Augmentin, suspension 200 mg + 28.5 mg / 5 ml, bottle 70 ml

5 ml of the finished suspension contain:

Active substance:

amoxicillin (in the form of a trihydrate) - 200 mg;

clavulanic acid (in the form of potassium salt) - 28.5 mg.

Excipients:

xanthan gum - 12.5 mg,

aspartame - 12.5 mg,

succinic acid - 0.84 mg,

colloidal silicon dioxide - 25 mg,

hypromellose - 79.65 mg,

orange flavor 1 - 15 mg,

orange flavor 2 - 11.25 mg,

raspberry flavor - 22.5 mg,

flavoring "Bright molasses" - 23.75 mg,

silicon dioxide - up to 552 mg.

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 β-lactamases, and therefore the spectrum of activity of amoxicillin does not extend to the microorganisms that produce this enzyme.

Clavulanic acid, a β-lactamase inhibitor structurally related to penicillins, has the ability to inactivate a wide range of β-lactamases found in penicillin and cephalosporin resistant microorganisms.

Clavulanic acid is sufficiently effective against plasmid β-lactamases, which most often cause bacterial resistance, and is less effective against chromosomal β-lactamases of type 1 that are not inhibited by clavulanic acid.

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

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

Bacteria commonly susceptible to a combination of amoxicillin with clavulanic acid

Gram-positive aerobes: Bacillus anthracis, Enterococcus faecalis, Listeria monocytogenes, Nocardia asteroides, Streptococcus pyogenes1,2, Streptococcus agalactiae1,2, Streptococcus spp. (other beta hemolytic streptococci) 1,2, Staphylococcus aureus (sensitive to methicillin) 1, Staphylococcus saprophyticus (sensitive to methicillin), Staphylococcus spp. (coagulase-negative, sensitive to methicillin).

Gram-negative aerobes: Bordetella pertussis, Haemophilus influenzae1, Helicobacter pylori, Moraxella catarrhalis1, Neisseria gonorrhoeae, Pasteurella multocida, Vibrio cholerae.

Other: Borrelia burgdorferi, Leptospira icterohaemorrhagiae, Treponema pallidum.

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

Gram-negative anaerobes: Bacteroides fragilis, Bacteroides spp., Capnocytophaga spp., Eikenella corrodens, Fusobacterium nucleatum, Fusobacterium spp., Porphyromonas spp., Prevotella spp.

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

Gram-negative aerobes: Escherichia coli1, Klebsiella oxytoca, Klebsiella pneumoniae1, Klebsiella spp., Proteus mirabilis, Proteus vulgaris, Proteus spp., Salmonella spp., Shigella spp.

Gram-positive aerobes: Corynebacterium spp., Enterococcus faecium, Streptococcus pneumoniae1,2, Streptococcus group Viridans2.

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 enter

Other: Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia spp., Coxiella burnetti, 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 β-lactamases. Sensitivity with amoxicillin monotherapy suggests a similar sensitivity to the combination of amoxicillin with clavulanic acid.

Bacterial infections caused by drug-sensitive microorganisms:

• Infections of the upper respiratory tract and ENT organs (for example, recurrent tonsillitis, sinusitis, otitis media), usually caused by Streptococcus pneumoniae, Haemophilus influenzae *, Moraxella catarrhalis *, Streptococcus pyogenes;
• Infections of the lower respiratory tract: exacerbations of chronic bronchitis, lobar pneumonia and bronchopneumonia, usually caused by Streptococcus pneumoniae, Haemophilus influenzae * and Moraxella catarrhalis * (except for tablets 250 mg / 125 mg);
• Urogenital tract infections: 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;
• Gonorrhea caused by Neisseria gonorrhoeae * (except 250 mg / 125 mg tablets);
• Skin and soft tissue infections commonly caused by Staphylococcus aureus *, Streptococcus pyogenes, and species of the genus Bacteroides *;
• Infections of bones and joints: osteomyelitis, usually caused by Staphylococcus aureus *, if necessary, long-term therapy;
• Odontogenic infections, for example, periodontitis, odontogenic, maxillary sinusitis, severe dental abscesses with spreading cellulite (for tablets 500 mg / 125 mg or 875 mg / 125 mg);
• Other mixed infections (e.g., septic abortion, postpartum sepsis, intra-abdominal sepsis) as part of step therapy (for tablets 250 mg / 125 mg or 500 mg / 125 mg, or 875 mg / 125 mg).

