How to use the drug Augmentin SR?

Bacterial infections caused by sensitive pathogens: lower respiratory tract infections (bronchitis, pneumonia, pleural empyema, lung abscess), infections of the ENT organs (sinusitis, tonsillitis, otitis media), infections of the genitourinary system and pelvic organs (pyelonephritis, pyelitis, cystitis, urethritis, prostatitis, cervicitis, salpingitis, salpingoophoritis, tubo-ovarian abscess, endometritis, bacterial vaginitis, septic abortion, postpartum sepsis, pelvioperitonitis, soft chancre, gonorrhea), infections of the skin and soft tissues (erysipelas, impetigo, secondary but infected dermatoses, abscesses, cellulitis, wound infection), osteomyelitis, postoperative infections, prevention of infections in surgery.

Dosage form

film-coated modified release tablets, lyophilisate for the preparation of a solution for intravenous administration, powder for the preparation of a suspension for oral administration, tablets, powder for the preparation of a solution for intravenous administration, dispersible tablets

Contraindications

Hypersensitivity to Augmentin SR components (including cephalosporins and other beta-lactam antibiotics), infectious mononucleosis (including the appearance of a measles-like rash), phenylketonuria, episodes of jaundice or impaired liver function due to the use of amoxicillin / clavulanova history of acid, CC less than 30 ml / min (for tablets 875 mg / 125 mg).

How to use: dosage and course of treatment

Doses of Augmentin SR are given in terms of amoxicillin. The dosage regimen is set individually depending on the severity of the course and the location of the infection, the sensitivity of the pathogen.

Children under 12 years of age - in the form of other LF preparations containing the same active substances: suspensions, syrup or drops for oral administration. A single dose is set depending on age: children up to 3 months - 30 mg / kg / day in 2 divided doses, 3 months and older - for infections of mild severity - 25 mg / kg / day in 2 divided doses or 20 mg / kg / day in 3 doses, with severe infections - 45 mg / kg / day in 2 doses or 40 mg / kg / day in 3 doses.

Adults and children over 12 years of age or weighing 40 kg or more: 500 mg 2 times / day or 250 mg 3 times / day. In severe infections and respiratory tract infections - 875 mg 2 times / day or 500 mg 3 times / day.

The maximum daily dose of amoxicillin for adults and children over 12 years old is 6 g, for children under 12 years old - 45 mg / kg body weight.

The maximum daily dose of clavulanic acid for adults and children over 12 years old is 600 mg, for children under 12 years old - 10 mg / kg body weight.

With difficulty swallowing in adults, the use of a suspension is recommended.

In case of chronic renal failure, a dose and frequency of administration is administered (administration of LF preparations containing the same active substances from other manufacturers) depending on QC: with QC over 30 ml / min, dose adjustment is not required, with QC 10-30 ml / min: inside - 250- 500 mg / day every 12 hours, with CC less than 10 ml / min - 1 g, then 500 mg / day iv or 250-500 mg / day orally in one go. For children, the dose should be reduced in the same way.

Patients on hemodialysis - 250 mg or 500 mg of Augmentin CP orally in one dose, an additional 1 dose during dialysis and another 1 dose at the end of the dialysis session.

Pharmachologic effect

The combined preparation of amoxicillin and clavulanic acid, a beta-lactamase inhibitor. It acts bactericidal, inhibits the synthesis of the bacterial wall.

Active against aerobic gram-positive bacteria (including beta-lactamase producing strains): Staphylococcus aureus,

aerobic gram-negative bacteria: Enterobacter spp., Escherichia coli, Haemophilus influenzae, Klebsiella spp., Moraxella catarrhalis.

The following pathogens are susceptible to Augmentin CP only in vitro: Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus anthracis, Streptococcus pneumoniae, Streptococcus viridans, Enterococcus faecalis, Coryneocococpococcus peptes.

aerobic gram-negative bacteria (including strains producing beta-lactamases): Proteus mirabilis, Proteus vulgaris, Salmonella spp., Shigella spp., Bordetella pertussis, Yersinia enterocolitica, Gardnerella vaginalis, Neisseria meningitidis, Neisseria gemoriöferis yerieriuliferidaeri yeriiferidaeriemoniferidaeeris, yeminerida gemoriferida ), Campylobacter jejuni,

anaerobic gram-negative bacteria (including strains producing beta-lactamases): Bacteroides spp., including Bacteroides fragilis.

