Amoxicillin + Clavulanic acid is a broad-spectrum antibiotic.

Release form and composition

Dosage forms Amoxicillin + Clavulanic acid:

• film-coated tablets: oval, biconvex, almost white or white, engraved “A” on one side, “63” (250 mg + 125 mg tablets) or “64” (500 mg + 125 mg tablets) on the other ), or engraving separated by a line – “6|5” (tablets 875 mg + 125 mg); a cross-section shows a light yellow core surrounded by a white or almost white shell (7 pieces in blisters, 2 blisters in a cardboard box);
• powder for the preparation of suspension for oral administration (strawberry): granulated, almost white or white (at a dosage of 125 mg + 31.25 mg/5 ml - 7.35 g each in translucent bottles of 150 ml, at a dosage of 250 mg + 62 .5 mg/5 ml – 14.7 g in translucent bottles of 150 ml; each bottle in a cardboard box);
• powder for preparing a solution for intravenous (IV) administration: from white to white with a yellowish tint (in 10 ml bottles, 1 or 10 bottles in a cardboard box; packaging for hospitals - from 1 to 50 bottles in a cardboard box) .

Composition of 1 tablet:

• active ingredients: amoxicillin (in the form of trihydrate) – 250 mg, or 500 mg, or 875 mg, clavulanic acid (in the form of potassium clavulanate) – 125 mg;
• auxiliary (inactive) components: sodium carboxymethyl starch, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, opadry white 06B58855 (titanium dioxide, macrogol, hypromellose-15cP, hypromellose-5cP).

Composition of 5 ml suspension (made from powder for preparing the suspension):

• active ingredients: amoxicillin (in the form of trihydrate) - 125 mg and clavulanic acid (in the form of potassium clavulanate) - 31.25 mg, or amoxicillin - 250 mg and clavulanic acid - 62.5 mg;
• auxiliary components: xanthan gum, silicon dioxide, hypromellose, aspartame, succinic acid, colloidal silicon dioxide, strawberry flavor.

Active ingredients in 1 bottle of powder for preparing a solution for intravenous administration: amoxicillin - 500 mg and clavulanic acid - 100 mg, or amoxicillin - 1000 mg and clavulanic acid - 200 mg.

Pharmacological properties

Pharmacodynamics

The effect of the drug Amoxicillin + Clavulanic acid is due to the properties of the active substances included in its composition.

Amoxicillin is a semi-synthetic antibiotic. It has a wide spectrum of action and is active against many gram-negative and gram-positive microorganisms. It has no effect on microorganisms producing beta-lactamase enzymes, since it is destroyed under their action.

Clavulanic acid is a beta-lactamase inhibitor, structurally related to penicillins. It has the ability to inactivate most beta-lactamases found in microorganisms resistant to cephalosporins and penicillins. Clavulanic acid is quite effective against plasmid beta-lactamases, which most often have resistance, but is not active against type 1 chromosomal beta-lactamases.

Clavulanic acid in the drug protects amoxicillin from the destructive effects of beta-lactamases and expands the spectrum of its activity, including against bacteria that are usually resistant to amoxicillin.

The following microorganisms are sensitive to the combination of amoxicillin + clavulanic acid:

• gram-positive aerobes: Streptococcus agalactiae 1, 2, Listeria monocytogenes, Bacillus anthracis, Nocardia asteroids, Enterococcus faecalis, Streptococcus pyogenes 1, 2, methicillin-sensitive Staphylococcus aureus, methicillin-sensitive coagulase-negative Staphylococcus spp., Staphylococcus saprophytic us, other beta-hemolytic streptococci Streptococcus spp. 12 ;
• gram-positive anaerobes: Clostridium spp., Peptostreptococcus magnus, Peptostreptococcus spp., Peptococcus niger, Peptostreptococcus micros;
• gram-negative aerobes: Neisseria gonorrhoeae, Haemophilus influenzael, Vibrio cholerae, Pasteurella multocida, Moraxella catarrhalisl (Branhamella catarrhalis), Helicobacter pylori, Bordetella pertussis;
• gram-negative anaerobes: Porphyromonas spp., Capnocytophaga spp., Prevotella spp., Eikenella corrodens, Bacteroides spp. (including Bacteroides fragilis), Fusobacterium spp., Fusobacterium nucleatum;
• others: Leptospira icterohaemorrhagiae, Treponema pallidum, Borrelia burgdorferi.

