Buy Augmentin

Amoxicillin is a semisynthetic broad-spectrum antibiotic with activity against many Gram-positive and Gram-negative microorganisms. At the same time, amoxicillin is prone to destruction by β-lactamases, and therefore the spectrum of amoxicillin activity does not extend to microorganisms that produce this enzyme.

Clavulanic acid, an inhibitor of β-lactamases structurally related to penicillins, has the ability to inactivate a wide range of β-lactamases found in microorganisms resistant to penicillins and cephalosporins.

Clavulanic acid has sufficient efficacy against plasmid β-lactamases, which most often cause bacterial resistance, and is less effective against type I chromosomal β-lactamases that are not inhibited by clavulanic acid.

The presence of clavulanic acid in the preparation of Augmentin protects amoxicillin from degradation by enzymes - β-lactamases, which allows to expand the antibacterial spectrum of amoxicillin.

The activity of a combination of amoxicillin with clavulanic acid in vitro is given below.

Bacteria, usually sensitive to a combination of amoxicillin and clavulanic acid

Gram-positive aerobes: Bacillus anthracis, Enterococcus faecalis, Listeria monocytogenes, Nocardia asteroides, Streptococcus pyogenes1,2, Streptococcus agalactiae1,2, Streptococcus spp. (other beta-hemolytic streptococci) 1,2, Staphylococcus aureus (sensitive to methicillin), 1 Staphylococcus saprophyticus (sensitive to methicillin), Staphylococcus spp. (coagulase-negative, sensitive to methicillin).

Gram-negative aerobes: Bordetella pertussis, Haemophilus influenzae1, Helicobacter pylori, Moraxella catarrhalis1, Neisseria gonorrhoeae, Pasteurella multocida, Vibrio cholerae.

Other: Borrelia burgdorferi, Leptospira icterohaemorrhagiae, Treponema pallidum.

Gram-positive anaerobes: Clostridium spp., Peptococcus niger, Peptostreptococcus magnus, Peptostreptococcus micros, Peptostreptococcus spp.

Gram-negative anaerobes: Bacteroides fragilis, Bacteroides spp., Capnocytophaga spp., Eikenella corrodens, Fusobacterium nucleatum, Fusobacterium spp., Porphyromonas spp., Prevotella spp.

Bacteria for which the acquired resistance to combination of amoxicillin with clavulanic acid is probable

Gram-negative aerobes: Escherichia coli1, Klebsiella oxytoca, Klebsiella pneumoniae1, Klebsiella spp., Proteus mirabilis, Proteus vulgaris, Proteus spp., Salmonella spp., Shigella spp.

Gram-positive aerobes: Corynebacterium spp., Enterococcus faecium, Streptococcus pneumoniae1,2, Streptococcus group Viridans2.

Bacteria that have natural resistance to a combination of amoxicillin and clavulanic acid

Gram-negative aerobes: Acinetobacter spp., Citrobacter freundii, Enterobacter spp., Hafnia alvei, Legionella pneumophila, Morganella morganii, Providencia spp., Pseudomonas spp., Serratia spp., Stenotrophomonas maltophilia, Yersinia enterocolitica.

Other: Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia spp., Coxiella burnetti, Mycoplasma spp.

1 - for these types of microorganisms, the clinical efficacy of a combination of amoxicillin with clavulanic acid has been demonstrated in clinical studies.

2 - strains of these bacterial species do not produce β-lactamases. Sensitivity to monotherapy with amoxicillin suggests a similar sensitivity to the combination of amoxicillin and clavulanic acid.

Suction

Both active components of the drug, Augmentin, amoxicillin and clavulanic acid, are rapidly and completely absorbed from the digestive tract after oral administration. Absorption of active substances is optimal in case of taking the drug at the beginning of food intake.

