Augmentin 228.5 instructions for use. Augmentin in the form of a suspension: instructions for use for children. Description of the dosage form

Augmentin: instructions for use and reviews

Latin name: Augmentin

ATX Code: J01CR02

Active substance: amoxicillin + clavulanic acid (Amoxicillin + Clavulanic acid)

Producer: GlaxoSmithKline public company (GlaxoSmithKline PLC) (UK)

Description and photo update: 19.08.2019

Augmentin is a broad-spectrum antibiotic that affects both gram-negative and gram-positive bacteria.

Release form and composition

The antibiotic is produced in the following forms:

  • film-coated tablets: oval-shaped, white or almost white, on a break - from white-yellowish to almost white [250 mg (250 + 125) each: with an indented inscription on one side of the AUGMENTIN tablet (in blisters of 10 pcs., in a cardboard pack 2 blisters); 500 mg each (500 + 125): with an embossed inscription "AC" and a risk on one side (in blisters of 7 or 10 pcs., in a cardboard bundle 2 blisters); 875 mg each (875 + 125): with the letters "A" and "C" on both sides of the tablet and the risk of breakage on one side (in blisters of 7 pcs., in a carton pack of 2 blisters)];
  • powder for suspension for oral administration: white or almost white, with a characteristic odor; when diluted, a suspension is obtained (white or almost white), in which a precipitate forms at rest (in glass bottles, 1 bottle with a measuring cap in a cardboard box);
  • powder for solution for intravenous administration: from white to almost white (10 vials in a carton pack).

As active substances in Augmentin, a combination of clavulanic acid (in the form of potassium salt) and amoxicillin (in the form of sodium salt) is used.

1 tablet contains:

  • active substances: clavulanic acid - 125 mg, amoxicillin (in the form of trihydrate) - 250, 500 or 875 mg;
  • excipients: sodium carboxymethyl starch, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose.

The composition of the film shell of the tablets includes: hypromellose, hypromellose (5cP), macrogol 6000, macrogol 4000, dimethicone, titanium dioxide.

5 ml of the prepared oral suspension contains:

  • active substances [ratio of amoxicillin (as trihydrate) to clavulanic acid (as potassium salt)]: 125 mg/31.25 mg, 200 mg/28.5 mg, 400 mg/57 mg;
  • excipients: hypromellose, xanthan gum, succinic acid, aspartame, colloidal silicon dioxide, flavors (orange 1, orange 2, raspberry, "Light molasses"), silicon dioxide.

1 vial (1200 mg) of intravenous solution contains active substances:

  • amoxicillin (in the form of sodium salt) - 1000 mg;
  • clavulanic acid (in the form of potassium salt) - 200 mg.

Pharmacological properties

Augmentin is characterized by antibacterial and bactericidal action and belongs to penicillins from the group of β-lactams.

Pharmacodynamics

Amoxicillin is a semi-synthetic broad-spectrum antibiotic that is active against many gram-negative and gram-positive microorganisms. However, amoxicillin is susceptible to degradation by β-lactamases, so its spectrum of activity does not extend to bacteria that produce this enzyme.

Clavulanic acid has a structure related to penicillins and is a β-lactamase inhibitor, which explains its ability to inactivate a wide range of β-lactamases that are present in microorganisms that demonstrate resistance to cephalosporins and penicillins. This active component effectively acts on plasmid β-lactamases, which most often provide bacterial resistance, and is ineffective against type 1 chromosomal β-lactamases that are not inhibited by clavulanic acid.

The inclusion of clavulanic acid in Augmentin helps protect amoxicillin from degradation by enzymes - β-lactamases, which ensures the expansion of the antibacterial spectrum of this substance.

In vitro, the following microorganisms are sensitive to the combination of amoxicillin with clavulanic acid:

  • gram-negative aerobes: Vibrio cholerae, Bordetella pertussis, Pasteurella multocida, Haemophilus influenzae, Neisseria gonorrhoeae, Moraxella catarrhalis, Helicobacter pylori;
  • gram-positive aerobes: coagulase-negative staphylococci (methicillin-sensitive strains), Staphylococcus saprophyticus (methicillin-sensitive), Staphylococcus aureus (methicillin-sensitive), Bacillus anthracis, Streptococcus agalactiae, Streptococcus spp. (other β-hemolytic streptococci), Streptococcus pyogenes, Enterococcus faecalis, Nocardia asteroides, Listeria monocytogenes;
  • gram-negative anaerobes: Prevotella spp., Bacteroides fragilis, Bacteroides spp., Porphyromonas spp., Fusobacterium spp., Fusobacterium nucleatum, Eikenella corrodens, Capnocytophaga spp.;
  • gram-positive anaerobes: Peptostreptococcus spp., Peptostreptococcus magnus, Peptostreptococcus micros, Peptostreptococcus niger, Clostridium spp.;
  • others: Treponema pallidum, Leptospira icterohaemorrhagiae, Borrelia burgdorferi.

