversible. Complications from the liver can be severe and, in extremely rare cases, be fatal. They almost always develop in patients with severe concomitant diseases or in patients taking other drugs that affect the liver.

The development of antibiotic-associated colitis is typical for any antibacterial drugs, including amoxicillin, and can vary in severity from moderate to life-threatening. Therefore, it is important to consider this diagnosis when prescribing the drug to patients suffering from diarrhea during or after the use of any antibiotics. If antibiotic-associated colitis occurs, you should immediately stop using Amoxiclav®. After consulting a doctor, appropriate therapy should be prescribed. Drugs that reduce peristalsis are contraindicated in this situation. During long-term therapy, it is recommended to regularly evaluate the function of organ systems, including kidney, liver and hematopoietic function. Dosage adjustment of oral anticoagulants is necessary to maintain the desired level of blood coagulation.

In patients with impaired renal function, dose adjustment is required depending on the severity of the impairment.

In patients with reduced diuresis, crystalluria was very rarely observed, mainly during parenteral therapy. During treatment, the patient is advised to drink plenty of fluids to avoid the possible development of crystalluria. According to the data obtained, amoxicillin settles in catheters Bladder(mainly with intravenous administration of large doses), in this case it is necessary to regularly monitor the patency of the catheter.

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

The presence of clavulanic acid in the drug may lead to nonspecific binding of immunoglobulin G and albumin to red blood cell membranes and false-positive Coombs test results. Positive results from the Bio-Rad Laboratories Platelia Aspergillus EIA assay have been reported in patients taking amoxicillin/clavulanic acid, which subsequently found to be free of Aspergillus infection, but no evidence of cross-reactions with non-Aspergillus polysaccharides and polyfuranoses. Therefore, positive test results in patients taking amoxicillin/clavulanic acid should be interpreted with caution and confirmed by other diagnostic methods. Pregnancy

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/fetal development, birth or postnatal development.

Currently exists limited quantity data on the use of amoxicillin/clavulanic acid during pregnancy in humans, which did not show an increased risk birth defects development. IN clinical trial In women with premature rupture of membranes, a causal relationship has been reported between prophylactic treatment with amoxicillin/clavulanic acid and increased risk necrotizing enterocolitis in a newborn. It is not recommended to use the drug during pregnancy; use is only possible if emergency as prescribed by a doctor.

Lactation

Both active substances are excreted into breast milk (there is no data on the effect of clavulanic acid on breast-feeding). Therefore, symptoms such as diarrhea and fungal infections mucous membranes, in these cases breastfeeding should be stopped. Amoxicillin/clavulanic acid should be used during breastfeeding only after a benefit/risk assessment by your doctor.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

No studies have been conducted to identify effects affecting the ability to drive a car or use machinery. However, Amoxiclav can cause undesirable reactions such as allergic reactions, convulsions, which can affect the ability to drive a car and operate moving machinery.

Overdose

Symptoms: possible gastrointestinal symptoms and disturbances of water and electrolyte balance. Amoxicillin crystalluria in some cases leads to renal failure. In patients with impaired renal function or in patients taking high doses of the drug, seizures are possible.

Treatment: symptomatic treatment taking into account water/electrolyte balance. Amoxicillin/clavulanic acid can be removed from the body using hemodialysis.

Release form and packaging

15 tablets in a brown glass bottle with a screw-on aluminum cap with tamper evident.

1 bottle each along with instructions for medical use in the state and Russian languages ​​are placed in a pack of cardboard.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of the reach of children!

Shelf life

Do not use after the expiration date stated on the packaging.

Conditions for dispensing from pharmacies

On prescription

Manufacturer/Packer

Address: Perzonali 47, SI - 2391 Prevalje, Slovenia

Registration Certificate Holder

Lek Pharmaceuticals d.d., Slovenia

Address: Verovskova, 57, 1526 Ljubljana, Slovenia

Address of the organization that accepts claims from consumers regarding the quality of products (products) on the territory of the Republic of Kazakhstan

Representative office of JSC Sandoz Pharmaceuticals d.d. in the Republic of Kazakhstan, Almaty, st. Luganskogo 96,

Phone number: +7 727 258 10 48, fax: +7 727 258 10 47

e-mail: [email protected]

Attached files

612641351477977188_ru.doc	133.5 kb
533015611477978343_kz.doc	152 kb

Active ingredients: amoxicillin and clavulanic acid.
Each tablet contains 875 mg amoxicillin trihydrate and 125 mg clavulanic acid potassium salt(ratio 7:1).
Excipients
Core: colloidal anhydrous silicon dioxide, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose; shell: hydroxypropyl cellulose, ethyl cellulose, polysorbate 80, triethyl citrate, talc, titanium dioxide E 171.

