Symptoms: disorders of the water-electrolyte balance can also be observed on the part of the gastrointestinal tract.
Amoxicillin crystalluria is described, which in some cases led to the development of renal failure (see "Special instructions").
Seizures 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. Amoxicillin and clavulanic acid can be removed from the bloodstream by hemodialysis.
The results of a prospective study, which was conducted with 51 children in a toxicology 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.
For all dosage forms
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 when using a combination of amoxicillin with clavulanic acid in the anamnesis.
Optional for powder for preparation of suspension for oral administration, 125 mg 31.25 mg
phenylketonuria.
Optional for oral suspension powder, 200 mg 28.5 mg, 400 mg 57 mg
phenylketonuria,
impaired renal function (Creatinine Cl less than 30 ml / min),
children under 3 months of age.
Optional for film-coated tablets, 250 mg 125 mg, 500 mg 125 mg
children under 12 years of age or body weight less than 40 kg.
Optional for film-coated tablets, 875 mg 125 mg
impaired renal function (Creatinine Cl less than 30 ml / min),
children under 12 years of age or body weight less than 40 kg.
With caution: liver function disorders.
Simultaneous use of the drug Augmentin® and probenecid is not recommended. Probenecid reduces the tubular secretion of amoxicillin, and therefore the 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.
Concomitant use of allopurinol and amoxicillin may increase the risk of skin allergic reactions. Currently, there is no data in the literature on the simultaneous use of a combination of amoxicillin with clavulanic acid and allopurinol.
Penicillins are able to slow the elimination of methotrexate from the body by inhibiting its tubular secretion, so the simultaneous use of the drug Augmentin and methotrexate can increase the toxicity of methotrexate.
Like other antibacterial drugs, the drug Augmentin® it can affect the intestinal microflora, leading to a decrease in the absorption of estrogens from the gastrointestinal tract and a decrease in the effectiveness of combined oral contraceptives.
The literature describes rare cases of increased MHO in patients with the combined use of acenocumarol or warfarin and amoxicillin. If necessary, simultaneous administration of the drug Augmentin® with anticoagulants PV or MHO should be carefully monitored when prescribing or discontinuing the drug Augmentin®, it may be necessary to adjust the dose of anticoagulants for oral administration.
Powder: white or almost white in color, with a characteristic smell. When diluted, a suspension of white or almost white color is formed. When standing, a sediment of white or almost white color is slowly formed.
Tablets, 250 mg 125 mg: covered with a film shell from white to almost white in color, oval in shape, with the inscription "AUGMENTIN" indented on one side. At the break: from yellowish-white to almost white.
Tablets, 500 mg 125 mg: covered with a film shell from white to almost white in color, oval in shape, with the inscription "AC" pressed out and a risk on one side.
Tablets, 875 mg 125 mg: covered with a film shell from white to almost white in color, oval in shape, with the letters " A " and " C " on both sides and a fault line on one side. At the break: from yellowish-white to almost white.
The adverse events presented below are listed according to the lesion of organs and organ systems and the frequency of occurrence. The frequency of occurrence is defined as follows: very often - ≥1/10, often - ≥1/100 and <1/10, infrequently - ≥1/1000 and <1/100, rarely - ≥1/10000 and <1/1000, very rarely - <1/10000, including individual cases. Frequency categories were formed based on clinical trials of the drug and post-registration follow-up.
Infectious and parasitic diseases: often-candidiasis of the skin and mucous membranes.
From the blood and lymphatic system: rarely-reversible leukopenia (including neutropenia), reversible thrombocytopenia, very rarely-reversible agranulocytosis and reversible hemolytic anemia, prolonged bleeding time and PV, anemia, eosinophilia, thrombocytosis.
On the part of 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, seizures (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 changes.