The following microorganisms are characterized by acquired resistance to the combination of amoxicillin with clavulanic acid:

  • gram-positive aerobes: streptococci of the Viridans group, Corynebacterium spp., Streptococcus pneumoniae (strains of this type of bacteria do not produce β-lactamase, and the therapeutic efficacy of the drug was confirmed by the results of clinical studies), Enterococcus faecium;
  • gram-negative aerobes: Shigella spp., Escherichia coli, Salmonella spp., Klebsiella spp., Klebsiella pneumoniae, Klebsiella oxytoca, Proteus spp., Proteus vulgaris, Proteus mirabilis.

The following bacteria have natural resistance to the drug, which includes amoxicillin and clavulanic acid:

  • gram-negative aerobes: Yersinia enterocolitica, Acinetobacter spp., Stenotrophomonas maltophilia, Citrobacter freundii, Serratia spp., Enterobacter spp., Pseudomonas spp., Hafnia alvei, Providencia spp., Morganella morganii, Legionella pneumophila;
  • others: Coxiella burnetii, Chlamydia psittaci, Chlamydia pneumoniae, Chlamydia spp., Mycoplasma spp.

The sensitivity of the pathogen to amoxicillin monotherapy suggests a similar sensitivity to the combination of amoxicillin with clavulanic acid.

Pharmacokinetics

Clavulanic acid and amoxicillin are rapidly and almost 100% absorbed from the gastrointestinal tract (GIT) when taken orally. The absorption of the active components of Augmentin is considered optimal when the drug enters the body at the beginning of a meal.

The oral suspension has been studied in clinical trials in healthy volunteers aged 2 to 12 years. They took Augmentin at a dosage of 125 mg / 31.25 mg 5 ml on an empty stomach in 3 doses, and the daily dose of amoxicillin and clavulanic acid was 40 and 10 mg / kg, respectively. As a result of the experiment, the following values ​​of pharmacokinetic parameters were obtained:

  • clavulanic acid: maximum concentration 2.7 ± 1.6 mg / ml, time to reach maximum plasma levels 1.6 hours (variation range 1–2 hours), AUC 5.5 ± 3.1 mg h / ml, elimination half-life 0.94±0.05 hours;
  • amoxicillin: maximum concentration 7.3±1.7 mg/ml, time to reach maximum plasma levels 2.1 hours (variation range 1.2–3 hours), AUC 18.6±2.6 mg×h/ml , half-life 1.0±0.33 hours.

Comparative studies were also conducted on the pharmacokinetics of Augmentin when taken in the form of film-coated tablets (on an empty stomach). The results of determining the pharmacokinetic parameters depending on the intake of Augmentin, clavulanic acid and amoxicillin at various doses were as follows:

  • one tablet of Augmentin with a dosage of 250 mg / 125 mg: for amoxicillin - the maximum concentration is 3.7 mg / l; time to reach maximum plasma concentration 1.1 hours; AUC (area under the concentration-time curve) 10.9 mg h / ml; elimination half-life (T 1/2) 1 hour. For clavulanic acid, the maximum concentration is 2.2 mg/l; the time to reach the maximum concentration in the blood plasma - 1.2 hours; AUC 6.2 mg h/mL; T 1/2 - 1.2 hours;
  • two tablets of Augmentin with a dosage of 250 mg / 125 mg: for amoxicillin - the maximum concentration is 5.8 mg / l; the time to reach the maximum concentration in the blood plasma is 1.5 hours; AUC 20.9 mg h/mL; T 1/2 - 1.3 hours. For clavulanic acid, the maximum concentration is 4.1 mg/l; time to reach maximum plasma concentration 1.3 hours; AUC 11.8 mg h/mL; T 1/2 - 1 hour;
  • one tablet of Augmentin with a dosage of 500 mg / 125 mg: for amoxicillin - the maximum concentration is 6.5 mg / l; the time to reach the maximum concentration in the blood plasma is 1.5 hours; AUC 23.2 mg h/mL; T 1/2 - 1.3 hours. For clavulanic acid, the maximum concentration is 2.8 mg/l; time to reach maximum plasma concentration 1.3 hours; AUC 7.3 mg h/mL; T 1/2 - 0.8 hours;
  • amoxicillin alone at a dose of 500 mg: maximum concentration 6.5 mg/l; time to reach maximum plasma concentration 1.3 hours; AUC 19.5 mg h / ml; T 1/2 - 1.1 hours;
  • clavulanic acid alone at a dose of 125 mg: maximum concentration 3.4 mg/l; time to reach maximum plasma concentration 0.9 hours; AUC 7.8 mg h/mL; T 1/2 - 0.7 hours.

