Amoxiclav kviktab is an antibiotic for the treatment of mixed infections and inhibition of the synthesis of the bacterial wall.

It belongs to the penicillin group and is active against many strains of anaerobic and aerobic bacteria (Staphylococcus aureus, Enterobacter spp., Haemophilus influenzae, Escherichia coli, etc.), streptococci, staphylococci, I, II, III, IV and V types of beta-lactamase and other pathogenic microorganisms.

It is produced in the form of white or yellow tablets, powder, suspensions and injections of various dosages. A variety of forms allows you to select a drug taking into account the individual characteristics of the patient and the specifics of the diagnosis. In medical practice it is known as complex remedy high level antimicrobial intensity.

Clinical pharmacology

The antibiotic amoxiclav kviktab combines two powerful substances of semi-synthetic origin - amoxicillin and clavuanic acid. It is the latter that has a decisive antimicrobial effect on the body. It slows down some biomolecules, enhancing the effect of amoxicillin.

The spectrum of activity of the drug does not include only bacteria that produce enzymes of the beta-lactamase group. The price of amoxiclav kitab is formed depending on the dosage active substance, drug release forms and sales representative's markup.

Medicinal effect of the drug

According to the specificity of the action, amoxiclav kviktab is a universal combined agent. While its main component fights infection, clavulanic acid, as a reliable rear, protects amoxicillin from destruction. The medicine has many advantages, including:

• Rapid dissolution and absorption of the drug, which significantly improves the absorption of its properties;
• Ability to reach maximum blood concentration in a short period of time;
• Natural, complete and safe excretion of the drug through the kidneys.

Amoxiclav leaves unchanged within 6 hours with urine.

For patients with pathological disorders of the kidneys or liver, the drug is prescribed with caution and with constant monitoring of the patient's condition.

When is an antibiotic used?

The drug is indicated for:

1. Sharp bacterial infections ENT organs - sinusitis, otitis media, tonsillitis;
2. Inflammations of the upper and lower respiratory tract- bronchitis, pneumonia, pleural empyema;
3. Urological and gynecological diseases- cystitis, pyelonephritis, urethritis, salpingitis, vaginitis, septic abortion, gonorrhea, prostatitis, etc.;
4. Skin infections and bacterial lesions of soft tissues - inflammation of the subcutaneous tissue, bite marks, abscesses, etc.;
5. Lesions of bones and joints - osteomyelitis, etc.;
6. Postoperative infections;
7. Cholecystitis and cholangitis;
8. Infections abdominal cavity;
9. Severe odontogenic abscess with extensive cellulite;
10. Prevention infectious diseases in surgery.

What are the contraindications for use?

• Hypersensitivity to the components of the drug;
• Infectious mononucleosis;
• Phenylketonuria;
• Hepatic dysfunction or fixation of episodes of cholestatic jaundice;
• Susceptibility to cephalosporins, penicillins and other antibiotics of the beta-lactam group;
• Lymphaleukemia.

Amoxiclav kitab is also contraindicated in children under 12 years of age or if the patient has a body weight of less than 40 kg.

Dosage and method of administration

As indicated in the instructions for use, amoxiclav kviktab is prescribed individually, with the calculation of the dosage by age and body weight, as well as taking into account functional state the patient's kidneys and the degree of infection.

The standard regimen for adults and children over 12 years old weighing more than 40 kg with an uncomplicated diagnosis involves the use of the drug at 500-125 mg every 12 hours twice a day. For the treatment of severe pathologies, the medication regimen is increased up to 3 times or every 8 hours. The maximum daily allowance should not exceed 1500 mg of amoxicillin and 375 mg of clavulanic acid.

Amoxiclav is used with a sufficient amount of water before meals. It helps to protect the gastrointestinal tract and reduce the risk of developing side effects from the drug. The duration of therapy is 2 weeks (14 days). The minimum therapy period is 5 days.

If necessary and appropriate indications, the course of treatment can always be extended. Therapy of patients with kidney and liver pathologies occurs under close medical supervision with possible adjustment of the dosage of the drug.

Treatment in this case is symptomatic with the appointment of activated carbon for the purpose of absorption and gastric lavage. The patient is placed under constant medical supervision.

There are no examples of death or life-threatening side effects due to overdose in medical practice.

Possible side effects of the drug

• Nausea;
• Vomit;
• Diarrhea;
• Gastritis;
• Stomatitis;
• Increased activity of liver transaminases;
• Cholestatic jaundice, liver failure with long-term treatment (more often in elderly patients), jaundice;
• Hemorrhagic and pseudomembranous colitis, enterocolitis;
• Dark staining of the tongue and tooth enamel;
• Thrombocytopenia, leukopenia, eosinophilia, increased blood clotting time, hemolytic anemia and agranulocytosis;
• Headache and dizziness;
• Increased anxiety;
• Behavior change;
• Seizures;
• Hyperactivity;
• Allergy in the form of urticaria, erythematous rashes, anaphylactic shock, exfoliative dermatitis, angioedema, malignant erythema, vasculitis, acute pustulosis;
• Phlebitis, hematuria, nephritis, crystalluria;
• Candidamycosis;
• Development of superinfection.

