DOSAGE FORM, COMPOSITION AND PACKAGING

Coated tablets from white to almost white, oval, with an embossed inscription "AUGMENTIN" on one side; at the break - from almost white to yellowish-white.

Excipients: magnesium stearate, sodium starch glycolate (type A), colloidal anhydrous silicon, microcrystalline cellulose.

Sheath composition: titanium dioxide, hydroxypropyl methylcellulose (5 cps), hydroxypropyl methylcellulose (15 cps), polyethylene glycol 4000, polyethylene glycol 6000, dimethicone (silicone oil).

10 pieces. - blisters in aluminum foil bags (2) - cardboard packs.

Film-coated tablets from white to almost white, oval, with an embossed lettering "AUGMENTIN" on one side.

PHARMACHOLOGIC EFFECT

Combined broad-spectrum antibiotic resistant to β-lactamases, containing amoxicillin and clavulanic acid.

Amoxicillin is a semi-synthetic broad-spectrum antibiotic that is active against many gram-positive and gram-negative microorganisms. Amoxicillin is degraded by β-lactamases, therefore, the spectrum of its antibacterial activity does not include microorganisms that produce β-lactamases.

Clavulanic acid - β-lactam compound, has the ability to inactivate wide rangeβ-lactamases, enzymes that are usually produced by microorganisms resistant to penicillins and cephalosporins.

The presence of clavulanic acid in Augmentin protects amoxicillin from the destructive action of β-lactamases and expands the spectrum of its antibacterial activity to include microorganisms that are usually resistant to other penicillins and cephalosporins.

Augmentin active against gram-positive aerobic microorganisms: Bacillis anthracis *, Corynebacterium spp., Enterococcus faecalis *, Enterococcus faecium *, Listeria monocytogenes, Nocardia asteroides, Staphylococcus aureus *, coagulase-negative Staphylococcus (including Stapidis) spp. (including Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans); in relation to gram-positive anaerobic microorganisms: Clostridium spp., Peptococcus spp., Peptostreptococcus spp .; in relation to gram-negative aerobic microorganisms: Bordetella pertussis, Brucella spp., Escherichia coli *, Gardnerella vaginalis, Haemophilus influenzae * , Helicobacter pylori, Klebsiella spp. *, Legionella spp., Moraxella catarrhalis * (Branhamella catarrhalis), Neisseria gonorrhoeae *, Neisseria meningitidis *, Pasteurella multocida, Proteus mirabilis *, Proteus vulgaris *, Salmonella spp. *, Shigella spp. *, Vibrio cholerae, Yersinia enterocolitica *; in relation to gram-negative anaerobic microorganisms: Bacteroides spp *. (including Bacteroides fragilis), Fusobacterium spp. *; for other microorganisms: Borrelia burgdorferi, Chlamydiae, Leptospira icterohaemorrhagiae, Treponema pallidum.

* - some strains of these types of bacteria produce β-lactamases, which causes resistance to monotherapy with amoxicillin.

Augmentin tablets, containing 500 mg of amoxicillin and 125 mg of clavulanic acid, are a sustained-release dosage form that differs from conventional tablets in other pharmacokinetic parameters. This provides drug sensitivity to those strains of Streptococcus pneumoniae in which resistance to amoxicillin is mediated by penicillin-binding proteins (penicillin-resistant strains of Streptococcus pneumoniae).

PHARMACOKINETICS

The pharmacokinetic parameters of amoxicillin and clavulanic acid were obtained in different studies in healthy volunteers after fasting: 1 Augmentin tablet (250 mg / 125 mg), or 2 Augmentin tablets (250 mg / 125 mg), or 1 Augmentin tablet (500 mg / 125 mg ), or amoxicillin (500 mg), or clavulanic acid (125 mg) separately.

The main pharmacokinetic parameters are presented in the table.

With the use of Augmentin, plasma concentrations of amoxicillin are similar to those with oral administration of amoxicillin alone in equivalent doses.

