The instruction for medical use
of Augmentin® medicine
the Trade name
the International unlicensed name
Is not present
the Dosage form
of the Tablet, coated, 500 mg / 125 mg and 875 mg / 125 mg
One tablet contains
active agents: amoxicillin (in the form of trihydrate amoxicillin) 500 mg or 875 mg,
clavulanic acid (in the form of clavulanate potassium) 125 mg,
excipients: magnesium stearate, sodium of starch glikolit type A, silicon dioxide colloidal anhydrous, cellulose microcrystalline,
structure of a cover: titan dioxide (E 171), gipromelloza (5 cps), gipromelloza (15 cps), macrogoal 4000, macrogoal 6000, oil silicone (dimetikon 500).
of the Tablet of 500 mg / 125
Tablet mg, coated, an oval form from white till whitish color, with an engraving of A S and risky on one party and smooth on the other hand.
Tablets of 875 mg / 125
Tablet mg, coated, an oval form from white till whitish color, with risky on one party and an engraving of A S on both sides of a tablet.
Antibacterial drugs for system use. Penicillin in a combination with inhibitors beta laktamaz. Clavulanic acid + amoxicillin.
The ATX J01CR02 code
Pharmacokinetics Absorption Amoxicillin properties and clavulanate are well dissolved in aqueous solutions with physiological value rn, quickly and completely soaked up from digestive tract after oral administration. Absorption of amoxicillin and clavulanic acid is optimum in case of administration of drug at the beginning of food. After administration of drug in its bioavailability makes 70%. Profiles of both components of drug are similar and reach peak concentration in plasma (Tmax) approximately in 1 hour. Concentration of amoxicillin and clavulanic acid in blood serum is identical as in case of combined use of amoxicillin and clavulanic acid, and each component separately.
Therapeutic concentration of amoxicillin and clavulanic acid are reached in different bodies and fabrics, interstitial liquid (lungs, abdominal organs, the gall bladder, fat, bone and muscular fabrics, pleural, synovial and peritoneal liquids, skin, bile purulent separated to a phlegm). Amoxicillin and clavulanic acid practically do not get into cerebrospinal fluid.
Linking of amoxicillin and clavulanic acid with proteins of plasma moderate: 25% for clavulanic acid and 18% for amoxicillin. Amoxicillin, as well as the majority of penicillin, is emitted with breast milk. In breast milk trace amounts of clavulanic acid are also found. Except for risk of a sensitization, amoxicillin and clavulanic acid has no negative impact on health of the babies raised by breast milk. Amoxicillin and clavulanic acid get through a placental barrier.
Amoxicillin is removed, mainly by kidneys whereas clavulanic acid – by means of both renal, and extrarenal mechanisms. After single dose in one tablet of 250 mg / 125 mg or 500 mg / 125 the mg about 60-70% of amoxicillin and 40-65% of clavulanic acid during the first 6 h is removed with urine in not changed look.
Amoxicillin is partially allocated with urine in the form of inactive penicillic acid in the quantity equivalent to 10-25% of the accepted dose. Clavulanic acid in an organism is exposed to intensive metabolism to 2.5-digidro-4-(2 hydroxyethyl) – 5-oxo-1H-pyrrol-3-carboxylic acid and 1 – amino – 4 – hydroxy – butane – 2 – it also is allocated with urine and a stake and also in the form of carbon dioxide through expired air.
of Augmentin® is the combined antibiotic containing amoxicillin and clavulanic acid with a wide range of bactericidal action, resistant to a beta laktamaze.
Amoxicillin is the semi-synthetic antibiotic of a broad spectrum of activity active concerning many gram-positive and gram-negative microorganisms. Amoxicillin collapses under the influence of a beta laktamaz and does not affect microorganisms which produce this enzyme. The mechanism of effect of amoxicillin consists in inhibition of biosynthesis of peptidoglikan of a cell wall of a bacterium that usually leads to lysis and death of a cell.
Clavulanic acid is beta laktamat, on chemical structure close to penicillin which has ability to inactivate enzymes beta laktamaz the microorganisms showing to rezistentnosit to penicillin and cephalosporins, thereby preventing an amoxicillin inactivation. Beta laktamazy are produced by many gram-positive and gram-negative bacteria. Action beta laktamaz can lead to destruction of some antibacterial drugs even prior to their impact on pathogens. Clavulanic acid blocks effect of enzymes, restoring sensitivity of bacteria to amoxicillin. In particular, it has high activity concerning plasmid beta laktamaz with which the medicinal resistance is often connected, but is less effective concerning chromosomal beta laktamaz 1 type.
Presence of clavulanic acid at structure of Augmentina® protects amoxicillin from the destroying action beta laktamaz and expands its range of antibacterial activity with inclusion in it of the microorganisms usually resistant to other penicillin and cephalosporins. Clavulanic acid in the form of monodrug does not render clinically significant antibacterial effect.
