Expiration date: 12/2024

Composition and form of issue:

Powder for preparation of suspension for oral administration 5 ml of finished suspension

active substance:

amoxicillin trihydrate 125, 200 or 400 mg

(based on amoxicillin) 

clavulanate potassium is 31.25, 28.5 or 57 mg

(based on clavulanic acid) 

excipients powder for suspension oral 125 mg + 31, 25 mg: xanthan gum — 12, 5 mg aspartame — 12, 5 mg of succinic acid — 0, 84 mg of silicon dioxide colloid — polymer 25 mg — 150 mg of orange flavor 1 — 15 mg orange flavor 2 — 11, 25 mg flavor raspberry — 22, 5 mg flavor "Light syrup" — 23, 75 mg silica dioxide 125 mg 

excipients powder for suspension for the reception inside 200 mg + 28, 5 mg and 400 mg + 57 mg: xanthan gum — 12, 5 mg aspartame — 12, 5 mg of succinic acid — 0, 84 mg of silicon dioxide colloidal 25 mg hypromellose — 79, 65 mg of orange flavor 1 — 15 mg orange flavor 2 — 11, 25 mg flavor raspberry — 22, 5 mg flavor "Light syrup" — 23, 75 mg of silicon dioxide to 552 and 900 mg 

in a bottle of 11, 5 g (for a powder for the preparation of a suspension for oral administration 125 mg + 31, 25 mg), 7, 7 g (for the preparation of a suspension for oral administration 200 mg + 28, 5) and 12, 6 g (for a powder for the preparation of a suspension for oral administration 400 mg + 57 mg) in a package of cardboard 1

Tablets, film-coated 1 tab.

active substance:

amoxicillin 250, 500 or 875 mg

(based on amoxicillin trihydrate) 

clavulanic acid 125 mg

(in terms of potassium clavulanate) 

excipients film coated tablets, 250 mg + 125 mg: magnesium stearate-6, 5 mg sodium carboxymethyl starch-13 mg silicon dioxide colloidal-6, 5 mg MCC-650 mg 

film shell: titanium dioxide — 9, 63 mg hypromellose (5 cps) — 7, 39 mg of hypromellose (15 cps) — 2, 46 mg, macrogol 4000 — 1, 46 mg, macrogol 6000 — 1, 46 mg Dimethicone — 0, 013 mg 

excipients film-coated tablets, 500 mg + 125 mg: magnesium stearate-7, 27 mg sodium carboxymethyl starch-21 mg silicon dioxide colloidal-10, 5 mg MKTS - up to 1050 mg 

film shell: titanium dioxide — 11, 6 mg hypromellose (5 cps) — 8, 91 mg of hypromellose (15 cps) — 2, 97 mg, macrogol 4000 — 1, 76 mg, macrogol 6000 — 1, 76 mg Dimethicone 500 (silicone oil) — 0, 013 mg 

in a package of aluminum foil 1 blister of 10 PCs. (tablets coated with a film of 250 mg + 125 mg) or 7 or 10 PCs. (tablets coated with a film of 500 mg + 125 mg) in a package of cardboard 2 packages or 7 PCs. (tablets coated with a film of 875 mg + 125 mg) in a package of cardboard 2 packages.

Description of dosage form:

Powder for the preparation of a suspension for oral administration: white or almost white, with a characteristic odor. When diluted forms a suspension of white or almost white. While standing slowly precipitate of white or nearly of white color.

Film-coated tablets, 250 mg + 125 mg: oval, white to almost white, with pressed "AUGMENTIN" on one side. Tablets from yellowish-white to almost white on the fracture.

Film-coated tablets, 500 mg + 125 mg 875 mg + 125 mg: oval, white to almost white, with the words "as" and the risk — on one side.

Tablets from yellowish-white to almost white on the fracture.

Pharmacokinetics:

Powder for the preparation of a suspension for oral administration and film coated tablets 250 mg + 125 mg

Suction. Both active components of the drug Augmentin, amoxicillin and clavulanic acid, quickly and completely absorbed from the gastrointestinal tract after oral administration. The best absorption is achieved in the case of taking the drug at the same time with eating. Below are the pharmacokinetic parameters of amoxicillin and clavulanic acid obtained in different studies, when healthy volunteers took on an empty stomach: 1 tab. drug Augmentin 250 mg + 125 mg (375 mg) or table 2. drug Augmentin 250 mg + 125 mg (375 mg) each.