Use during pregnancy

Despite the fact that laboratory studies have not confirmed the harmful effect of the drug on the development of the embryo, Amoxiclav is prescribed to pregnant women only with clear indications and in the case when the benefits of using the drug for the mother are higher than the potential danger to the child or fetus.

The agent in small quantities penetrates into breast milk, therefore, during this period, the use of Amoxiclav should be strictly justified. Otherwise, babies may experience sensitization, thrush oral cavity, diarrhea, necrotizing enterocolitis and other serious pathologies.

Compatibility with other medications

Amoxiclav Kviktab, when combined with some antibacterial, chemotherapeutic and bacteriostatic drugs, can enhance their antagonistic properties and toxicity, as well as increase the risk of bleeding.

Amoxiclav is not compatible with chloramphenicol, sulfonamides or tetracyclines, macrolides, methotrexate, allopurinol, mycophenolate mofetil, probenecid and oral coagulants.

As for the negative effect of the drug on the ability to control vehicle, then there are no direct contraindications to this.

However, taking into account the possible development of certain side effects from the central nervous system (dizziness, convulsions, myalgia), careful handling of mechanical means and the manifestation of increased attention during the implementation of certain activities associated with concentration and rapid psychomotor reactions are required.

Caveats

An antibiotic is used with special caution in case of a history of pseudomembranous colitis, diseases gastrointestinal tract, severe kidney pathologies, pregnancy and other diseases.

Storage conditions

The general shelf life of the drug is 3 years, after which the drug loses its pharmacological properties and become toxic to the body. Store Amoxiclav Kvitab at a temperature not exceeding 25 ° C, in a dry place away from the reach of children.

Release form

Tablets

Compound

1 tablet contains: Amoxicillin (in the form of trihydrate) 500 mg and clavulanic acid (in the form of potassium salt) 125 mg

Pharmacological effect

Antibiotic wide range actions; contains a semi-synthetic penicillin amoxicillin and an irreversible β-lactamase inhibitor clavulanic acid. Clavulanic acid forms a stable inactivated complex with these enzymes and ensures the resistance of amoxicillin to the action of β-lactamases produced by microorganisms. Clavulanic acid, similar in structure to beta-lactam antibiotics, has a weak intrinsic antibacterial activity. Amoxiclav is active against strains sensitive to amoxicillin, including strains producing β-lactamases, incl. aerobic gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Streptococcus bovis, Enterococcus spp., Staphylococcus aureus (except for methicillin-resistant strains), Staphylococcus Stphyry-epidermidis, aerobic gram-negative bacteria: Bordetella pertussis, Brucella spp., Campylobacter jejuni, Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae, Helicobacter pylori, Klebsiella spp., Moraxella catarrhalis, Neisseria gonorrhoeae, Neisseria meningitidis, Pasteurella multocida, Proteus spp., Salmonella spp., Shigella spp., Vibrio cholerae, Yersinia enterocolitica, Eikenella corrodens; gram-positive anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Actinomyces israelii, Fusobacterium spp., Prevotella spp., gram-negative anaerobes: Bacteroides spp.

Pharmacokinetics

Absorption After taking the drug inside, both components are well absorbed from the gastrointestinal tract, food intake does not affect the degree of absorption. The oral bioavailability of amoxicillin and clavulanic acid is 90% and 70%, respectively. Cmax in blood plasma is reached 1 hour after taking the drug and is (depending on the dose) for amoxicillin 3-12 μg / ml, for clavulanic acid - about 2 μg / ml. T1 / 2 of amoxicillin - 78 min, clavulanic acid - 60-70 min. Distribution Both components are characterized by a good volume of distribution in body fluids and tissues (secret paranasal sinuses nose, synovial fluid, palatine tonsils, middle ear, pleural fluid, saliva, bronchial secretions, lungs, uterus, ovaries, liver, prostate, muscle, gall bladder, peritoneal fluid). In urine, the drug is present in high concentrations. Amoxicillin and clavulanic acid do not penetrate the BBB with non-inflamed meninges. Active substances penetrate the placental barrier and are excreted in trace concentrations with breast milk... The degree of binding to blood plasma proteins is low. Metabolism Amoxicillin is partially metabolized, clavulanic acid undergoes intensive metabolism. Excretion Amoxicillin is excreted by the kidneys practically unchanged by tubular secretion and glomerular filtration. Clavulanic acid is excreted by glomerular filtration, partly in the form of metabolites. Small amounts can be excreted through the intestines and lungs. T1 / 2 of amoxicillin in adults is about 1 hour. T1 / 2 of clavulanate in adults is about 1 hour. Pharmacokinetics in special clinical cases. renal failure T1 / 2 increases to 7.5 hours for amoxicillin and 4.5 hours for clavulanic acid. Both components are removed by hemodialysis and minor amounts by peritoneal dialysis.

