Augmentin 875mg+125mg tablets p pl o 14
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875 mg+125 mg
- Amoxicillin (in the form of trihydrate) - 875 mg;
- clavulanic acid (in the form of potassium salt) - 125 mg.
Excipients: magnesium stearate - 14.5 mg, sodium carboxymethyl starch - 29 mg, silicon dioxide colloidal - 10 mg, microcrystalline cellulose - 243.16 mg.
Composition of the film shell Opadrai OY-S-7300 white: titanium dioxide - 43%, hypromellose 5 cPz - 33%, hypromellose 15 cPz - 11%, macrogol 4000 - 6.5%, macrogol 6000 - 6.5%.
Amoxicillin is a semi-synthetic broad-spectrum antibiotic with activity against many gram-positive and gram-negative microorganisms.
At the same time, amoxicillin is subject to destruction by β-lactamases, and therefore the spectrum of amoxicillin activity does not extend to microorganisms that produce this enzyme.
Clavulanic acid is 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 is quite effective against plasmid β-lactamases, which most often cause resistance of bacteria.
The two main mechanisms of resistance to the combination of amoxicillin with clavulanic acid are:
- Inactivation by bacterial β-lactamases, which themselves are not inhibited by clavulanic acid, including various amino acid sequences belonging to classes B, C, and D according to the Ambler classification.
- Changes in penicillin-binding proteins that reduce the degree of affinity of the antibacterial agent to Target. Reduced outer membrane permeability and eflux pump mechanisms can cause or contribute to the formation of resistance, especially among Gram-negative microorganisms.
The presence of clavulanic acid in the preparation Augmentin ® protects amoxicillin from destruction by enzymes - β-lactamases, which allows you to expand the antibacterial spectrum of amoxicillin.
Below is a classification of microorganisms according to their in vitro sensitivity to the combination of amoxicillin and clavulanic acid.
Bacteria commonly sensitive to the combination of amoxicillin with clavulanic acid
Gram-positive aerobes: Bacillus anthracis, Enterococcus faecalis, Listeria monocytogenes, Nocardia asteroides, Streptococcus pyogenes 1,2 , Streptococcus agalactiae 1,2 , Streptococcus spp. (other β-hemolytic streptococci) 1,2 , Staphylococcus aureus (methicillin sensitive) 1 , Staphylococcus saprophyticus (methicillin sensitive), Staphylococcus spp. (coagulazonegative, sensitive to methicillin).
Gram-negative aerobes: Bordetella pertussis, Haemophilus influenzae 1 , Helicobacter pylori, Moraxella catarrhalis 1 , Neisseria gonorrhoeae, Pasteurella multocida, Vibrio cholerae.
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.
Other: Borrelia burgdorferi, Leptospira icterohaemorrhagiae, Treponema pallidum.
Bacteria for whom acquired resistance to the combination of amoxicillin with clavulanic acid is likely
Gram-negative aerobes: Escherichia coli 1 , Klebsiella oxytoca, Klebsiella pneumoniae 1 , Klebsiella spp., Proteus mirabilis, Proteus vulgaris, Proteus spp., Salmonella spp., Shigella spp.
Gram-positive aerobes: Corynebacterium spp., Enterococcus faecium, Streptococcus pneumoniae 1,2 , Streptococcus group Viridans 2 .
Bacteria with natural resistance to the combination of amoxicillin with 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 species of bacteria, the clinical efficacy of the combination of amoxicillin with clavulanic acid has been demonstrated in clinical studies.
2 Strains of these species of bacteria do not produce β-lactamase. Sensitivity during amoxicillin monotherapy suggests a similar sensitivity to the combination of amoxicillin with clavulanic acid.
Both active ingredients of the drug Augmentin ® , amoxicillin and clavulanic acid, quickly and completely absorbed from the gastrointestinal tract after oral administration. Absorption of active substances is optimal in the case of taking the drug at the beginning of a meal.
Below are the pharmacokinetic parameters of amoxicillin and clavulanic acid obtained in separate studies when healthy volunteers took Fasting:
- 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 amoxicillin;
- 125 mg of clavulanic acid;
- 2 tablets of the drug Augmentin ® 875 mg/125 mg (1000 mg).
Main pharmacokinetic parameters
|Drugs||Dose (mg)||With max (mg/L)||T max (h)||AUC (mg×h/L)||T 1/2 (h)|
|Amoxicillin in the composition of the drug Augmentin ®|
|Augmentin ® 250 mg/125 mg||250||3.7||1.1||10.9||1.0|
|Augmentin ® 250 mg/125 mg, 2 tab.||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 composition of the drug Augmentin ®|
|Augmentin ® 250 mg/125 mg||125||2.2||1.2||6.2||1.2|
|Augmentin ® 250 mg/125 mg, 2 tab.||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||3.4||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|
As with intravenous administration of a combination of amoxicillin with clavulanic acid, therapeutic concentrations of amoxicillin and clavulanic acid are created in various organs and tissues, interstitial fluid (abdominal organs, fatty, bone and muscle tissues, synovial and peritoneal fluids, skin, bile, purulent discharge).