Clavulanic acid in Augmentin CP suppresses type II, III, IV and V types of beta-lactamases, inactive against type I beta-lactamases, produced by Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid has a high tropism for penicillinases, due to which it forms a stable complex with the enzyme, which prevents the enzymatic degradation of amoxicillin under the influence of beta-lactamases.

Side effects

From the digestive system: nausea, vomiting, diarrhea, gastritis, stomatitis, glossitis, increased activity of "liver" transaminases, in isolated cases - cholestatic jaundice, hepatitis, liver failure (more often in the elderly, men, with prolonged therapy), pseudomembranous and hemorrhagic colitis (can also develop after therapy), enterocolitis, black “hairy” tongue, darkening of tooth enamel.

Hematopoietic organs: a reversible increase in prothrombin time and bleeding time, thrombocytopenia, thrombocytosis, eosinophilia, leukopenia, agranulocytosis, hemolytic anemia.

From the nervous system: dizziness, headache, hyperactivity, anxiety, behavior change, convulsions.

Local reactions: in some cases, phlebitis at the site of iv injection.

Allergic reactions to Augmentin SR components: urticaria, erythematous rashes, rarely multiforme exudative erythema, anaphylactic shock, angioedema, extremely rare exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), allergic vasculitis, serum vasculitis acute generalized exanthematous pustulosis.

Other: candidiasis, development of superinfection, interstitial nephritis, crystalluria, hematuria.

Special instructions

With the course treatment with Augmentin SR, it is necessary to monitor the state of the function of the blood, liver and kidneys.

In order to reduce the risk of side effects from the gastrointestinal tract, the drug should be taken with meals.

It is possible to develop superinfection due to the growth of microflora insensitive to it, which requires a corresponding change in antibiotic therapy.

May give false positive results in the determination of glucose in the urine. In this case, it is recommended to use the glucose oxidant method for determining the concentration of glucose in the urine.

After dilution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen.

In patients with hypersensitivity to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible.

Cases of the development of necrotizing colitis in newborns and in pregnant women with premature rupture of the membranes were revealed.

Interaction

Antacids, glucosamine, laxatives, aminoglycosides slow down and reduce the absorption of Augmentin CP components, ascorbic acid increases absorption.

Bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) have an antagonistic effect.

Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index). With the simultaneous administration of anticoagulants, it is necessary to monitor the indicators of blood coagulability.

Reduces the effectiveness of oral contraceptives, drugs, during the metabolism of which PABA is formed, ethinyl estradiol - the risk of bleeding "breakthrough".

Diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs blocking tubular secretion increase the concentration of amoxicillin in the composition of Augmentin SR (clavulanic acid is excreted mainly by glomerular filtration).

Allopurinol increases the risk of developing a skin rash.

Questions, answers, reviews on the drug Augmentin SR


The information provided is intended for medical and pharmaceutical professionals. The most accurate information about the drug is contained in the instructions that are attached to the packaging by the manufacturer. No information posted on this or any other page of our site can serve as a substitute for a personal appeal to a specialist.

Release form

Augmentin is available in film-coated tablets, powders for injection solutions, and dry matter for diluting drops. Powders for the preparation of Augmentin suspension and syrup are also produced. Analogues of the drug with the same active substances are: Amoxiclav, Bactoclav, Arlet, Klamosar.

Dosage and administration

In accordance with the instructions Augmentin is recommended to be taken at the beginning of a meal, doses of the drug are prescribed individually depending on the age of the patient and the severity of infection. With treatment, it is possible to carry out step therapy - first, intravenous administration of the drug is used, and then they switch to oral administration. The course of treatment with Augmentin usually does not exceed 14 days without revising the clinical picture. For adults and children over 12 years of age, it is prescribed for mild and moderate infections 1 tablet 0.375 g 3 times a day, for severe illness 1 tablet 0.625 g or 2 tablets 0.375 g 3 times a day. With intravenous administration, it is allowed to use the drug every 6 hours with a maximum daily dose of 7.2 g. Patients with impaired renal function during treatment require correction of the prescribed doses of the drug.