Table 1

Main pharmacokinetic parameters

PreparationDose, mgCmax, mg/lTmax, hAUC, mcg/ml·hT1/2, h
Amoxicillin
Augmentin 250 mg + 125 mg 1 tablet
2503, 71, 110, 91, 0
Augmentin 250 mg + 125 mg 2 tablets5005, 81, 520, 91, 3
Clavulanic acid
Augmentin 250 mg + 125 mg 1 tablet
1252, 21, 26, 21, 2
Augmentin 250 mg + 125 mg 2 tablets
2504, 11, 311, 81, 0

When Using the drug Augmentin amoxicillin plasma concentrations are similar to those in oral administration of equivalent doses in monotherapy amoxicillin.

Distribution. Therapeutic concentrations of amoxicillin and clavulanic acid are created in various organs and tissues, interstitial fluid (lungs, abdominal fat, bone and muscle tissue pleural, synovial and peritoneal fluid skin, bile, purulent discharge, sputum).

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

In animal studies, the cumulation of the ingredients of the drug Augmentin was not found.

Amoxicillin, like most penicillins, can be detected in breast milk. Trace amounts of clavulanic acid were also found in breast milk. Amoxicillin and clavulanic acid penetrate the placental barrier, with no signs of negative impact on the fetus.

Metabolism. Amoxicillin is partially excreted by the kidneys as inactive penicillic acid in an amount equivalent to 10-25% of the initial dose. Clavulanic acid is largely subjected to metabolism to form 2, 5-dihydro-4-(2-hydroxyethyl)-5-oxo-1H-pyrrol-3-carboxylic acid and 1-amino-4-hydroxy-butane-2-it, which are excreted by the kidneys and intestines, as well as exhaled air in the form of carbon dioxide.

Breeding. Like other penicillins, amoxicillin is excreted mainly by the kidneys, whereas clavulanic acid through both renal and extrarenal mechanisms. Approximately 60-70% of amoxicillin and about 40-65% of clavulanic acid is excreted by the kidneys unchanged in the first 6 hours after administration of 1 table. 250 mg + 125 mg.

Film-coated tablets, 500 mg + 125 mg 875 mg + 125 mg

Suction. Both active ingredients of the drug Augmentin, amoxicillin and clavulanic acid, dissolve well in aqueous solutions with a physiological pH value, quickly and completely absorbed from the gastrointestinal tract after oral administration. The absorption of active substances is optimal in the case of taking the drug at the same time with food.

Below are the pharmacokinetic parameters of amoxicillin and clavulanic acid after taking the drug Augmentin 500 mg + 125 mg healthy volunteers fasting (table 2) and Augmentin 875 mg + 125 mg (table 3).

Table 2

The average value of pharmacokinetic parameters

PreparationDose, mgCmax, mg/lTmax, hAUC, mcg/ml·hT1/2, h
Amoxicillin
Augmentin 500 mg + 125 mg 1 tablet
5006, 51, 523, 21, 3
Clavulanic acid
Augmentin 500 mg + 125 mg 1 tablet
1252, 81, 37, 30, 8

Table 3

The average value of pharmacokinetic parameters

PreparationDose, mgCmax, mg/lTmax, hAUC, mcg/ml·hT1/2, h
Amoxicillin
Augmentin 875 mg + 125 mg 1 tablet
87512, 41, 529, 91, 36
Clavulanic acid
Augmentin 875 mg + 125 mg 1 tablet
1253, 31, 36, 880, 92

The plasma protein binding and blood distribution. Therapeutic concentrations of amoxicillin and clavulanic acid are created in various organs and tissues, interstitial fluid (lungs, abdominal fat, bone and muscle tissue pleural, synovial and peritoneal fluid skin, bile, purulent discharge, sputum).

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

In animal studies there was no cumulation of the ingredients of the drug Augmentin in any organ.

Amoxicillin, like most penicillins, can be detected in breast milk. Trace amounts of clavulanic acid were also found in breast milk. With the exception of the risk of sensitisation, no other adverse effects of amoxicillin and clavulanic acid on the health of infants fed with breast milk are known.

Studies of reproductive function in animals when taking the drug Augmentin showed that amoxicillin and clavulanic acid penetrate the placental barrier. However, there was no violation of fertility or negative impact on the fetus.

Metabolism and excretion. Amoxicillin metabolized in slightly & in the urine is detected in 10-25% of active metabolite penicilloic acid. Clavulanic acid is subjected to intense metabolism to 2, 5-dihydro-4-(2-hydroxyethyl)-5-oxo-1H-pyrrolo-3-carboxylic acid and 1-amino-4-hydroxy-butane-2-it, excreted kidneys and intestines.