Tablets Augmentin 250 mg / 125 mg (375 mg), Augmentin 250 mg / 125 mg (375 mg), Augmentin 500 mg / 125 mg (625 mg), Augmentin 875 mg / 125 mg (1000 mg)

The pharmacokinetic parameters of amoxicillin and clavulanic acid, obtained in different studies, when healthy volunteers were taken on an empty stomach, are shown below:

- 1 tablet of the drug Augmentin 250 mg / 125 mg (375 mg);

- 2 tablets of the drug Augmentin 250 mg / 125 mg (375 mg);

- 1 tablet of the drug Augmentin 500 mg / 125 mg (625 mg);

- 500 mg of amoxicillin;

125 mg of clavulanic acid;

- 2 tablets of the drug Augmentin 875 mg / 125 mg (1000 mg)

The main pharmacokinetic parameters are presented in the table.

Preparations Dose (mg) Cmax (mg / l) Tmax (h) AUC (mg × h / l) T1 / 2 (h)
Amoxicillin in the drug Augmentin
Augmentin 250 mg / 125 mg 250 3.7 1.1 10.9 1.0
Augmentin 250 mg / 125 mg, 2 tablets. 500 5.8 1.5 20.9 1.3
Augmentin 500 mg / 125 mg 500 6.5 1.5 23.2 1.3
Amoxicillin 500 mg 500 6.5 1.3 19.5 1.1
Augmentin 875 mg / 125 mg 1750 11.64 ± 2.78 1.5 (1-2.5) 53.52 ± 12.31 1.19 ± 0.21
Clavulanic acid in the drug Augmentin
Augmentin 250 mg / 125 mg 125 2.2 1.2 6.2 1.2
Augmentin 250 mg / 125 mg, 2 tablets. 250 4.1 1.3 11.8 1.0
Augmentin 500 mg / 125 mg 125 2.8 1.3 7.3 0.8
Clavulanic acid 125 mg 125 3.3 0.9 7.8 0.7
Augmentin 875 mg / 125 mg 250 2.18 ± 0.99 1.25 (1-2) 10.16 ± 3.04 0.96 ± 0.12
When applying Augmentin, the concentrations of amoxicillin in plasma are similar to those in oral administration of one amoxicillin in equivalent doses.

Powder for the preparation of suspension for ingestion Augmentin 125 mg / 31.25 mg per 5 ml

The pharmacokinetic parameters of amoxicillin and clavulanic acid obtained in different studies are shown below when healthy volunteers aged 2-12 years were taken on an empty stomach at 3 doses of 40 mg / 10 mg / kg body weight per day of Augmentin, a powder for oral suspension , 125 mg / 31.25 mg in 5 ml (156.25 mg).

Basic pharmacokinetic parameters.

Dosage formulations
(mg / kg) Cmax
(mg / l) Tmax (h) AUC
(mg × h / l) T1 / 2 (h)
Amoxicillin
Augmentin 125 mg / 31.25 mg per 5 ml 40 7.3 ± 1.7 2.1 (1.2-3) 18.6 ± 2.6 1 ± 0.33
Clavulanic acid
Augmentin 125 mg / 31.25 mg per 5 ml 10 2.7 ± 1.6 1.6 (1-2) 5.5 ± 3.1 1.6 (1-2)
Powder for the preparation of suspension for ingestion Augmentin 200 mg / 28.5 mg in 5 ml

The pharmacokinetic parameters of amoxicillin and clavulanic acid obtained in different studies are shown below when healthy volunteers aged 2-12 years received an Augmentin drug on an empty stomach, powder for oral suspension, 200 mg / 28.5 mg in 5 ml (228.5 mg) in dose of 45 mg / 6.4 mg / kg / day, divided into two doses.

Basic pharmacokinetic parameters

Active substance Cmax (mg / l) Tmax (h) AUC (mg × h / l) T1 / 2 (h)
Amoxicillin 11.99 ± 3.28 1 (1-2) 35.2 ± 5 1.22 ± 0.28
Clavulanic acid 5.49 ± 2.71 1 (1-2) 13.26 ± 5.88 0.99 ± 0.14
Powder for the preparation of suspension for ingestion Augmentin 400 mg / 57 mg in 5 ml

The pharmacokinetic parameters of amoxicillin and clavulanic acid obtained in different studies are shown below when healthy volunteers took a single dose of Augmentin, a powder for oral suspension, 400 mg / 57 mg in 5 ml (457 mg).