Description

White or almost white, oval, biconvex tablets with beveled edges, film-coated, scored and embossed “875/125” on one side, and “AMC” embossed on the other side.

pharmachologic effect

Amoxiclav®2X is a combination of amoxicillin, an antibiotic from the penicillin group, with wide range bactericidal activity, and clavulanic acid, an irreversible b-lactamase inhibitor that forms a stable inactive complex with this enzyme and thus protects amoxicillin from degradation.

Like other semisynthetic penicillins, amoxicillin inhibits cell wall synthesis. Type of action - bactericidal.

Amoxiclav® 2X has a wide spectrum of activity. It is active against amoxicillin-sensitive microorganisms, as well as the following resistant b-lactamase-producing bacteria:

Gram-positive aerobes: Streptococcus pneumoniae, S. pyogenes, S. viridans, S. bovis, Staphylococcus aureus (except methicillin-resistant strains), S. epidermidis (except methicillin-resistant strains), Listeria spp., Enteroccocus spp.

Gram-negative aerobes: Bordetella pertussis, Brucella spp., Campylobacter jejuni, E. coli, Gardnerella vaginalis, H. influenzae, H. ducreyi, Klebsiella spp., Moraxella catarrhalis, N.gonorrhoeae, N. meningitidis, Pasteurelamultocida, Proteus spp., Salmonella spp., Shigella spp., Vibrio cholerae, Yersenia enterocolitica.

Anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Actinimycesisraelli.

Pharmacokinetics

The basic pharmacokinetic properties of amoxicillin and clavulanic acid are similar. The combination of amoxicillin and clavulanic acid does not change the pharmacokinetics of the individual components.

Both components are well absorbed after oral administration; food has no effect on the degree of absorption. Maximum serum concentrations are achieved 1 hour after administration.

Approximately 17-20% of amoxicillin and 22-30% of clavulanic acid are bound to plasma proteins.

Amoxicillin and clavulanic acid easily penetrate into most tissues and fluids of the body (lungs, middle ear tissue, secretions of the lower sinuses, pleural and peritoneal fluids, uterus, ovaries), and into the brain and cerebrospinal fluid - only with inflammation of the meninges. High concentrations in body tissues are created 1 hour after maximum serum concentrations are reached. Both components easily pass through the placenta. In low concentrations, both components also pass into breast milk. Amoxicillin is excreted in the urine mainly unchanged, clavulanic acid undergoes active metabolism and is excreted mainly in the urine and partly in feces and exhaled air.

The half-life of amoxicillin and clavulanic acid is 1-1.5 hours. In patients with severe renal impairment, the elimination half-life increases to 7.5 hours for amoxicillin and to 4.5 hours for clavulanic acid.

Both components are removed by hemodialysis and minor amounts by peritoneal dialysis.

Indications for use

infections of the upper respiratory tract(spicy chronic sinusitis, acute and chronic otitis media, tonsilopharyngitis, paratonsillar abscess)

lower respiratory tract infections (acute and Chronical bronchitis, pneumonia)

urinary tract infections

salpingitis, salpingoophoritis, endometritis, septic abortion, pelvioperitonitis

bone and joint infections

skin and soft tissue infections (cellulitis, infected wounds)

biliary tract infections (cholangitis, cholecystitis)

sexually transmitted diseases (chancroid, gonorrhea)

odontogenic infections (periodontitis)

abdominal infections, postoperative complications in the abdominal cavity.

Contraindications

Hypersensitivity to amoxicillin, clavulanic acid or any of the components of the drug

History of allergic reactions to any beta-lactam antibiotics (such as penicillins and cephalosporins)

Severe liver dysfunction, and patients with a history of cholestatic jaundice or other liver dysfunction that occurred when using penicillin or amoxicillin/clavulanic acid.

Infectious mononucleosis

Lymphocytic leukemia

Pregnancy and lactation

Data indicate the absence of undesirable effects of amoxicillin/clavulanic acid on the course of pregnancy, as well as on the fetus and newborn child. However, in a study of pregnant women with premature rupture of the aqueous membrane, it was reported that

Prophylactic use of amoxicillin/clavulanic acid may be associated with an increased risk of necrotizing enterocolitis in neonates. As a precautionary measure, Amoxiclav® 2X should be used during pregnancy only if the doctor considers that the benefits of therapy outweigh the possible risks.

During breastfeeding, the combination of amoxicillin/clavulanic acid can be used. With the exception of the risk of sensitization associated with the release of trace amounts of the drug into breast milk, no other negative effects have been found on breast-fed infants.