Suction

Amoxicillin and clavulanic acid dissolve well in aqueous solutions with a physiological pH value and after taking Augmentin inside, they are quickly and completely absorbed from the gastrointestinal tract. Absorption of Augmentin's active substances is optimal if taken at the beginning of a meal.

Distribution

Therapeutic concentrations of both active substances are determined in various organs, tissues and body fluids (including in the lungs, organs abdominal cavity; adipose, bone and muscle tissues; pleural, synovial and peritoneal fluids; in the skin, bile, urine, purulent discharge, sputum, in the interstitial fluid).

Plasma protein binding is moderate: 25% for clavulanic acid and 18% for amoxicillin.

Amoxicillin (like most penicillins) is excreted in breast milk. V breast milk also found trace amounts of clavulanic acid.

With the exception of the risk of sensitization, no other adverse effects of amoxicillin and clavulanic acid on the health of breastfed infants are known.

Experimental studies on animals have shown that amoxicillin and clavulanic acid penetrate the placental barrier. However, there was no evidence of impaired fertility or negative effects on the fetus.

In animal studies, no cumulation of Augmentin ingredients has been found in any organ.

Metabolism and excretion

Amoxicillin is excreted primarily by the kidneys, while clavulanic acid is eliminated by both renal and extrarenal mechanisms. After a single oral administration of one tablet of 250 mg / 125 mg or 500 mg / 125 mg, approximately 60-70% of amoxicillin and 40-65% of clavulanic acid are excreted unchanged in the urine during the first 6 hours. About 10-25% of the initial dose of amoxicillin is excreted in the urine as inactive penicillic acid. Clavulanic acid in the human body undergoes intensive metabolism with the formation of 2,5-dihydro-4- (2-hydroxyethyl) -5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-butan-2-one and is excreted in urine and feces.

INDICATIONS

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

Upper section infections respiratory tract and ENT organs (including recurrent tonsillitis, sinusitis, otitis media), usually caused by Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pyogenes;

Lower respiratory tract infections: exacerbations chronic bronchitis, lobar pneumonia and bronchopneumonia, usually caused by Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis;

Infections of the genitourinary tract: cystitis, urethritis, pyelonephritis, infections of the female genital organs, usually caused by species of the Enterobacteriaceae family (mainly Escherichia coli), Staphylococcus saprophyticus and species of the genus Enterococcus, as well as gonorrhea caused by Neisseria gonorrhoeae;

Skin and soft tissue infections commonly caused by Staphylococcus aureus, Streptococcus pyogenes and Bacteroides species;

Bone and joint infections: osteomyelitis, usually caused by Staphylococcus aureus, when long-term therapy is necessary;

Other mixed infections, such as septic abortion, obstetric sepsis, intra-abdominal infections.

DOSING MODE

The dosage regimen is set individually, depending on the age, body weight, kidney function of the patient, as well as the severity of the infection.

For optimal absorption and reduction of potential side effects from the side digestive system Augmentin is recommended to be taken at the beginning of a meal.

Treatment should not be continued for more than 14 days without reviewing the clinical situation.

If necessary, it is possible to carry out stepwise therapy (at the beginning of the intravenous administration of the drug, followed by a switch to oral administration).

Adults and children over 12 years old or weighing more than 40 kg

1 tablet (875 mg + 125 mg) 2 times / day or 1 tablet (500 mg + 125 mg) 3 times / day.

Children under 12 years of age

The dose, depending on age and body weight, is indicated in mg / kg of body weight per day, or in ml of suspension.

Children weighing 40 kg or more the drug should be prescribed in the same doses as for adults.

Single doses of the drug Augmentin, depending on age and body weight, are presented in the table.

* for amoxicillin

Two Augmentin tablets (250 mg + 125 mg) are not equivalent to one tablet (500 mg + 125 mg), because the content of clavulanic acid in them is 2 times higher.

For the correct dosing of the volume of the suspension in children under 3 months it is recommended to use a graduated syringe.

For the convenience of receiving children under 2 years old the suspension can be diluted in half with water.