Basic pharmacokinetic parameters

The active substance Cmax (mg / l) Tmax (h) AUC (mg × h / l)
Amoxicillin 6.94 ± 1.24 1.13 (0.75-1.75) 17.29 ± 2.28
Clavulanic acid 1.1 ± 0.42 1 (0.5-1.25) 2.34 ± 0.94
Distribution

Therapeutic concentrations of amoxicillin and clavulanic acid are created in various organs and tissues, interstitial fluid (organs of the abdominal cavity, fatty, bone and muscle tissues, synovial and peritoneal fluids, skin, bile, purulent discharge).

Amoxicillin and clavulanic acid have a weak degree of binding to plasma proteins. Studies have shown that 25% of the total amount of clavulanic acid and 18% of amoxicillin bind to plasma proteins.

In animal studies, no cumulation of ingredients of the Augmentin drug was detected.

Amoxicillin, like most penicillins, penetrates into breast milk. Traces of clavulanic acid have also been found in breast milk. Studies of reproductive function in animals have shown that amoxicillin and clavulanic acid penetrate through the placental barrier, while there were no signs of negative effects on the fetus.

Metabolism

10-25% of the initial dose of amoxicillin is excreted by the kidneys in the form of an inactive metabolite (penicillic acid). Clavulanic acid, undergoes intensive metabolism to 2,5-dihydro-4- (2-hydroxyethyl) -5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxybutan-2-one and is excreted by the kidneys , through the gastrointestinal tract, and also with exhaled air in the form of carbon dioxide.

Excretion

Like other penicillins, amoxicillin is excreted mainly by the kidneys, whereas clavulanic acid is excreted both by the kidney and the adrenal mechanisms. Studies have shown that, on average, approximately 60-70% amoxicillin and about 40-65% clavulanic acid is excreted by the kidneys unchanged in the first 6 hours after taking 1 tablet 250 mg / 125 mg or 1 tablet 500 mg / 125 mg.

Bacterial infections caused by microorganisms that are sensitive to the drug:

- upper respiratory tract infections and ENT organs (eg, relapsing tonsillitis, sinusitis, otitis media), commonly caused by Streptococcus pneumoniae, Haemophilus influenzae *, Moraxella catarrhalis *, Streptococcus pyogenes;

- Lower respiratory tract infections: exacerbations of chronic bronchitis, lobar pneumonia and bronchopneumonia, commonly caused by Streptococcus pneumoniae, Haemophilus influenzae * and Moraxella catarrhalis * (except tablets 250 mg / 125 mg);

- genitourinary tract infections: cystitis, urethritis, pyelonephritis, infections of female genitalia, usually caused by species of the Enterobacteriaceae family (mainly Escherichia coli *), Staphylococcus saprophyticus and species of the genus Enterococcus;

- gonorrhea caused by Neisseria gonorrhoeae * (except tablets 250 mg / 125 mg);

- skin and soft tissue infections, usually caused by Staphylococcus aureus *, Streptococcus pyogenes and species of the genus Bacteroides *;

- infections of bones and joints: osteomyelitis, usually caused by Staphylococcus aureus *, if long-term therapy is necessary;

- odontogenic infections, for example, periodontitis, maxillary sinusitis, severe dental abscesses with spreading cellulitis (for tablets 500 mg / 125 mg or 875 mg / 125 mg);

- other mixed infections (eg, septic abortion, postpartum sepsis, intra-abdominal sepsis) within the framework of stepwise therapy (for tablets 250 mg / 125 mg or 500 mg / 125 mg or 875 mg / 125 mg).

* - individual representatives of this kind of microorganisms, produce β-lactamase, which makes them insensitive to amoxicillin.

Infections caused by microorganisms sensitive to amoxicillin can be treated with Augmentin, since amoxicillin is one of its active ingredients. The Augmentin drug is also indicated for the treatment of mixed infections caused by microorganisms that are sensitive to amoxicillin, as well as microorganisms producing β-lactamase that are sensitive to a combination of amoxicillin and clavulanic acid.

The sensitivity of bacteria to the combination of amoxicillin and clavulanic acid varies depending on the region and over time. Wherever possible, local sensitivity data should be taken into account. If necessary, the collection of microbiological samples and analysis for bacteriological sensitivity should be carried out.