From the gastrointestinal tract:
- adults: very often — diarrhea, often-nausea, vomiting,
- children: often-diarrhea, nausea, vomiting,
- whole population: nausea was most often associated with the use of high doses of the drug. If after the start of taking the drug, there are adverse reactions from the gastrointestinal tract, they can be eliminated if you take Augmentin® at the beginning of a meal, rarely-digestive disorders, very rarely-antibiotic-associated colitis (including pseudomembranous colitis and hemorrhagic colitis), black "hairy" tongue, gastritis, stomatitis, discoloration of the surface layer of tooth enamel in children. Oral care helps to prevent discoloration of the teeth, as it is enough to brush your teeth.
From the liver and biliary tract: rarely, a moderate increase in the activity of AST and/or ALT. This phenomenon is observed in patients receiving beta-lactam antibiotics, but its clinical significance is unknown. Very rarely — hepatitis and cholestatic jaundice. These phenomena are observed in patients receiving therapy with penicillin-type antibiotics and cephalosporins. Increase in the concentration of bilirubin and alkaline phosphatase.
Adverse events from the liver are observed mainly in men and elderly patients and may be associated with long-term therapy. These adverse events 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 they may not appear for several weeks after the end of therapy. Adverse events are usually reversible. Adverse events from the liver can be severe, in extremely rare cases, there have been reports of fatal outcomes. In almost all cases, these were patients with serious comorbidities or patients 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 epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis.
In case of skin allergic reactions, treatment with Augmentin® it must be stopped.
From the kidneys and urinary tract: very rarely-interstitial nephritis, crystalluria (see "Overdose"), hematuria.
According to the recipe.
Before starting treatment with Augmentin® It is necessary to collect a detailed history of previous hypersensitivity reactions to penicillins, cephalosporins or other substances that cause an allergic reaction in the patient.
Serious and sometimes fatal hypersensitivity reactions (anaphylactic reactions) to penicillins have been described. The risk of such reactions is highest in patients with a history of hypersensitivity reactions to penicillins. In the event of an allergic reaction, it is necessary to stop treatment with Augmentin® and start appropriate alternative therapy.
In case of serious anaphylactic reactions, epinephrine should be administered immediately to the patient. Oxygen therapy, intravenous administration of corticosteroids, and airway patency, including intubation, may also be required.
In case of suspected infectious mononucleosis, the drug Augmentin® It should not be used, because in patients with this disease, amoxicillin can cause a bark-like skin rash, which makes it difficult to diagnose the disease.
Long-term treatment with Augmentin® may lead to excessive proliferation of insensitive microorganisms.
In general, the drug Augmentin® it is well tolerated and has a low toxicity characteristic of all penicillins. During long-term therapy with Augmentin® It is recommended to periodically evaluate the function of the kidneys, liver and hematopoiesis.
In order to reduce the risk of side effects from the gastrointestinal tract, you should take the drug at the beginning of a meal.
In patients treated with a combination of amoxicillin and clavulanic acid together with indirect (oral) anticoagulants, an increase in PV (an increase in MHO) was rarely reported. When co-prescribing indirect (oral) anticoagulants with a combination of amoxicillin and clavulanic acid, it is necessary to monitor the appropriate parameters. To maintain the desired effect of oral anticoagulants, it may be necessary to adjust their dose.
In patients with impaired renal function, the dose of the drug Augmentin® it should be prescribed according to the degree of violation (see " Method of administration and doses», Patients with impaired renal function).
In patients with reduced diuresis, crystalluria occurs very rarely, mainly with parenteral therapy. During the administration of high doses of amoxicillin, it is recommended to take a sufficient amount of fluid and maintain adequate diuresis to reduce the likelihood of amoxicillin crystals forming (see "Overdose").
Taking the drug Augmentin® ingestion leads to a high content of amoxicillin in the urine, which can lead to false positive results when determining glucose in the urine (for example, the Benedict test, the Fehling 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 to prevent tooth discoloration associated with taking the drug, since it is enough to brush your teeth (for suspensions).