At treating infections of the skin and soft tissues, as well as recurrent tonsillitis the drug can be prescribed at a dose of 20 mg / kg / day in 3 divided doses (suspension 4: 1) and 25 mg / kg / day in 2 doses (suspension 7: 1).

If the frequency of excretion of pneumococcus with high level penicillin resistance (with the MIC of penicillin 2-4 mg / l) in the region (or a closed institution) exceeds 10%, it is necessary to use amoxicillin / clavulanate (Augmentin) at a dose of 80-90 mg / kg / day, divided into 3 doses.

Optimal dosage form Augmentin for children from 6 to 12 years old are tablets 500 mg + 125 mg, taken 2 times / day.

Patients with impaired renal function

Adults

Tablets 875 mg + 125 mg should be used only in patients with CC> 30 ml / min.

Children

In most cases, parenteral therapy should be preferred whenever possible.

Patients on hemodialysis

Adults appoint 1 tab. (500 mg + 125 mg) or 2 tab. (250 mg + 125 mg) every 24 hours.

Additionally, 1 dose is prescribed during the dialysis session and 1 more dose at the end of the dialysis session (to compensate for the decrease in serum concentrations of amoxicillin and clavulanic acid).

Tablets (875 mg + 125 mg) should be used only in patients with CC> 30 ml / min.

For children appoint 15 mg + 3.75 mg / kg 1 time / day.

Before a hemodialysis session, one additional dose of 15 mg + 3.75 mg / kg should be administered. To restore the concentration of the active ingredients of Augmentin in the blood, a second additional dose of 15 mg + 3.75 mg / kg should be administered after the hemodialysis session.

Patients with impaired liver function

Treatment is carried out with caution; liver function is monitored regularly. There is not enough data to correct the dosage regimen in this category of patients.

Elderly patients

It is not required to reduce the dose of Augmentin; doses are the same as for adults. Have elderly patients with impaired renal function the dose should be adjusted as indicated above for adults with impaired renal function.

Method of using the suspension

The suspension is prepared immediately before the first use. The powder should be dissolved boiled water chilled to room temperature shaking gradually and adding water up to the mark on the vial. Then let sit for about 5 minutes to ensure complete dissolution. The bottle should be shaken well before each use. For accurate dosage of the drug, a measuring cap-lid should be used, which should be well rinsed with water after each use. After reconstitution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen.

SIDE EFFECT

Determination of the incidence of side effects: very often (> 10%), often (> 1% and<10%), иногда (>0.1% and<1%), редко (>0.01% and<0.1%), очень редко (<0.01%).

From the hematopoietic system: rarely - reversible leukopenia (including neutropenia), thrombocytopenia; very rarely - reversible agranulocytosis and hemolytic anemia, increased bleeding time and prothrombin time.

Allergic reactions: very rarely - angioedema, anaphylaxis, a syndrome similar to serum sickness, allergic vasculitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis.

In the event of any form of allergic dermatitis, treatment with Augmentin must be discontinued.

Dermatological reactions: sometimes - skin rash, urticaria; rarely, erythema multiforme.

From the side of the central nervous system: sometimes - dizziness, headache; very rarely - reversible hyperactivity and seizures. Seizures can occur in patients with impaired renal function and in patients receiving high doses of the drug.

From the digestive system: very often - diarrhea (in adults); often - diarrhea (in children), nausea (more often when taking the drug in high doses), vomiting; sometimes - dyspepsia; very rarely - a change in the color of the surface layer of the tooth enamel (in children taking the suspension).

From the liver: sometimes during treatment with beta-lactam antibiotics, there is a moderate increase in ACT and / or ALT levels (clinical significance not established); very rarely - hepatitis, cholestatic jaundice. These side effects are seen with other penicillins or cephalosporins.

Liver side effects are reversible, occurring during or shortly after the end of treatment. Children develop very rarely. They occur predominantly in men and elderly patients and may be associated with long-term therapy.

In extremely rare cases, in patients with serious previous medical conditions or in those receiving potentially hepatotoxic drugs, the side effects can be severe and fatal.

From the urinary system: very rarely - interstitial nephritis, crystalluria.