Amoxicillin and clavulanic acid have a weak degree of binding to blood plasma proteins. Studies have shown that about 25% of the total amount of clavulanic acid and 18% of amoxicillin bind to blood plasma proteins.
In animal studies, the cumulation of Augmentin ingredients ® not detected.
Amoxicillin, like most penicillins, penetrates into breast milk. Trace amounts of clavulanic acid have also been found in breast milk.
Except for the possibility of sensitization, diarrhea and candidiasis of the mucous membranes No other negative effects of amoxicillin and clavulanic acid on the health of infants fed breast milk are known.
Studies of reproductive function in animals have shown that amoxicillin and clavulanic acid penetrate the placental barrier, while there were no signs of a negative effect on the fetus.
10-25% of the initial dose of amoxicillin is excreted by the kidneys in the form of an inactive metabolite (penicilloic acid).
Clavulanic acid undergoes intensive metabolism to 2,5-dihydro-4-(2-hydroxyethyl)-5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-butane-2-one and is excreted by the kidneys, through the gastrointestinal tract, as well as with exhaled air in the form of carbon dioxide.
Like other penicillins, amoxicillin is excreted mainly by the kidneys, whereas clavulanic acid is excreted through both renal and extranetic acid. Mechanisms.
Studies have shown that, on average, approximately 60-70% of amoxicillin and about 40-65% of clavulanic acid are excreted by the kidneys unchanged in the first 6 hours after the drug is prescribed.
Indications for use
Bacterial infections caused by microorganisms sensitive to the drug:
- upper respiratory tract and ENT infections (e.g., recurrent tonsillitis, sinusitis, otitis media), usually caused by Streptococcus pneumoniae, Haemophilus influenzae*, Moraxella catarrhalis*, Streptococcus pyogenes;
- lower respiratory tract infections (e.g., exacerbations of chronic bronchitis, lobar pneumonia and bronchopneumonia), usually caused by Streptococcus pneumoniae, Haemophilus influenzae* and Moraxella catarrhalis* (except tablets 250 mg/125 mg);
- urinary tract infections: cystitis, urethritis, pyelonephritis, infections of the female genital organs, usually caused by species the families Enterobacteriaceae (mainly Escherichia coli*), Staphylococcus saprophyticus, and species of the genus Enterococcus;
- gonorrhea caused by Neisseria gonorrhoeae* (except 250 mg/125 mg tablets);
- skin and soft tissue infections usually caused by Staphylococcus aureus*, Streptococcus pyogenes and species of the genus Bacteroides*;
- infections of bones and joints (for example, osteomyelitis, usually caused by Staphylococcus aureus *), if long-term therapy is necessary;
- odontogenic infections (eg, periodontitis, maxillary sinusitis, severe dental abscesses with spreading cellulite) - for tablets 500 mg / 125 mg or 875 mg / 125 mg;
- other mixed infections (e.g., septic abortion, postpartum sepsis, intra-abdominal sepsis) as part of step therapy.
* Individual members of this genus of microorganisms produce β-lactamase, which makes them insensitive to amoxicillin.
Infections caused by amoxicillin-sensitive microorganisms can be treated with Augmentin ® since amoxicillin is one of its active ingredients.
Augmentin ® it is also indicated for the treatment of mixed infections caused by microorganisms sensitive to amoxicillin, as well as microorganisms producing β-lactamase, sensitive to the combination of amoxicillin with clavulanic acid.
The sensitivity of bacteria to the combination of amoxicillin with clavulanic acid varies by region and over time. Where possible, local sensitivity data should be taken into account. If necessary, microbiological samples should be collected and bacteriological sensitivity analyzed.
- hypersensitivity to amoxicillin, clavulanic acid, other components of the drug, beta-lactam antibiotics (eg, penicillins, cephalosporins) in the anamnesis;
- previous episodes of jaundice or impaired liver function when using a combination of amoxicillin with clavulanic acid in the anamnesis;
- children's age up to 12 years and body weight less than 40 kg;
- impaired renal function (CK ≤30 ml / min) - (for tablets 875 mg / 125 mg).
With caution: impaired liver function.
Dosage and Administration
The drug is taken orally.
The dosage 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 reduce possible side effects from the digestive system Augmentin ® it is recommended to take at the beginning of meals.