Features of the effect of the drug on the ability to drive vehicles and potentially dangerous mechanisms

Amoxicillin/clavulanic acid has an extremely weak effect on the ability to drive a car and operate complex machinery.

In extremely rare cases, amoxicillin/clavulanic acid may cause adverse reactions such as confusion, dizziness and seizures, which may impair the ability to drive and complex mechanisms and/or work safely.

Directions for use and doses

Adults and children over 12 years of age (or over 40 kg body weight): Usual dose for mild to moderate severe course infections is one 625 mg tablet every 12 hours, in case of severe infections one 1000 mg tablet every 12 hours.

Children: Amoxiclav® 2X tablets are not prescribed to children under 12 years of age (or less than 40 kg of body weight).

The maximum daily dose of Amoxiclav® 2X is 4 tablets for adults.

The duration of treatment is determined by the severity of the infectious process and the activity of the pathogen.

The average duration of treatment is 5-10 days.

Dosage for odontogenic infections: 1 tablet 625 mg every 12 hours for 5 days.

Dosage for Renal Impairment: For patients with renal impairment moderate degree(creatinine clearance 10-30 ml/min) dose is 1 tablet of 625 mg every 12 hours;

for patients with severe renal failure (creatinine clearance less than 10 ml/min) the dose is 1 625 mg tablet every 24 hours.

For anuria, the interval between dosing should be increased to 48 hours or more.

Side effect

Candidiasis of the genitals, mucocutaneous candidiasis

Nausea, vomiting, diarrhea, itching in the anal area

Skin rash, itching, urticaria

Thrombocytosis, hemolytic anemia

Dizziness, headache and seizures

Abdominal pain, stomatitis, colitis, antibiotic-associated colitis (including pseudomembranous colitis and hemorrhagic colitis), superficial discoloration of teeth

Erythema multiforme

Some increase in AST and/or ALT

Very rarely

Leukopenia, granulocytopenia, neutropenia, eosinophilia, thrombocytopenia, pancytopenia, anemia, agranulocytosis, myelosuppression, increased bleeding time and prothrombin time

Black tongue ("hairy" tongue)

Interstitial nephritis, hematuria, crystalluria

Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis (AGEP), Lyell's syndrome

Angioedema, anaphylaxis, serum sickness syndrome, allergic vasculitis, drug fever

Hepatitis cholestatic jaundice

Hyperactivity, anxiety, drowsiness, confusion, aggression

Overdose

Symptoms: Most patients with overdose did not experience any symptoms. However, possible stomach pain, abdominal pain, vomiting, diarrhea, fluid and electrolyte imbalance, skin rash, hypersensitivity, drowsiness, convulsions, muscle fasciculations, decreased level of consciousness, coma, hemolytic reactions, renal failure, acidosis and crystalluria. In exceptional circumstances, shock may develop within 20-40 minutes.

Treatment: The patient should be monitored and, if necessary, appropriate symptomatic treatment should be provided. If the drug was taken relatively recently (4 hours or less), in the absence of contraindications, the patient's stomach should be emptied by inducing vomiting or lavage, and the patient should be given activated charcoal to reduce absorption. Amoxicillin/potassium clavulanate can be removed from the body by hemodialysis.

Interaction with other drugs

Amoxiclav®2X cannot be combined with some bacteriostatic chemotherapeutic/antibacterial drugs (such as chloramphenicol, macrolides, tetracyclines or sulfonamides), since laboratory conditions an antagonistic effect is observed.

Concomitant use of the drug with allopurinol may increase the risk of skin rash.

The combined use of Amoxiclav® 2X and methotrexate may increase the toxicity of methotrexate (leukopenia, thrombocytopenia, skin ulcers).

Probenecid reduces renal tubular secretion of amoxicillin. Its simultaneous use with Amoxiclav can lead to increased levels of amoxicillin in the blood, however, this is not observed with clavulanic acid. Like other broad-spectrum antibiotics, Amoxiclav®2X may reduce effectiveness oral contraceptives. In some cases, the drug may prolong prothrombin time; for this reason, caution should be exercised when using oral anticoagulants and Amoxiclav® 2X simultaneously.

Aminopenicillin may reduce plasma concentrations of sulfasalazine. It is also possible that the degree of absorption of digoxin will increase when used concomitantly with amoxicillin/clavulanic acid.

Amoxiclav®2X should not be used simultaneously with disulfiram.

Features of application

In order to reduce the risk of side effects from the gastrointestinal tract, the drug should be taken with meals.

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 severe allergic conditions or asthma, Amoxiclav® 2X should be used with caution, since they are likely to experience an allergic reaction to treatment with the drug. In patients who are hypersensitive to penicillins, cross-allergic reactions to cephalosporin antibiotics are possible.