For the following microorganisms, acquired resistance to the drug Amoxicillin + Clavulanic acid is likely:

• gram-negative aerobes: Proteus spp. (including Proteus vulgaris and Proteus mirabilis), Escherichia coli 1, Salmonella spp., Klebsiella spp. (including Klebsiella pneumoniae 1 and Klebsiella oxytoca), Shigella spp.;
• gram-positive aerobes: Enterococcus faecium, Streptococcus pneumonia 1, 2, Corynebacterium spp., Streptococcus spp. groups

The following microorganisms are naturally resistant to the action of amoxicillin in combination with clavulanic acid:

• gram-negative aerobes: Stenotrophomonas maltophilia, Pseudomonas spp., Enterobacter spp., Yersinia enterocolitica, Legionella pneumophila, Hafnia alvei, Citrobacter freundii, Serratia spp., Providencia spp., Morganella morganii, Acinetobacter spp.;
• other: Mycoplasma spp., Chlamydia psittaci, Chlamydia spp., Coxiella burnetii, Chlamydia pneumoniae.

Notes:

1 For these bacteria, clinical studies have established the effectiveness of amoxicillin in combination with clavulanic acid.

2 Strains of these types of microorganisms do not produce beta-lactamases and are sensitive to amoxicillin, and therefore, presumably, to the combination of amoxicillin + clavulanic acid.

Pharmacokinetics

After taking the drug Amoxicillin + Clavulanic acid orally, the active substances are quickly and completely absorbed from the gastrointestinal tract. Maximum concentrations are reached after 1–2 hours. Optimal absorption was observed when taking the drug at the beginning of a meal.

When taken orally and intravenously, the active substances have a moderate degree of binding to plasma proteins: amoxicillin - 17-20%, clavulanic acid - 22-30%.

Both components are characterized by a good volume of distribution in body fluids and tissues. Found in the lungs, middle ear, pleural and peritoneal fluids, uterus, and ovaries. They penetrate into the secretions of the paranasal sinuses, palatine tonsils, synovial fluid, bronchial secretions, muscle tissue, prostate gland, gall bladder and liver. Amoxicillin can pass into breast milk, as do most penicillins. Trace amounts of clavulanic acid have also been found in breast milk.

Amoxicillin and clavulanic acid penetrate the placental barrier. They do not penetrate the blood-brain barrier provided that the meninges are not inflamed.

Both components are metabolized in the liver: amoxicillin - about 10% of the dose, clavulanic acid - about 50% of the dose.

Amoxicillin (50–78% of the dose) is excreted almost unchanged by the kidneys by glomerular filtration and tubular secretion. Clavulanic acid (25–40% of the dose) is excreted by glomerular filtration by the kidneys, partly in the form of metabolites and unchanged. Both components are eliminated within the first 6 hours. Small amounts may be excreted through the lungs and intestines.

In severe renal failure, the half-life increases: for amoxicillin - up to 7.5 hours, for clavulanic acid - up to 4.5 hours.

Both active substances of the antibiotic are removed by hemodialysis, and in small quantities by peritoneal dialysis.

Indications for use

According to the instructions, Amoxicillin + Clavulanic acid is used for the treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the combination of active ingredients:

• infections of the ENT organs and upper respiratory tract: acute and chronic sinusitis, recurrent tonsillitis, acute and chronic otitis media, pharyngitis and retropharyngeal abscess, usually caused by Streptococcus pyogenes, Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis;
• lower respiratory tract infections: exacerbation of chronic bronchitis, acute bronchitis with bacterial superinfection, bronchopneumonia, pneumonia usually caused by Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis;
• infections of bone and connective tissue and joints, including osteomyelitis, usually caused by Staphylococcus aureus;
• biliary tract infections: cholangitis, cholecystitis;
• genitourinary tract infections: pyelitis, pyelonephritis, urethritis, cystitis, chancroid, prostatitis, gonorrhea (caused by Neisseria gonorrhoeae), infections of the female genital organs, usually caused by species of the family Enterobacteriaceae (mainly Escherichia coli), species of the genus Enterococcus, Staphylococcus saprophyticus, such as bacterial vaginitis, salpingitis, endometritis, salpingoophoritis, cervicitis, tubo-ovarian abscess, septic abortion;
• skin and soft tissue infections: secondary infected dermatoses, cellulitis, erysipelas, abscess, impetigo and wound infections, usually caused by species of the genus Bacteroides, Streptococcus pyogenes, Staphylococcus aureus;
• meningitis, peritonitis, endocarditis, sepsis;
• odontogenic infections;
• other mixed infections, for example, intra-abdominal infections, post-abortion or postpartum sepsis (as part of stepwise therapy).

In surgery, antibiotics are used to prevent postoperative infections.