The pharmacokinetics of the drug was also studied with intravenous bolus administration of Augmentin to healthy volunteers. As a result, the following values ​​of pharmacokinetic parameters depending on the dose were obtained:

  • dosage 1000 mg / 200 mg: for amoxicillin - the maximum concentration is 105.4 μg / ml; T 1/2 - 0.9 hours; AUC 76.3 mg h / ml, excreted in the urine during the first 6 hours after administration of 77.4% of the active substance. For clavulanic acid - the maximum concentration is 28.5 μg / ml; T 1/2 - 0.9 hours; AUC 27.9 mg h / ml, excreted in the urine during the first 6 hours after administration of 63.8% of the active substance;
  • dosage 500 mg / 100 mg: for amoxicillin - the maximum concentration is 32.2 μg / ml; T 1/2 - 1.07 hours; AUC 25.5 mg h / ml, excreted in the urine during the first 6 hours after administration of 66.5% of the active substance. For clavulanic acid - the maximum concentration is 10.5 μg / ml; T 1/2 - 1.12 hours; AUC 9.2 mg h / ml, excreted in the urine during the first 6 hours after administration of 46% of the active substance.

Both with oral administration and with intravenous administration of the drug, clavulanic acid and amoxicillin in therapeutic concentrations are determined in the interstitial fluid and various tissues (in the tissues of the abdominal cavity, adipose and muscle tissues, skin, gallbladder, purulent discharge, bile, peritoneal and synovial liquids).

Both active components of Augmentin bind weakly to plasma proteins. The results of studies indicate that the degree of binding of amoxicillin to blood plasma proteins is approximately 18%, and clavulanic acid - 25%. Animal experiments do not confirm the accumulation of active substances in any organs.

Amoxicillin penetrates into breast milk, in which clavulanic acid is also determined in trace concentrations. Negative effects of these substances on the health of breastfed children, in addition to the development of candidiasis of the mucous membranes of the oral cavity, diarrhea and the risk of sensitization, have not been identified.

The study of reproductive function in animals when using amoxicillin in combination with clavulanic acid showed that the active components of Augmentin penetrate the placental barrier, but do not have a negative effect on the fetus.

From 10 to 25% of the accepted dose of amoxicillin is excreted in the urine in the form of penicillic acid, a metabolite that does not show pharmacological activity. Clavulanic acid is extensively metabolized to form 1-amino-4-hydroxy-butan-2-one and 2,5-dihydro-4-(2-hydroxyethyl)-5-oxo-1H-pyrrole-3-carboxylic acid, and is excreted through the gastrointestinal tract. , with urine, as well as with exhaled air in the form of carbon dioxide.

Amoxicillin is excreted mainly through the kidneys, while clavulanic acid is characterized by both renal and extrarenal mechanism. Approximately 45-65% of clavulanic acid and about 60-70% of amoxicillin are excreted unchanged in the urine during the first 6 hours after taking 1 tablet of 500mg / 125 mg or 250 mg / 125 mg or after a single bolus injection of Augmentin at a dosage of 500 mg / 100 mg or 1000 mg/200 mg. The simultaneous administration of probenecid inhibits the excretion of amoxicillin, but does not affect the excretion of clavulanic acid.

Indications for use

According to the instructions, Augmentin is prescribed for bacterial infections caused by microorganisms that are sensitive to the antibiotic:

  • infections of the skin, soft tissues;
  • respiratory tract infections: bronchitis, lobar bronchopneumonia, empyema, lung abscess;
  • infections of the genitourinary system: cystitis, urethritis, pyelonephritis, abortion sepsis, syphilis, gonorrhea, infections of the organs in the pelvic area;
  • bone and joint infections: osteomyelitis;
  • odontogenic infections: periodontitis, odontogenic maxillary sinusitis, severe dental abscesses;
  • infections that arose as a complication after surgery: peritonitis.

Contraindications

  • hypersensitivity to clavulanic acid, amoxicillin, other components of the drug and beta-lactam antibiotics (cephalosporins, penicillins) in history;
  • previous cases of jaundice or abnormal liver function when using a combination of clavulanic acid with amoxicillin in history;
  • impaired renal function (powder for suspension for oral administration 200 mg / 28.5 mg and 400 mg / 57 mg; tablets 875 mg / 125 mg);
  • phenylketonuria (powder for oral suspension).

Contraindications to Augmentin for children: tablets - age up to 12 years and body weight less than 40 kg; powder for suspension for oral administration 400 mg / 57 mg and 200 mg / 28.5 mg - age up to 3 months.

In case of impaired liver function, Augmentin should be taken with caution.

During pregnancy and breastfeeding, the decision on the need to use the drug is made by the attending physician.

Instructions for use Augmentin: method and dosage

Before prescribing Augmentin, it is recommended to undergo an examination to identify the sensitivity of the microflora that caused the disease to this antibiotic. Next, the doctor sets the dosage regimen, taking into account the patient's age, weight, kidney function, and the severity of the disease.

The minimum effective course of treatment is 5 days, the maximum duration of therapy without adjusting the clinical situation is 2 weeks. The drug should be taken at the beginning of a meal.

If necessary, the first time the drug is administered parenterally, then oral administration can be prescribed.