Like other penicillins, amoxicillin is excreted mainly by the kidneys, whereas clavulanic acid is excreted by both the kidneys and the intestines. Approximately 60-70% amoxicillin and about 40-65% of the clavulanic acid are excreted by the kidneys in unchanged form.

Description of the pharmacological action:

Powder for preparation of oral suspension and film-coated tablets, 250 mg + 125 mg

Amoxicillin is a broad-spectrum semi-synthetic antibiotic that is active against many gram-positive microorganisms. Amoxicillin is destroyed by microbial enzymes (&beta-lactamase) and does not affect the microorganisms that produce these enzymes. Clavulanic acid is a & beta-lactam structurally related to penicillin, which has the ability to inactivate &beta-lactamases. Clavulanic acid in the preparation Augmentin protects amoxicillin from destructive action &beta-lactamase and expands its spectrum of activity, including bacteria, usually resistant to amoxicillin, as well as to other penicillins and cephalosporins.

The drug Augmentin has a bactericidal effect in vivo on the following microorganisms:

  • gram-positive aerobes: Staphylococcus aureus*, Streptococcus pneumoniae, Streptococcus pyogenes
  • gram-negative aerobes: Enterobacter species**, Escherichia coli*, Haemophilus influenzae* Klebsiella species*, Moraxella catarrhalis* (Branhamella catarrhalis)

The drug Augmentin has a bactericidal effect in vitro on the following microorganisms (but the clinical significance is still unknown):

  • gram-positive airbags: Bacillis anthracis * species of genus Corynebacterium, Enterococcus faecalis*, Enterococcus faecium*, Listeria monocytogenes, Nocardia asteroides coagulase-negative staphylococci* (including Staphylococcus epidermidis*), Streptococcus agalactiae other genus species, streptoccus Streptococcus viridans
  • gram-positive anaerobes: the genus species Clostridium species Peptococcus species of the genus Peptostreptococcus
  • gram-negative aerobes: Bordetella pertussis a species of the genus Brucella Gardnerella vaginalis, Helicobacter pylori species of the genus Legionella, Neisseria gonorrhoeae*, Neisseria meningitidis*, Pasteurella multocida, Proteus mirabilis* Proteus vulgaris* Salmonella species* Shigella species* Vibrio cholerae Yersinia enterocolitica*
  • gram-negative anaerobes: Bacteroides species* (including Bacteroides fragilis) Fusobacterium species*
  • others: Borrelia burgdorferi, Chlamydia spp., Leptospira icterohaemorrhagiae, Treponema pallidum.

Film-coated tablets, 500 mg + 125 mg

Note

* some strains of these bacteria produce & beta-lactamases, making them insensitive to amoxicillin monotherapy.

** most strains of these bacteria are resistant to the drug Augmentin in vitro, but the clinical efficacy of the drug was demonstrated in the treatment of urinary system infections caused by these strains.

Indications:

Powder for preparation of suspension for oral administration

Bacterial infections caused by microorganisms sensitive to amoxicillin/clavulanic acid:

ENT infections, such as recurrent tonsillitis, sinusitis, otitis media, usually caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes

infections of the lower respiratory tract, such as acute exacerbations of chronic bronchitis, lobar pneumonia and bronchopneumonia, usually caused by Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis

infections of the genitourinary tract, such as cystitis, urethritis, pyelonephritis, female genital infections, usually caused by the types of family Enterobacteriaceae (mainly Escherichia coli), Staphylococcus saprophyticus and species of the genus Enterococcus, as well as gonorrhoea caused by Neisseria gonorrhoeae

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

infections of bones and joints, such as osteomyelitis, usually caused by Staphylococcus aureus, if necessary, long-term therapy.

Film-coated tablets

Treatment of infections caused by sensitive microorganisms:

infections of the upper respiratory ways (including infections of the ear, nose and throat), such as recurrent tonsillitis, sinusitis, otitis media typically caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pyogenes

infections of the lower respiratory tract, such as acute exacerbations of chronic bronchitis, lobar pneumonia and bronchopneumonia, usually caused by Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis

infections of the genitourinary tract, such as cystitis, urethritis, pyelonephritis, infections in gynecology, usually caused by strains of the Enterobacteriaceae family (mainly Escherichia coli), Staphylococcus saprophyticus and strains of the genus Enterococcus, as well as gonorrhoea caused by Neisseria gonorrhoeae

skin and soft tissue infections usually caused by Staphylococcus aureus, Streptococcus pyogenes and strains of the genus Bacteroides

bone and joint infections, such as osteomyelitis, usually caused by Staphylococcus aureus, if necessary, long-term therapy

other mixed infections, such as septic abortion, obstetric sepsis, intra-abdominal infection.

