The instruction for medical use
of Augmentin® medicine
the Trade name
the International unlicensed name
Is not present
the Dosage form
Powder for preparation of suspension for intake of 200 mg / 28.5 mg / 5 ml, 70 ml
of 5 ml of suspension contain
active agents: amoxicillin (in the form of trihydrate amoxicillin) 200 mg,
clavulanic acid (in the form of clavulanate potassium) 28.50 mg,
excipients: xanthane gum, aspartame, succinic acid, silicon dioxide colloidal anhydrous, gipromelloza, fragrance orange dry 610271 E, fragrance orange dry 9/027108, fragrance crimson dry NN07943, Light Treacle fragrance dry 52927/AP, silicon dioxide anhydrous.
Powder of white or almost white color with a characteristic smell. The prepared suspension of white or almost white color, when standing is slowly formed a deposit of white or almost white color.
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
– acute bacterial sinusitis
– acute average otitis
– lower respiratory tract infections (exacerbation of chronic
bronchitis, share pneumonia, bronchial pneumonia,
– cystitis, an urethritis
– gynecologic infections, gonorrhea
– infections of skin and soft tissues (in particular, cellulitis, stings
of animals, acute abscesses and phlegmons of maxillofacial
– infections of bones and joints (in particular, osteomyelitis)
the Route of administration and doses
Suspension for intake is intended for use in pediatrics.
The sensitivity to Augmentinu® can vary 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.
The mode of dosing is set individually depending on age, body weight, function of kidneys, infectious agents and also from severity of an infection.
Аугментин® it is recommended to accept at the beginning of food. 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).
Children from 2 months to 12 years or with body weight less than 40 kg
, depending on age and weight, specify the Dose in body weight mg/kg a day or in milliliters of ready suspension.
The recommended dosing mode:
– from 25 mg / 3.6 mg/kg/days up to 45 mg / 6.4 the mg/kg/days divided into 2 receptions, in slight and moderate infections (recurrent tonsillitis, infections of skin and soft tissues)
– from 45 mg / 6.4 mg/kg/days up to 70 mg / 10 the mg/kg/days divided into 2 receptions for treatment of more serious infections (average otitis, sinusitis, lower respiratory tract infections).
The table of the choice of a single dose of the drug Augmentin® depending on body weight.
The body weight (kg)
of 25 mg / 3.6 mg/kg/days
of 45 mg / 6.4 mg/kg/days *
5 1,6 ml 2 times in day
of 2.8 ml 2 times in day
of 6 1,9 ml 2 times in day
of 3.4 ml 2 times in day
of 7 2,2 ml 2 times in day
of 3.9 ml 2 times in day
of 8 2,5 ml 2 times in day
of 4.5 ml 2 times in day
of 9 2,8 ml 2 times a day
10 3,1 ml 2 times a day
11 3,4 ml 2 times a day
12 3,8 ml 2 times a day
13 4,1 ml 2 times a day
14 4,4 ml 2 times a day
15 4,7 ml 2 times a day
* For children with the body weight & gt, 8 kg use Аугментин® 400 mg / 57 mg in order to avoid single administration of drug more than 5 ml.
There are no clinical these uses of this dosage of Augmentina® over 45 mg / 6.4 mg/kg/days at children 2 years are younger.
There are no clinical these uses
of Аугментина® 200 mg / 28.5 mg / 5 ml at children 2 months in this connection recommendations to dosing at this cohort of patients are absent are younger.
For children with body weight less than 40 kg the maximum daily dose makes 2400 mg of amoxicillin / 600 clavulanic acid mg. In need of purpose of higher daily dose of amoxicillin, it is necessary to appoint other dosage of Augmentina® in order to avoid reception of high doses of clavulanic acid needlessly.
Patients with a renal failure
of Correction of doses are 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
also lt, 30 ml/min.
Patients with abnormal liver functions
the Treatment is not recommended carry out with care, regularly carry out monitoring of function of a liver.
The suspension route of administration
Suspension gets divorced just before the first use.