  • in case of infections of mild and moderate severity: 1 tablet (250 mg + 125 mg) 3 times a day;
  • in severe or chronic infections: 1 tablet (500 mg + 125 mg) 3 times a day or 1 tablet (875 mg + 125 mg) 2 times a day.

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

  • children over 12 years old and adults: 11 ml suspension 400 mg / 57 mg / 5 ml 2 times a day (corresponding to 1 tablet 875 mg + 125 mg);
  • children from 3 months to 12 years (weighing up to 40 kg): the daily dose is determined based on body weight and age (in ml - for suspension, or mg / kg / day). The calculated value should be divided into 3 doses with an 8-hour interval (for a suspension of 125 mg / 31.25 mg / 5 ml), or into 2 doses (for a suspension of 400 mg / 57 mg / 5 ml or 200 mg / 28.5 mg /5 ml) at 12-hour intervals. For 125 mg/31.25 mg/5 ml suspension, low* doses are 20 mg/kg/day, high** doses are 40 mg/kg/day. For suspension 400 mg / 57 mg / 5 ml and 200 mg / 28.5 mg / 5 ml low doses - 25 mg / kg / day, high doses - 45 mg / kg / day.

*Low doses are used in the treatment of recurrent tonsillitis and soft tissue and skin infections.

** High doses are required for the treatment of sinusitis, otitis media, joint and bone infections, urinary and respiratory tract infections.

  • children over 12 years of age and adults: 1000 mg / 200 mg 3 times a day (every 8 hours), in severe infections, the interval between injections can be reduced to 4-6 hours;
  • children from 3 months to 12 years: 3 times a day at the rate of 50 mg / 5 mg / kg or 25 mg / 5 mg / kg, depending on the severity of the infection, the interval between injections is 8 hours;
  • children under the age of 3 months: weighing more than 4 kg - 25 mg / 5 mg / kg or 50 mg / 5 mg / kg every 8 hours, weighing less than 4 kg - 25 mg / 5 mg / kg every 12 hours.

Augmentin should be taken strictly in the doses prescribed by the doctor, following the prescribed regimen.

Side effects

The use of Augmentin in rare cases can cause the following (mostly mild and transient) side effects:

  • hematopoietic system: thrombocytopenia, leukopenia (including neutropenia), hemolytic anemia and agranulocytosis (reversible), increased prothrombin index and bleeding time;
  • immune system: allergic reactions in the form of anaphylaxis, angioedema, a syndrome similar to serum sickness, Stevens-Johnson syndrome, allergic vasculitis, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis. The use of Augmentin should be discontinued if any of the forms of allergic dermatitis occurs;
  • skin manifestations: rash, urticaria, erythema multiforme;
  • central nervous system: hyperactivity and convulsions (reversible), headache, dizziness;
  • liver: cholestatic jaundice, hepatitis, moderate increase in AST and/or ALT levels (these side effects occur during or immediately after therapy, most often in elderly patients and in men (with long-term treatment), in children - very rarely, and are reversible);
  • urinary system: crystalluria, interstitial nephritis.

Very often, the use of Augmentin can cause diarrhea in adults and children, nausea, vomiting, dyspepsia (these digestive disorders can be reduced if the drug is taken with food).

Occasionally, in children taking Augmentin suspension, the color of the integumentary layer of tooth enamel may change.

The microbiological effect of the drug often causes candidiasis of the mucous membranes, in rare cases it can cause hemorrhagic and pseudomembranous colitis.

Overdose

With an overdose of Augmentin, there may be disturbances in the water and electrolyte balance and negative symptoms from the gastrointestinal tract. There are reports of the development of amoxicillin crystalluria, which in some cases provoked the development of renal failure. Patients with kidney dysfunctions, as well as those who take the drug in high doses, may experience seizures.

To stop the negative phenomena associated with the functioning of the gastrointestinal tract, symptomatic therapy is prescribed, in the selection of which special attention should be paid to the normalization of water and electrolyte balance. Clavulanic acid and amoxicillin can be removed from the systemic circulation through a hemodialysis procedure.

A prospective study at a poison control center in 51 children confirms that the administration of amoxicillin at a dose not exceeding 250 mg/kg did not lead to the development of clinically significant symptoms of overdose and did not require gastric lavage.

After intravenous administration of amoxicillin in large doses, it can form a precipitate in urinary catheters, so their patency should be checked regularly.

special instructions

When treating with Augmentin, it is necessary to first collect a detailed history to find out if there were previous hypersensitivity reactions to cephalosporins, penicillins or other allergens.

Serious anaphylactoid reactions, sometimes fatal, have been reported in some cases. The risk of such conditions is especially high in patients with a history of hypersensitivity reactions to penicillins. If an allergic reaction occurs, Augmentin therapy should be stopped immediately, in severe cases, adrenaline should be administered immediately. Oxygen therapy, intravenous glucocorticosteroids, and airway management, including intubation, may be necessary.

With prolonged use of Augmentin, the risk of excessive reproduction of microorganisms insensitive to it increases.