Effects due to microbiological action: often - candidiasis of the mucous membranes; very rarely - pseudomembranous and hemorrhagic colitis.

When taking Augmentin, side effects are rare and are mostly mild and transient.

CONTRAINDICATIONS

Jaundice or abnormal liver function with a history of Augmentin use;

Hypersensitivity to beta-lactam antibiotics (including penicillins and cephalosporins).

PREGNANCY AND LACTATION

In studies of reproductive functions in animals when taking Augmentin, it was shown that oral and parenteral administration of this drug did not cause teratogenic effects.

In a single study in women with premature rupture of the membranes, it was found that prophylactic therapy with Augmentin may be associated with an increased risk of necrotizing enterocolitis in newborns. Augmentin is not recommended for use during pregnancy, unless, in the opinion of the doctor, it is necessary.

Augmentin can be used during breastfeeding. With the exception of the risk of sensitization associated with the release of trace amounts of active substances of the drug into breast milk, no other adverse effects were observed in breastfed infants.

SPECIAL INSTRUCTIONS

Before starting treatment with Augmentin, it is necessary to collect a detailed history of previous hypersensitivity reactions to penicillins, cephalosporins or other allergens.

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 antibiotics of this group. In the event of an allergic reaction, it is necessary to discontinue treatment with Augmentin and begin alternative therapy. For severe hypersensitivity reactions, epinephrine (epinephrine) should be given immediately. Oxygen therapy, IV steroid administration, and airway management, including intubation, may also be required.

Use Augmentin with caution in patients with impaired liver function.

The severity of side effects from the digestive system can be reduced by taking Augmentin at the beginning of a meal.

Oral care can help prevent discoloration of your teeth by brushing your teeth.

In patients receiving Augmentin, an increase in prothrombin time is occasionally observed, and therefore, with the simultaneous use of Augmentin and anticoagulants, appropriate monitoring should be carried out.

Crystalluria is very rare in patients with reduced urine output, mainly with parenteral therapy. When taking amoxicillin in high doses, it is recommended to take enough fluids and maintain adequate urine output to reduce the likelihood of amoxicillin crystals forming.

Long-term treatment with Augmentin may be accompanied by an excessive growth of insensitive microorganisms.

In general, Augmentin is well tolerated and has low toxicity characteristic of all penicillins. During long-term therapy with Augmentin, it is recommended to periodically monitor the functions of the kidneys, liver, and hematopoiesis.

In the medical literature, there is no data on the abuse of Augmentin and on the dependence on this drug.

Influence on the ability to drive vehicles and use mechanisms

Augmentin does not adversely affect the ability to drive vehicles and work with mechanisms.

OVERDOSE

Symptoms: possible gastrointestinal disorders and disturbances in water and electrolyte balance. Amoxicillin crystalluria has been described, in some cases leading to the development of renal failure.

Treatment: symptomatic therapy, correction of water and electrolyte balance. Amoxicillin and clavulanic acid are removed from the blood by hemodialysis.

DRUG INTERACTIONS

It is not recommended to use Augmentin simultaneously with probenecid. Probenecid reduces the tubular secretion of amoxicillin, and therefore the simultaneous use of Augmentin and probenecid can lead to an increase and persistence in the blood of amoxicillin, but not clavulanic acid levels.

With the simultaneous use of allopurinol and amoxicillin, the risk of allergic reactions may increase. There are currently no data on the simultaneous use of Augmentin and allopurinol.

Like other broad-spectrum antibiotics, Augmentin can reduce the effectiveness of oral contraceptives (patients should be informed about this).

TERMS OF RELEASE FROM PHARMACIES

The drug is available with a prescription.

STORAGE CONDITIONS AND PERIODS

List B. The drug should be stored in a dry place inaccessible to children at a temperature not exceeding 25 ° C. Shelf life of tablets (250 mg + 125 mg) and (875 mg + 125 mg) - 2 years, tablets (500 mg + 125 mg) - 3 years. Shelf life of powder for suspension preparation is 2 years.