Augmentin for children under 1 year of age is usually prescribed in the form of drops. The instructions indicate that at the age of up to 3 months, a single dosage is 0.75 ml, from 3 to 12 months - 1.25 ml. In case of severe infection with intravenous administration of the drug every 6-8 hours, a single dose of Augmentin for children from 3 months to 12 years old is 30 mg / kg body weight, up to 3 months at the same dose every 12 hours. Also, children under 12 years of age are prescribed a suspension of Augmentin or syrup. According to the instructions, children from 9 months to 2 years are prescribed 2.5 ml (0.156 g / 5 ml), from 2 to 7 years - 5 ml (0.156 g / 5 ml), from 7 to 12 years - 10 ml (0.156 g / 5 ml) three times a day, with severe illness, the dose is allowed to double.

Augmentin suspension is prepared for use immediately before use, the powder is dissolved in boiled water at room temperature. Water is added to the mark marked on the vial, while the contents are gradually gently shaken, and then settled until completely dissolved in about 5 minutes. Before each use, the vial must be shaken vigorously, to determine the exact dosage, a measuring cap-cap is used, carefully rinsed with water after each use. The diluted suspension is stored in the refrigerator for no more than 7 days, but does not freeze.

Pharmacological properties

Farmakokinetics

Both components of Augmentin® SR (amoxicillin and clavulanic acid) are completely soluble in aqueous solutions at physiological pH values. Both components are quickly and well absorbed by oral administration. Augmentin Absorption® SR improves when taken at the start of a meal.

A drug

Dose(mg)

T> MIC^ h(%)

Cmax (mg/l)

Tmax (h)

Auc

T1 / 2 (h)

Amoxicillin

Augmentin SR 1000 / 62.5 mg x 2

Clavulanate

Augmentin SR 1000 / 62.5 mg x 2

ND - not defined

T> MIC time> minimum inhibitory concentration

Augmentin Sustained Release Tablets® SRs have an exceptional pharmacokinetic / pharmacodynamic profile.

Indicator T> MIC obtained when prescribing the drug Augmentin® SR is significantly different from that obtained with the same doses of tablets with immediate release of active substances.

When administered orally, therapeutic concentrations of amoxicillin and clavulanic acid are observed in tissues and interstitial fluid. Therapeutic concentrations of both substances are found in the gall bladder, tissues of the abdominal cavity, skin, adipose and muscle tissues, as well as in synovial and peritoneal fluids, bile and pus. Amoxicillin and clavulanic acid weakly bind to proteins, studies have found that protein binding rates are 25% for clavulanic acid and 18% for amoxicillin of their total plasma concentrations. In animal studies, no cumulation of any of these components in any organ has been established.

Amoxicillin, like other penicillins, can be found in breast milk. Traces of clavulanic acid can also be found in breast milk. Animal reproductive studies have shown that amoxicillin and clavulanic acid can cross the placental barrier, but no evidence has been found regarding impaired fertility or harmful effects on the fetus.

Amoxicillin is partially excreted in the urine in the form of inactive penicillinic acid in an amount equivalent to 10-25% of the dose taken. Clavulanic acid is metabolized in the human body to 2,5-dihydro-4- (2-hydroxyethyl) -5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-butan-2-one and is excreted with urine and feces, as well as in the form of carbon dioxide with exhaled air.

Amoxicillin is excreted mainly by the kidneys, while clavulanic acid is excreted by both the renal and extrarenal mechanisms. About 60-70% of amoxicillin and about 40-65% of clavulanic acid are excreted unchanged in the urine. The combined use with probenecid inhibits the excretion of amoxicillin, but does not delay the excretion of clavulanate by the kidneys.

No dose adjustment is required.

Patients with impaired renal function

There is no need to adjust the dose of the drug with creatinine clearance> 30 ml / min. In patients with creatinine clearance less than 30 ml / min, taking the drug is not recommended.