It is necessary to use the drug Augmentin® within 30 days of opening the laminated aluminum foil package (for tablets)
Abuse and drug addiction. There was no drug dependence, addiction, or euphoric reactions associated with the use of the drug Augmentin®.
Influence on the ability to drive vehicles and work with mechanisms. Since the drug can cause dizziness, it is necessary to warn patients about precautions when driving a vehicle or working with moving mechanisms.
The combination of amoxicillin with clavulanic acid is indicated for the treatment of bacterial infections of the following localizations caused by microorganisms sensitive to the combination of amoxicillin with clavulanic acid:
upper respiratory tract infections (including ENT infections), e.g. recurrent tonsillitis, sinusitis, otitis media, commonly caused by Streptococcus pneumoniae, Haemophilus influenzae1, Moraxella catarrhalis1 and Streptococcus pyogenes, (except the tablet of Augmentin 250 mg/125 mg),
lower respiratory tract infections, such as exacerbations of chronic bronchitis, lobar pneumonia, and bronchopneumonia, commonly caused by Streptococcus pneumoniae, Haemophilus influenzae1 and Moraxella catarrhalis1,
infections of the genitourinary tract, such as cystitis, urethritis, pyelonephritis, female genital infections, usually caused by species of the family Enterobacteriaceae1 (mostly Escherichia coli1), Staphylococcus saprophyticus and species of the genus Enterococcus, as well as gonorrhea caused by Neisseria gonorrhoeae1,
skin and soft tissue infections, commonly caused by Staphylococcus aureus1, Streptococcus pyogenes and species of the genus Bacteroides1,
bone and joint infections, such as osteomyelitis, commonly caused by Staphylococcus aureus1, if necessary, it is possible to conduct long-term therapy.
odontogenic infections, such as periodontitis, odontogenic maxillary sinusitis, severe dental abscesses with spreading cellulite (only for tablet forms of Augmentin, dosages of 500 mg/125 mg, 875 mg/125 mg),
other mixed infections (e.g. septic abortion, postpartum sepsis, intraabdominal sepsis) as part of step therapy (only for tablet forms of Augmentin dosage 250 mg / 125 mg, 500 mg/125 mg, 875 mg/125 mg),
1 Some representatives of this genus of microorganisms produce beta-lactamase, which makes them insensitive to amoxicillin (see "Pharmacodynamics").
Infections caused by amoxicillin-sensitive microorganisms can be treated with Augmentin® since amoxicillin is one of its active ingredients. The drug Augmentin® It is also indicated for the treatment of mixed infections caused by microorganisms sensitive to amoxicillin, as well as beta-lactamase-producing microorganisms sensitive to the combination of amoxicillin with clavulanic acid.
The sensitivity of bacteria to the combination of amoxicillin with clavulanic acid varies depending on the region and over time. Where possible, local sensitivity data should be taken into account. If necessary, microbiological samples should be collected and analyzed for bacteriological sensitivity.
Amoxicillin is a broad-spectrum semi-synthetic antibiotic with activity against many Gram-positive and Gram-negative microorganisms. At the same time, amoxicillin is susceptible to destruction by beta-lactamases, and therefore the spectrum of activity of amoxicillin does not extend to microorganisms that produce this enzyme.
Clavulanic acid, a beta-lactamase inhibitor structurally related to penicillins, has the ability to inactivate a wide range of beta-lactamases found in microorganisms resistant to penicillins and cephalosporins. Clavulanic acid is sufficiently effective against plasmid beta-lactamases, which most often cause bacterial resistance, and less effective against chromosomal beta-lactamases of type 1, which are not inhibited by clavulanic acid.
The presence of clavulanic acid in the preparation Augmentin® protects amoxicillin from destruction by enzymes-beta-lactamases, which allows you to expand the antibacterial spectrum of amoxicillin.
Below is the activity of the combination of amoxicillin with clavulanic acid in vitro.