Contraindications

• infectious mononucleosis (including with the appearance of a measles-like rash);
• impaired liver function and cholestatic jaundice associated with the use of a combination of amoxicillin and clavulanic acid or penicillin in the anamnesis;
• children under 12 years of age (for tablets);
• phenylketonuria (for suspension);
• creatinine clearance less than 30 ml/min (for tablets 875 mg + 125 mg);
• hypersensitivity to the components of the drug, beta-lactam antibiotics, cephalosporins or penicillins.

Amoxicillin + Clavulanic acid should be used with caution in the following cases:

• severe liver failure;
• chronic renal failure;
• diseases of the gastrointestinal tract (including a history of colitis caused by the use of penicillins);
• pregnancy and lactation period.

Instructions for use Amoxicillin + Clavulanic acid: method and dosage

Film-coated tablets

In tablet form, the drug is indicated for oral use. For optimal absorption and to reduce the risk of side effects from the digestive system, it is recommended to take the tablets at the beginning of a meal.

If necessary, step-down therapy is carried out: first, the drug Amoxicillin + Clavulanic acid is administered intravenously, then switched to oral administration.

• mild to moderate infections: 250 mg + 125 mg every 8 hours or 500 mg + 125 mg every 12 hours;
• severe infections, respiratory infections: 500 mg + 125 mg 3 times a day or 875 mg + 125 mg 2 times a day.

The maximum daily dose of amoxicillin should not exceed 6000 mg, clavulanic acid - 600 mg.

The minimum duration of treatment is 5 days, the maximum is 14 days. 2 weeks after the start of the therapeutic course, the doctor assesses the clinical situation and, if necessary, decides to continue treatment. The duration of therapy for uncomplicated acute otitis media is 5–7 days.

It is important to consider that 2 tablets of 250 mg + 125 mg are not equivalent in clavulanic acid content to 1 tablet of 500 mg + 125 mg.

If renal function is impaired, the dose of amoxicillin is adjusted depending on creatinine clearance (CC):

• QC >
• CC 10–30 ml/min: 2 times a day, 1 tablet 250 mg (for mild and moderate infections) or 1 tablet 500 mg;
• QC< 10 мл/мин: 1 раз в сутки по 1 таблетке 250 мг (при легких и среднетяжелых инфекциях) или 1 таблетке 500 мг.

Tablets 875 mg + 125 mg can only be used in patients with CC > 30 ml/min.

Adults on hemodialysis are prescribed 1 tablet of 500 mg + 125 mg or 2 tablets of 250 mg + 125 mg 1 time per day. Additionally, one dose is prescribed during the dialysis session and another dose at the end of the session.

Powder for suspension for oral administration

Amoxicillin + Clavulanic acid suspension is usually prescribed to children under 12 years of age.

In this dosage form, the drug is intended for oral administration. A suspension is prepared from the powder: boiled and cooled to room temperature drinking water is poured into the bottle 2/3 full, shaken well, then the volume is adjusted to the mark (100 ml) and shaken vigorously again. The bottle must be shaken before each dose.

For precise dosing, the kit includes a measuring cap with marks of 2.5 ml, 5 ml and 10 ml. It must be washed with clean water after each use.

The doctor determines the dosage regimen individually depending on the severity of the infectious process, the patient’s age, body weight and kidney function.

For optimal absorption of active substances and reducing the risk of side effects from the digestive system, it is recommended to take the Amoxicillin + Clavulanic acid suspension at the beginning of meals.

The duration of treatment is at least 5 days, but not more than 14 days. 2 weeks after the start of the therapeutic course, the doctor assesses the clinical situation and, if necessary, decides to continue treatment.

For children from 3 months to 12 years or weighing up to 40 kg, the suspension is prescribed at a dose of 125 mg + 31.25 mg per 5 ml or 250 mg + 62.5 mg per 5 ml three times a day at intervals of 8 hours.

The minimum daily dose of amoxicillin is 20 mg/kg, the maximum is 40 mg/kg. In low doses, the drug is used for recurrent tonsillitis, infections of the skin and soft tissues. In high doses – for sinusitis, otitis media, infections of the lower respiratory tract, urinary tract, bones and joints.

If renal function is impaired, the dose of amoxicillin is adjusted depending on QC:

• CC > 30 ml/min: no correction required;
• CC 10–30 ml/min: 15 mg + 3.75 mg per kg body weight twice a day, but not more than 500 mg + 125 mg twice a day;
• QC< 10 мл/мин: по 15 мг + 3,75 мг на кг массы тела один раз в сутки, но не более чем 500 мг + 125 мг.

Children on hemodialysis are prescribed 15 mg + 3.75 mg per kg of body weight once a day. Additionally, one dose is prescribed before the hemodialysis session, the second - after the end of the session.

Powder for the preparation of solution for intravenous administration

A solution for intravenous injection/infusion is prepared from the powder.