The mechanism of development of resistance
Exists 2 mechanisms of development of resistance to Augmentinu®
– an inactivation bacterial beta lactamelements which are insensitive to clavulanic acid influence, including the classes B, C, D
– deformation penicillin – the connecting protein that
the Impermeability of a bacterial wall leads to reduction of affinity of an antibiotic in relation to a microorganism and also mechanisms of a pomp can cause or contribute to the development of resistance, especially at gram-negative microorganisms.
Аугментин® has bactericidal effect on the following microorganisms:
Gram-positive aerobes: Enterococcus faecalis, Gardnerella vaginalis, Staphylococcus aureus (sensitive to Methicillinum), a coagualase – negative staphylococcus (sensitive to Methicillinum), Streptococcus agalactiae, Streptococcus pneumoniae1, Streptococcus pyogenes and other beta and hemolytic streptococci, the group Streptococcus viridans, Bacillius anthracis, Listeria monocytogenes, Nocardia asteroides
Gram-negative aerobes: Actinobacillus actinomycetemcomitans, Capnocytophaga spp., Eikenella corrodens, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae, Pasteurella multocida
anaerobic microorganisms: Bacteroides fragilis, Fusobacterium nucleatum, Prevotella spp.
Microorganisms with the possible acquired resistance
Gram-positive aerobes: Enterococcus faecium *
Gram-negative aerobes: Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris
Microorganisms with natural resistance:
gram-negative aerobes: Acinetobacter species, Citrobacter freundii, Enterobacter species, Legionella pneumophila, Morganella morganii, Providencia species, Pseudomonas species, Serratia species, Stenotrophomonas maltophilia,
other: Chlamydia trachomatis, Chlamydophila pneumoniae, Chlamydophila psittaci, Coxiella burnetti, Mycoplasma pneumoniae.
* The natural sensitivity in the absence of the acquired resistance
1 except for strains of Streptococcus pneumoniae resistant to penicillin
– upper respiratory tract infections (recurrent tonsillitis, sinusitis, average otitis)
– lower respiratory tract infections (exacerbation of chronic bronchitis, share pneumonia, bronchial pneumonia)
– infections of an urinogenital path (cystitis, an urethritis, pyelonephritis, gynecologic infections, gonorrhea)
– infections of skin and soft tissues (in particular, cellulitis, stings of animals, acute abscesses and phlegmons of maxillofacial area)
– infections of bones and joints (in particular, osteomyelitis)
– septic abortion, patrimonial sepsis, intraabdominal sepsis
the Route of administration and doses
can vary Sensitivity to Augmentinu® from the geographic location and time. Before prescribing of drug it is whenever possible necessary to estimate sensitivity of strains according to local data and to define sensitivity by a fence and the analysis of samples at the specific patient, especially in case of heavy infections.
Аугментин® it can be applied to treatment of the infections caused amoxicillin – sensitive microorganisms, and the multi-infections caused amoxicillin – and clavulanate – the sensitive strains producing beta lactamazu.
The mode of dosing is set individually depending on age, body weight, function of kidneys, infectious agents and also from severity of an infection.
For decrease in potential risk of influence on digestive tract, Augmentin® is recommended to be accepted together with food, at the beginning of food for its maximum absorption. Time of the carried-out therapy depends on the response of the patient to the carried-out treatment. Some pathologies (in particular, osteomyelitis) can demand longer course. It is not necessary to continue treatment more than 14 days without repeated assessment of a condition of the patient. If necessary performing step therapy is possible (intravenous administration of drug with the subsequent transition to oral administration in the beginning).
Adults and children are more senior than 12 years or with body weight more than 40 kg
the Easy and medium-weight course of an infection (standard dose)
1 tablet of 500 mg / 125 mg 2-3 times a day or 1 tablet of 875 mg / 125 mg 2 times a day
Heavy infections (a lower respiratory tract infection, an infection of an urinogenital path)
1-2 tablet of 500 mg / 125 mg 3 times a day or 1 tablet of 875 mg / 125 mg 2 or 3 times a day
the Maximum daily dose for adults and children is more senior than 12 years applying tablets a dosage of 500 mg / 125 mg, makes 1500 mg of amoxicillin / 375 clavulanic acid mg. For tablets a dosage of 875 mg / 125 to mg the maximum daily dose is equal to 1750 mg of amoxicillin / 250 to clavulanic acid mg (at reception 2 times a day) or 2625 mg of amoxicillin / 375 to clavulanic acid mg (at reception 3 times a day).
Children are younger than 12 years or with body weight less than 40 kg
This dosage form is not intended for children 12 years or children with body weight less than 40 kg are younger. To such children appoint Augmentin® in the form of suspension for intake.