Influence on the ability to drive vehicles and complex mechanisms

Augmentin does not have a negative effect on the ability to drive vehicles and mechanisms.

Use during pregnancy and lactation

The results of studies of reproductive function in animals with parenteral and oral administration of Augmentin confirm the absence of teratogenic effects caused by the drug. A single study in patients with preterm rupture of the membranes suggests that prophylactic therapy with this antibiotic may increase the risk of neonatal necrotizing enterocolitis. Therefore, Augmentin should be used only in cases where the potential benefit of treatment for the mother significantly outweighs the possible adverse effects on the fetus.

Appointment of Augmentin during lactation is allowed. However, if adverse reactions develop in children (candidiasis of the mucous membranes of the oral cavity, diarrhea, increased sensitization), it is recommended to stop breastfeeding.

Application in childhood

It is allowed to prescribe Augmentin for children according to indications in compliance with the dosing regimen:

  • powder for suspension for oral administration and powder for solution for intravenous administration - from birth;
  • film-coated tablets - from 12 years.

For impaired renal function

In patients with renal dysfunction, dose adjustments are based on the maximum therapeutic dose of amoxicillin and are based on creatinine clearance (CC) values.

When taken by adult patients whose CC exceeds 30 ml / min, Augmentin tablets with a dosage of 500 mg / 125 mg or 250 mg / 125 mg, as well as a suspension with a dosage of 125 mg / 31.25 mg in 5 ml, there is no need for dose adjustment. If the CC value is from 10 to 30 ml / min, patients are advised to take 1 tablet 500 mg / 125 mg or 1 tablet 250 mg / 125 mg (for mild and moderately severe infections) 2 times a day or 20 ml of a suspension of 125 mg / min. 31.25 mg in 5 ml 2 times a day.

With a CC value of less than 10 ml / min, Augmentin is used at a dosage of 1 tablet 500 mg / 125 mg or 1 tablet 250 mg / 125 mg (for mild and moderately severe infection) 1 time per day or 20 ml of suspension 125 mg / 31.25 mg in 5 ml once a day.

Tablets 875 mg / 125 mg are prescribed only to patients whose CC exceeds 30 ml / min, so dose adjustment is not required. In most cases, it is recommended to give preference to parenteral administration of Augmentin.

When used in adults and children over 12 years of age or weighing more than 40 kg who are on hemodialysis, the recommended dose of Augmentin is 1 tablet 500 mg / 125 mg (2 tablets 250 mg / 125 mg) once every 24 hours or 20 ml suspensions 125 mg / 31.25 mg 1 time per day.

During the dialysis procedure, as well as at its end, the patient receives an additional one tablet (1 dose), which allows compensating for the decrease in the concentrations of clavulanic acid and amoxicillin in the blood serum.

For impaired liver function

In patients with liver dysfunction, treatment is carried out with caution. It is recommended to regularly monitor the condition of the liver. The limited data regarding the use of Augmentin in this category of patients does not allow for correction of the dosing regimen.

Use in the elderly

There is no need to reduce the dose for elderly patients: it is prescribed in the same doses as for adult patients. In elderly patients with renal dysfunction, the dose should be adjusted in the same way as for patients with renal insufficiency.

drug interaction

Probenecid and drugs of similar action (phenylbutazone, diuretics, NSAIDs) reduce the tubular secretion of amoxicillin. Simultaneous administration is not recommended, since it may be accompanied by persistence and an increase in the concentration of amoxicillin in the blood (while the renal excretion of clavulanic acid does not slow down).

Fibell.

Analogues of Augmentin according to the mechanism of action, drugs of the same pharmacological subgroup: Ampiox, Ampisid, Libaktsil, Oksamp, Oxampicin, Oxamsar, Sulbacin, Sultasin, Santaz, etc.

Terms and conditions of storage

Store at temperatures up to 25 ° C in a dry place out of the reach of children.

Best before date:

  • tablets containing amoxicillin 875 mg and 250 mg - 2 years;
  • tablets containing amoxicillin 500 mg - 3 years;
  • powder for solution for intravenous administration - 2 years;
  • powder for the preparation of a suspension in unopened form - 2 years;
  • prepared suspension (at a temperature within 2-8 ° C) - 7 days.

In choosing an antibiotic for the treatment of any infection, drugs with a broad spectrum of antimicrobial activity are often preferred. One of them is Augmentin. For children, this medicine is more convenient to give in liquid form. When is it prescribed to young children and how is the suspension prepared? Is the drug taken before or after meals? How long to treat a child? These and other questions are of interest to every mother if her son or daughter is to take an antibiotic.

Release form

Augmentin, from which the suspension is prepared, is represented by a powder placed in a glass vial. Such a powder has a white color and a characteristic odor, and after adding water, a white suspension is obtained from it, which separates during storage with the formation of a white precipitate. The drug is also available in injection form (it is intended for intravenous administration) and in coated tablets with different dosages (they can contain 250, 500 or 875 mg of the antibiotic each).