Indications

Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug: - infections of the upper respiratory tract and ENT organs (including acute and chronic sinusitis, acute and chronic otitis media, retropharyngeal abscess, tonsillitis, pharyngitis); - infections of the lower parts of the respiratory tract (incl. acute bronchitis with bacterial superinfection, Chronical bronchitis, pneumonia); - urinary tract infections; - gynecological infections; - infections of the skin and soft tissues, including human and animal bites; - bone and connective tissue infections; - biliary tract infections (cholecystitis, cholangitis); - odontogenic infections.

Contraindications

A history of indications of cholestatic jaundice and / or other liver dysfunctions caused by taking amoxicillin / clavulanic acid; - children under 12 years of age or weighing less than 40 kg; - hypersensitivity to drug components; - history of hypersensitivity to any antibiotic from the group of penicillins, cephalosporins and other beta-lactam antibiotics.

Precautionary measures

The drug should be used with caution in patients with a history of pseudomembranous colitis, liver failure, severe renal impairment, during lactation. infectious mononucleosis and lymphocytic leukemia, who received ampicillin, observed the appearance of an erythematous rash, the use of antibiotics of the ampicillin group for such patients is not recommended.

Application during pregnancy and lactation

Amoxiclav Kviktab can be used during pregnancy if there are clear indications. Amoxicillin and clavulanic acid are excreted in breast milk in small quantities.

Method of administration and dosage

Inside. The tablets must be dissolved in half a glass of water (at least 30 ml) and mixed thoroughly and drunk. It is possible to hold the tablets in the mouth until completely dissolved, and then swallow. In order to reduce the risk of side effects from the gastrointestinal tract, the drug should be taken at the beginning of a meal. Adults and children over 12 years of age (weighing more than 40 kg) with a mild or moderate course of infection are prescribed 1 tab. (625 mg) every 12 hours, in case severe course infections and infections of the respiratory tract - 1 tab. (625 mg) every 8 hours or 1 tab. (1000 mg) every 12 hours The duration of treatment is up to 14 days. In case of starting treatment with parenteral administration of the drug, it is possible to continue therapy with oral administration of Amoxiclav Kviktab tablets. In accordance with the severity functional disorders the kidneys should reduce the dose of the drug and / or increase the interval of use. With renal failure medium severity (CC 10-30 ml / min) appoint 1 tab. (625 mg) every 12 hours. In severe renal failure (CC less than 10 ml / min) - 1 tab. (625 mg) every 24 hours. With anuria, the interval between doses should be increased to 48 hours or more.

Side effects

Side effects in most cases are mild and transient. digestive system: loss of appetite, nausea, vomiting, diarrhea; rarely - an increase in the activity of liver enzymes (ALT, AST), an increase in the level of alkaline phosphatase, liver dysfunction; in isolated cases - cholestatic jaundice, hepatitis, pseudomembranous colitis. From the side of the central nervous system: dizziness, headache; very rarely - convulsions (can occur in patients with impaired renal function when taking the drug in high doses). From the hematopoietic system: rarely - reversible leukopenia (including neutropenia), thrombocytopenia; very rarely - hemolytic anemia, a reversible increase in prothrombin time (with joint application with anticoagulants) From the urinary system: very rarely - interstitial nephritis, crystalluria. Allergic reactions: erythematous rash, pruritus, urticaria; very rarely - exudative erythema multiforme, angioedema, anaphylactic shock, allergic vasculitis; in isolated cases - exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustularis. Other: rarely - the development of superinfection (including candidiasis).

Overdose

There are no reports of death or the occurrence of life-threatening side effects due to an overdose of the drug. Symptoms: disorders of the gastrointestinal tract - abdominal pain, diarrhea, vomiting; anxiety, insomnia, dizziness is also possible; in some cases - convulsive seizures. Treatment: symptomatic, in the case of a recent drug intake (less than 4 hours), it is necessary to wash the stomach and prescribe activated charcoal to reduce the absorption of the drug. The patient must be under medical supervision. Amoxicillin / potassium clavulanate is removed by hemodialysis.

Interaction with other drugs

With the simultaneous use of the drug Amoxiclav Kviktab with antacids, glucosamine, laxatives, aminoglycosides, absorption slows down, with ascorbic acid it increases. Diuretics, allopurinol, phenylbutazone, NSAIDs and others medicines, blocking tubular secretion, increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration). With the simultaneous use of Amoxiclav Kviktab increases the toxicity of methotrexate. With the simultaneous use of the drug Amoxiclav Kviktab with allopurinol, the frequency of exanthema development increases. In some cases, taking the drug can lengthen the prothrombin time, in this regard, care should be taken with the simultaneous administration of anticoagulants and the drug Amoxiclav Kviktab. The combination of amoxicillin with rifampicin is antagonistic (there is a mutual weakening of the antibacterial action). antibiotics (macrolides, tetracyclines), sulfonamides. Probenecid reduces the excretion of amoxicillin, increasing its serum concentration. Amoxiclav Kviktab reduces the effect the effectiveness of oral contraceptives.

special instructions

During the course of treatment, the functions of the hematopoietic organs, liver and kidneys should be monitored. Patients with severely impaired renal function require an adequate correction of the dosage regimen or an increase in the intervals between doses of the drug. In order to reduce the risk of development adverse reactions on the part of the gastrointestinal tract, the drug should be taken at the beginning of a meal.When using Amoxiclav Kviktab, a false positive reaction is possible when determining the level of glucose in urine when using Benedict's reagent or Felling's solution (it is recommended to use enzymatic reactions with glucosidase) .Effect on the ability to drive vehicles and control mechanisms There is no negative effect of the drug Amoxiclav Kviktab in recommended doses on the ability to drive vehicles and control mechanisms.