Check integrity of a cover before use. Stir up a bottle with powder.
Powder should be dissolved in 64 ml of the boiled water cooled to room temperature gradually stirring up and adding water to a tag on a bottle. The ready volume of suspension is equal to 70 ml. The bottle should be turned and to stir up carefully before full dissolution. The bottle should be shaken up before each use. For drug dosing it is necessary to use a measured cap cover which needs to be rinsed well with water after each use. For more exact dosing of small volumes of suspension, especially at children is younger than 3 months, use of the standard disposable medical syringe is necessary.
At treatment of children under 2 years, ready Augmentina® suspension can be dissolved with water half.
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 antibiotiko-associated colitis (including pseudomembranous and hemorrhagic)
– black hairy language (chronic hyperplasia of threadlike
nipples of language)
– change of coloring of a blanket of adamantine substance of tooth
– 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
– hypersensitivity or to any component
– 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
– phenylketonuria (in connection with presence of aspartame as a part of drug)
– glyukozo-galaktozny malabsorption (in connection with presence
of maltodextrin (glucose) as a part of drug)
is not recommended to apply Augmentin® along with probenitsidy to penicillin. Probenitsid reduces canalicular secretion of amoxicillin and therefore simultaneous use of Augmentina® and a probenitsid can lead to 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, 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.
to Adults and children are more senior than 12 years or with body weight more than 40 kg are recommended use of Augmentina® in tablets.
Before an initiation of treatment of Augmentinom® it is necessary to collect 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.
In case of confirmation of the disease caused amoxicillin – sensitive strains, it is necessary to refuse a combination amoxicillin/clavulanic acid and to appoint amoxicillin separately.
It is not recommended to apply Augmentin® at high risk of possible resistance to a beta lactamnoma to a drug component. Аугментин® it should not be applied to treatment of the pathologies caused by Streptococcus pneumoniae, having resistance to penicillin.
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.
When prescribing drug to patients with reduced function of kidneys or when using high doses the development of spasms is possible.
Combined use of Allopyrinolum and amoxicillin increases a likelihood of development of skin allergic reactions.
Long-term treatment of Augmentinom® can be followed by the overgrowth of microorganisms, insensitive to it.
For prevention of discoloration of adamantine substance of tooth it is necessary to brush teeth after each intake of suspension.
Cases of development of pseudomembranous colitis against the background of use of antibiotics which weight varied from easy to heavy degree 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 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.
Cases of development of the antibiotiko-associated colitis against the background of reception of Augmentina® which extent was from insignificant to life-threatening were reported. In this regard it is necessary to consider the possibility of development of colitis in patients with the diarrhea which developed in time or after reception of antibiotics. At confirmation of the diagnosis of colitis, Augmentin® has to be immediately cancelled, the patient has to consult with the doctor for performing necessary therapy.
At patients with a renal failure the dose of drug has to be adjusted according to disease severity.
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.
During treatment by amoxicillin for determination of content of glucose in urine it is necessary to use methods of fermental oxidation of glucose, so 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.
Аугментин®, powder for preparation of suspension for intake of 200 mg / 28.5 mg / 5 the ml, contains 2.5 mg/ml of aspartame, a phenylalanine source. It is not recommended to use drug to patients with phenylketonuria.
Drug contains maltodextrin (glucose). It is not recommended to use drug to patients with glyukozo-galaktozny malabsorption.
Pregnancy and the period of a lactation
Suspension for intake is intended for use in pediatrics.
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 (allergy, 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.
A form of release and packing
Powder for preparation of suspension for intake of 200 mg / 28.5 mg / 5 ml, 70 ml.
Powder for preparation of suspension is placed in bottles from transparent III glass with the screwing-up aluminum cover with internal varnish coating with protection against the first opening and the polymeric laying from PVC or polyolefin supplied with a cap doser.
On 1 bottle together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the dry place at a temperature not above 25 °C. To store the prepared suspension in the fridge at a temperature from 2 of 0C up to 8 0C and to use within 7 days. Not to freeze!
To store out of children’s reach!
not to accept 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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