Hemodialysis patients

Patients with impaired liver function

Use with caution; data for dosing recommendations are insufficient.

Pharmacodynamics

Augmentin® SR is a combination antibiotic containing amoxicillin and clavulanic acid, with a wide spectrum of bactericidal action, resistant to beta-lactamase.

Amoxicillin is a semi-synthetic broad-spectrum antibiotic that is active against many gram-positive and gram-negative microorganisms. Amoxicillin is destroyed by beta-lactamase and does not affect the microorganisms that produce this enzyme.

Clavulanic acid is beta-lactamate, similar in chemical structure to penicillins, which has the ability to inactivate beta-lactamase enzymes of microorganisms that are resistant to penicillins and cephalosporins, thereby preventing the inactivation of amoxicillin. In particular, it has high activity against plasmid beta-lactamases, with which drug resistance is often associated, but less effective against type 1 chromosomal beta-lactamases.

The presence of clavulanic acid in Augmentin® SR protects amoxicillin from the damaging effects of beta-lactamases and expands its spectrum of antibacterial activity with the inclusion of microorganisms that are usually resistant to other penicillins and cephalosporins. Clavulanic acid in the form of a single drug does not have a clinically significant antibacterial effect.

Resistance development mechanism

Clavulanic acid protects against the development of resistance caused by beta-lactamase enzymes. The form of the drug with the gradual release of active substances increases the effectiveness of the drug against microorganisms with resistance caused by penicillin-binding protein.

Amoxicillin causes cross-resistance to other beta-lactam antibiotics, beta-lacamase inhibitors and cephalosporins.

To Augmentin®SrThe following microorganisms are sensitive:

Gram-positive aerobes: Bacillius anthracis, Enterococcus faecalis, Listeria monocytogenes, Nocardia asteroids, Streptococcuspneumoniae *†,

Streptococcus pyogenes*†, Streptococcus agalactiae*†, Viridans group streptococcus, Streptococcus spp. (other β-hemolytic species)*†, Staphylococcus aureus (sensitive to methicillin) *, Staphylococcus saprophyticus (sensitive to methicillin) Coagulase negative staphylococcus (methicillin sensitive)

Gram-negative aerobes: Bordetella pertussis,Haemophilus influenzae *,

Haemophilus parainfluenzae,Helicobacter pylori,Moraxella catarrhalis *,

Neisseria gonorrhoeae,Pasteurella multocida,Vibrio cholera

Borreliaburgdorferi,Leptospiraictterohaemorrhagiae,Treponema pallidum

Gram-positive anaerobes: Clostridium spp.,Peptococcus niger,Peptostreptococcus magnus,Peptostreptococcus micros,Peptostreptococcusspp.

Gram-negative anaerobes: Bacteroides fragilis,Bacteroides spp., Capnocytophaga spp., Eikenellacorrodens,Fusobacteriumnucleatum,Fusobacterium spp., Porphyromonas spp., Prevotellaspp.

Microorganisms with possible acquired resistance

Corynebacterium spp., Enterococcus faecium

Gram negativeaerobes:Escherichia coli *, Klebsiella oxytoca, Klebsiella pneumoniae *, Klebsiella spp., Proteus mirabilis, Proteus vulgaris, Proteus spp., Salmonella spp., Shigella spp.

Microorganisms with natural resistance:

Acinetobacter spp., Citrobacter freundii, Enterobacter spp., Hafnia alvei,Legionella pneumophila,Morganella morganii,Providencia spp., Pseudomonas spp., Serratia spp., Stenotrophomas maltophilia,Yersinia enterolitica

Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia spp., Coxiella burnetti, Mycoplasma spp.

* Efficacy has been demonstrated in clinical trials.

† Non-beta-lactamase-producing microorganisms

Dosage and administration

Augmentin® SR should be used in accordance with local official guidelines for the medical use of antibiotics, as well as local data on susceptibility to the drug.

Augmentin® SR is intended for the short-term treatment of bacterial infections caused by microorganisms sensitive to the drug.