• active substances: amoxicillin trihydrate - 574 mg (equivalent to 500 mg of amoxicillin); potassium clavulanate - 148.87 mg (equivalent to 125 mg clavulanic acid);
• excipients: flavoring tropical mixture - 26 mg; sweet orange flavor - 26 mg; aspartame - 6.5 mg; colloidal anhydrous silicon dioxide - 13 mg; iron (III) oxide yellow (E172) - 3.5 mg; talc - 13 mg; Castor oil hydrogenated - 26 mg; MCC silicon-containing - up to 1300 mg.

Dispersible tablets - 1 tab .:

Dispersible tablets, 500 mg + 125 mg or 875 mg + 125 mg. 2 tables. in a blister. 5 or 7 blisters are placed in a cardboard box.

Description of the dosage form

Dispersible tablets: oblong, octagonal, light yellow interspersed with brown, with a fruity odor.

pharmachologic effect

Broad spectrum bactericidal, antibacterial.

Pharmacokinetics

The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar. Amoxicillin and clavulanic acid dissolve well in aqueous solutions with a physiological pH value and after taking the drug Amoxiclav ® inside is quickly and completely absorbed from the gastrointestinal tract. The absorption of active substances - amoxicillin and clavulanic acid - is optimal if the drug is 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 ingestion. The C max values ​​for amoxicillin (depending on the dose) are 3–12 μg / ml, for clavulanic acid - about 2 μg / ml.

C max in blood plasma after a bolus injection at a dose of 1.2 g (1000 + 200 mg) of the drug is 105.4 mg / l for amoxicillin and 28.5 mg / l for clavulanic acid.

When using the drug Amoxiclav ®, the plasma concentrations of amoxicillin / clavulanic acid are similar to those for oral administration of the corresponding doses of amoxicillin or clavulanic acid in equivalent doses.

Both components are characterized by sufficient V d in various organs, tissues and body fluids (including in the lungs, abdominal organs; adipose, bone and muscle tissues; pleural, synovial and peritoneal fluids; in the skin, bile, urine, purulent discharge, sputum, interstitial fluid).

Plasma protein binding is moderate - 25% for clavulanic acid and 18% for amoxicillin.

Vd 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 cross the blood-brain barrier in non-inflamed meninges.

Amoxicillin (like most penicillins) is excreted in breast milk. Trace amounts of clavulanic acid have also been found in breast milk. Amoxicillin and clavulanic acid cross the placental barrier.

Amoxicillin is excreted primarily by the kidneys, while clavulanic acid is eliminated by both renal and extrarenal mechanisms. After a single oral administration of one tablet of 250 + 125 mg or 500 + 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 T 1/2 of amoxicillin / clavulanic acid is approximately 1 hour, the average total clearance is approximately 25 l / h in healthy patients. In the course of various studies, it was found that the excretion of amoxicillin in the urine within 24 hours is approximately 50-85%, clavulanic acid - 27-60%. The greatest amount of clavulanic acid is excreted during the first 2 hours after ingestion.

Pharmacokinetic parameters of amoxicillin and clavulanic acid are summarized in Table 1.

Patients with impaired liver function

In patients with severe renal failure, T 1/2 increases to 7.5 hours for amoxicillin and up to 4.5 hours for clavulanic acid.

For patients with impaired liver function, the dose of the drug should be selected with caution: constant monitoring of the liver is necessary.

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

Pharmacodynamics

The drug Amoxiclav® is a combination of amoxicillin and clavulanic acid.

Amoxicillin is a semi-synthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthetic pathway of peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to a loss of cell wall strength, which usually leads to 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 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 the spectrum of its activity, including bacteria that are usually resistant to amoxicillin, as well as to other penicillins and cephalosporins. By itself, clavulanic acid has no clinically significant antibacterial effect.

The drug Amoxiclav® 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 influenzae *, species of the genus Klebsiella *, Moraxella catarrhalis * (Branhamella catarrhalis).

The drug Amoxiclav® has an in vitro bactericidal effect on the following microorganisms (however, the clinical significance is still unknown):

• gram-positive aerobes - Bacillis anthracis *, species of the genus Corynebacterium, Enterococcus faecalis *, Enterococcus faecium *, Listeria monocytogenes, Nocardia asteroides, coagulase-negative staphylococci * (including Staphylococcus Streptococcus epidermcidis, others)
• 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 meningitidis *, Pasteurella multocida, Proteus mirabilis *, Proteus mirabilis *, Proteus Vuligella *, species of the genus Salmonella vulgaris * cholerae, Yersinia enterocolitica *;
• gram-negative anaerobes - species of the genus Bacteroides * (including Bacteroides fragilis), species of the genus Fusobacterium *;
• others - Borrelia burgdorferi, Chlamydia spp., Leptospira icterohaemorrhagiae, Treponema pallidum.