In patients with impaired renal function, Amoxiclav®2X should be used with caution. The dose should be reduced or the intervals between doses increased depending on the severity of the disorder and the patient’s weight. In patients with creatinine clearance
Impaired renal function affects the pharmacokinetic properties of both amoxicillin and clavulanic acid.

In patients with liver disease, the drug should be used with caution, and organ function should be monitored with a certain frequency. Liver damage may occur even several weeks after stopping treatment.

The drug should not be used in patients with severe gastrointestinal disorders accompanied by vomiting and/or diarrhea, since adequate absorption cannot be guaranteed in this situation.

When using almost any antibacterial drug, pseudomembranous colitis can develop, and it can proceed as follows: mild form, and in a severe, life-threatening form. For this reason, it is very important not to forget about this diagnosis in patients who have severe persistent diarrhea that develops after the use of antibacterial drugs. If severe, prolonged diarrhea occurs, you should immediately inform your doctor. Drugs that inhibit peristalsis are contraindicated.

With long-term use of the drug - as well as other broad-spectrum antibiotics - superinfection may occur due to the growth of insensitive bacteria and fungi (Pseudomonas spp., Candida albicans), which may require discontinuation of treatment or appropriate changes or additions to antimicrobial therapy.

In patients with reduced diuresis, crystalluria was observed extremely rarely, mainly with parenteral administration of amoxicillin and clavulanic acid. When using high doses of amoxicillin, it is recommended to maintain adequate fluid intake and diuresis to reduce the likelihood of amoxicillin-induced crystalluria. When using high doses of amoxicillin, the drug may precipitate in urinary catheters; for this reason, catheters should be checked regularly.

In patients with infectious mononucleosis or lymphocytic leukemia, a morbilliform rash may occur when using the drug.

Children under 12 years of age and weighing less than 40 kg

The use of the dosage form - tablets - is not recommended. For such patients, a powder is provided for the preparation of an oral suspension, 457 mg/5 ml.

Impact on the results of diagnostic laboratory tests: Oral administration of Amoxiclav® 2X causes the appearance of amoxicillin in the urine. High concentrations of amoxicillin give a false-positive reaction to urine glucose when using Benedict's reagent or Felling's solution. It is recommended to use enzymatic reactions with glucose oxidase. The reaction to urobilinogen can be changed in a similar way. It is also possible that false positive results may occur in the Coombs reaction.

When ampicillin was administered to pregnant women, a transient decrease in the concentration of total conjugated estriol, estriol glucuronide, conjugated estrion and estradiol in plasma was observed. This effect can also be observed when using amoxicillin, and therefore Amoxiclav® 2X.

The child's body is very sensitive and is not always able to resist viruses and infections. Many parents have encountered the fact that young children get sick much more often than adults, especially when they begin to actively communicate with children, visiting kindergarten, school, sections and collective classes.

Sometimes treatment requires the use of antibacterial drugs, which mothers are wary of. However, these medications are effective means to combat pathological processes. These include the broad-spectrum drug Amoxiclav, which is suitable for both children and adults.

Amoxiclav: composition and indications for use

Amoxiclav – combination antibiotic, which can be taken to treat a variety of diseases, from bronchitis to kidney problems. The active ingredients of the drug are:

1. Amoxicillin trihydrate. Belongs to the group of penicillins.
2. Potassium salt of clavulanic acid. Provides increased biological activity active substance and reducing the rate at which bacteria become accustomed to it. This problem faces all antibacterial agents. After 1–2 therapeutic courses of taking one antibiotic, its effectiveness decreases, as the bacterial microflora of the body gets used to it.

The auxiliary components of Amoxiclav include:

Antibiotics are prescribed only if the cause of the disease is a harmful bacterium. Amoxiclav for children and adults is prescribed for infections of the upper and lower respiratory tract and ENT organs. To such inflammatory processes relate:

• tonsillitis (tonsillitis);
• sinusitis in acute or chronic form;
• acute otitis;
• pharyngitis;
• pyelonephritis;
• retropharyngeal abscess;
• sinusitis;
• bronchitis;
• pneumonia.

The use of an antibiotic is advisable in the following cases:

• diseases of a urogenital nature;
• inflammatory process in bone or connective tissues;
• infection biliary tract And genitourinary system(cystitis, urethritis) (more details in the article:);
• infection of the skin and soft tissues, which can be caused by insect or animal bites;
• inflammatory dental diseases.

Release forms: suspension and tablets

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The pharmacological industry offers the consumer two forms of antibacterial drug release. The first is tablets. It is more suitable for adults. The great advantage of this form is that the tablets are convenient to take anywhere, following the dosage regimen. They are available in dosages of 250 and 500 mg of amoxicillin and 125 mg of clavulanic acid. The blister contains 15 or 20 tablets.