Patients with a renal failure
the Correction of doses is based on the maximum recommended dose of amoxicillin and value of clearance of creatinine.
Clearance of creatinine
the Mode of dosing Augmentina®
& gt, 30 ml/min.
Correction of a dose is not required
to 10-30 ml/min.
1 tablet of 500 mg / 125 by mg 2 times a day
& lt, 10 ml/min.
1 tablet of 500 mg / 125 the mg of 1 times in day
of the Tablet with a dosage of 875 mg / 125 mg should be applied only at patients with clearance of creatinine & gt, 30 ml/min.
The patients who are on a hemodialysis
the Correction of doses is based on the maximum recommended amoxicillin dose.
Adults: 1 tablet of 500 mg / 125 mg each 24 h. 1 dose is in addition appointed during the session of dialysis and one more dose at the end of dialysis session (for compensation of decrease in serumal concentration of amoxicillin and clavulanic acid).
Tablets with a dosage of 875 mg / 125 mg should be applied only at patients with clearance of creatinine & gt, 30 ml/min.
Patients with abnormal liver functions
carry out Treatment with care, regularly carry out monitoring of function of a liver.
it is not necessary to Reduce a dose of Augmentina®, a dose same, as for adults. At elderly patients with renal failures the dose should be adjusted as it is stated above for adults with renal failures.
Very often ≥ 1 of 10, is frequent ≥ 1 of 100 and & lt, 1 of 10, sometimes ≥ 1 of 1000 and & lt, 1 of 100, is rare ≥ 1 of 10000 and & lt, 1 of 1.000, also lt is very rare, 1 of 10000
– candidiasis of skin and mucous covers
– nausea, vomiting, diarrhea
Nausea meets at use of high doses of drug more often. For decrease in extent of manifestation it is recommended to accept suspension at the beginning of meal.
– dizziness, a headache
– moderate increase in level of liver enzymes of ALT/nuclear heating plant
– skin rash, an itching, a small tortoiseshell
– a reversible leukopenia (including a neutropenia), thrombocytopenia
– a multiformny erythema
– a reversible agranulocytosis and hemolytic anemia, increase in a bleeding time and the index of a prothrombin time
– a Quincke’s disease, an anaphylaxis, the syndrome similar to a serum disease, an allergic vasculitis
– reversible superactivity and spasms
– the antibtotiko-associated colitis (including pseudomembranous and hemorrhagic)
– black hairy language (chronic hyperplasia of threadlike nipples of language)
– hepatitis, cholestatic jaundice
– Stephens-Johnson’s syndrome, a toxic epidermal necrolysis, bullous exfoliative dermatitis, sharp generalized exanthematous pustulyoz. At development of these symptoms, drug has to be cancelled.
– interstitial nephrite,
the Contraindication crystalluria
– the known hypersensitivity to penicillin or to any component of drug
– the known hypersensitivity to others beta laktamnym to antibiotics (cephalosporins, karbapenema, monobaktama)
– the jaundice or an abnormal liver function which developed against the background of reception of a combination of amoxicillin/clavulanic acid
– children is younger than 12 years or children with body weight less than 40 kg
are not recommended to apply Augmentin® along with probenitsidy. Probenitsid reduces canalicular secretion of amoxicillin and therefore simultaneous use of Augmentina® and probenitsid can lead to the isolated increase in amoxicillin level blood.
Simultaneous use of Allopyrinolum and Augmentina® can increase risk of emergence of allergic reactions. Data on simultaneous use of Allopyrinolum and Augmentina® are absent now.
Аугментин® influences indestinal flora and leads to reduction of the return absorption of estrogen and decrease in efficiency of the combined oral contraceptives.
Cases of increase in a prothrombin time were revealed (atsenokumarol and warfarin) at simultaneous use of Augmentina® and anticoagulants it is necessary to carry out the corresponding monitoring with correcting of a dose of Augmentina® if necessary.
Penicillin can reduce removal of a methotrexate that is potential risk of increase in its toxicity.
At the patients accepting mikofenolat mofetit, at combined use with Augmentinom® the concentration of an active metabolite of mikofenolovy acid when assigning an initial dose decreases approximately by 50%. Change of level of concentration of an initial dose can not correspond to changes of concentration of total exposure of mikofenolovy acid.
Before an initiation of treatment of Augmentinom® need to be collected the detailed anamnesis concerning the previous reactions of hypersensitivity to penicillin, cephalosporins or others beta laktamnye antibiotics.
Also fatal reactions of hypersensitivity (acute anaphylaxis) on penicillin which came to light at patients with the previous hypersensitivity on penicillin more often are described serious, and sometimes. In case of allergic reaction it is necessary to stop treatment of Augmentinom® and to begin alternative therapy. At development of serious reactions of hypersensitivity the patient should enter adrenaline immediately. Oxygenotherapy, the intravenous administration of steroids and ensuring passability of airways including an intubation can be required.