Bacteria usually sensitive to the combination of amoxicillin with clavulanic acid
Gram-positive airbags: Bacillus anthracis, Enterococcus faecalis, Listeria monocytogenes, Nocardia asteroides, Streptococcus spp., incl. Streptococcus pyogenes1,2, Streptococcus agalactiae1,2 (other beta-hemolytic streptococci)1,2, Staphylococcus aureus (sensitive to methicillin)1, Staphylococcus saprophyticus (sensitive to methicillin), coagulase-negative staphylococci (sensitive to methicillin).
Gram-positive anaerobes: Clostridium spp., Peptococcus niger, Peptostreptococcus spp., incl. Peptostreptococcus magnus, Peptostreptococcus micros.
Gram-negative aerobes: Bordetella pertussis, Haemophilus influenzae1, Helicobacter pylori, Moraxella cafarrhalis1, Neisseria gonorrhoeae, Pasteurella multocida, Vibrio cholerae.
Gram-negative anaerobes: Bacteroides spp., incl. Bacteroides fragilis, Capnocytophaga spp., Eikenella corrodens, Fusobacterium spp., incl. Fusobacterium nucleatum, Porphyromonas spp., Prevotella spp.
Other: Borrelia burgdorferi, Leptospira icterohaemorrhagiae, Treponema pallidum.
Bacteria that are likely to have acquired resistance to the combination of amoxicillin with clavulanic acid
Gram-negative aerobes: Escherichia coli1, Klebsiella spp., incl. Klebsiella oxytoca, Klebsiella pneumoniae1, Proteus spp., incl. Proteus mirabilis, Proteus vulgaris, Salmonella spp., Shigella spp.
Gram-positive airbags: Corynebacterium spp., Enterococcus faecium, Streptococcus pneumoniae1,2, streptococci group Viridans.
Bacteria that are naturally resistant to the 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 spp., incl. Chlamydia pneumoniae, Chlamydia psittaci, Coxiella burnetii, Mycoplasma spp.
1 For these bacteria, the clinical efficacy of the combination of amoxicillin with clavulanic acid has been demonstrated in clinical studies.
2 Strains of these types of bacteria do not produce beta-lactamase. The sensitivity of amoxicillin monotherapy suggests a similar sensitivity to the combination of amoxicillin with clavulanic acid.
Suction
Both active ingredients of the drug Augmentin® - amoxicillin and clavulanic acid-quickly and completely absorbed from the gastrointestinal tract after oral administration. Absorption of the active substances of the drug Augmentin® it is optimal in the case of taking the drug at the beginning of a meal.
The data on the pharmacokinetic parameters of amoxicillin and clavulanic acid obtained in different studies are shown below, when healthy volunteers aged 2-12 years on an empty stomach took three doses of 40 mg 10 mg/kg/day of the drug Augmentin®, powder for preparation of suspension for oral administration, 125 mg 31.25 mg in 5 ml (156.25 mg).
Table 1
Basic pharmacokinetic parameters
| Medication | Dose, mg / kg | Cmax, mg/l | Tmax, h | AUC, mg * h/l | T1/2, h |
| Amoxicillin | |||||
| Augmentin®, 125 mg 31.25 mg in 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 in 5 ml | 10 | 2,7±1,6 | 1,6 (1–2) | 5,5±3,1 | 1,6 (1–2) |
The data on the pharmacokinetic parameters of amoxicillin and clavulanic acid obtained in different studies when healthy volunteers aged 2-12 years took the drug Augmentin on an empty stomach are shown below®, powder for preparation of suspension for oral administration, 200 mg 28.5 mg in 5 ml (228.5 mg) at a dose of 45 mg 6.4 mg / kg / day, divided into two doses.