The prepared suspension should be stored in the refrigerator at 2 ° to 8 ° C for 7 days.

With inflammatory processes of a bacterial nature, the drug Augmentin is very often prescribed today. This antibiotic is quite effective against most infections. The medicine is produced both in tablet form and in the form of a powder, from which it is necessary to prepare a suspension before use. Less commonly, this drug is used in the form of injections, the solution for which is produced in glass ampoules. We will talk about its properties, mechanism of action and application in urology later in the article.

Description of the drug and its use

This antibiotic inhibits the growth of the population of microorganisms that caused the infectious process... The active substances of the drug destroy bacteria, which after a certain time are excreted from the body mainly in the urine. If the causative agents of the infection have retained sensitivity to drugs of the penicillin series, then Augmentin can be quite effective in combating them. If necessary, for example, if any side effects occur, the doctor will replace the drug.

Indications for taking the drug

Augmentin is prescribed for the treatment of various diseases, which are based on the inflammatory process of a bacterial nature.

The main prescription condition is the sensitivity of bacteria to this drug. Its active substances are amoxicillin and clavulanic acid. In addition, it contains excipients, the list of which depends on the form of release of the drug (Augmentin tablets contain silicon dioxide, magnesium stearate, suspension - xanthan gum, silicon dioxide, flavorings).

As noted earlier, the indications for the use of this drug are various infectious diseases. In particular, the use of this medicinal product is carried out when:

• lesions of the ENT organs and the respiratory system;
• diseases of the joints and bones of an infectious nature;
• bacterial lesions of the bladder and kidneys;
• oral infections;
• various types of sepsis and for its prevention after surgery;
• skin infections

Before prescribing this agent as a drug therapy, appropriate tests should be carried out to determine the sensitivity / resistance of the infectious agent to the active component of the drug.

Order of use

The scheme of using the Augmentin drug and its dosage are determined by the attending physician and depend on the severity of the disease, kidney function, age (weight) of the patient. The duration of the course ranges from 5 to 14 days. Augmentin is best taken with food, more precisely at the very beginning of this process.

The antibiotic Augmentin can be used as the main drug in the fight against infectious diseases in children. In this case, a powder for preparing suspensions is advantageously used. The age and weight of the child, as well as the features of the pathology, are taken into account. For children under 12 years of age, the dosage is calculated as follows: milligram per kilogram of body weight. In general, Augmentin for children and adults is prescribed as follows:

1. A baby under three months old this drug is given as a suspension twice a day.
2. Older children who have reached the age of three months, it is recommended to use the same form of the drug, but three times a day.
3. Child aged 2 to 12 years the antibiotic is also prescribed in the form of a suspension.
4. For children from 12 years old, the drug is prescribed as for adults: in the form of tablets and in the same dosage.
5. Adults - one tablet three times a day.

It is undesirable to use Augmentin during pregnancy. Usually potent, including antibacterial agents, are prescribed during this period only if absolutely necessary. During lactation, Augmentin is also prescribed in extreme cases, however, GV, in the absence of any other way out, can be stopped. The drug can be prescribed to women during this period for various genitourinary infections: with cystitis, pyelonephritis, etc.

Important! In case of negative reactions in the baby to the use of the drug, feeding should be interrupted.

If the drug is to be used to treat a child, you need to know how to prepare the suspension and how to give it to the baby. To do this, add 60 ml of boiled cold water to the bottle with the powder. You need to dissolve all the powder, otherwise there is a possibility of incorrect dosage of the active substance.

The suspension prepared in the proper way can be stored in the refrigerator for a week without freezing. Therefore, you should not prepare it in advance, the powder should be diluted immediately before starting the course of treatment, so as not to waste the time allotted for storage. At the same time, it is advisable to measure water with a measuring cup, and the finished suspension with a syringe, this will allow you to more accurately observe the dosage.

Some features of the application

For Augmentin, contraindications are possible negative reactions of the body (first of all, the liver) to the substances contained in the drug, even if they happened in this person for a long time. In general, before prescribing this antibiotic, it is necessary to carefully examine the patient's history, and if cases of allergy to such substances are found in it, Augmentin cannot be prescribed.