* - individual representatives of the specified kind of microorganisms produce β-lactamase, which makes them insensitive to amoxicillin.

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

The sensitivity of bacteria to the combination of amoxicillin with clavulanic acid varies depending on the region and over time. Where possible, local sensitivity data should be taken into account. If necessary, microbiological samples should be collected and analyzed for bacteriological sensitivity.

In studies of reproductive function in animals, oral and parenteral administration of Augmentin® 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® is not recommended for use during pregnancy, unless the expected benefit to the mother outweighs the potential risk to the fetus.

The drug Augmentin® 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 breast-fed infants. In case of adverse effects in breast-fed infants, breast-feeding should be discontinued.

• Hypersensitivity to amoxicillin, clavulanic acid, other components of the drug, beta-lactam antibiotics (e.g. penicillins, cephalosporins) in the anamnesis.
• Previous episodes of jaundice or impaired liver function when using a combination of amoxicillin with clavulanic acid in history.
• Children under 12 years of age and body weight less than 40 kg (for tablets 250 mg / 125 mg or 500 mg / 125 mg, or 875 mg / 125 mg).
• Children's age up to 3 months (for powder for the preparation of a suspension for oral administration of 200 mg / 28.5 mg and 400 mg / 57 mg).
• Impaired renal function (CC ≤ 30 ml / min) - (for tablets 875 mg / 125 mg, for powder for suspension for oral administration 200 mg / 28.5 mg and 400 mg / 57 mg).
• Phenylketonuria (for powder for oral suspension).

Precautions: impaired liver function.

The adverse events presented below are listed in accordance with the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows: very often (≥1 / 10), often (≥ 1/100, <1/10), infrequently (≥ 1/1000, <1/100), rarely (≥ 1/10 000, < 1/1000), very rarely (<1/10 000).

Frequency categories were formed on the basis of clinical studies of the drug and post-registration observation.

Infectious and parasitic diseases: often - candidiasis of the skin and mucous membranes.

On the part of the blood and lymphatic system: rarely - reversible leukopenia (including neutropenia) and reversible thrombocytopenia; very rarely - reversible agranulocytosis and reversible hemolytic anemia, lengthening of prothrombin time and bleeding time, anemia, eosinophilia, thrombocytosis.

On the part of the immune system: very rarely - angioedema, anaphylactic reactions, a syndrome similar to serum sickness, allergic vasculitis.

From the nervous system: infrequently - dizziness, headache; very rarely - reversible hyperactivity, convulsions (convulsions can occur in patients with impaired renal function, as well as in those who receive high doses of the drug), insomnia, agitation, anxiety, and behavior change.

From the digestive tract: adults: very often - diarrhea, often - nausea, vomiting; children - often - diarrhea, nausea, vomiting; entire population: nausea is most often observed when taking high doses of the drug. If after the start of taking the drug there are undesirable reactions from the gastrointestinal tract, they can be eliminated if you take the drug at the beginning of the meal. Infrequently - digestive disorders; very rarely - antibiotic-associated colitis induced by taking antibiotics (including pseudomembranous colitis and hemorrhagic colitis), black “hairy” tongue, gastritis, stomatitis. In children, when applying the suspension, a discoloration of the surface layer of tooth enamel is very rarely observed. Oral care helps prevent discoloration of the tooth enamel, since it is enough to brush your teeth.

On the part of the liver and biliary tract: infrequently - a moderate increase in the activity of ACT and / or ALT (observed in patients receiving therapy with beta-lactam antibiotics, but its clinical significance is unknown); very rarely - hepatitis and cholestatic jaundice (these phenomena were noted during therapy with other penicillins and cephalosporins), an increase in the concentration of bilirubin and alkaline phosphatase. Adverse events from the liver were observed mainly in men and elderly patients and may be associated with long-term therapy. These adverse events are very rarely observed in children.