* Some strains of these bacterial species produce beta-lactamases, which makes them insensitive to amoxicillin monotherapy.

** Most strains of these bacteria are resistant to the amoxicillin / clavulanic acid combination in vitro, but the clinical effectiveness of this combination has been demonstrated in the treatment of urinary tract infections caused by these strains.

Indications for use Amoxiclav kviktab

Infections caused by susceptible strains of microorganisms:

• upper respiratory tract and ENT organs (including acute and chronic sinusitis, acute and chronic otitis media, retropharyngeal abscess, tonsillitis, pharyngitis);
• lower respiratory tract (including acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia);
• urinary tract (eg cystitis, urethritis, pyelonephritis);
• in gynecology;
• skin and soft tissues, including human and animal bites;
• bone and connective tissue;
• biliary tract (cholecystitis, cholangitis);
• odontogenic.

Contraindications to the use of Amoxiclav kviktab

• hypersensitivity to the components of the drug;
• a history of hypersensitivity to penicillins, cephalosporins and other beta-lactam antibiotics;
• a history of cholestatic jaundice and / or other liver dysfunctions caused by taking amoxicillin / clavulanic acid;
• infectious mononucleosis and lymphocytic leukemia;
• children under 12 years of age or weighing less than 40 kg;
• phenylketonuria;
• renal failure (Cl creatinine

With care: a history of pseudomembranous colitis, gastrointestinal diseases, liver failure, severe renal dysfunction, pregnancy, lactation, simultaneous use with anticoagulants.

Amoxiclav kviktab Use during pregnancy and children

During pregnancy and lactation, Amoxiclav® is used only if the intended benefit to the mother outweighs the potential risk to the fetus and child.

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

Small amounts of amoxicillin and clavulanic acid pass into breast milk.

Amoxiclav kviktab Side effects

On the part of the hematopoietic and lymphatic system: rarely - reversible leukopenia (including neutropenia), thrombocytopenia; very rarely - eosinophilia, thrombocytosis, reversible agranulocytosis, increased bleeding time and reversible increase in PT, anemia, incl. reversible hemolytic anemia.

From the side immune system: frequency unknown - angioedema, anaphylactic reactions, allergic vasculitis, a syndrome similar to serum sickness.

From the side nervous system: infrequently - dizziness, headache; very rarely - insomnia, agitation, anxiety, behavior change, reversible hyperactivity, seizures; seizures can occur in patients with impaired renal function, as well as in those who receive high doses of the drug.

From the gastrointestinal tract: often - loss of appetite, nausea, vomiting, diarrhea. Nausea is more common with ingestion of high doses. If gastrointestinal disturbances are confirmed, they can be eliminated by taking the drug at the beginning of a meal; infrequently - indigestion; very rarely - antibiotic-associated colitis induced by taking antibiotics (including pseudomembranous and hemorrhagic colitis), black "hairy" tongue, gastritis, stomatitis. In children, a change in the color of the surface layer of the tooth enamel was very rarely observed. Oral care helps prevent discoloration of tooth enamel.

On the part of the skin: infrequently - skin rash, itching, urticaria; rarely - exudative erythema multiforme; frequency unknown - Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis.

From the urinary system: very rarely - crystalluria, interstitial nephritis, hematuria.

From the liver and biliary tract: infrequently - an increase in the activity of ALT and / or AST (this phenomenon is observed in patients receiving therapy with beta-lactam antibiotics, but its clinical significance is unknown); Adverse events from the liver were observed mainly in men and elderly patients and may be associated with long-term therapy. These adverse events are very rare in children.

The listed signs and symptoms usually occur during or immediately after the end of therapy, but in some cases they may not appear for several weeks after the end of therapy. Adverse events are usually reversible. Adverse events from the liver can be severe, in extremely rare cases there have been reports of deaths. In almost all cases, these were patients with serious comorbidities or patients receiving simultaneously potentially hepatotoxic drugs. Very rarely - increased ALP activity, increased bilirubin levels, hepatitis, cholestatic jaundice (observed with concomitant therapy with other penicillins and cephalosporins).

Other: often - candidiasis of the skin and mucous membranes; frequency unknown - growth of insensitive microorganisms.

Drug interactions

For all dosage forms

Antacids, glucosamine, laxative drugs, aminoglycosides slow down absorption, ascorbic acid increases absorption.

Diuretics, allopurinol, phenylbutazone, NSAIDs 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 Amoxiclav® and methotrexate increases the toxicity of methotrexate.

Prescribing in conjunction with allopurinol increases the incidence of exanthema. Simultaneous use with disulfiram should be avoided.

Reduces the effectiveness of drugs, in the process of metabolism of which PABA is formed; ethinyl estradiol - the risk of breakthrough bleeding.