To prepare a solution for intravenous injection, the contents of the bottle are dissolved in water for injection: at a dose of 500 mg + 100 mg (600 mg) - in 10 ml, at a dose of 1000 mg + 200 mg (1200 mg) - in 20 ml. Enter slowly (over 3-4 minutes).

For infusion administration, further dilution of the drug is required: the resulting solutions are diluted in 50 ml (500 mg + 100 mg) or 100 ml (1000 mg + 200 mg) infusion solution. Ringer's solutions, sodium chloride or potassium chloride can be used as a solvent. The duration of the infusion is 30–40 minutes.

The doctor determines the dosage regimen individually depending on the sensitivity of the pathogen, the severity and location of the infection, the patient’s age, body weight and kidney function.

Adults and adolescents over 12 years of age are prescribed 1200 mg 3 times a day (at intervals of 8 hours), for severe infections - 4 times a day (at intervals of 6 hours).

The maximum permissible daily dose is 6000 mg.

Children from 3 months to 12 years are prescribed 30 mg/kg (based on the entire drug) 3 times a day, in case of severe infection - 4 times a day.

Children under 3 months of age are prescribed 30 mg/kg (based on the entire drug): in the postperinatal period - 3 times a day, in premature and perinatal period - 2 times a day.

Duration of treatment is 5–14 days.

To prevent postoperative infections, the drug Amoxicillin + Clavulanic acid is prescribed in a dose of 1200 mg during induction of anesthesia for operations lasting less than 1 hour, 1200 mg every 6 hours during the day for longer operations. If there is a high risk of infection, the drug may be used for several days.

For patients with renal failure, the dose and/or interval between doses is adjusted depending on QC:

• CC 10–30 ml/min: initial dose – 1200 mg, then – 600 mg every 12 hours;
• QC< 10 мл/мин: начальная доза – 1200 мг, далее – по 600 мг 1 раз в сутки.

For children, doses and frequency of administration are reduced in the same way.

For patients undergoing hemodialysis, an additional dose is indicated at the end of each session.

For peritoneal dialysis, no dose adjustment is required.

Side effects

• from the central nervous system: infrequently – headache, dizziness; very rarely - agitation, insomnia, anxiety, confusion, behavioral changes, reversible hyperactivity and convulsions (convulsions are possible in patients receiving the drug in high doses and in patients with impaired renal function);
• from the gastrointestinal tract: very often – diarrhea; often – nausea and vomiting; infrequently – dyspepsia; very rarely - glossitis, black “hairy” tongue, stomatitis, enterocolitis, gastritis, antibiotic-associated pseudomembranous or hemorrhagic colitis;
• from the hematopoietic system: rarely - reversible thrombocytopenia, reversible leukopenia (including neutropenia); very rarely - eosinophilia, anemia, reversible hemolytic anemia, thrombocytosis, thrombocytopenic purpura, reversible agranulocytosis, increased prothrombin time and bleeding time;
• from the skin and subcutaneous tissues: infrequently – urticaria, itching, skin rash; rarely - erythema multiforme; very rarely - erythematous rashes, erythema, allergic vasculitis, a syndrome similar to serum sickness, bullous exfoliative dermatitis, anaphylactic reactions, anaphylactic shock, angioedema, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis;
• from the kidneys and urinary tract: very rarely - hematuria, crystalluria, interstitial nephritis;
• from the liver*: infrequently - moderate increase in the activity of alanine aminotransferase and/or aspartate aminotransferase; very rarely - increased concentrations of bilirubin and alkaline phosphatase, impaired liver function; with simultaneous use of other penicillins and cephalosporins - cholestatic jaundice, hepatitis;
• other: discoloration of teeth (yellow, gray or brown discoloration); often – candidiasis of the mucous membranes.

* Liver side effects are usually reversible and occur during or shortly after treatment. Occurs mainly in older people and men. May be associated with long-term use of the drug. Liver dysfunction can vary in severity, from mild to life-threatening (mainly in patients with severe pre-existing diseases and people treated with potentially hepatotoxic drugs).

Overdose

In most cases, overdose causes gastrointestinal disorders (diarrhea, abdominal pain, vomiting) and disturbances in water and electrolyte balance. Anxiety, dizziness, insomnia, and in isolated cases (in patients receiving the drug in high doses and patients with impaired renal function) – seizures are also possible. The development of amoxicillin crystalluria, in some cases leading to renal failure, has been described.

Treatment of overdose is symptomatic. Particular attention is paid to normalizing water and electrolyte balance. If necessary, hemodialysis is performed.

special instructions

Before initiating antibiotic therapy, the physician should obtain a detailed personal history from the patient regarding previous sensitivity reactions to penicillins, cephalosporins, or other allergens.