The listed signs and symptoms usually occur during or immediately after the end of therapy, however in some cases they may not appear for several weeks after completion of therapy. Adverse events are usually reversible. Adverse events from the liver can be severe, in extremely rare cases there have been reports of fatal outcomes. In almost all cases, these were persons with serious concomitant pathology or those receiving simultaneously hepatotoxic drugs.

On the part of the skin and subcutaneous tissues: infrequently - rash, itching, urticaria; rarely - multiforme erythema; very rarely - Stevens-Johnson syndrome, toxic spidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis.

In case of skin allergic reactions, treatment with Augmentin® should be discontinued.

From the kidneys and urinary tract: very rarely - interstitial nephritis, crystalluria, hematuria.

The simultaneous use of the drug Augmentin® and probenecid is not recommended. Probenecid reduces the tubular secretion of amoxicillin, and therefore, the simultaneous use of the drug Augmentin® and probenecide can lead to an increase and persistence in the blood concentration of amoxicillin, but not clavulanic acid.

The simultaneous use of allopurinol and amoxicillin may increase the risk of skin allergic reactions. Currently, there is no data in the literature on the simultaneous use of a combination of amoxicillin with clavulanic acid and allopurinol. Penicillins can slow the elimination of methotrexate from the body by inhibiting its tubular secretion, therefore, the simultaneous use of Augmentin® and methotrexate may increase the toxicity of methotrexate.

Like other antibacterial drugs, Augmentin® can affect the intestinal microflora, leading to a decrease in the absorption of estrogen from the gastrointestinal tract and a decrease in the effectiveness of combined oral contraceptives.

The literature describes rare cases of an increase in the international normalized ratio (MHO) in patients with the combined use of acenocoumarol or warfarin and amoxicillin. If necessary, the simultaneous administration of the Augmentin® preparation with anticoagulants, prothrombin time or MHO should be carefully monitored when prescribing or discontinuing the Augmentin® preparation; dose adjustment of anticoagulants for oral administration may be required.

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

To optimally absorb and reduce possible side effects from the digestive system, Augmentin® is recommended to be taken at the beginning of a meal.

The minimum course of antibiotic therapy is 5 days.

Treatment should not continue for more than 14 days without a review of the clinical situation.

If necessary, it is possible to conduct staged therapy (at the beginning of therapy, parenteral administration of the drug with subsequent transition to oral administration).

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

1 tablet of 250 mg / 125 mg 3 times / day (for infections of mild to moderate severity), or 1 tablet of 500 mg / 125 mg 3 times / day, or 1 tablet of 875 mg / 125 mg 2 times / day, or 11 ml of a suspension of 400 mg / 57 mg / 5 ml 2 times / day (which is equivalent to 1 tablet of 875 mg / 125 mg).

2 tablets of 250 mg / 125 mg are not equivalent to 1 tablet of 500 mg / 125 mg.

Children from 3 months to 12 years old with body weight less than 40 kg

The drug is prescribed in the form of a suspension for oral administration.

Dose calculation is carried out depending on age and body weight, indicated in mg / kg body weight / day (calculation according to amoxicillin) or in ml of suspension.

The multiplicity of the suspension 125 mg / 31.25 mg in 5 ml - 3 times / day every 8 hours

The multiplicity of the suspension 200 mg / 28.5 mg in 5 ml or 400 mg / 57 mg in 5 ml - 2 times / day every 12 hours.

The recommended dosage regimen and frequency of administration are presented below:

Multiplicity of admission - 3 times / day; 4: 1 suspension (125 mg / 31.25 mg in 5 ml):

• Low doses - 20 mg / kg / day.
• High doses - 40 mg / kg / day.

Multiplicity of admission - 2 times / day; suspension 7: 1 (200 mg / 28.5 mg in 5 ml or 400 mg / 57 mg in 5 ml):

• Low doses - 25 mg / kg / day.
• High doses - 45 mg / kg / day.