- Hypersensitivity to amoxicillin, clavulanic acid, other components of the drug, beta-lactam antibiotics (for example, penicillins, cephalosporins) in the anamnesis;

- previous episodes of jaundice or impaired liver function with a combination of amoxicillin and clavulanic acid in history;

- children under 12 years of age and body weight less than 40 kg (for tablets 250 mg / 125 mg or 500 mg / 125 mg, or 875 mg / 125 mg);

- children's age to 3 months (for powder for the preparation of a suspension for oral administration of 200 mg / 28.5 mg and 400 mg / 57 mg);

- renal dysfunction (CK ≤ 30 ml / min) - (for tablets 875 mg / 125 mg, for powder for oral suspension 200 mg / 28.5 mg and 400 mg / 57 mg);

- phenylketonuria (for powder for the preparation of a suspension for oral administration).

With caution: violations of the liver.

The dosage regimen is set individually depending on the age, body weight, function of the patient's kidneys, and also on the severity of the infection.

For optimal absorption and reduction of possible side effects from the digestive system, Augmentin is recommended to be taken at the beginning of the meal.

The minimum course of antibiotic therapy is 5 days.

Treatment should not last more than 14 days without reviewing the clinical situation.

If necessary, it is possible to perform stepwise therapy (at the beginning of therapy, parenteral administration of the drug followed by a transition to oral administration).

Adults and children over 12 years of age or with a body weight of 40 kg or more:

1 tablet 250 mg / 125 mg 3 times / day (for infections of mild and moderate severity), or 1 tablet 500 mg / 125 mg 3 times / day, or 1 tablet 875 mg / 125 mg 2 times / day, or 11 ml of a suspension of 400 mg / 57 mg / 5 ml 2 times / day (equivalent to 1 tablet of 875 mg / 125 mg).

2 tablets 250 mg / 125 mg are not equivalent to 1 tablet of 500 mg / 125 mg.

Children from 3 months to 12 years with a body weight of less than 40 kg

The drug is administered in the form of a suspension for oral administration.

Calculation of the dose is made depending on the age and body weight, indicate in mg / kg of body weight / day (calculation for amoxicillin) or in ml of suspension.

Multiplicity of taking the suspension 125 mg / 31.25 mg in 5 ml - 3 times / day every 8 hours.

The frequency of reception of the suspension is 200 mg / 28.5 mg in 5 ml or 400 mg / 57 mg in 5 ml - 2 times / day every 12 hours.

The recommended dosing regimen and the frequency of reception are shown in the table below.

Table of dosage regimen of the drug Augmentin (calculation of the dose is made for amoxicillin)

Multiplicity of admission - 3 times / day
Suspension 4: 1 (125 mg / 31.25 mg in 5 ml) Multiplicity of administration - 2 times / day
A suspension of 7: 1 (200 mg / 28.5 mg in 5 ml or 400 mg / 57 mg in 5 ml)
Low doses of 20 mg / kg / day 25 mg / kg / day
High doses of 40 mg / kg / day 45 mg / kg / day
Low doses of the drug Augmentin are used to treat infections of the skin and soft tissues, as well as relapsing tonsillitis.

High doses of the Augmentin drug are used to treat diseases such as otitis media, sinusitis, lower respiratory tract infections and urinary tract infections, infections of bones and joints.

There is insufficient clinical data to recommend the use of Augmentin in a dose of more than 40 mg / kg / day in 3 divided doses (4: 1 suspension) in children younger than 2 years.

Children from birth to 3 months

Due to the immaturity of the excretory function of the kidneys, the recommended dose of the Augmentin drug (calculation for amoxicillin) is 30 mg / kg / day in 2 divided doses as a 4: 1 suspension.

The use of a 7: 1 suspension (200 mg / 28.5 mg in 5 ml or 400 mg / 57 mg in 5 ml) is not recommended in this population.

Children born prematurely

There are no recommendations regarding the dosage regimen.

Elderly patients

No dose adjustment is required. In elderly patients with impaired renal function, the dose should be adjusted as described below for adults with impaired renal function.

Patients with impaired renal function

Correction of doses is based on the maximum recommended dose of amoxicillin and is performed taking into account the values ​​of CC.