The literature describes rare cases of increased INR in patients with the combined use of acenocoumarol or warfarin and amoxicillin. If necessary, simultaneous use with anticoagulants, PT or INR should be carefully monitored when prescribing or discontinuing the drug.

The combination with rifampicin is antagonistic (mutual weakening of the antibacterial effect). The drug Amoxiclav® should not be used simultaneously in combination with bacteriostatic antibiotics (macrolides, tetracyclines), sulfonamides due to a possible decrease in the effectiveness of the drug Amoxiclav®.

The drug Amoxiclav® reduces the effectiveness of oral contraceptives.

For dispersible tablets

Increases efficiency indirect anticoagulants(suppressing the intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index). In some cases, taking the drug can lengthen PV, in this regard, care should be taken with the simultaneous use of anticoagulants and the drug Amoxiclav Kviktab.

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

In patients receiving mycophenolate mofetil, after the start of the combination of amoxicillin with clavulanic acid, a decrease in the concentration of the active metabolite, mycophenolic acid, was observed before taking the next dose of the drug by approximately 50%. Changes in this concentration may not accurately reflect general changes in mycophenolic acid exposure.

Dosage of Amoxiclav quicktab

Inside. The dosage regimen is set individually depending on the age, body weight, renal function of the patient and the severity of the infection.

The tablets must be dissolved in half a glass of water (at least 30 ml) and mixed thoroughly, then drink or hold the tablets in the mouth until they are completely dissolved, and then swallow.

In order to reduce the risk of side effects from the gastrointestinal tract, the drug should be taken at the beginning of a meal.

Dispersible tablets of the drug Amoxiclav ® Kviktab 500 mg / 125 mg:

For the treatment of infections of mild to moderate severity - 1 table. (500 mg / 125 mg) every 12 hours (2 times a day).

For the treatment of severe infections and respiratory tract infections - 1 table. (500 mg / 125 mg) every 8 hours (3 times a day).

Maximum daily dose the drug Amoxiclav ® Kviktab is 1500 mg of amoxicillin / 375 mg of clavulanic acid.

Patients with impaired renal function. In patients with Cl creatinine above 30 ml / min, there is no need for dose adjustment.

Adults and children over 12 years of age weighing ≥40 kg (the indicated dosage regimen is used for moderate to severe infections):

Dispersible tablets of the drug Amoxiclav ® Kviktab 875 mg / 125 mg:

Adults and children over 12 years of age weighing ≥40 kg

At severe infections and respiratory infections - 1 table. (875 mg / 125 mg) every 12 hours (2 times a day).

The daily dose of the drug Amoxiclav ® Kviktab when used 2 times a day is 1750 mg of amoxicillin / 250 mg of clavulanic acid.

Patients with impaired renal function. In patients with Cl creatinine more than 30 ml / min, there is no need for dose adjustment.

For patients with Cl creatinine less than 30 ml / min, the use of dispersible tablets of the drug Amoxiclav ® Kviktab, 875 mg / 125 mg is contraindicated.

Such patients should take the drug at a dosage of 500 mg / 125 mg after a dose adjustment corresponding to the level of Cl-creatinine.

Patients with impaired liver function. Care should be taken when taking Amoxiclav Kviktab. It is necessary to carry out regular monitoring of liver function. In the case of starting treatment with parenteral administration of the drug, therapy can be continued by taking the tablets of the drug Amoxiclav ® Kviktab.

The duration of the course of treatment is determined by the attending physician!

Minimum rate antibacterial therapy is 5 days. Treatment should not continue for more than 14 days without reviewing the clinical situation.

Overdose

There are no reports of death or life-threatening side effects due to drug overdose.

Symptoms: in most cases - gastrointestinal disorders (abdominal pain, diarrhea, vomiting), possibly agitation, insomnia, dizziness, in rare cases - seizures.

Treatment: in case of an overdose, the patient should be under medical supervision, treatment is symptomatic.

In the case of a recent intake (less than 4 hours) of the drug, it is necessary to wash the stomach and prescribe activated charcoal to reduce absorption. Amoxicillin / potassium clavulanate is removed by hemodialysis.

Precautionary measures

For all dosage forms

During the 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, an adequate dose adjustment or an increase in the intervals between doses is required.

The development of superinfection is possible due to the growth of microflora insensitive to it, which requires a corresponding change in antibiotic therapy.

In patients with hypersensitivity to penicillins, crossover is possible. allergic reactions with cephalosporin antibiotics.

In women with premature rupture of the membranes, it was found that prophylactic therapy with amoxicillin + clavulanic acid may be associated with an increased risk of necrotizing colitis in newborns.

Crystalluria is very rare in patients with reduced urine output. During the use of large doses of amoxicillin, it is recommended to take a sufficient amount of fluid and maintain adequate diuresis to reduce the likelihood of amoxicillin crystals forming.

Laboratory tests. High concentrations 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.

For dispersible tablets additionally

Before starting treatment, it is necessary to interview the patient to identify a history of hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam antibiotics.

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

When using high doses of the drug Amoxiclav®Kviktab, patients with crystalluria need to adequately replenish the loss of fluid.