The second form of release is powder from which a suspension is prepared. It is better for children to purchase Amoxiclav in this form, especially for those who do not yet know how to chew or swallow tablets.

The table below shows the dosages in which Amoxiclav powder is produced for children:

The powder and prepared suspension are white or yellowish-white in color. The product is available in 100 ml dark glass containers. The bottle contains 25 grams of powder. The package is equipped with a measuring spoon or pipette. How to prepare the suspension can be read in the attached instructions and watch the video for the article with step by step algorithm actions.

How to calculate the dosage of the drug?

To achieve fast positive result from taking an antibiotic and minimizing the likelihood of side effects, you need to correctly determine the dose of the drug and properly dilute and give the syrup or tablets to the child.

• baby's age;
• weight of a small patient;
• specific disease;
• severity of the disease.

For children from five months to ten years with moderate severity During the course of the infectious process, it is enough to dilute the powder with a dosage of 125 mg. If a sore throat, pneumonia or other pathology is severe, then a product containing an antibacterial agent is prescribed. active substance in an amount of 250 or 400 mg.

An important feature is that you cannot interrupt the reception. You need to drink the entire course, strictly observing the intervals between doses, even if there is a significant improvement. Symptoms may return, but the antibiotic will not have an effect due to the bacteria developing resistance to it.

In suspension - for children under twelve years of age

When using the powder form, the first step is to prepare the suspension. To do this, you need to fill the powder with water in the bottle up to the mark that is present on its glass surface. The water must be boiled and cooled. Afterwards, shake the mixture to mix it. The prepared suspension can be stored for no longer than a week in the refrigerator.

Using a measuring spoon or syringe, measure the required volume of syrup. You can find out exactly how much syrup to give to an infant under one year old or an older child from the instructions for use. It contains tables and clearly describes how to use them to calculate the required amount of the drug. When prescribing an antibiotic, the doctor must indicate the dose for a specific case, taking into account age and disease, and also say how many days the antibacterial drug should be taken.

If the child is not yet 3 months old, then daily dosage is 30 mg per 1 kilogram of body weight. The medication is taken every 12 hours. After 3 months, the dose is 20 mg per kilogram, but the drug is given every 8 hours. This is for mild or moderate disease. In severe cases, it increases to 40 mg/kg with the same time interval.

For convenience, below are the dosages of Amoxiclav suspension for different ages in teaspoons:

In tablets – for older children

The tablet form of the antibacterial drug Amoxiclav is intended for adults and children over 12–14 years of age. One tablet contains 375 mg of active ingredient. They are taken three times a day, one tablet.

The dose varies depending on the situation. For angina, children are given a tablet every 8 hours, for other diseases - every 12 hours. In severe cases, to achieve a faster effect, the attending physician may increase the single dose.

How to give the drug to children of different ages?

Regardless of the patient’s age, there are rules on how to take Amoxiclav correctly:

1. Take with meals. If you take the drug with food, this significantly reduces the risk of developing side effects from the gastrointestinal tract.
2. Preparation of the suspension before use.
3. Monitoring the baby's condition. It is important to carefully monitor all changes in the condition and behavior of the little patient, both positive and negative. If any negative symptoms occur, you should stop taking the drug and consult a specialist.
4. Don't interrupt the course. The effect is consolidated after completely completed therapy.
5. Keep an eye on the expiration date. It is 2 years. The finished suspension is stored in the refrigerator for no more than 7 days.
6. Following prescribed doses.
7. Control over the condition of the kidneys, liver and circulatory system.

For mild to moderate disease

The amount of the prescribed drug is largely determined not by the patient’s age, but by his body weight, because all children are different, and their weight at the same age can vary greatly. However, the severity of the disease plays an equally important role in the antibiotic prescription regimen.

Regarding easy and medium shape diseases, then the standard scheme is applicable here. A suspension of 125 or 250 ml is prescribed three times a day. You need to drink the antibacterial drug for 5–7 days. True, it is solely the doctor’s responsibility to decide this. You cannot independently exceed the duration, frequency or daily volume. This is dangerous and can lead to complications. If the selected treatment regimen does not produce an effect, then the antibiotic is not suitable for combating a specific infection.

For severe infection

For severe cases pathological process the scheme changes. For treatment, preference is given to suspensions containing an antibacterial component in a volume of 400 mg. They are also prescribed to drink three times a day. Therapy is carried out under the supervision of the attending physician. Any adjustments can be made only with his consent. For example, the daily volume increases by a third from the standard version. The course of treatment can last for two weeks. The patient’s condition plays an important role in this.