There have been reports of serious hypersensitivity reactions to penicillins, including death. The risk of such reactions is especially high in patients with a history of hypersensitivity reactions to penicillins. If allergic reactions develop, the drug Amoxicillin + Clavulanic acid is immediately discontinued and alternative therapy is prescribed. If serious anaphylactic reactions occur, immediate appropriate measures (administration of epinephrine) are necessary. Intravenous administration of glucocorticosteroids, oxygen therapy, and airway management (if necessary, intubation) may be required.

During therapy, it is necessary to remember about the possible development of superinfection (it is usually caused by Candida fungi and Pseudomonas bacteria). In this case, discontinue the drug and/or prescribe appropriate therapy.

If infectious mononucleosis is suspected, the use of Amoxicillin + Clavulanic acid is not recommended, since there is a high risk of measles-like skin rash, which makes diagnosing the disease difficult.

During long-term therapy, the growth of insensitive microorganisms is possible.

Amoxicillin + Clavulanic acid, like other antibacterial drugs, can cause mild to life-threatening pseudomembranous colitis. In this regard, in case of diarrhea that occurs during treatment or after its completion, it is necessary to assume the likelihood of pseudomembranous colitis. If diarrhea is severe or occurs for a long time, the drug is discontinued and the patient is examined. You should not take medications that inhibit intestinal motility.

In rare cases, patients with reduced diuresis may develop crystalluria, mainly during parenteral therapy. When administering amoxicillin in high doses, drinking plenty of fluids and maintaining adequate diuresis is recommended to reduce the risk of amoxicillin crystal formation.

Due to clavulanic acid in the composition, the antibiotic may cause a false-positive Coombs test result.

Amoxicillin + Clavulanic acid in oral dosage forms leads to high levels of amoxicillin in the urine, which distorts the results when determining glucose in the urine (for example, Fehling's test or Benedict's test). If this diagnostic test is necessary, the glucose oxidant method should be used.

When prescribing anticoagulants simultaneously, prothrombin time or INR (international normalized ratio) should be carefully monitored. If necessary, their dose should be adjusted.

Amoxicillin + Clavulanic acid in oral dosage forms may cause discoloration of the surface layer of tooth enamel. To prevent this, you should ensure adequate oral care (brushing your teeth regularly and thoroughly).

Impact on the ability to drive vehicles and complex mechanisms

The drug Amoxicillin + Clavulanic acid can cause side effects from the central nervous system, so caution should be used when performing any work that requires speed of reactions and/or attention.

Use during pregnancy and lactation

In studies of reproductive function in animals with oral and parenteral use of the combination of amoxicillin + clavulanic acid, no teratogenic effect was detected. A single study in women with premature rupture of membranes found that prophylactic use of amoxicillin in combination with clavulanic acid may increase the risk of developing necrotizing enterocolitis in newborns. During pregnancy, the drug is prescribed only if the expected benefits of therapy for the woman outweigh the potential risks to the fetus.

Amoxicillin + Clavulanic acid can be used during lactation. No adverse effects have been observed in breastfed children, except for the risk of hypersensitivity reactions, oral candidiasis or diarrhea, which is due to the penetration of trace amounts of the active substances of the drug into breast milk. If these reactions occur in a child, breastfeeding should be stopped during treatment.

Use in childhood

Amoxicillin + Clavulanic acid in tablet form is not used to treat children under 12 years of age.

For impaired renal function

In chronic renal failure, the drug should be used with caution.

For liver dysfunction

The drug Amoxicillin + Clavulanic acid is contraindicated in case of impaired liver function and cholestatic jaundice associated with the use of a combination of amoxicillin and clavulanic acid or penicillin in the anamnesis.

In severe liver failure, the drug should be used with caution. Treatment must be carried out under regular monitoring of liver function.

Drug interactions

Bacteriostatic agents (sulfonamides, macrolides, tetracyclines, lincosamides, chloramphenicol) have an antagonistic effect.

With the simultaneous use of bactericidal antibiotics (including cephalosporins, aminoglycosides, rifampicin, vancomycin, cycloserine), a synergistic effect is observed.

The drug Amoxicillin + Clavulanic acid enhances the effect of indirect anticoagulants (suppresses intestinal microflora, reduces the prothrombin index and vitamin K synthesis). If it is necessary to use such a combination, blood clotting indicators should be monitored.

Diuretics, non-steroidal anti-inflammatory drugs, phenylbutazone, allopurinol and drugs that block tubular secretion, when used simultaneously, increase the concentration of amoxicillin.