Susceptibility to Augmentin® SR varies by geographic region and time. It is necessary to study local data on the susceptibility to the drug, as well as, if possible, to take the material and conduct its sensitivity analysis.

In order to maximize the absorption of Augmentin® SR is recommended at the start of a meal. Treatment should not be continued for more than 14 days without re-evaluating the patient's condition.

Augmentin Pills® SR have a dividing groove, allowing them to be broken in half for ease of swallowing, but not to reduce the dose: both halves must be taken simultaneously.

The recommended dose is 2 tablets twice a day.

Adults and teenagers (16 years and older))

2 tablets twice a day for 7 to 10 days

Exacerbation of chronic bronchitis

2 tablets twice a day for 7 days

Acute bacterial sinusitis

2 tablets twice a day for 10 days

Prevention of local infectious complications in surgical dentistry

2 tablets twice a day for 5 days, start taking should be within 3 hours after surgery

This dosage form is not intended for children under 16 years of age.

Reduce Augmentin Dose® SR is not needed, the doses are the same as for adults.

Patients with impaired renal function

There is no need to adjust the dose of the drug with creatinine clearance> 30 ml / min. In patients with creatinine clearance less than 30 ml / min, taking the drug is not recommended.

Hemodialysis patients

Patients with impaired liver function

To use with caution, it is necessary to monitor hepatic function at regular intervals. There is insufficient data to recommend dosing.

Overdose

Symptoms gastrointestinal upsets and disturbances in water-electrolyte balance are possible. Amoxicillin crystalluria is described, in some cases leading to the development of renal failure.

Treatment: symptomatic therapy, correction of water-electrolyte balance. Augmentin® SR is eliminated from the blood via hemodialysis.

Registration Certificate Holder

Laboratoire GlaxoSmithKline, France

(100, route de Versailles, 78163 Marly-Le-Roi, Cedex)

The address of the organization that accepts claims from consumers on the quality of products (goods) in the Republic of Kazakhstan

GlaxoSmith Klein Export Ltd Representative Office in Kazakhstan 050059, Almaty, st. Furmanova, 273

Phone number: +7 727 258 28 92, +7 727 259 09 96

3D images

Film-coated tablets1 tab.
Instant Release Layer
active substances:
amoxicillin trihydrate654.1 mg
(equivalent to 562.5 mg of amoxicillin)
potassium clavulanate76.2 mg
(equivalent to 62.5 mg of clavulanic acid)
Excipients: MCC - 136.4 mg, sodium carboxymethyl starch - 18 mg, anhydrous colloidal silicon dioxide - 6.3 mg, magnesium stearate - 9 mg
Gradual Release Layer
active substance:
amoxicillin sodium480.8 mg
(equivalent to 437.5 mg of amoxicillin)
Excipients: MCC - 111.7 mg, xanthan gum - 14 mg, citric acid - 78 mg, anhydrous colloidal silicon dioxide - 1.5 mg, magnesium stearate - 14 mg
Shell film water: hypromellose 6 cps - 11.6 mg, hypromellose 15 cps - 3.9 mg, titanium dioxide - 15.1 mg, macrogol 3350 - 2.3 mg, macrogol 8000 - 2.3 mg

Pharmacodynamics

Amoxicillin is a semi-synthetic broad-spectrum 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 penicillin and cephalosporin resistant microorganisms. Clavulanic acid is sufficiently effective against plasmid beta-lactamases, which are most often responsible for bacterial resistance, and is less effective against chromosomal beta-lactamases of the 1st type, which are not inhibited by clavulanic acid.

The presence of clavulanic acid in the Augmentin ® preparation protects amoxicillin from destruction by enzymes - beta-lactamases, which allows to expand the antibacterial spectrum of amoxicillin.

Slow release of amoxicillin in the Augmentin ® SR preparation allows maintaining the sensitivity of those strains S. pneumoniaein which amoxicillin resistance is due to penicillin-binding proteins (penicillin-resistant S. pneumoniae, or PRSP).

The following is the activity of a combination of amoxicillin with clavulanic acid in vitro.