If antibiotic-associated colitis occurs, Amoxiclav® Kviktab should be discontinued immediately, consult a doctor and initiate appropriate treatment. Drugs that inhibit peristalsis are contraindicated in such situations.

Treatment must continue for 48-72 hours after disappearance clinical signs diseases. With the simultaneous use of estrogen-containing oral contraceptives and amoxicillin, other or additional methods contraception.

Amoxicillin and clavulanic acid can provoke nonspecific binding of immunoglobulins and albumin to the erythrocyte membrane, which can cause a false positive reaction in Coombs' test.

The use of amoxicillin and clavulanic acid is contraindicated in infectious mononucleosis, because can cause a measles rash.

Special precautions for disposal of unused medicinal product... There is no need for special precautions when destroying unused Amoxiclav®.

Impact on the ability to drive a car or perform work that requires an increased speed of physical and mental reactions. Due to the possibility of developing side effects from the central nervous system, such as dizziness, headache, convulsions, during treatment, care should be taken when driving and other activities that require concentration of attention and speed of psychomotor reactions.

For film-coated tablets, dispersible tablets, powder for preparation of suspension for oral administration additionally

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

Information for patients on a diet with reduced content Sodium: Each 600 mg vial (500 + 100 mg) contains 29.7 mg sodium. Each vial of 1.2 g (1000 + 200 mg) contains 59.3 mg of sodium. The amount of sodium in the maximum daily dose is greater than 200 mg.

Release form

Tablets

Compound

1 tablet contains: Amoxicillin (in the form of trihydrate) 875 mg and clavulanic acid (in the form of potassium salt) 125 mg

Pharmacological effect

Broad-spectrum antibiotic; contains a semi-synthetic penicillin amoxicillin and an irreversible β-lactamase inhibitor clavulanic acid. Clavulanic acid forms a stable inactivated complex with these enzymes and ensures the resistance of amoxicillin to the action of β-lactamases produced by microorganisms. Clavulanic acid, similar in structure to beta-lactam antibiotics, has a weak intrinsic antibacterial activity. Amoxiclav is active against strains sensitive to amoxicillin, including strains producing β-lactamases, incl. aerobic gram-positive bacteria: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Streptococcus bovis, Enterococcus spp., Staphylococcus aureus (except for methicillin-resistant strains), Staphylococcus Stphyry-epidermidis, aerobic gram-negative bacteria: Bordetella pertussis, Brucella spp., Campylobacter jejuni, Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae, Helicobacter pylori, Klebsiella spp., Nepp., Nepp. g. spp., Shigella spp., Vibrio cholerae, Yersinia enterocolitica, Eikenella corrodens; gram-positive anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Actinomyces israelii, Fusobacterium spp., Prevotella spp., gram-negative anaerobes: Bacteroides spp.

Pharmacokinetics

Absorption After taking the drug inside, both components are well absorbed from the gastrointestinal tract, food intake does not affect the degree of absorption. The oral bioavailability of amoxicillin and clavulanic acid is 90% and 70%, respectively. Cmax in blood plasma is reached 1 hour after taking the drug and is (depending on the dose) for amoxicillin 3-12 μg / ml, for clavulanic acid - about 2 μg / ml. T1 / 2 of amoxicillin - 78 min, clavulanic acid - 60-70 min. Distribution Both components are characterized by a good volume of distribution in body fluids and tissues (sinus secretions, synovial fluid, palatine tonsils, middle ear, pleural fluid, saliva, bronchial secretions, lungs, uterus, ovaries, liver, prostate gland, muscle tissue, gallbladder, peritoneal fluid). In urine, the drug is present in high concentrations. Amoxicillin and clavulanic acid do not penetrate the BBB with non-inflamed meninges. Active substances penetrate the placental barrier and are excreted in trace concentrations in breast milk. The degree of binding to blood plasma proteins is low. Metabolism Amoxicillin is partially metabolized, clavulanic acid undergoes intensive metabolism. Excretion Amoxicillin is excreted by the kidneys practically unchanged by tubular secretion and glomerular filtration. Clavulanic acid is excreted by glomerular filtration, partly in the form of metabolites. Small amounts can be excreted through the intestines and lungs. T1 / 2 of amoxicillin in adults is about 1 hour. T1 / 2 of clavulanate in adults is about 1 hour. Pharmacokinetics in special clinical cases In severe renal failure, T1 / 2 increases to 7.5 hours for amoxicillin and up to 4.5 hours for clavulanic acid. Both components are removed hemodialysis and small amounts of peritoneal dialysis.

Indications

Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug: - infections of the upper respiratory tract and ENT organs (including acute and chronic sinusitis, acute and chronic otitis media, retropharyngeal abscess, tonsillitis, pharyngitis); - infections of the lower parts of the respiratory tract (including acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia); - urinary tract infections; - gynecological infections; - infections of the skin and soft tissues, including human and animal bites; - infections of bone and connective tissue; - biliary tract infections (cholecystitis, cholangitis); - odontogenic infections.