See. there is also a list of sensitive strains in the section "Pharmacodynamics".

Infections caused by microorganisms sensitive to unprotected amoxicillin can be treated with Augmentin, since amoxicillin is one of its active ingredients.

Contraindications:

Powder for preparation of suspension for oral administration

hypersensitivity to &beta-lactams, such as penicillins, cephalosporins and other components of the drug

previous episodes of jaundice or liver dysfunction due to the use of amoxicillin/clavulanic acid in the anamnesis

phenylketonuria.

Caution: patients with impaired liver function, regularly monitoring.

Tablets, film-coated, 250 mg + 125 mg, 875 mg + 125 mg

hypersensitivity to &beta-lactams, such as penicillins and cephalosporins or other components of the drug

previous episodes of jaundice or liver dysfunction in the application of amoxicillin/clavulanic acid in the anamnesis

children under 12 years of age-for this dosage form.

the impairment of renal function, creatinine Cl &le30 ml/min

Caution: impaired liver function.

Film-coated tablets, 500 mg + 125 mg

known hypersensitivity to &beta-lactam antibiotics (penicillins and cephalosporins)

jaundice or liver dysfunction, developed against the background of the use of &beta-lactam antibiotics.

Caution: suspected infectious mononucleosis, as patients with this disease amoxicillin can cause skin rash, which makes it difficult to diagnose the disease.

Application for pregnancy and breastfeeding:

In studies of reproductive functions in animals when taking the drug Augmentin it was shown that oral and parenteral administration of this 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 Augmentin may be associated with increased risk of necrotizing enterocolitis in newborns. As with all drugs, the drug Augmentin is not recommended during pregnancy, except in cases where the expected benefit exceeds the potential risk.

The drug Augmentin can be used during breastfeeding. With the exception of the risk of sensitisation associated with the penetration of trace amounts of active ingredients of this drug into breast milk, no other adverse effects were observed in infants receiving breast-feeding.

Side effect:

Powder for preparation of oral suspension and tablets coated with a film coating 250 mg + 125 mg 500 mg + 125 mg 875 mg + 125 mg

Below are the adverse reactions classified by organ systems with an indication of the frequency of their occurrence. The frequency of adverse reactions is defined as follows: very often (&ge1/10), often (&ge1/100 and <1/10), sometimes (&ge1/1000 and <1/100), rarely (&ge1/10,000 and <1/1000) and very rarely (<1/10 000).

Superinfection: often-candidiasis of the skin and mucous membranes.

On the part of the hematopoietic and lymphatic systems: rarely-reversible leukopenia (including neutropenia) and thrombocytopenia very rare — reversible agranulocytosis and hemolytic anemia, prolongation of PV and bleeding time eosinophilia, thrombocytosis, anemia.

From the immune system: sometimes - skin rash, itching, urticaria rarely-erythema multiforme very rarely-angioedema, anaphylactic reactions, serum-like syndrome, allergic vasculitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustules.

In the development of any symptoms of hypersensitivity should stop using the drug.

From the nervous system: sometimes-dizziness, headache is very rare-reversible hyperactivity, seizures (may occur in patients with impaired renal function when taking high doses of the drug), insomnia, excitement, anxiety, behavior change.

On the part of the digestive tract: very often — diarrhea often — nausea, vomiting, dyspeptic disorders very rarely — colitis (including pseudomembranous and hemorrhagic), gastritis, stomatitis, black "hairy" tongue, discoloration of the surface layer of tooth enamel. Oral care helps prevent tooth discoloration, as it is enough to brush your teeth.

From the liver and biliary tract: sometimes — moderate increase in ACT and ALT very rarely — hepatitis and cholestatic jaundice (noted in concomitant therapy with other penicillins and cephalosporins), an increase in the level of schf and/or bilirubin.

Liver side effects occur predominantly in males and elderly patients and may be associated with prolonged therapy, usually during or shortly after treatment, but in some patients they develop only a few weeks after the end of treatment. Usually side effects from the liver are reversible. Extremely rare in patients with serious pre-existing diseases or those who have received potentially hepatotoxic drugs, they can be quite severe, up to death.

From the kidneys and urinary tract: very rare — interstitial nephritis, crystalluria (see section "Overdose"), hematuria.

Drug interaction:

Powder for preparation of oral suspension and film-coated tablets, 250 mg + 125 mg

Probenecid reduces the tubular secretion of amoxicillin, and therefore the concomitant use of the drug Augmentin and probenecid may increase and maintain high levels of amoxicillin, but not clavulanic acid.