Compound

Augmentin includes two active ingredients at once, thanks to which it has a wide range of effects on microorganisms:

  1. Amoxicillin. This antibiotic is presented in the form of a trihydrate and is contained in 5 ml of the finished drug at a dosage of 125 mg, 200 mg or 400 mg.
  2. clavulanic acid. Such a compound is a potassium salt and the dosage of this acid is, depending on the dose of amoxicillin, 31.25 mg, 28.5 mg or 57 mg per 5 ml of suspension.

The ratio of these two components is represented by a ratio of 4:1 and 7:1. Additionally, the bottle contains silicon dioxide, xanthan gum, hypromellose and succinic acid. For sweetness, aspartame is added to the preparation, and the smell of the suspension is provided with orange, raspberry and molasses flavors.

Operating principle

Amoxicillin in the composition of Augmentin has an antimicrobial effect on many types of microorganisms. It acts bactericidal, causing the death of bacteria due to inhibition of the synthesis of their cell walls. However, this antibiotic can be destroyed by beta-lactamases, so it cannot kill the bacteria that produce these enzymes.

It is to prevent this destruction that clavulanic acid is present in the preparation. It inactivates beta-lactamase, which makes even amoxicillin-resistant microbes sensitive to the suspension.

The drug is effective against:

  • Various types of staphylococci, including saprophytic and golden.
  • Pertussis sticks.
  • Various types of streptococci, including hemolytic, pyogenic and group B.
  • Nocardius.
  • Listeria.
  • Hemophilic rods.
  • Enterococci.
  • Helicobacter pylori.
  • Gonococcus.
  • Vibrio cholerae.
  • Pasteurell.
  • Peptococcus and Peptostreptococcus.
  • Moraxell.
  • Pale treponemas.
  • Leptospir.
  • Borrelia.
  • Bacteroids.
  • Clostridia.
  • Fusobacterium.

The suspension may be powerless against Escherichia coli, Proteus, Salmonella, Corynebacterium, Pneumococcus, Klebsiella and Shigella, therefore, when infected with these microorganisms, it is recommended to first do a sensitivity test.

The drug is considered ineffective when infected with Citrobacter, Enterobacter, Morganella, Providence, Legionella, Hafnia, Pseudomonas, Yersinia, Chlamydia, Coxiella, Mycoplasmas and Serrations. In addition, this medicine does not help with influenza, herpetic sore throat, SARS, mononucleosis, chickenpox and other viral infections.

Indications

Augmentin in the form of a suspension is prescribed:

  • With bacterial lesions of the ENT organs and the upper respiratory system, for example, with otitis media, sinusitis or recurrent tonsillitis.
  • With whooping cough or scarlet fever.
  • With exacerbation of chronic bronchitis, acute bronchitis, lobar pneumonia and other bacterial lesions of the lower respiratory tract.
  • With urinary infections, for example, with urethritis or pyelonephritis.
  • With gonorrhea.
  • When infected with streptococci or Staphylococcus aureus of soft tissues or skin.
  • With bacterial infections of the joints or bones.

At what age is it allowed to take?

Augmentin is prescribed by pediatricians for children of any age, even infants. At the same time, suspensions with a dosage of amoxicillin 200 mg or 400 mg per five milliliters do not give babies the first three months of life. Such drugs are prescribed in childhood only from 3 months.

Contraindications

The drug should not be given to a child with hypersensitivity to any component of the suspension, as well as allergies to other penicillin antibiotics or cephalosporins. Also, treatment is prohibited for phenylketonuria, which is associated with the presence of aspartame in the composition.

Very carefully prescribe the medicine to children who have impaired kidney function or liver disease. If infectious mononucleosis is suspected in a baby, the use of Augmentin can cause a measles-like rash.

Side effects

As a result of treatment with Augmentin, a child may experience:

  • Allergy in the form of itching, hives or rash.
  • Loose stools, as well as vomiting or nausea.
  • Deterioration of the parameters of the general blood test - a decrease in the level of platelets and leukocytes, sometimes agranulocytosis and anemia, as well as a change in the parameters of the coagulation system.
  • Candida infection that affects the mucous membranes or skin.
  • Increased activity of liver enzymes.
  • Headache or dizziness.

Very rare side effects of taking the suspension include Quincke's edema, anaphylaxis, nervous excitement, convulsions, intestinal inflammation, stomatitis, discoloration of tooth enamel, nephritis and other negative phenomena. When they occur, stop treatment and immediately consult a doctor.

Instructions for use

To prepare a suspension, boiled and cooled to room temperature water in a certain amount is added to Augmentin in powder. In a preparation containing amoxicillin at a dose of 125 mg per 5 milliliters, first pour 60 ml of water. Next, the medicine is shaken and left for 5 minutes, after which more water is added so that its total volume is approximately 92 ml.

If a suspension containing 200 or 400 mg of amoxicillin in five milliliters is used in the treatment, then the powder is first mixed with 40 ml of water, and after five minutes a little more water is added to the bottle so that its total amount is approximately 64 ml.