Low doses of Augmentin® are used to treat infections of the skin and soft tissues, as well as recurrent tonsillitis.

High doses of Augmentin® are used to treat diseases such as otitis media, sinusitis, infections of the lower respiratory tract and urinary tract, infections of bones and joints.

There is insufficient clinical data to recommend the use of the drug Augmentin® at a dose of more than 40 mg / kg / day in 3 divided doses (4: 1 suspension) in children under the age of 2 years.

Children from birth to 3 months

Due to the immaturity of the excretory function of the kidneys, the recommended dose of Augmentin® (calculation for amoxicillin) is 30 mg / kg / day in 2 divided doses of 4: 1.

The use of a 7: 1 suspension (200 mg / 28.5 mg in 5 ml or 400 mg / 57 mg in 5 ml) is not recommended in this population.

Premature babies

There are no recommendations regarding the dosage regimen.

Elderly patients

No dose adjustment is required. In elderly patients with impaired renal function, the dose should be adjusted as follows for adults with impaired renal function.

Patients with impaired renal function

Dose adjustment is based on the maximum recommended dose of amoxicillin and is carried out taking into account the values ​​of QC.

Adults

Tablets 250 mg + 125 mg or 500 mg + 125 mg:

• KK> 30 ml / min - correction of the dosage regimen is not required.
• KK 10-30 ml / min - 1 tab. 250 mg + 125 mg 2 times / day or 1 tab. 500 mg + 125 mg (for mild to moderate infection) 2 times / day.
• KK <10 ml / min - 1 tab. 250 mg + 125 mg 1 time / day or 1 tab. 500 mg + 125 mg (for mild and moderate infections) 1 time / day.

Suspension 4: 1 (125 mg / 31.25 mg in 5 ml):

• KK> 30 ml / min - correction of the dosage regimen is not required.
• KK 10-30 ml / min - 15 mg / 3.75 mg / kg 2 times / day, the maximum dose is 500 mg / 125 mg 2 times / day.
• CC <10 ml / min - 15 mg / 3.75 mg / kg 1 time / day, the maximum daily dose is 500 mg / 125 mg.

875 mg + 125 mg tablets and a 7: 1 suspension (200 mg / 28.5 mg in 5 ml or 400 mg / 57 mg in 5 ml) should be used only in patients with CC> 30 ml / min, with no dose adjustment required.

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

Hemodialysis patients

Dose adjustments are based on the maximum recommended dose of amoxicillin: 2 tab. 250 mg / 125 mg in one dose every 24 hours, or 1 tab. 500 mg / 125 mg in one dose every 24 hours, or a suspension at a dose of 15 mg / 3.75 mg / kg 1 time / day.

Tablets: during the hemodialysis session, an additional 1 dose (one tablet) and another 1 dose (one tablet) at the end of the dialysis session (to compensate for the decrease in serum concentrations of amoxicillin and clavulanic acid).

Suspension: before an hemodialysis session, one additional dose of 15 mg / 3.75 mg / kg should be administered. To restore the concentration of the active components of the drug Augmentin® in the blood, a second additional dose of 15 mg / 3.75 mg / kg should be introduced after a hemodialysis session.

Patients with impaired liver function

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

Rules for the preparation of the suspension

The suspension is prepared immediately before the first use.

Suspension (125 mg / 31.25 mg in 5 ml): approximately 60 ml of boiled water cooled to room temperature should be added to the powder bottle, then close the bottle with a lid and shake until the powder is completely diluted, allow the bottle to stand for 5 minutes to ensure complete breeding. Then add water to the mark on the bottle and shake the bottle again. In total, about 92 ml of water is required to prepare the suspension. The bottle should be shaken well before each use. For accurate dosing of the drug should use a measuring cap, which must be washed well with water after each use. After dilution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen.

For children under 2 years of age, a measured single dose of a suspension of the Augmentin® preparation can be diluted in half with water.