Bacteria commonly susceptible to a combination of amoxicillin with clavulanic acid

Gram-positive aerobes: Bacillus anthracis, Enterococcus faecalis, Listeria monocytogenes, Nocardia asteroides, Streptococcus pneumoniae 1,2, Streptococcus pyogenes 1,2, Streptococcus agalactiae 1,2, streptococcus group Viridans 2, Streptococcus spp. (other beta hemolytic streptococci) 1,2, Staphylococcus aureus (sensitive to methicillin) 1, Staphylococcus saprophyticus (sensitive to methicillin), coagulase-negative staphylococci (sensitive to methicillin).

Gram-negative aerobes: Bordetella pertussis, Haemophilus influenzae 1, Helicobacter pylori, Moraxella catarrhalis 1, Neisseria gonorrhoeae, Pasteurella multocida, Vibrio cholerae.

Other: Borrelia burgdorferi, Leptospira icterohaemorrhagiae, Treponema pallidum.

Gram-positive anaerobes: Clostr> including Peptococcus niger, Peptostreptococcus magnus, Peptostreptococcus micros.

Gram-negative anaerobes: Bactero> including Bactero> including Fusobacterium nucleatum, Porphyromonas spp., Prevotella spp.

Bacteria for which acquired resistance to a combination of amoxicillin with clavulanic acid is likely

Gram-negative aerobes: Escherichia coli 1, Klebsiella spp., including Klebsiella oxytoca, Klebsiella pneumoniae 1, Proteus spp., including Proteus mirabilis, Proteus vulgaris, Salmonella spp., Shigella spp.

Gram-positive aerobes: Corynebacterium spp., Enterococcus faecium.

Bacteria that are naturally resistant 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 spp., including Chlamydia pneumoniae, Chlamydia psittaci, Coxiella burnetii, Mycoplasma spp.

1 For these types of microorganisms, the clinical efficacy of a combination of amoxicillin with clavulanic acid has been demonstrated in clinical studies.

2 Strains of these types of bacteria do not produce beta-lactamases. Sensitivity with amoxicillin monotherapy suggests a similar sensitivity to the combination of amoxicillin with clavulanic acid.

Cross resistance. Amoxicillin directly demonstrates cross-resistance with other beta-lactam antibiotics, as well as a combination of beta-lactam antibiotics with beta-lactamase inhibitors and cephalosporins.

Resistance mechanisms. Clavulanic acid protects amoxicillin from the damaging effects of beta-lactamases. Slow release of the active ingredients of the Augmentin ® SR drug increases the effectiveness of amoxicillin against microorganisms whose resistance is due to the modification of penicillin-binding proteins.

Pharmacokinetics

Both active ingredients of Augmentin ® SR, amoxicillin and clavulanic acid, dissolve well in aqueous solutions with physiological pH, and are quickly and completely absorbed from the gastrointestinal tract after oral administration. Absorption of active substances is optimal in case of taking the drug at the beginning of a meal.

Below are the pharmacokinetic parameters of amoxicillin and clavulanic acid after taking 2 tablets. Augmentin ® SR by healthy volunteers at the beginning of a meal.

Average pharmacokinetic parameters

Clavulanic acid

A drugDose mgT> IPC 1, h (%) 2Cmax mg / lTmax hAUC, mcg · h / mlT1/2 h
Amoxicillin
Augmentin CP 1000 mg + 62.5 mg × 220005,9 (49,4)171,571,61,27
Augmentin CP 1000 mg + 62.5 mg × 2125Undefined2,051,035,291,03

1 For bacteria with IPC 4 mg / L.

2 T> IPC, h (%) - time (as a percentage of the time interval between doses), during which the concentration of the drug in the blood is higher than the IPC for a specific pathogen.

The drug Augmentin ® SR has a unique pharmacological profile, the T> MPC characteristic of this drug is not achieved when taking tablets with the immediate release of active substances containing a combination of amoxicillin and clavulanic acid.

As with the iv administration of a combination of amoxicillin and clavulanic acid, therapeutic concentrations of amoxicillin and clavulanic acid are created in various tissues and interstitial fluid (gall bladder, abdominal tissues, skin, fat and muscle tissue, synovial and peritoneal fluids, 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 blood plasma binds to blood plasma proteins.