The drug Amoxicillin + Clavulanic acid increases the toxicity of methotrexate and reduces the effect of oral contraceptives. When combined with ethinyl estradiol or with drugs whose metabolism produces para-aminobenzoic acid, there is a risk of breakthrough bleeding.

Allopurinol increases the likelihood of developing skin allergic reactions.

The drug solution is pharmaceutically incompatible with solutions containing bicarbonate, glucose, dextran, lipids, proteins, and blood. Incompatible with aminoglycosides. The solution cannot be mixed with any other medications in the same syringe/infusion bottle.

The absorption of amoxicillin and clavulanic acid is increased by ascorbic acid, and reduced by laxatives, glucosamine, aminoglycosides, and antacids.

The suspension prepared from the powder can be stored for no more than 7 days in the refrigerator (at a temperature of + 6 ° C). Do not freeze.

Bacteria for which acquired resistance to the combination of amoxicillin and clavulanic acid is likely
Gram-negative aerobes: Escherichia coH1, Klebsiella oxytoca, Klebsiella pneumoniae, species of the genus Klebsiella, Proteus mirabilis, Proteus vulgaris, species of the genus Proteus, species of the genus Salmonella, species of the genus Shigella.
Gram-positive aerobes: species of the genus Corynebacterium, tnterococcus faecium, Streptococcus pneumoniae 1,2, group streptococci Viridans.

Bacteria that are naturally resistant to the combination of amoxicillin and clavulanic acid
Gram-negative aerobes: species of the genus Acinetobacter, Citrobacter freundii, species of the genus tnterobacter, Hafnia alvei, Legionella pneumophila, Morganella morganii, species of the genus Providencia, species of the genus Pseudomonas, species of the genus SerratiaStenotrophomonas maltophilia, Yersinia enterocolitica.
Others: Chlamydia pneumoniae, Chlamydia psittaci, species of the genus Chlamydia, Coxiella burnetii, species of the genus Mycoplasma.
1 For these bacteria, the clinical effectiveness of the combination of amoxicillin with clavulanic acid has been demonstrated in clinical studies.
2 strains of these bacterial species do not produce beta-lactamases. Sensitivity during amoxicillin monotherapy suggests similar sensitivity to the combination of amoxicillin and clavulanic acid.

Pharmacokinetics
Suction
Below are the results of a pharmacokinetic study of intravenous bolus administration of amoxicillin and clavulanic acid to healthy volunteers at a dosage of 500 mg + 100 mg (0.6 g) or 1000 mg + 200 mg (1.2 g) over 30 minutes.

Average value of pharmacokinetic parameters

• infections of the upper respiratory tract and ENT organs (acute and chronic sinusitis, acute and chronic otitis media, tonsillitis);
• lower respiratory tract infections (exacerbation of chronic bronchitis, lobar pneumonia and bronchopneumonia);
• urinary tract infections (cystitis, urethritis, pyelonephritis);
• infections in gynecology;
• skin and soft tissue infections, including human and animal bites;
• bone and joint infections (eg, osteomyelitis);
• abdominal infections, incl. biliary tract (cholecystitis, cholangitis);
• sexually transmitted infections (gonorrhea, chancroid);
• prevention of infections after surgery.

• hypersensitivity to amoxicillin and other penicillins, clavulanic acid, and other components of the drug;
• history of severe hypersensitivity reactions (for example, anaphylactic reactions) to other beta-lactam antibiotics (cephalosporin, carbapenem or monobactam);
• history of cholestatic jaundice and/or other liver dysfunction caused by the use of amoxicillin/clavulanic acid.

Use during pregnancy and breastfeeding
Pregnancy
In preclinical reproductive studies, parenteral administration of amoxicillin + clavulanic acid did not cause teratogenic effects. In a single study in women with premature rupture of membranes, it was found that prophylactic therapy with the drug may be associated with an increased risk of developing necrotizing entercolitis in newborns. Amoxiclav ® is not recommended for use during pregnancy, unless the expected benefit to the mother outweighs the potential risk to the fetus.
Breast-feeding
With the exception of the possibility of sensitization, diarrhea or candidiasis of the oral mucosa associated with the penetration of trace amounts of the active ingredients of this drug into breast milk, no other adverse reactions were observed in breastfed infants. However, during breastfeeding, Amoxiclav ® is used only if the expected benefit to the mother outweighs the potential risk to the fetus and child. If adverse reactions occur, breastfeeding should be discontinued.