Adults

QC Tablets
250 mg + 125 mg or 500 mg + 125 mg Suspension 4: 1
(125 mg / 31.25 mg in 5 ml)
> 30 ml / min Correction of the dosing regimen is not required Correction of the dosing regimen is not required
10-30 ml / min. 1 tab. 250 mg + 125 mg 2 times / day or
1 tab. 500 mg + 125 mg (for mild and moderate infections) 2 times / day 15 mg / 3.75 mg / kg 2 times / day, the maximum dose is 500 mg / 125 mg 2 times / day
<10 ml / min. 1 tab. 250 mg + 125 mg 1 time / day or
1 tab. 500 mg + 125 mg (for mild and moderate infections) 1 time / day 15 mg / 3.75 mg / kg 1 time / day, the maximum daily dose is 500 mg / 125 mg
Tablets 875 mg + 125 mg and a 7: 1 suspension (200 mg / 28.5 mg in 5 ml or 400 mg / 57 mg in 5 ml) should be used only in patients with CK> 30 ml / min, with no dose adjustment required.

In most cases, parenteral therapy should be preferred where possible.

Patients on hemodialysis

Dose adjustments are based on the maximum recommended dose of amoxicillin: 2 tablets. 250 mg / 125 mg in a single dose every 24 hours, or 1 tab. 500 mg / 125 mg in a single dose every 24 hours, or a suspension at a dose of 15 mg / 3.75 mg / kg 1 time / day.

Tablets: during the hemodialysis session, 1 additional dose (one tablet) and 1 dose (one tablet) at the end of the dialysis session (to compensate for the decrease in serum concentrations of amoxicillin and clavulanic acid).

Suspension: before the hemodialysis session, one additional dose of 15 mg / 3.75 mg / kg should be given. To restore the concentrations of the active components of the Augmentin drug in the blood, a second additional dose of 15 mg / 3.75 mg / kg should be administered after a hemodialysis session.

Patients with hepatic impairment

Treat with caution; regularly monitor liver function. There is insufficient data for correcting the dosing regimen in this category of patients.

Rules for the preparation of suspension

The suspension is prepared immediately before the first use.

Suspension (125 mg / 31.25 mg in 5 ml): approximately 60 ml of boiled water cooled to room temperature should be added to the vial with powder, then cover the vial with a lid and shake until the powder is completely diluted, allow the vial to stand for 5 minutes to ensure complete breeding. Then add water to the label on the vial and shake the bottle again. In general, about 92 ml of water is required to prepare the slurry. The vial should be shaken well before each use. To accurately dispense the drug should use a measuring cap, which must be thoroughly rinsed with water after each use. After reconstitution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen.

For children under 2 years, a measured single dose of the suspension of the drug Augmentin can be diluted with water by half.

Suspension (200 mg / 28.5 mg in 5 ml or 400 mg / 57 mg in 5 ml): add about 40 ml of boiled water cooled to room temperature in the vial with powder, then cover the vial with a lid and shake until the powder is completely diluted, give vial for 5 minutes to ensure complete dilution. Then add water to the label on the vial and shake the bottle again. In general, about 64 ml of water is required to prepare the slurry. The vial should be shaken well before each use. To accurately dispense the drug should use a measuring cap or metering syringe, which must be thoroughly rinsed with water after each use. After reconstitution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen.

For children younger than 2 years, a measured single dose of a suspension of the drug Augmentin can be diluted with water in a ratio of 1: 1.

The adverse events presented below are listed in accordance with the damage to organs and organ systems and frequency of occurrence. Frequency of occurrence is defined as follows: very often (≥1 / 10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100), rarely (≥1 / 10,000, < 1/1000), very rarely (<1/10 000).

Frequency categories were formed on the basis of clinical studies of the drug and post-registration surveillance.

Infectious and parasitic diseases: often - candidiasis of the skin and mucous membranes.

On the part of the blood and lymphatic system: rarely - reversible leukopenia (including neutropenia) and reversible thrombocytopenia; very rarely - reversible agranulocytosis and reversible hemolytic anemia, prolongation of prothrombin time and bleeding time, anemia, eosinophilia, thrombocytosis.