Аугментин® it is not necessary to appoint at suspicion of an infectious mononucleosis as with this disease amoxicillin can cause skin rash in patients that complicates diagnosis of a disease.
Long-term treatment of Augmentinom® can be followed by the overgrowth of microorganisms, insensitive to it.
Cases of development of pseudomembranous colitis against the background of use of antibiotics which weight varied from easy to heavy degree, life-threatening patients were revealed. Thus, it must be kept in mind possibility of this pathology at patients with diarrhea at reception of antibiotics or after the termination of a course of therapy. In case of development of long or considerable diarrhea, in the presence of spasms in a stomach, treatment of Augmentinom® has to be immediately stopped and patients have to be directed to further inspection.
In general, Augmentin® is transferred well and has hypotoxicity inherent to all penicillin. At long treatment of Augmentinom® it is recommended to estimate periodically functions of kidneys, a liver, bodies of a hemopoiesis.
At the patients receiving Augmentin® the increase in a prothrombin time therefore at simultaneous use of Augmentina® and anticoagulants it is necessary to carry out the corresponding monitoring with a possible dose decline of anticoagulant in case of need is occasionally observed.
With care it is necessary to apply Augmentin® at patients with an abnormal liver function. Signs and symptoms of damage of a liver usually arise in time or right after an initiation of treatment, but in certain cases can not be shown within several weeks after the therapy termination. As a rule, they are reversible. Hepatic violations can be very serious, and in extremely exceptional cases was reported about death. Almost always they were registered at patients with a serious basic disease or at those who at the same time took the drugs known as potentially influencing a liver.
At patients with a renal failure the dose of drug has to be adjusted according to disease severity.
When prescribing drug to patients with reduced function of kidneys or when using high doses the development of spasms is possible.
Patients with a reduced diuresis in rare instances can have a crystalluria. During introduction of high doses of amoxicillin it is recommended to accept enough liquid and to support an adequate diuresis for reduction of probability of formation of crystals of amoxicillin. At patients with a catheter constant assessment of their state is necessary.
Combined use of Allopyrinolum and amoxicillin increases a likelihood of development of skin allergic reactions.
During treatment by amoxicillin for determination of content of glucose in urine it is necessary to use methods of fermental oxidation of glucose as not fermental methods can lead to obtaining false positive results.
Presence of clavulanic acid at Augmentine® can be the cause of nonspecific binding of IgG and albumine with a membrane of erythrocytes that leads to false positive reaction of Koombs.
Pregnancy and the period of a lactation
of Augmentin® is not recommended to be applied during pregnancy unless, according to the doctor, it is necessary.
Аугментин® it can be appointed when breastfeeding. Except for risk of development of a sensitization in connection with trace amounts of the drug getting into breast milk, undesirable effects at the children who are on breastfeeding are not revealed.
At women at a premature rupture of fetal membranes and premature births it was revealed that preventive treatment by a combination of amoxicillin and clavulanate was associated with increase in risk of developing a necrotizing coloenteritis at newborns.
There Is no feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms data, however, in connection with a possibility of development of side reactions (dizziness, spasms) it is necessary to be careful.
Symptoms: gastrointestinal disorders and disturbances of water and electrolytic balance are possible. The amoksitsillinovy crystalluria in certain cases leading to development of a renal failure is described.
When prescribing drug to patients with reduced function of kidneys or when using high doses the development of spasms is possible.
Sedimentation of amoxicillin on vesical catheters, especially after purpose of high doses by intravenous administration is possible.
Treatment: performing symptomatic therapy, correction of water and electrolytic balance. Аугментин® it is brought out of blood by means of a hemodialysis.
Form of release and packing
of the Tablet, coated, 500 mg / 125 mg and 875 mg / 125 mg.
On 7 tablets place in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 1 planimetric packing place in a package from aluminum foil.
On 2 packages together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions at a temperature not over 25 ºС.
To store out of children’s reach.
not to apply a period of storage after an expiration date.
According to the prescription
of Proizvoditel SmitKlyayn Bichem Limited, Great Britain
(Clarendon Road, Worthing, West Sussex, BN 14 8QH, United Kingdom).
Owner of the registration certificate
of SmitKlyayn Bichem Limited, Great Britain
(980 Great West Road, Brentford, Middlesex, TW89GS, United Kingdom).
The address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of Predstavitelstvo GlaksoSmit Klein Export Ltd in Kazakhstan 050059, Almaty, Furmanov St., 273
Phone number: +7 727 258 28 92, +7 727 259 09 96
Fax number: +7 727 258 28 90
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