In addition, treatment with the liquid form of Augmentin provides for such nuances:

  • Before each use, the medicine should be shaken so that the exfoliated syrup becomes homogeneous.
  • The measuring cap that comes with the antibiotic bottle helps to measure the exact dose of the medication. When the child has drunk the suspension, this cap is thoroughly washed with water.
  • For a child under two years of age, a single dosage of the drug can be further diluted with water 1: 1.
  • The mode of application and calculation of a single dosage of the drug is affected by both the age of the child and his weight, and the condition of the kidneys, and the severity of the infection.
  • In order for the active substances of the drug to be optimally absorbed, and the risk of side effects is less, it is advised to drink the medicine at the beginning of the meal. Suspension is given to infants during feeding.
  • How many days to drink the drug, in each case is determined individually, but the minimum course of treatment is considered to be a period of 5 days. In addition, it is undesirable to give the suspension longer than 14 days.
  • To prevent staining of the teeth, it is recommended to brush them thoroughly several times a day.

Dosage

Babies of the first three months of life are given only a suspension, the active substances of which are presented in a ratio of 4: 1 (125 mg / 31.25 mg).

To calculate the daily dose of the drug, you need to know the weight of the baby in kilograms. It is multiplied by 30 and get the number of milligrams of amoxicillin. By dividing the resulting figure by 2, a single amount of ml of suspension is determined, which is given to the child twice a day.

For a child aged 3 months to 12 years who weighs less than 40 kilograms, the suspension is dosed as follows:

  • Preparation containing active compounds 125mg/31.25mg give three times a day with an interval between doses of 8 hours.
  • A medicine containing the active ingredients in an amount 200mg/28.5mg or 400mg/57mg, prescribed twice, that is, such suspensions are taken twice a day.

If the child has soft tissue or skin infection then Augmentin is prescribed at a low dose. It is presented at 20 mg per 1 kg of baby's weight per day for a suspension of 125 mg / 31.25 mg / 5 ml or 25 mg per day per kilogram of a child's weight for suspensions with a 7: 1 ratio of active ingredients. The same dosage is used with relapses of tonsillitis.

If Augmentin is being treated otitis, sinusitis, infections of the joints, urinary organs, lower respiratory tract or bones, high doses are used. This is 40 mg per 1 kilogram of the child's body weight per day for a 4:1 suspension. If the baby is given the drug 7:1, then the dosage will be 45 mg per day per 1 kg of the patient's weight. All calculations are performed on amoxicillin.

Children over 12 years old and children weighing more than 40 kg give 11 ml of suspension containing 400 mg of amoxicillin and 57 mg of clavulanic acid. The drug is prescribed twice. It should be noted that such patients are more preferable to use the drug in tablet form.

Overdose

If you exceed the dose of the suspension prescribed by the doctor, this can disrupt the child's digestive system and affect the water and electrolyte balance in his body. It is also possible the formation of crystals in the urine, due to which an overdose can provoke kidney failure. If the child has diseased kidneys, then an excess of the dose can cause convulsions.

Interaction with other drugs

  • Co-administration with antacids, laxatives or glucosamine impairs the absorption of amoxicillin.
  • When administered simultaneously with macrolides (for example, with a suspension of Sumamed or Azitrox), the effect of Augmentin will be weaker. The same effect is observed when combined with tetracyclines, sulfonamides, lincosamides and chloramphenicol.
  • The suspension can be used together with nitrofurans, for example, Enterofuril.
  • Augmentin should not be given to a child along with allopurinol, as this combination can provoke skin allergies.
  • When administered with anticoagulants (indirect), the effectiveness of these drugs will increase.
  • The drug is not prescribed together with methotrexate, since penicillins increase its toxicity.

Terms of sale

To buy powder at a pharmacy, you first need to get a prescription from a doctor. The price of one bottle depends on the dosage and can vary from 130 to 250 rubles.

Storage Features

An unopened bottle of powder can be stored until the end of its shelf life, which is 2 years, in a dry place away from babies, where the temperature does not rise above +25 degrees. The preparation diluted with water should be placed in the refrigerator, but the solution should not be allowed to freeze. The shelf life of the liquid medicine is 7 days.

AUGMENTIN™ (AUGMENTIN™)

GlaxoSmithKline J01C R02

COMPOSITION AND FORM OF RELEASE:

AUGMENTIN™

tab. po 500 mg + 125 mg blister, № 14


Other Ingredients: colloidal anhydrous silica, sodium starch glycolate, magnesium stearate, microcrystalline cellulose, titanium dioxide, hypromellose (5cps), hypromellose (15cps), macrogol 4000, macrogol 6000, dimethicone 500 (silicone oil).

No. UA/0987/02/02 from 07/05/2013 to 07/05/2018

AUGMENTIN™ (BD)

tab. po 875 mg + 125 mg, No. 14

Amoxicillin ............................................... 875 mg
Clavulanic acid .............................. 125 mg

The drug contains amoxicillin in the form of trihydrate and clavulanic acid in the form of potassium salt.