In animal studies, no cumulation of the components of the drug Augmentin ® SR in any organ was found.

Amoxicillin, like most penicillins, passes into breast milk. Traces of clavulanic acid have also been found in breast milk. With the exception of the possibility of developing diarrhea and candidiasis of the oral mucous membranes, no other negative effects of amoxicillin and clavulanic acid on the health of breast-fed children are known.

Studies of reproductive function in animals when taking the drug Augmentin ® SR showed that amoxicillin and clavulanic acid cross the placental barrier. However, no adverse effects on the fetus were detected.

10–25% of the initial dose of amoxicillin is excreted by the kidneys as an inactive metabolite (penicillic acid). Clavulanic acid is extensively metabolized to 2,5-dihydro-4- (2-hydroxyethyl) -5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-butan-2-one and excreted by the kidneys, through the digestive tract, as well as with expired air in the form of carbon dioxide.

Like other penicillins, amoxicillin is excreted mainly by the kidneys, while clavulanic acid is excreted by both the renal and extrarenal mechanisms.

Studies have shown that on average about 60–70% of amoxicillin and about 40–65% of clavulanic acid are excreted by the kidneys unchanged.

The simultaneous administration of probenecid slows down the excretion of amoxicillin, but does not slow down the excretion of clavulanic acid (see “Interaction”).

Indications Augmentin ® SR

The drug Augmentin ® SR is indicated for the treatment of bacterial infections of the following locations caused by microorganisms sensitive to the combination of amoxicillin with clavulanic acid:

respiratory tract infections, such as community-acquired pneumonia, exacerbation of chronic bronchitis, acute bacterial sinusitis, usually caused by Streptococcus pneumoniae (including penicillin-resistant strains), Haemophilus influenzae 1, Moraxella catarrhalis 1 and Streptococcus pyogenes,

prevention of local infections after surgery in dentistry.

1 Some strains of these bacteria produce beta-lactamases, which makes them insensitive to amoxicillin monotherapy.

Infections caused by microorganisms sensitive to amoxicillin can be treated with Augmentin ® CP, since amoxicillin is one of its active substances. Augmentin ® SR is also indicated for the treatment of mixed infections caused by microorganisms sensitive to amoxicillin, as well as microorganisms producing beta-lactamase, sensitive to the combination of amoxicillin with clavulanic acid.

Augmentin ® SR demonstrated efficacy against strains S. pneumoniaeresistant to penicillin (strains with IPC ≥2 mg / l).

Preparations containing a combination of amoxicillin with clavulanic acid must be used according to Russian guidelines for antibiotic therapy and regional data on the sensitivity of pathogens to a 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.

Pregnancy and lactation

In studies of reproductive function in animals, oral and parenteral administration of Augmentin ® CP did not cause teratogenic effects.

In a single study in women with premature rupture of the membranes, it was found that prophylactic drug therapy may be associated with an increased risk of necrotizing enterocolitis in newborns. Like all medicines, Augmentin ® CP is not recommended for use during pregnancy, unless the expected benefit to the mother outweighs the potential risk to the fetus.

The drug Augmentin ® SR can be used during breastfeeding. With the exception of the possibility of developing diarrhea or candidiasis of the mucous membranes of the oral cavity associated with the penetration of trace amounts of the active ingredients of this drug into breast milk, no other adverse effects were observed in infants who were breast-fed. In case of adverse effects in infants who are breast-feeding, it is necessary to stop breast-feeding.

Manufacturer

Glaxo Wellcome Production. 53100, Terra II, Z.I. de la Payenier, Mayenne, France.

Name and address of the legal entity in whose name the registration certificate is issued: GlaxoSmithKline Trading CJSC. 119180, Moscow, Yakimanskaya nab., 2.

For more information, contact: GlaxoSmithKline Trading CJSC. 121614, Moscow, st. Krylatskaya, 17, bldg. 3, floor 5. Business Park "Krylatsky hills."

Phone: (495) 777-89-00, fax: (495) 777-89-04.

Watch the video: Augmentin Medication Information dosing, side effects, patient counseling (April 2020).