Interaction with other drugs
Concomitant use with probenecid is not recommended. Probenecid reduces the tubular secretion of amoxicillin. Concomitant use of probenecid may lead to increased and prolonged blood concentrations of amoxicillin, but not clavulanic acid.
Diuretics, allopurinol, phenylbutazone, non-steroidal anti-inflammatory drugs (NSAIDs) and other drugs that block tubular secretion increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).
The simultaneous use of Amoxiclav ® and methotrexate increases the toxicity of methotrexate.
Bacteriological drugs ( macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) have an antagonistic effect. Reduces the effectiveness of drugs, during the metabolism of which para-aminobenzoic acid is formed, ethinyl estradiol - the risk of developing “breakthrough” bleeding. Increases the effectiveness of indirect anticoagulants (suppressing intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index). In some cases, taking the drug may prolong the prothrombin time; therefore, caution should be exercised when using anticoagulants and the drug Amoxiclav ® simultaneously.
Indirect anticoagulants and penicillin antibiotics are widely used in practice; no interactions were noted. However, the literature describes cases of an increase in the international normalized ratio (INR) in patients with simultaneous use of acenocoumarin or warfarin with amoxicillin. If simultaneous use with anticoagulants is necessary, prothrombin time or INR should be carefully monitored when prescribing or discontinuing the drug; dose adjustment of anticoagulants may be required.
In patients receiving mycophenolate mofetil, after starting 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 overall changes in mycophenolic acid exposure.
Concomitant use of allopurinol and amoxicillin may increase the risk of allergic skin reactions. Currently, there is no data in the literature on the simultaneous use of a combination of amoxicillin with clavulanic acid and allopurinol. When combined with rifampicin, a mutual weakening of the antibacterial effect is observed.
Concomitant use with disulfiram should be avoided.
The drug Amoxiclav ® and aminoglycoside antibiotics are physically and chemically incompatible. The simultaneous use of amoxicillin and digoxin may lead to an increase in the concentration of digoxin in the blood plasma.
The drug Amoxiclav ® reduces the effectiveness of oral contraceptives.
Pharmaceutical incompatibility
Amoxiclav ® should not be mixed with blood products, other protein-containing fluids such as protein hydrolases, or intravenous lipid emulsions. When used concomitantly with aminoglycosides, antibiotics should not be mixed in the same syringe or in the same vial for intravenous fluids, since under such conditions the aminoglycosides lose activity.
Avoid mixing with solutions of dextrose, dextran, sodium bicarbonate.

special instructions

Release form

Storage conditions

Best before date

2 years.
Do not use the drug after the expiration date indicated on the package!

Conditions for dispensing from pharmacies

Manufacturer

People often encounter bacterial infections that pose a danger to humans. When such diseases appear, it is necessary to immediately begin to eliminate them. Among the drugs that effectively fight bacterial pathologies is Amoxicillin. Before using such a combined product, you need to understand the instructions for use of Amoxicillin and clavulanic acid.

Every person who intends to use a drug for the treatment of infectious diseases in the future must determine what it is made of.

When creating a medicine, two active components are combined at once. The first substance is amoxicillin sodium, and the second is clavulanate potassium. It is worth noting that the medicine “Ecoclave Plus” is also made from these components.

The medicine is available in various forms, which are best familiarized with in advance. Pharmacies sell film-coated tablets, as well as powder for creating a suspension or injection solution.

Pharmacological properties

When familiarizing yourself with the features of Amoxicillin with clavulanic acid, you should understand their pharmacological properties. This will help understand the effect of the drug on the human body.

Pharmacodynamics

This combination product has a bactericidal effect, which eliminates pathogens. The drug is especially effective in the fight against gram-positive bacteria, which include lactamases and strains.

Pharmacokinetics

When using the medicine, its main components quickly penetrate the body. Thanks to this, the effect of taking it appears within an hour. The kidneys are responsible for removing the medication, completely cleansing the body in 4-5 hours.

Indications for use

Before using any medicine, you need to determine the scope of its application. Amoxicillin with acid is used to combat infectious diseases that appear due to the effects of bacteria on the body. Most often, the remedy is used to eliminate respiratory diseases, but there are other pathologies that can be cured. These include:

• damage to the respiratory tract and respiratory organs;
• skin infectious diseases;
• gynecological or urological pathologies;
• damage to bone tissue.

The drug is also regularly used to get rid of the symptoms of diseases affecting the genitourinary organs:

• urethritis;
• cystitis;
• salpingitis;
• prostatitis.

How correctly and in what doses is the medicine used?

It is necessary to understand in advance the nuances of using a bactericidal drug. To do this, you will have to separately consider each way of using it.

Film-coated tablets

Often, a drug available in tablet form is used for therapy. Take three tablets daily after or before meals. The duration of therapy depends on the characteristics of the disease and possible complications.