Table 2
Basic pharmacokinetic parameters
| Active ingredient | 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 |
The data on the pharmacokinetic parameters of amoxicillin and clavulanic acid obtained in different studies when healthy volunteers took a single dose of Augmentin are shown below®, powder for preparation of suspension for oral administration, 400 mg 57 mg in 5 ml (457 mg).
Table 3
Basic pharmacokinetic parameters
| Active ingredient | 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 |
The data on the pharmacokinetic parameters of amoxicillin and clavulanic acid obtained in different studies when healthy volunteers on an empty stomach took:
- 1 table of the drug Augmentin®, 250 mg 125 mg (375 mg),
- 2 tab. of the drug Augmentin®, 250 mg 125 mg (375 mg),
- 1 table of the drug Augmentin®, 500 mg 125 mg (625 mg),
- 500 mg of amoxicillin,
- 125 mg of clavulanic acid.
Table 4
Basic pharmacokinetic parameters
| Medication | Dose, mg | Cmax, mg / ml | Tmax, h | AUC, mg * h/l | T1/2, h |
| Amoxicillin in the composition of the drug Augmentin® | |||||
| Augmentin®, 250 mg 125 mg | 250 | 3,7 | 1,1 | 10,9 | 1 |
| 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 |
| 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 |
| Clavulanic acid, 125 mg | 125 | 3,4 | 0,9 | 7,8 | 0,7 |
| Augmentin®, 500 mg 125 mg | 125 | 2,8 | 1,3 | 7,3 | 0,8 |
When using the drug Augmentin® Plasma concentrations of amoxicillin are similar to those of oral equivalent doses of amoxicillin.
The data on the pharmacokinetic parameters of amoxicillin and clavulanic acid obtained in separate studies when healthy volunteers on an empty stomach took:
- 2 tab. of the drug Augmentin®, 875 mg 125 mg (1000 mg).
Table 5
Basic pharmacokinetic parameters
| Medication | Dose, mg | Cmax, mg/l | Tmax, h | AUC, mg * h/l | T1/2, h |
| Amoxicillin in the composition of the drug Augmentin® | |||||
| 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®, 875 mg 125 mg | 250 | 2,18±0,99 | 1,25 (1–2) | 10,16±3,04 | 0,96±0,12 |
Distribution
As with the intravenous administration of a combination of amoxicillin and clavulanic acid, therapeutic concentrations of amoxicillin and clavulanic acid are found in various tissues and interstitial fluid (gallbladder, abdominal tissue, skin, adipose and muscle tissue, synovial and peritoneal fluid, bile, purulent discharge).
Amoxicillin and clavulanic acid have a weak degree of binding to plasma proteins. Studies have shown that about 25% of the total amount of clavulanic acid and 18% of amoxicillin in the blood plasma binds to plasma proteins.
In animal studies, no accumulation of the components of the drug Augmentin was found® in any body.
Amoxicillin, like most penicillins, can be detected in breast milk. Trace amounts of clavulanic acid may also be found in breast milk. With the exception of the possibility of diarrhea and candidiasis of the oral mucosa, no other negative effects of amoxicillin and clavulanic acid on the health of infants fed with breast milk are known.
Studies of reproductive function in animals have shown that amoxicillin and clavulanic acid penetrate the placental barrier. However, there was no negative effect on the fetus.
Metabolism
10-25% of the initial dose of amoxicillin is excreted by the kidneys as an inactive metabolite (penicillic acid). Clavulanic acid undergoes intensive metabolism to 2,5-dihydro-4 - (2-hydroxyethyl) - 5-oxo-3H-pyrrole-3-carboxylic acid and-amino-4-hydroxy-butane-2-one and is excreted by the kidneys, through the gastrointestinal tract, and with exhaled air in the form of carbon dioxide.
Output
Like other penicillins, amoxicillin is mainly excreted by the kidneys, while clavulanic acid is excreted by both the renal and extrarenal mechanisms.
Approximately 60-70% of amoxicillin and about 40-65% of clavulanic acid are excreted unchanged by the kidneys in the first 6 hours after taking 1 table 250 mg 125 mg or 1 table 500 mg 125 mg.