Contraindications to the use of antibiotics

Since Amoxiclav belongs to antibacterial drugs penicillin, it is not prescribed to a child who is allergic to penicillin. It should not be given to children who are hypersensitive to cephalosporins and beta-lactam antibiotics.

Other factors limiting the use of the drug include:

• individual intolerance to the components of the drug, both primary and auxiliary;
• liver failure and problems with liver function;
• cholestatic jaundice, which can be provoked by taking an antibacterial agent;
• lymphocytic leukemia;
• mononucleosis of infectious origin;
• renal failure;
• colitis;
• pathological processes affecting the gastrointestinal tract.

What are the possible side effects and complications?

Antibacterial drugs are an effective remedy that gives a quick effect. There is also a negative side - an impressive list of adverse reactions. Negative influence The antibiotic Amoxiclav often affects the functioning of the gastrointestinal tract and manifests itself as an allergy. In the first case, the child experiences:

Much less frequently, taking Amoxiclav is accompanied by abdominal pain, colitis, liver failure, hepatitis, and jaundice. As for an allergic reaction, it manifests itself as:

• skin rashes;
• erythema;
• swelling;

In addition to the above negative symptoms negative impact Other body systems may also be affected: hematopoietic, lymphatic, urinary and central nervous. The child appears:

• thrombocytopenia;
• leukopenia;
• anemia;
• eosinophilia;
• pancytopenia;
• crystalluria;
• interstitial nephritis;
• dizziness;
• headache;
• hyperactivity;
• sleep disorders;
• excessive anxiety;
• convulsions.

Amoxiclav is a modern antibacterial agent of the penicillin group with a wide spectrum of action. Contains the antibiotic amoxicillin and clavulanic acid, which enhances its effect. Today it is considered the most effective treatment for infectious diseases in patients of different age groups.

Is it possible to use Amoxiclav 250 mg tablets for children, what do their instructions for use say about this? Which dosage forms Are they intended for young patients? What are the indications and contraindications for the drug? Let's talk about this in detail on the Popular About Health website:

Dosage forms for children

Let us immediately note that Amoxiclav tablets according to the instructions are not intended for the treatment of children under 12 years of age. For young patients, the drug is available in the form of a suspension. The suspension packaging contains a bottle of powder, which is diluted with boiled water immediately before use. For ease of use, the bottle comes with a measuring pipette and a plastic spoon.

What does the drug help with??

This antibiotic is prescribed for a variety of infectious diseases of a bacterial nature.

In particular, it is used in the treatment of infections respiratory system, such as: bronchitis, infectious sore throats, etc.

The medicine is also used for infectious pathologies connective and bone tissue, dontogenic infections (complications of diseases of the oral cavity), treat infections from animal bites.

Prescribed to eliminate bladder infections, digestive tract, kidneys and skin (except allergic manifestations).

In combination with other drugs, Amoxiclav can be prescribed for the treatment of gonorrhea, listeriosis, and mucosal lesions. Included in therapy acute course gastritis and peptic ulcer.

Dosage for children and method of administration

For young patients, the dosage is calculated not only taking into account age, but also body weight.

Powder for suspension can be presented in dosages of 125 and 250 mg. As for the finished suspension of 250 mg, 5 ml of the drug contains 250 mg of antibiotic and 62.5 mg of clavulanic acid.
Use of tablets. Also, children over 12 years of age and weighing more than 40 kg are prescribed 1 tablet every 8 hours.

The dosage regimen for a 250 mg suspension for children during treatment is determined as follows:

Newborns and babies up to 3 months -30 mg/kg body weight. This volume is divided into 2 doses per day (the dosage is calculated per serving of amoxicillin). The required amount of powder is diluted with boiled water. Give it to the baby using a pipette attached to the bottle.

Children over 3 months - 20 mg/kg body weight. For severe infectious diseases, such as pneumonia, increase to 40 mg/kg.

Age Body weight (kg) Suspension 250 mg

3-12 months 5 - 10 1.25 ml
1-2 years 10 -12 2 ml
2-4 years 12 -15 2.5 ml
4 - 6 years 15 - 20 3 ml
6 -10 years 20 -30 4.5 ml
10 - 12 years 30 - 40 6.5 ml

The daily dosage used for children should not exceed more than 40 mg of antibiotic per 1 kg of body weight. Even if a severe course of the disease is being treated. The entire amount of medication prescribed to the child by the doctor is divided into 2-3 doses (before meals), at intervals of 8-12 hours.

It is imperative to remember that optimal mode dosage and duration of treatment should be determined by the attending physician, taking into account the severity of the infection, age, weight of the patient and other factors.