From the immune system: very rarely - angioedema, anaphylactic reactions, a syndrome similar to serum sickness, allergic vasculitis.

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

From the gastrointestinal tract: adults: very often - diarrhea, often - nausea, vomiting; children - often - diarrhea, nausea, vomiting; the entire population: nausea is most often observed when taking high doses of the drug. If after the beginning of taking the drug there are undesirable reactions from the digestive tract, they can be eliminated if you take the drug at the beginning of food intake. Infrequent digestion is infrequent; very rarely - antibiotic-associated colitis, induced by the intake of antibiotics (including pseudomembranous colitis and hemorrhagic colitis), black hairy tongue, gastritis, stomatitis. Children with the use of suspension very rarely noticed a discoloration of the surface layer of tooth enamel. Oral care helps prevent discoloration of tooth enamel, as it is enough to brush your teeth.

From the liver and bile ducts: infrequent - moderate increase in ACT and / or ALT activity (observed in patients receiving beta-lactam antibiotic therapy, but its clinical significance is unknown); very rarely - hepatitis and cholestatic jaundice (these phenomena were noted during therapy with other penicillins and cephalosporins), an increase in the concentration of bilirubin and alkaline phosphatase. Undesirable liver side effects were observed mainly in men and elderly patients and may be associated with long-term therapy. These undesirable phenomena are very rare in children.

These signs and symptoms usually occur in the process or immediately after the end of therapy, but in some cases may not appear for several weeks after the completion of therapy. Undesirable phenomena, as a rule, are reversible. Undesirable phenomena on the part of the liver can be severe, in extremely rare cases there have been reports of lethal outcomes. In almost all cases, these were persons with serious concomitant pathology or persons receiving potentially hepatotoxic drugs at the same time.

From the skin and subcutaneous tissues: infrequently - rash, itching, urticaria; rarely erythema multiforme; very rarely - Stevens-Johnson syndrome, toxic zidermalnoe necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis.

In case of skin allergic reactions treatment with the drug Augmentin should be discontinued.

From the side of the kidneys and urinary tract: very rarely - interstitial nephritis, crystalluria, hematuria.

Symptoms: symptoms may arise from the gastrointestinal tract and disturb the water-electrolyte balance. Amoxicillin crystalluria is described, in some cases leading to the development of renal failure.

Cramps can occur in patients with impaired renal function, as well as in those who receive high doses of the drug.

Treatment: symptoms from the gastrointestinal tract - symptomatic therapy, paying special attention to the normalization of the water-electrolyte balance. In case of an overdose, amoxicillin and clavulanic acid can be removed from the bloodstream by hemodialysis.

The results of a prospective study, which was conducted with the participation of 51 children in a toxicological center, showed that the administration of amoxicillin at a dose of less than 250 mg / kg did not lead to significant clinical symptoms and did not require gastric lavage.

In studies of reproductive function in animals, oral and parenteral administration of the Augmentin drug did not cause teratogenic effects.

In a single study in women with premature rupture of membranes, it was found that preventive therapy with the drug may be associated with an increased risk of developing necrotizing enterocolitis in newborns. Like all medicines, Augmentin is not recommended for use during pregnancy, except when the expected benefit to the mother exceeds the potential risk to the fetus.

The drug Augmentin can be used during breastfeeding. With the exception of the possibility of developing diarrhea or candidiasis of the oral mucosa associated with the penetration of trace amounts of the active ingredients of this preparation into breast milk, no other adverse effects were observed in infants fed breastfeeding. In case of adverse effects in infants who are breastfeeding, it is necessary to stop breastfeeding.

Simultaneous use of the drug Augmentin and probenecid is not recommended. Probenecid reduces tubular secretion of amoxicillin, and therefore simultaneous use of the drug Augmentin and probenecid can lead to an increase and persistence in the blood concentration of amoxicillin, but not clavulanic acid.

The simultaneous use of allopurinol and amoxicillin may increase the risk of skin allergic reactions. At present, there is no literature on the simultaneous use of a combination of amoxicillin with clavulanic acid and allopurinol.

Penicillins can slow the excretion of methotrexate from the body by inhibiting its tubular secretion, therefore, simultaneous use of the drug Augmentin and methotrexate may increase the toxicity of methotrexate.