Powder for preparing suspension

The suspension is used in the treatment of newborns and children under ten years of age. A solution prepared from powder is taken orally after meals. You need to familiarize yourself with the optimal dosage, since it directly depends on the age of the child. The daily dose for children up to one year is 25 mg/kg, from one to three years - 35 mg/kg, from three to ten years - 40 mg/kg.

Powder for the preparation of solution for intravenous administration

You should not administer the injection solution yourself, as this should be done by medical personnel. The exact dosage of the drug is determined by the doctor, based on the diagnosis and the patient’s well-being.

Consequences of overdose

If the correct dosage is not followed during therapy, certain complications may occur. Due to the use of the drug in large doses, sleep problems occur, which lead to insomnia. Also, patients who have experienced an overdose complain of convulsions, nervous disorders, dizziness and water-electrolyte imbalance.

Abuse of the drug is accompanied by amoxicillin crystalluria, which leads to the development of renal failure. All of these symptoms are very dangerous, and therefore, in case of an overdose of the drug, immediately seek help from a doctor.

Possible unwanted effects

It is no secret that after using medications, side effects may appear that disrupt the functioning of certain body systems.

Gastrointestinal tract

Problems with the digestive system manifest themselves in the form of jaundice, diarrhea, vomiting and nausea. Sometimes patients develop hemorrhagic colitis and hepatitis.

Blood-forming organs

People complain of thrombocytosis, hemolytic anemia and leukopenia. Symptoms of thrombocytopenia and eosinophilia also appear.

central nervous system

Due to the incorrect use of Amoxicillin with clavulanic acid, problems with the central nervous system may occur. These include anxiety, depression, hyperactivity.

Allergies

Allergic reactions are among the most common side effects of the drug. They manifest themselves in the form of swelling, urticaria and dermatitis.

Impact on the ability to operate machinery

The medicine negatively affects the control of mechanisms only if taken in large doses.

Contraindications to the use of the drug

Before using the medicine, be sure to study its contraindications. This will help you figure out in what cases it should not be used. Amoxicillin is contraindicated in patients who are allergic to any of the components of the drug. Also, doctors do not advise people with lymphocytic leukemia and infectious mononucleosis to take the drug.

Use of the drug for impaired renal or liver function

People who have problems with the liver or kidneys should use Amoxicillin with caution. With such diseases, the removal of drug components from the body slows down, which often leads to an overdose. Therefore, to protect yourself from complications, it is recommended to take the medicine in reduced doses. Also, between each dose you will have to take a break of 10-12 hours.

Special instructions for the medication

Anyone who plans to use this or that medicine should familiarize themselves with the special instructions for its use.

Use in childhood

Amoxicillin and clavulanic acid are used to treat children from three months of age. In this case, not tablets are used, but powder to prepare syrup.

During pregnancy and lactation

It is better for pregnant girls to refrain from using this remedy, as this can lead to the development of enterocolitis in the baby. However, some girls still use the drug after prior consultation with a doctor.

Use in old age

There are no restrictions on taking the medicine for older people. Therefore, during treatment they should follow the usual dosage for adults.

Compatibility with other drugs and alcohol

It is known that the drug can be combined with other medications and used in complex therapy. However, before this, it is necessary to determine its compatibility with medications.

Amoxicillin should not be used together with laxatives, glucosamine and antacids. These drugs reduce the absorption of the drug and reduce its effectiveness. To increase the therapeutic effect of tablets or injections, they must be combined with anticoagulants.

Amoxicillin is incompatible with alcohol, and therefore you should not drink alcohol during therapy.

Terms of sale of medicine

To purchase Amoxicillin, you will have to see a doctor for diagnostic procedures. After confirming the diagnosis, the doctor will be able to decide on treatment and write prescriptions for the purchase of the necessary medications. You cannot purchase the drug at a pharmacy without a doctor's prescription.

Terms and conditions of storage

Everyone should familiarize themselves with the rules for storing medications at home, as this will extend the shelf life of the medications. Amoxicillin in tablet form should be stored in a dimly lit place at a temperature of 15-25 degrees.

It is contraindicated to store tablets under sunlight, since bright lighting changes the properties of the drug.

Prepared injection solutions are best stored in the refrigerator at a temperature of 1-2 degrees Celsius.

Analogues of the drug "Amoxicillin" + clavulanic acid

Patients who cannot be treated with Amoxicillin use similar drugs. Among them is Amoxiclav, which has the same pharmacological properties. This drug helps get rid of acute otitis media, chronic bronchitis and pneumonia. Amoxiclav is taken twice a day in the amount of 200-300 mg.

Conclusion

Amoxicillin with clavulanic acid is considered an excellent combination remedy against bacterial diseases. Before using such a medicine, it is better to familiarize yourself with its indications, pharmacological properties and shelf life.