Minimal course of antibacterial therapy is 5 days.
Treatment should not last more than 14 days without review of the clinical situation.
If necessary, it is possible to conduct step therapy (initially intravenous administration of the drug Augmentin ® in the dosage form powder for the preparation of a solution for intravenous administration with the subsequent transition to the drug Augmentin ® in dosage forms for oral administration).
It must be remembered that 2 tablets of 250 mg / 125 mg are not equivalent to 1 tablet of 500 mg / 125 mg.
Adults and children over 12 years of age or weighing 40 kg or more
1 tab. 250 mg / 125 mg 3 times / day for infections of mild and moderate severity.
For severe infections (including chronic and recurrent urinary tract infections, chronic and recurrent lower respiratory tract infections), other dosages of Augmentin are recommended. ® - 1 tab. 500 mg / 125 mg 3 times / day or 1 tab. 875 mg / 125 mg 2 times / day.
Special groups of patients
Children under 12 years of age weighing less than 40 kg
It is recommended to use other dosage forms of the drug Augmentin ® .
No dose adjustment of the drug is required. In elderly patients with impaired renal function, the dose should be adjusted as indicated below for adults with impaired renal function.
Patients with impaired renal function
Dose adjustment is based on the maximum recommended dose of amoxicillin and is carried out taking into account the values of CK.
|QC||Tablets 250 mg + 125 mg||Pills
500 mg+125 mg
|>30 ml/min||Correction of the dosage regimen is not required||Correction of the dosage regimen is not required|
|10-30 ml/min||1 tab. 250 mg + 125 mg (with mild and moderate course of infection) 2 times / day||1 tab. 500 mg + 125 mg (with medium and severe course of infection) 2 times / day|
|<10 ml/min||1 tab. 250 mg + 125 mg (with mild and moderate course of infection) 1 time / day||1 tab. 500 mg + 125 mg (with medium and severe course of infection) 1 time / day|
In most cases, parenteral therapy should be preferred if possible.
Tablets of 875 mg + 125 mg should be used only in patients with CK >30 ml / min, while correction of the dosage regimen is not required.
Patients on hemodialysis
Dose adjustment is based on the maximum recommended dose of amoxicillin: 2 tab. 250 mg/125 mg or 1 tab. 500 mg / 125 mg in one dose every 24 h. During the hemodialysis session, an additional 1 dose (1 tab.) and another 1 dose (1 tab.) at the end of the dialysis session (to compensate for the decrease in serum concentrations of amoxicillin and clavulanic acid).
Patients with impaired liver function
Treatment is carried out with caution; regularly monitor liver function. There is not enough data to correct the dosage regimen in this category of patients.
Undesirable reactions presented below are listed in accordance with the defeat of organs and organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows: very often (≥1/10), often (≥1/100, <1/10), infrequently (≥1/1000, <1/100), rarely (≥1/10,000, <1/1000), very rare (<1/10,000, including isolated cases).
Frequency categories were formed on the basis of clinical studies of the drug and post-registration observation.
Infectious and parasitic diseases: often - candidiasis of the skin and mucous membranes.
On the part of the hematopoietic 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 be observed 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 digestive system: 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 starting the drug, undesirable reactions from the gastrointestinal tract are observed, they can be eliminated if you take the drug at the beginning of a meal.
Infrequently - digestive disorders; very rarely - antibiotic-associated colitis induced by taking antibiotics (including pseudomembranous colitis and hemorrhagic colitis) (see section "Special instructions"), black "hairy" tongue, gastritis, stomatitis.
From the liver and biliary tract: infrequently - moderate increase in the activity of ACT and / or ALT (observed in patients receiving therapy with beta-lactam antibiotics, but its clinical significance is unknown); very rarely - hepatitis and cholestatic jaundice (these reactions were noted during therapy with other penicillins and cephalosporins), an increase in the concentration of bilirubin and alkaline phosphatase.
Undesirable reactions from the liver have been observed mainly in men and elderly patients and may be associated with long-term therapy. These undesirable reactions are very rarely observed in children.
The listed signs and symptoms usually occur during or immediately after the end of therapy, but in some cases may not appear for several weeks after the completion of therapy. Adverse reactions are usually reversible.
Adverse reactions from the liver can be severe, in extremely rare cases there have been reports of deaths. 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 zpidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis.
In case of skin allergic reactions, treatment with Augmentin ® must stop.
From the urinary system: very rarely - interstitial nephritis, crystalluria, hematuria.
The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C.
The shelf life of the drug after opening the package of laminated aluminum foil is 30 days.
- Dosage form
- Amoxicillin+[Clavulanic Acid]
- Number of tablets
- INN Russian
- Амоксициллин+[Клавулановая кислота]
- Russian title