Simultaneous use of allopurinol and amoxicillin can increase the risk of allergic reactions. Currently, there are no data on the joint use of the drug Augmentin and allopurinol in the literature.

Drug Augmentin may affect intestinal flora, which can lead to reduce reverse suction of estrogen and consequently reduce the effectiveness of combined oral contraceptives.

The drug Augmentin inside leads to high concentrations of amoxicillin in urine, which can lead to false-positive results in the determination of glucose in urine (e.g. Benedict's test, test of Fading). In this case, it is recommended to use glucose oxidase method to determine the concentration of glucose in the urine.

The literature describes rare cases of mho increase in patients with the combined use of acenocumarol or warfarin and amoxicillin. If necessary, the simultaneous administration of the drug Augmentin with anticoagulants PV or MHO should be carefully monitored in the appointment or withdrawal of the drug Augmentin.

Method of application and doses:

Inside.

Dosing regimen is set individually, depending on the age, body weight, kidney function of the patient, as well as the severity of the infection.

For optimal absorption and reduction of possible side effects from the gastrointestinal tract drug Augmentin recommended to take at the beginning of the meal.

The minimum course of antibacterial therapy is 5 days. 2 weeks after the start of treatment, it is recommended to assess the clinical situation to decide on the continuation of the course of antibacterial therapy. The duration of treatment of uncomplicated acute otitis media is 5 to 7 days, children up to 2 years for 7-10 days.

If necessary, it is possible to carry out step therapy (at the beginning of parenteral administration of the drug with the subsequent transition to oral administration).

Powder for preparation of suspension for oral administration

Table 4

Ratio of active ingredients in suspension

Dosage form
The ratio of active components
Amoxicillin (in the form of trihydrate amoxicillin), mg
Clavulanic acid( in the form of potassium clavulanate), mg
Powder for suspension preparation 125 mg + 31, 25 mg in 5 ml
4:112531, 25
Powder for suspension preparation 200 mg + 28, 5 mg in 5 ml
7:120028, 5
Powder for preparation of oral suspension 400 mg + 57 mg in 5 ml
7:140057

The suspension is prepared immediately before the first application. The powder should be dissolved in boiled water, cooled to room temperature, gradually shaking bottle and adding water to the mark on the bottle. Then let stand the suspension for about 5 min, to ensure complete dilution. The bottle should be shaken well before each use. For an accurate dosage of the drug should be used measuring cap-cap, which should be well rinsed with water after each use. After dilution, the suspension should be stored for no more than 7 days in the refrigerator, but do not freeze.

For correct dosing of the amount of suspension in children under 3 months it is recommended to use a syringe with graduation. For the convenience of taking the suspension in children under 2 years of age can be diluted twice with water.

Children

Dose calculation is performed depending on the age and weight, indicated in mg/kg body weight per day (calculation of amoxicillin) or in ml suspension per day. Children weighing 40 kg or more should be prescribed the same dose as adults.

Children from birth to 3 months: due to immaturity of excretory renal function recommended dose of the drug Augmentin (amoxicillin calculation) is 30 mg/kg/day in 2 admission as a suspension 4:1.

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

Children aged 3 months to 12 years: recommended dosing regimen and frequency of administration are shown in Table 5.

Table 5

The dosage regimen of the drug Augmentin (calculation of the dose produced by amoxicilina)

DosesSuspension 4:1 (125 mg + 31, 25 mg in 5 ml) multiplicity of reception-3 times a day
Suspension 7:1 (200 mg + 28, 5 mg in 5 ml or 400 mg + 57 mg in 5 ml) multiplicity of reception-2 times a day
Low dose
20 mg / kg / day
25 mg / kg / day
High dose
40 mg / kg / day
45 mg / kg / day

Low doses Of Augmentin are used to treat infections of the skin and soft tissues, as well as recurrent tonsillitis.

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

Insufficient clinical data to recommend the use of the drug Augmentin dose of more than 40 mg/kg 3 times a day (suspension 4:1) or 45 mg / kg 2 times a day (suspension 7:1) in children under 2 years.

Adults: the recommended dosage regimen is 20 ml of the suspension at 125 mg + 31, 25 mg at 5 ml 2-3 times a day or 11 ml of the suspension at 400 mg + 57 mg at 5 ml 2 times a day.

Elderly patients: dose adjustment is not required, the same dosing regimen as in younger patients. In elderly patients with impaired renal function, appropriate doses are prescribed for adult patients with impaired renal function.

Augmentin
(Amoxicillin
+
Clavulanic
acid)