Simultaneous administration of probenecid slows down the removal of amoxicillin but not of clavulanic acid (see "Interaction").
In a dry place, at a temperature not exceeding 25 °C. The prepared suspension is stored in the refrigerator at a temperature of 2-8 °C.
Keep out of reach of children.
Shelf life of the drug Augmentin®film-coated tablets 250 mg 125 mg — 2 years.
film-coated tablets 500 mg 125 mg — 3 years.
film-coated tablets 875 mg 125 mg — 3 years.
powder for preparation of suspension for oral administration 125mg 31.25 mg/5ml — 2 years. Prepared suspension — 7 days.
powder for preparation of suspension for oral administration 200 mg 28.5 mg/5 ml 200 mg 28.5 mg/5-2 years. Prepared suspension — 7 days.
powder for preparation of suspension for oral administration 400 mg 57 mg/5 ml 400 mg 57 mg/5-2 years. Prepared suspension — 7 days.
Do not use after the expiration date indicated on the package.
| Powder for preparation of suspension for oral administration | 5 ml |
| active ingredients: | |
| amoxicillin trihydrate (in terms of amoxicillin) | 125 mg |
| 200 mg | |
| 400 mg | |
| potassium clavulanate (in terms of clavulanic acid)1 | 31.25 mg |
| 28.5 mg | |
| 57 mg | |
| excipients: xanthan gum— 12,5/12,5/12,5 mg, aspartame— 12,5/12,5/12,5 mg, succinic acid— 0,84/0,84/0,84 mg, colloidal silicon dioxide-25/25/25 mg, hypromellose-150/79, 65/79, 65 mg, orange flavor 1-15/15/15 mg, orange flavor 2 — 11,25/11,25/11,25 mg, raspberry flavor— 22,5/22,5/22,5 mg, flavoring "Light molasses"— 23,75/23,75/23,75 mg, silicon dioxide-125/up to 552/up to 900 mg |
1 In the production of the drug, potassium clavulanate is laid with a 5% excess.
| Film-coated tablets | 1 table. |
| active ingredients: | |
| amoxicillin trihydrate (in terms of amoxicillin) | 250 mg |
| 500 mg | |
| 875 mg | |
| potassium clavulanate (in terms of clavulanic acid) | 125 mg |
| 125 mg | |
| 125 mg | |
| excipients: magnesium stearate— 6,5/7,27/14,5 mg, sodium carboxymethyl starch-13/21/29 mg, colloidal silicon dioxide— 6,5/10,5/10 mg, MCC-650/up to 1050/396. 5 mg | |
| the shell film: titanium dioxide— 9,63/11,6/13,76 mg, hypromellose (5 cps)— 7,39/8,91/10,56 mg, hypromellose (15 cps) — 2,46/2,97/3,52 mg, macrogol 4000 — 1,46/1,76/2,08 mg, macrogol 6000 — 1,46/1,76/2,08 mg, dimethicone 500 (silicone oil) — 0,013/0,013/0,013 mg, purified water1 — -/-/- |
1 The purified water is removed during the application of the film shell.
Release formPowder for preparation of suspension for oral administration, 125 mg 31.25 mg in 5 ml. In a transparent glass bottle, closed with a screw-on aluminum lid with the control of the first opening, 11.5 g. 1 fl. together with a measuring cap in a cardboard pack.
Powder for preparation of suspension for oral administration, 200 mg 28.5 mg in 5 ml, 400 mg 57 mg in 5 ml. In a clear glass bottle, closed with a screw-on aluminum lid with the control of the first opening, 7.7 g (for a dosage of 200 mg 28.5 mg in 5 ml) or 12.6 g (for a dosage of 400 mg 57 mg in 5 ml). 1 fl.together with a measuring cap or a dosing syringe in a cardboard pack.