Like other antibacterial drugs, the drug Augmentin can affect the intestinal microflora, leading to a decrease in absorption of estrogens from the digestive tract and a decrease in the effectiveness of combined oral contraceptives.

In the literature, rare cases of an increase in MHO in patients with joint use of acenocoumarol or warfarin and amoxicillin are described. If it is necessary to simultaneously prescribe the drug Augmentin with anticoagulants prothrombin time or MHO should be carefully monitored with the appointment or withdrawal of the drug Augmentin, a correction of the dose of anticoagulants for oral administration may be required.

Before starting treatment with Augmentin, you need to collect a detailed history of previous hypersensitivity reactions to penicillins, cephalosporins or other allergens.

Serious, and sometimes lethal, hypersensitivity reactions (anaphylactic reactions) to penicillins are described. The risk of occurrence of such reactions is highest in patients who have a history of hypersensitivity reactions to penicillins. In the event of an allergic reaction, it is necessary to stop treatment with the Augmentin drug and begin the appropriate alternative therapy. In severe hypersensitivity reactions, epinephrine should be administered immediately. Oxygen therapy, iv administration of GCS, and airway patency, including intubation, may also be required.

It is not recommended to use the drug Augmentin in case of suspected infectious mononucleosis, because in patients with this disease, amoxicillin can cause a measles-like rash, which makes it difficult to diagnose the disease.

Long-term treatment with Augmentin sometimes leads to excessive reproduction of insensitive microorganisms.

In general, the drug Augmentin is well tolerated and has a characteristic of all penicillins low toxicity.

During prolonged therapy with the drug Augmentin, it is recommended to periodically evaluate the function of the kidneys, liver and hematopoiesis.

To reduce the risk of side effects from the gastrointestinal tract should take the drug at the beginning of food intake.

In patients who received a combination of amoxicillin with clavulanic acid together with indirect (oral) anticoagulants, in rare cases, increased prothrombin time (increased MHO) was reported. When co-administration of indirect (oral) anticoagulants with a combination of amoxicillin and clavulanic acid, monitoring of the relevant indicators is necessary. To maintain the necessary effect of oral anticoagulants, their dose may need to be adjusted.

In patients with impaired renal function, the dose of Augmentin should be reduced accordingly.

In patients with reduced diuresis, in very rare cases, the development of crystalluria was reported, mainly with the parenteral administration of the drug. During the administration of high doses of amoxicillin, it is recommended to take a sufficient amount of fluid and maintain an adequate diuresis to reduce the likelihood of amoxicillin crystals.

Taking the drug Augmentin leads to a high content of amoxicillin in the urine, which can lead to false positive results in determining glucose in the urine (for example, the Benedict test, Feeling's test). In this case, it is recommended to use a glucose oxidant method for determining the concentration of glucose in the urine.

Oral care helps prevent tooth discoloration, as it is sufficient to brush your teeth.

Tablets should be used within 30 days of opening the package of laminated aluminum foil.

Abuse and drug dependence

There was no drug dependence, addiction and reactions of euphoria associated with the use of the drug Augmentin.

Impact on the ability to drive vehicles and manage mechanisms

Since the drug may cause dizziness, it is necessary to warn patients about precautions when driving a vehicle or working with moving machinery.

Children under 12 years of age

The drug is administered in the form of a suspension for oral administration.

Calculation of the dose is made depending on the age and weight, indicate in mg / kg of body weight per day (calculation for amoxicillin) or in milliliters of suspension.

Children with a body weight of 40 kg or more should be given the same dose as an adult.

Children from birth to 3 months. Due to the immaturity of the excretory function of the kidneys, the recommended dose of the Augmentin drug (calculation for amoxicillin) is 30 mg / kg / day in 2 divided doses as a 4: 1 suspension.

The use of a 7: 1 suspension in this population is not recommended.

Children aged 3 months to 12 years. The recommended dosing regimen and the frequency of reception are shown in the table below.