Contraindications

A history of indications of cholestatic jaundice and / or other liver dysfunctions caused by taking amoxicillin / clavulanic acid; - children under 12 years of age or weighing less than 40 kg; - hypersensitivity to drug components; - history of hypersensitivity to any antibiotic from the group of penicillins, cephalosporins and other beta-lactam antibiotics.

Precautionary measures

The drug should be used with caution in patients with a history of pseudomembranous colitis, liver failure, severe renal impairment, during lactation. the use of antibiotics of the ampicillin group is not recommended for such patients.

Application during pregnancy and lactation

Amoxiclav Kviktab can be used during pregnancy if there are clear indications. Amoxicillin and clavulanic acid are excreted in breast milk in small quantities.

Method of administration and dosage

Inside. The tablets must be dissolved in half a glass of water (at least 30 ml) and mixed thoroughly and drunk. It is possible to hold the tablets in the mouth until completely dissolved, and then swallow. In order to reduce the risk of side effects from the gastrointestinal tract, the drug should be taken at the beginning of a meal. Adults and children over 12 years of age (weighing more than 40 kg) with a mild or moderate course of infection are prescribed 1 tab. (625 mg) every 12 hours, in case of severe infection and respiratory tract infections - 1 tab. (625 mg) every 8 hours or 1 tab. (1000 mg) every 12 hours Duration of treatment - up to 14 days. In case of starting treatment with parenteral administration of the drug, it is possible to continue therapy with oral administration of Amoxiclav Kviktab tablets. In accordance with the severity of functional renal impairment, the dose of the drug should be reduced and / or the interval of use should be increased. With renal failure of moderate severity (CC 10-30 ml / min), 1 tab is prescribed. (625 mg) every 12 hours. In severe renal failure (CC less than 10 ml / min) - 1 tab. (625 mg) every 24 hours. With anuria, the interval between doses should be increased to 48 hours or more.

Side effects

Side effects in most cases are mild and transient. From the digestive system: loss of appetite, nausea, vomiting, diarrhea; rarely - an increase in the activity of liver enzymes (ALT, AST), an increase in the level of alkaline phosphatase, liver dysfunction; in isolated cases - cholestatic jaundice, hepatitis, pseudomembranous colitis. From the side of the central nervous system: dizziness, headache; very rarely - convulsions (can occur in patients with impaired renal function when taking the drug in high doses). From the hematopoietic system: rarely - reversible leukopenia (including neutropenia), thrombocytopenia; very rarely - hemolytic anemia, a reversible increase in prothrombin time (when used together with anticoagulants). From the urinary system: very rarely - interstitial nephritis, crystalluria. Allergic reactions: erythematous rash, itching, urticaria; very rarely - exudative erythema multiforme, angioedema, anaphylactic shock, allergic vasculitis; in isolated cases - exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustularis. Other: rarely - the development of superinfection (including candidiasis).

Overdose

There are no reports of death or the occurrence of life-threatening side effects due to an overdose of the drug. Symptoms: disorders of the gastrointestinal tract - abdominal pain, diarrhea, vomiting; anxiety, insomnia, dizziness is also possible; in some cases - convulsive seizures. Treatment: symptomatic, in the case of a recent drug intake (less than 4 hours), it is necessary to wash the stomach and prescribe activated charcoal to reduce the absorption of the drug. The patient must be under medical supervision. Amoxicillin / potassium clavulanate is removed by hemodialysis.

Interaction with other drugs

With the simultaneous use of the drug Amoxiclav Kviktab with antacids, glucosamine, laxatives, aminoglycosides, absorption slows down, with ascorbic acid - increases.Diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion, With the simultaneous use of Amoxiclav Kviktab increases the toxicity of methotrexate. With the simultaneous use of Amoxiclav Kviktab with allopurinol, the incidence of exanthema increases. Simultaneous use of the drug Amoxiclav Kviktab with disulfiram should be avoided. In some cases, taking the drug may lengthen the prothrombin time, due to this care should be taken with the simultaneous administration of anticoagulants and the drug Amoxiclav Kviktab. The combination of amoxicillin with rifampicin is antagonistic (there is a mutual weakening of the antibacterial effect Amoxiclav Kviktab should be used several hours before taking bacteriostatic antibiotics (macrolides, tetracyclines), sulfonamides. Probenecid reduces the excretion of amoxicillin, increasing its serum concentration. Amoxiclav Kviktab reduces the effectiveness of oral contraceptives.

special instructions

During the course of treatment, the functions of the hematopoietic organs, liver and kidneys should be monitored. In patients with severely impaired renal function, an adequate adjustment of the dosage regimen or an increase in the intervals between doses of the drug is required. In order to reduce the risk of adverse reactions from the gastrointestinal tract, the drug should be taken at the beginning of a meal. When using Amoxiclav Kviktab, a false-positive reaction is possible when determining the level of glucose in urine when using Benedict's reagent or Felling's solution (it is recommended to use enzymatic reactions with glucosidase) .Effect on the ability to drive vehicles and control mechanisms Data on the negative effect of the drug Amoxiclav Kviktab in recommended doses on the ability to driving vehicles and operating machinery is not.