Film-coated tablets, 250 mg 125 mg. In aluminum / PVC blister 10 pcs. 1 blister with a bag of silica gel in a package of laminated aluminum foil. 2 foil packages in a cardboard pack.
Film-coated tablets, 500 mg 125 mg. In aluminum/PVC/PVDH blister 7 or 10 pcs. 1 blister with a bag of silica gel in a package of laminated aluminum foil. 2 packages of laminated aluminum foil in a cardboard pack.
Film-coated tablets, 850 mg 125 mg. In an aluminum / PVC blister 7 pcs. 1 blister with a bag of silica gel in a package of laminated aluminum foil. 2 foil packages in a cardboard pack.
In studies of reproductive functions in animals, oral and parenteral administration of the drug Augmentin® it did not cause teratogenic effects.
In a single study in women with premature rupture of the fetal membranes, it was found that preventive therapy with the drug Augmentin® It may be associated with an increased risk of necrotizing enterocolitis in newborns. Like all drugs, the drug Augmentin® it is not recommended to use during pregnancy, except in cases where the expected benefit to the mother exceeds the potential risk to the fetus.
The drug Augmentin® it can be used during breastfeeding. With the exception of the possibility of diarrhea or candidiasis of the oral mucosa associated with the penetration of trace amounts of the active substances of this drug into breast milk, no other adverse effects were observed in infants who were breastfed. If adverse effects occur in infants who are breastfed, it is necessary to stop breastfeeding.
Inside.
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.
To reduce potential gastrointestinal disorders and to optimize absorption, the drug should be taken at the beginning of a meal. The minimum course of antibacterial therapy is 5 days.
Treatment should not last more than 14 days without reviewing the clinical situation.
If necessary, it is possible to conduct step-by-step therapy (first, parenteral administration of the drug, followed by a transition to oral administration).
It should be remembered that 2 table. of the drug Augmentin®, 250 mg 125 mg are not equivalent to 1 tablet of the drug Augmentin®, 500 mg 125 mg.
Adults and children 12 years and older or with a body weight of 40 kg or more. It is recommended to use 11 ml of suspension at a dosage of 400 mg 57 mg in 5 ml, which is equivalent to 1 table of the drug Augmentin®, 875 mg 125 mg.
1 table. 250 mg 125 mg 3 times a 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 table. 500 mg 125 mg 3 times a day.
1 table. 875 mg 125 mg 2 times a day.
Children aged 3 months to 12 years with a body weight of less than 40 kg. The dose is calculated depending on the age and body weight, indicated in mg/kg/day or in ml of suspension. The daily dose is divided into 3 doses every 8 hours (125 mg 31.25 mg) or 2 doses every 12 hours (200 mg 28.5 mg, 400 mg 57 mg). The recommended dosage regimen and the frequency of administration are shown in the table below.
Table 6
Dosage regimen of the drug Augmentin® (the dose was calculated using amoxicillin)
| Doses | Suspension 4:1 (125 mg 31.25 mg in 5 ml), in 3 doses every 8 hours | Suspension 7: 1 (200 mg 28.5 mg in 5 ml or 400 mg 57 mg in 5 ml), in 2 doses every 12 hours |
| Low prices | 20 mg / kg / day | 25 mg / kg / day |
| High | 40 mg / kg / day | 45 mg / kg / day |
Low-dose Augmentin® recommended for the treatment of skin and soft tissue infections, as well as recurrent tonsillitis.
High doses of the drug Augmentin® recommended for the treatment of diseases such as otitis media, sinusitis, lower respiratory tract and urinary tract infections, bone and joint infections.
Insufficient clinical data to recommend the use of Augmentin® at a dose of more than 40 mg 10 mg / kg in 3 doses (suspension 4:1) in children under 2 years of age.
Children from birth to 3 months. Due to immaturity of the excretory function of the kidneys, the recommended dose of the drug Augmentin® (calculation for amoxicillin) is 30 mg / kg / day in 2 doses in the form of a 4:1 suspension.