Table of dosage regimen of the drug Augmentin (calculation of the dose is made for amoxicillin)

Multiplicity of admission - 3 times / day
Suspension 4: 1 (125 mg / 31.25 mg in 5 ml) Multiplicity of administration - 2 times / day
A suspension of 7: 1 (200 mg / 28.5 mg in 5 ml or 400 mg / 57 mg in 5 ml)
Low doses of 20 mg / kg / day 25 mg / kg / day
High doses of 40 mg / kg / day 45 mg / kg / day
Low doses of the drug Augmentin are used to treat infections of the skin and soft tissues, as well as relapsing tonsillitis.

High doses of the Augmentin drug are used to treat diseases such as otitis media, sinusitis, lower respiratory tract infections and urinary tract infections.

There is insufficient clinical data to recommend the use of Augmentin in a dose of more than 40 mg / kg / day in 3 divided doses (4: 1 suspension) or 45 mg / kg / day in 2 divided doses (7: 1 suspension) in children younger than 2 years.

Children

Dosing regimen Augmentin
> 30 ml / min Dose correction is not required
10-30 ml / min 15 mg / 3.75 mg / kg 2 times / day, the maximum dose of 500 mg / 125 mg (20 ml of the suspension at a dose of 125 mg / 31.25 mg in 5 ml) 2 times / day
<10 ml / min 15 mg / 3.75 mg / kg 1 time / day, the maximum daily dose of 500 mg / 125 mg (20 ml of suspension at a dose of 125 mg / 31.25 mg in 5 ml).
In most cases, parenteral therapy should be preferred where possible.

Children on hemodialysis

Assign 15 mg / 3.75 mg / kg 1 time / day. Before a hemodialysis session, one additional dose of 15 mg / 3.75 mg / kg should be given. To restore the concentrations of the active components of the Augmentin drug in the blood, a second additional dose of 15 mg / 3.75 mg / kg should be administered after a hemodialysis session.

Patients with impaired renal function:

Correction of doses is based on the maximum recommended dose of amoxicillin and is performed taking into account the values ​​of CC.

Adults:

QC Tablets
500 mg + 125 mg or 250 mg + 125 mg Suspension 4: 1
(125 mg / 31.25 mg in 5 ml)
> 30 ml / min Dose correction is not required Dose correction is not required
10-30 ml / min. 1 tab. 500 mg + 125 mg 2 times / day or 1 tab. 250 mg + 125 mg (for mild and moderate infections) 2 times / day 500 mg / 125 mg (20 ml suspension in a dose of 125 mg / 31.25 mg in 5 ml) 2 times / day
<10 ml / min. 1 tab. 500 mg + 125 mg once a day or 1 tab. 250 mg + 125 mg (for mild and moderate infections) 1 time / day 500 mg / 125 mg (20 ml suspension in a dose of 125 mg / 31.25 mg in 5 ml) 1 time / day
Tablets 875 mg + 125 mg should be used only in patients with CK> 30 ml / min, with no dose adjustment required.

In most cases, parenteral therapy should be preferred where possible.

Adults and children over 12 years of age or with a body weight of more than 40 kg who are on hemodialysis:

Dose adjustments are based on the maximum recommended dose of amoxicillin: 1 tab. 500 mg + 125 mg in one dose every 24 hours or 2 tab. 250 mg / 125 mg once a day every 24 hours, or 500 mg / 125 mg (20 ml suspension in a dose of 125 mg / 31.25 mg in 5 ml) 1 time / day.

During the dialysis session, 1 additional dose (one tablet) and one more tablet at the end of the dialysis session (to compensate for the decrease in serum concentrations of amoxicillin and clavulanic acid).

Treat with caution; regularly monitor liver function. There is insufficient data for correcting the dosing regimen in this category of patients.

Elderly patients do not need to reduce the dose of Augmentin; Doses are the same as for adults. In elderly patients with impaired renal function, the dose should be adjusted as for adults with impaired renal function.

The drug should be stored in a dry place inaccessible to children at a temperature of no higher than 25 ° C. Shelf life of tablets (250 mg + 125 mg) and (875 mg + 125 mg) - 2 years, tablets (500 mg + 125 mg) - 3 years. Shelf life of powder for suspension in an unopened vial is 2 years.

The prepared suspension should be stored in the refrigerator at a temperature of 2 ° to 8 ° C for 7 days.