Preparation of the suspension

Before preparing the solution, shake the bottle of powder vigorously. Next, add 85 ml of water, but in two stages. Shake the contents well each time. When calculating the dosage, keep in mind that the measuring spoon and pipette attached to the drug are designed for 5 ml of the drug.

The prepared suspension can be kept in the refrigerator, but no more than a week. Before each use, shake the contents of the bottle thoroughly.

For a better understanding of the method of preparing the suspension and use of the drug, carefully read the package insert. Amoxiclav's instructions for use accurately describe all these points.

Contraindications

This drug should not be used in severe cases of diseases of the digestive tract, in severe stages of pathologies of the biliary organs, as well as in pronounced violations liver functions caused by taking amoxicillin and/or clavulanic acid.

It is better to choose a different drug if there is an individual intolerance to the components of Amoxiclav or there is increased sensitivity to penicillins, as well as cephalosporins and other beta-lactam antibiotics.

There are contraindications for use if there are infectious mononucleosis, or lymphocytic leukemia.

Amoxiclav suspension should be prescribed with caution to children with allergic diathesis, as well as those suffering from bronchial asthma, hay fever.

The simultaneous use of 250 mg of the drug with Metronidazole is contraindicated in patients with impaired hematopoietic functions and diseases nervous system, as well as for lymph leukemia.

When treating with this drug, it should be remembered that Amoxiclav, like any other antibiotics, suppresses intestinal microflora. Long-term use can provoke the development of dysbacteriosis, digestive disorders and painful sensations in the epigastric region. In addition, the drug interferes with the synthesis of vitamin K.

Therefore, in addition to the prescribed treatment, the doctor may prescribe vitamins and probiotics.

In conclusion, it should be noted that Amoxiclav, although it has a wide range of applications, is not safe to use on its own. This is especially true for children. It is necessary to have full confidence that the disease is caused precisely bacterial infection, and not another pathogen. It is known that the use of antibiotics for viral or fungal infections is, at best, useless, and at worst, can cause serious harm.

In addition, you need to remember that there are contraindications for this drug, just like other antibacterial agents, there are many more indications for use.
Such drugs can cause allergies and have other side effects. Therefore, children (as well as adults) should only be prescribed this medicine by a qualified doctor, after diagnosis and identification of the pathogen.

Detailed instructions for use are published on this page. Amoxiclava. The available dosage forms of the drug are listed (tablets 125 mg, 250 mg, 500 mg, 875 mg, 1000 mg, suspension), as well as its analogues. Provides information about side effects, which can be caused by the antibiotic Amoxiclav, about interactions with other medications. In addition to information about diseases for the treatment and prevention of which a drug is prescribed (tonsillitis, otitis, sinusitis and others infectious diseases), reception algorithms are described in detail, possible dosages for adults, for children, the possibility of use during pregnancy and breastfeeding is being clarified. The abstract for Amoxiclav is supplemented with reviews from patients and doctors.

Instructions for use and dosage

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. 250 + 125 mg every 8 hours or 1 tablet. 500 + 125 mg every 12 hours, in case of severe infection and respiratory tract infections - 1 table. 500 + 125 mg every 8 hours or 1 tablet. 875 + 125 mg every 12 hours. Tablets are not prescribed to children under 12 years of age (less than 40 kg body weight).

The maximum daily dose of clavulanic acid (in the form of potassium salt) is 600 mg for adults and 10 mg/kg body weight for children. The maximum daily dose of amoxicillin is 6 g for adults and 45 mg/kg body weight for children.

The course of treatment is 5-14 days. The duration of treatment is determined by the attending physician. Treatment should not continue for more than 14 days without repeated medical examination.

Dosage for odontogenic infections: 1 table. 250 +125 mg every 8 hours or 1 tablet. 500 + 125 mg every 12 hours for 5 days.

Release forms

Powder for the preparation of injection solution for intravenous administration (4) 500 mg, 1000 mg.

Powder for the preparation of a suspension for oral administration 125 mg, 250 mg, 400 mg (convenient pediatric form of the drug).

Film-coated tablets 250 mg, 500 mg, 875 mg.

Amoxiclav- is a combination of amoxicillin - a semi-synthetic penicillin with a wide spectrum of antibacterial activity and clavulanic acid - an irreversible inhibitor of beta-lactamases. Clavulanic acid forms a stable inactivated complex with these enzymes and ensures the resistance of amoxicillin to the effects of beta-lactamases produced by microorganisms.

Clavulanic acid, similar in structure to beta-lactam antibiotics, has weak intrinsic antibacterial activity.

Amoxiclav has a wide spectrum of antibacterial action.