Suspension (200 mg / 28.5 mg in 5 ml or 400 mg / 57 mg in 5 ml): add approximately 40 ml of boiled water cooled to room temperature to the powder bottle, then close the bottle with a lid and shake until the powder is completely diluted Allow vial to stand for 5 minutes to ensure complete dilution. Then add water to the mark on the bottle and shake the bottle again. In total, about 64 ml of water is required to prepare the suspension. The bottle should be shaken well before each use. For accurate dosing of the drug, use a measuring cap or a dosing syringe, which must be washed well with water after each use. After dilution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen.

For children under 2 years of age, a measured single dose of a suspension of the Augmentin® preparation can be diluted with water in a ratio of 1: 1.

Symptoms: gastrointestinal symptoms and water-electrolyte imbalance may occur. Amoxicillin crystalluria is described, in some cases leading to the development of renal failure.

Convulsions may occur in patients with impaired renal function, as well as in those who receive high doses of the drug.

Treatment: gastrointestinal symptoms - symptomatic therapy, paying particular attention to normalizing the water-electrolyte balance. In case of an overdose, amoxicillin and clavulanic acid can be removed from the bloodstream by hemodialysis.

The results of a prospective study conducted with 51 children at a poison center showed that the administration of amoxicillin at a dose of less than 250 mg / kg did not lead to significant clinical symptoms and did not require gastric lavage.

Before starting treatment with Augmentin®, a detailed medical history should be collected regarding previous hypersensitivity reactions to penicillins, cephalosporins or other allergens.

Serious, and sometimes fatal, hypersensitivity reactions (anaphylactic reactions) to penicillins are described. The risk of such reactions is highest in patients with a history of hypersensitivity reactions to penicillins. In case of an allergic reaction, it is necessary to discontinue treatment with Augmentin® and begin appropriate alternative therapy. In case of serious hypersensitivity reactions, epinephrine should be administered immediately. Oxygen therapy, iv administration of GCS and provision of airway patency, including intubation, may also be required.

The appointment of the drug Augmentin® is not recommended in cases of suspected infectious mononukpeosis, since in patients with this disease, amoxicillin can cause a measles-like rash, which complicates the diagnosis of the disease.

Long-term treatment with Augmentin® sometimes leads to excessive reproduction of insensitive microorganisms.

In general, Augmentin® is well tolerated and has low toxicity characteristic of all penicillins.

During prolonged therapy with Augmentin®, it is recommended to periodically evaluate renal, hepatic, and hematopoietic function.

In order to reduce the risk of side effects from the gastrointestinal tract, the drug should be taken at the beginning of a meal.

In patients receiving a combination of amoxicillin with clavulanic acid together with indirect (oral) anticoagulants, in rare cases, an increase in prothrombin time (increase in MHO) was reported. With the joint appointment of indirect (oral) anticoagulants with a combination of amoxicillin with clavulanic acid, monitoring of the relevant indicators is necessary. To maintain the desired effect of oral anticoagulants, dosage adjustment may be required.

In patients with impaired renal function, the dose of Augmentin® should be reduced accordingly to the degree of impairment.

In patients with reduced diuresis, in very rare cases, the development of crystalluria was reported, mainly with parenteral use of the drug. During the administration of high doses of amoxicillin, it is recommended to take a sufficient amount of liquid and maintain adequate diuresis to reduce the likelihood of formation of amoxicillin crystals.

Taking the drug Augmentin® inside leads to a high content of amoxicillin in the urine, which can lead to false-positive results in the determination of glucose in the urine (for example, a Benedict test, a Feling test). In this case, it is recommended to use the glucose oxidant method for determining the concentration of glucose in the urine.

Oral care helps prevent discoloration of the teeth, since brushing your teeth is enough.

Tablets must be used within 30 days from the moment of opening the package of laminated aluminum foil.

Abuse and drug dependence

No drug dependence, addiction and euphoria reactions associated with the use of the drug Augmentin® were observed.

Influence on the ability to drive vehicles and control mechanisms

Since the drug may cause dizziness, it is necessary to warn patients about precautions when driving or working with moving machinery.

Powder for suspension for oral administration.