The use of Augmentin can lead to some side effects, which include, first of all, diarrhea and nausea. Other reactions of the body can also be observed. However, it should be noted that such phenomena are observed quite rarely. In addition, there is a likelihood of other side effects, but it is also very low.

In any case, if there are suspicions of side effects, you should immediately consult a doctor and stop using this drug.

It should be noted that all side effects of Augmentin are almost always reversible. They often occur if there has been a prolonged use of the drug or an overdose. Reactions begin to appear in most cases in the process of taking the drug, but in some cases they can occur some time after the end of therapy.

Do not forget that long-term use of antibiotics, including Augmentin, leads to an increase in the population of microorganisms resistant to the drug. In addition, if it is unreasonable to use this drug for a long period, it can have a negative effect on the function of hematopoiesis, as well as the functioning of the liver and kidneys. Therefore, it is necessary during the course of therapy to monitor possible negative changes in this area and, if necessary, replace the drug.

While taking Augmentin, you must monitor a sufficient volume of urine output. To this end, it is recommended to drink as much liquid as possible, thereby provoking an outflow of urine. In the case of a decrease in diuresis, a phenomenon such as crystalluria may occur. In other words, under conditions of increasing urine concentration, amoxicillin can form crystals. To avoid this, it is necessary to exclude the possibility of even a slight stagnation.

It should be added that in rare cases, the use of this drug leads to a discoloration of the teeth, especially in children. It is necessary to monitor the oral cavity, the condition of the mucous membranes and teeth. Regular oral hygiene procedures, including brushing your teeth, will help avoid this negative reaction.

In general, the drug is generally well tolerated by patients, since it has low toxicity. It is not addictive or drug-dependent.

Important! However, it should be remembered that in some cases Augmentin can cause dizziness, so special care must be taken when driving vehicles.

Treatment of urological diseases with Augmentin

Among inflammatory diseases of an infectious nature, lesions of the urinary system occupy one of the most prominent places. Cystitis, pyelonephritis, glomerulonephritis, etc. can occur in children and adults, in men and women. The causative agents of these diseases are a wide variety of bacteria:

• ureaplasma;
• mycoplasma;
• gonococci;
• staphylococcus
• Escherichia coli, etc.

Each of the pathogens requires its own treatment, but while the doctor determines the nature of the inflammatory lesion of the urinary system, a broad-spectrum antibiotic can be prescribed to stop the inflammation, in particular Augmentin, which can neutralize these bacteria. In diseases of the genitourinary system, the standard doses of the drug described above are used.

Subsequently, when the test results are received, the doctor can make adjustments to the prescribed treatment plan, for example, replace the originally selected drug. However, if there is no reason for this, the patient will continue therapy, the basis of which will remain Augmentin.

Nevertheless, do not forget that the use of the same antibiotic for more than the recommended period is highly undesirable. As a result of such abuse, the effectiveness of the drug may be lost due to the development of resistance in microorganisms to it. Therefore, the doctor, if the disease requires long-term treatment, replaces the drug after a certain time.

Prompt and effective treatment of kidney and bladder diseases is very important as these diseases can lead to very serious and dangerous complications. In small children, and even more so in infants, the disease generally develops very rapidly. Delay in this case is unacceptable, therefore, in the absence of contraindications, Augmentin can stop the inflammatory process by suppressing the focus of infection.

With antibacterial treatment of cystitis or pyelonephritis, after three, maximum five days, there should be a tangible improvement in the condition. If this does not happen, you must immediately inform your doctor about it, you may need an immediate replacement of the drug.

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With proper and timely treatment, infectious diseases of the bladder and kidneys pass quickly enough. If the patient's body is strong, recovery takes about 10 days. The effectiveness of Augmentin in this case is due to the peculiarity of its composition, since the clavulanic acid contained in it protects amoxicillin from antibiotic-degrading enzymes, which makes this drug more effective compared to other drugs.

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