Active against amoxicillin-sensitive strains, including strains producing beta-lactamases, incl. aerobic gram-positive bacteria, aerobic gram-negative bacteria, anaerobic gram-positive bacteria, gram-negative anaerobes.

Pharmacokinetics

The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar. Both components are well absorbed after taking the drug orally; food intake does not affect the degree of absorption. Both components are characterized by a good volume of distribution in body fluids and tissues (lungs, middle ear, pleural and peritoneal fluids, uterus, ovaries, etc.). Amoxicillin also penetrates into synovial fluid, liver, prostate gland, tonsils, muscle tissue, gallbladder, secret paranasal sinuses nose, saliva, bronchial secretions. Amoxicillin and clavulanic acid do not penetrate the BBB in non-inflamed meninges. Amoxicillin and clavulanic acid penetrate the placental barrier and are excreted in trace concentrations breast milk. Amoxicillin and clavulanic acid are characterized by low binding to plasma proteins. Amoxicillin is partially metabolized, clavulanic acid appears to be extensively metabolized. Amoxicillin is excreted by the kidneys almost unchanged through tubular secretion and glomerular filtration. Clavulanic acid is excreted by glomerular filtration, partly in the form of metabolites.

Indications

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 (incl. acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia);
• urinary tract infections;
• gynecological infections;
• skin and soft tissue infections, including animal and human bites;
• infections of bone and connective tissue;
• biliary tract infections (cholecystitis, cholangitis);
• odontogenic infections.

Contraindications

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

special instructions

During a course of treatment, the functions of the hematopoietic organs, liver and kidneys should be monitored.

In patients with severely impaired renal function, adequate adjustment of the dosage regimen or increased intervals between dosing is required.

In order to reduce the risk of developing adverse reactions from the gastrointestinal tract, the drug should be taken with meals.

Laboratory tests: High concentrations of amoxicillin give a false-positive reaction for urine glucose when using Benedict's reagent or Felling's solution. It is recommended to use enzymatic reactions with glucosidase.

The use of Amoxiclav with simultaneous consumption of alcohol in any form is prohibited, since the risk of liver disorders is seriously increased when taken simultaneously.

Impact on the ability to drive vehicles and operate machinery

Data about negative impact Amoxiclav in recommended doses does not affect the ability to drive a car or operate machinery.

Side effect

Side effects are in most cases mild and transient.

• loss of appetite;
• nausea, vomiting;
• diarrhea;
• stomach ache;
• itching, urticaria, erythematous rash;
• angioedema;
• anaphylactic shock;
• allergic vasculitis;
• exfoliative dermatitis;
• Stevens-Johnson syndrome;
• reversible leukopenia (including neutropenia);
• thrombocytopenia;
• hemolytic anemia;
• eosinophilia;
• dizziness, headache;
• convulsions (may occur in patients with impaired renal function when taking the drug in high doses);
• sense of anxiety;
• insomnia;
• interstitial nephritis;
• crystalluria;
• development of superinfection (including candidiasis).

Drug interactions

With simultaneous use of the drug Amoxiclav with antacids, glucosamine, laxatives, aminoglycosides, absorption slows down, with ascorbic acid- increases.

Diuretics, allopurinol, phenylbutazone, NSAIDs and others medicines, blocking tubular secretion, increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).

When used simultaneously, Amoxiclav increases the toxicity of methotrexate.

With the simultaneous use of Amoxiclav with allopurinol, the incidence of exanthema increases.

Concomitant use with disulfiram should be avoided.

In some cases, taking the drug may prolong the prothrombin time; therefore, caution should be exercised when prescribing anticoagulants and the drug Amoxiclav simultaneously.

The combination of amoxicillin with rifampicin is antagonistic (mutual weakening of the antibacterial effect is noted).

Amoxiclav should not be used simultaneously with bacteriostatic antibiotics (macrolides, tetracyclines), sulfonamides due to a possible decrease in the effectiveness of Amoxiclav.

Probenecid reduces the excretion of amoxicillin, increasing its serum concentration.

Antibiotics reduce the effectiveness of oral contraceptives.

Analogues of the antibiotic Amoxiclav

Structural analogues of the active substance:

• Amovycombe;
• Amoxiclav Quiktab;
• Arlet;
• Augmentin;
• Bactoclav;
• Verklav;
• Clamosar;
• Liklav;
• Honeyclave;
• Panclave;
• Ranklav;
• Rapiklav;
• Taromentin;
• Flemoklav Solutab;
• Ecoclave.

Use during pregnancy and breastfeeding

Amoxiclav can be prescribed during pregnancy if there are clear indications.

Amoxicillin and clavulanic acid are excreted in breast milk in small quantities.