Children born prematurely. There are no recommendations regarding the dosage regimen.
Special patient groups
Elderly patients. Correction of the dosage regimen is not required, the same dosage regimen is used as in younger patients. In elderly patients with impaired renal function, appropriate doses are prescribed for adult patients with impaired renal function.
Patients with impaired liver function. Treatment is carried out with caution, liver function is regularly monitored. There is not enough data to change the dose recommendations in these patients.
Patients with impaired renal function. The correction of the dosage regimen is based on the maximum recommended dose of amoxicillin and the value of creatinine clearance.
Table 7
Dosage regimen of the drug Augmentin®
| Cl creatinine clearance, ml/min | Suspension 4:1 (125 mg 31.25 mg in 5 ml) | Suspension 7: 1 (200 mg 28.5 mg in 5 ml or 400 mg 57 mg in 5 ml) | Film-coated tablets, 250 mg 125 mg | Film-coated tablets, 500 mg 125 mg | Film-coated tablets, 875 mg 125 mg |
| >30 | Correction of the dosage regimen is not required | Correction of the dosage regimen is not required | Correction of the dosage regimen is not required | Correction of the dosage regimen is not required | Correction of the dosage regimen is not required |
| 10–30 | 15 mg 3.75 mg / kg 2 times a day, the maximum dose is 500 mg 125 mg 2 times a day | — | 1 table. (for mild and moderate infection) 2 times a day | 1 table. (for mild and moderate infection) 2 times a day | — |
| <10 | 15 mg 3.75 mg / kg / day, maximum dose-500 mg 125 mg/day | — | 1 table. (for mild and moderate infection) 1 time per day | 1 table. (for mild and moderate infection) 1 time per day | — |
In most cases, if possible, preference should be given to parenteral therapy.
Patients undergoing hemodialysis. Powder for the preparation of a solution for oral administration: 15 mg 3.75 mg / kg / day.
Before the hemodialysis session, one additional dose of 15 mg 3.75 mg/kg should be administered.
To restore the concentrations of the active components of the drug Augmentin® in the blood, a second additional dose of 15 mg 3.75 mg / kg should be administered after the hemodialysis session.
Film-coated tablets, 250 mg 125 mg: correction of the dosage regimen is based on the maximum recommended dose of amoxicillin.
2 table. 250 mg 125 mg in 1 dose every 24 hours.
During the dialysis session, an additional 1 dose (1 table) and another 1 table. at the end of the dialysis session (to compensate for the decrease in serum concentrations of amoxicillin and clavulanic acid).
Film-coated tablets, 500 mg 125 mg: correction of the dosage regimen is based on the maximum recommended dose of amoxicillin.
1 table. 500 mg 125 mg in 1 dose every 24 hours.
During the dialysis session, an additional 1 dose (1 table) and another 1 table. at the end of the dialysis session (to compensate for the decrease in serum concentrations of amoxicillin and clavulanic acid).
Method of preparing a suspension of
The suspension is prepared immediately before the first application. In the bottle with the powder, add approximately 60 ml of boiled water, cooled to room temperature, then close the bottle with a lid and shake until the powder is completely diluted, let the bottle stand for 5 minutes to ensure complete dilution. Then add water to the label on the bottle and shake the bottle again. In general, the preparation of the suspension requires about 92 ml of water for a dosage of 125 mg 31.25 mg and 64 ml of water for dosages of 200 mg 28.5 mg and 400 mg 57 mg.
The bottle should be shaken well before each use. For accurate dosing of the drug, a measuring cap should be used, which should be well washed with water after each application. After dilution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen.
For children under 2 years of age, a measured single dose of the suspension of the drug Augmentin® it can be diluted with water in a ratio of 1:1.
J01CR02 Amoxicillin in combination with a beta-lactamase inhibitor