No. UA/0987/02/01 from 03.11.2009 to 03.11.2014

AUGMENTIN™

since. d/p in. solution 0.6 g fl., No. 10

Amoxicillin ............................................... 500 mg
Clavulanic acid .................................. 100 mg

The drug contains amoxicillin in the form of trihydrate and clavulanic acid in the form of potassium salt.

No. UA/0987/01/02 from 03/26/2009 to 03/26/2014

since. d/p in. solution 1.2 g fl., No. 5, No. 10


Clavulanic acid .................................. 200 mg

The drug contains amoxicillin in the form of trihydrate and clavulanic acid in the form of potassium salt.

No. UA/0987/01/01 from 26.03.2009 to 26.03.2014

AUGMENTIN™

since. d/n susp. 200 mg/5 ml vial +28.5 mg/5 ml vial, No. 1

Amoxicillin .............................. 200 mg / 5 ml
Clavulanic acid ................................. 28.5 mg / 5 ml

Other Ingredients: xanthan gum, hydroxypropyl methylcellulose, anhydrous colloidal silicon dioxide, succinic acid, silicon dioxide, dry orange flavors (610271E and 9/027108), dry raspberry flavor, dry molasses flavor, aspartame (E951).

The drug contains amoxicillin in the form of trihydrate and clavulanic acid in the form of potassium salt.

No. UA/0987/05/01 from 07/05/2013 to 07/05/2018

AUGMENTIN™ ES

since. d/n susp. 600 mg/5 ml + 42.9 mg/5 ml vial 100 ml

Amoxicillin ............................................... 600 mg / 5 ml
Clavulanic acid .............................. 42.9 mg / 5 ml

Other Ingredients: Anhydrous colloidal silica, sodium carboxymethylcellulose, aspartame, xanthan gum, silica, strawberry flavor.

The drug contains amoxicillin in the form of trihydrate and clavulanic acid in the form of potassium salt.

No. UA/0987/04/01 from 11/18/2009 to 11/18/2014

AUGMENTIN™ SR

tab. prolongation real, p / o 1000 mg + 62.5 mg, No. 16, No. 28

Amoxicillin ............................................... 1000 mg
Clavulanic acid .............................. 62.5 mg

Other Ingredients: Microcrystalline cellulose, sodium starch glycolate, anhydrous colloidal silica, magnesium stearate, xantham, citric acid, hypromellose 6cp, hypromellose 15cp, titanium dioxide, polyethylene glycol 3350, polyethylene glycol 8000.

The drug contains amoxicillin in the form of trihydrate and clavulanic acid in the form of potassium salt.

No. UA/0987/03/01 from 06/09/2010 to 06/09/2015

PHARMACOLOGICAL PROPERTIES: Pharmacodynamics. Amoxicillin is a semi-synthetic penicillin antibiotic with a wide spectrum of antibacterial activity against many gram-positive and gram-negative microorganisms. Amoxicillin is sensitive to the action of beta-lactamase and decomposes under its influence, so the spectrum of activity of amoxicillin does not include microorganisms that synthesize this enzyme. Clavulanic acid has a beta-lactam structure similar to that of penicillins, and also has the ability to inactivate beta-lactamase enzymes produced by microorganisms resistant to penicillins and cephalosporins. In particular, it has a pronounced activity against clinically important plasmid beta-lactamases, which are often responsible for the occurrence of cross-resistance to antibiotics. The presence of clavulanic acid in Augmentin protects amoxicillin from decay under the action of beta-lactamase enzymes and expands the spectrum of antibacterial action of amoxicillin, including many microorganisms resistant to amoxicillin and other penicillins and cephalosporins.

Thus, Augmentin has the properties of a broad-spectrum antibiotic and beta-lactamase inhibitor. Augmentin has a bactericidal effect against a wide range of microorganisms, including:

Gram-positive aerobes: Bacillus anthracis*, Corynebacterium spp., Enterococcus faecalis*, Enterococcus faecium*, Listeria monocytogenes, Nocardia asteroides, Staphylococcus aureus*, coagulase-negative staphylococci (including Staphylococcus epidermidis), Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, kinds Streptococcus, Streptococcus viridans;

Gram-positive anaerobes: Clostridium spp., Peptococcus spp., Peptostreptococcus spp.;

Gram-negative aerobes: Bordetella pertussis, Brucella spp., Escherichia coli*, Gardnerella vaginalis, Haemophilus influenzae*, Helicobacter pylori, kinds Klebsiella*, kinds Legionella, Moraxella catarrhalis* (Branhamella catarrhalis), Neisseria gonorrhoeae*, Neisseria meningitidis*, Pasteurella multocida, Proteus mirabilis*, Proteus vulgaris*, kinds Salmonella*, kinds Shigella*, Vibrio cholerae, Yersinia enterocolitica*;

gram-negative anaerobes: species Bacteroides(including Bacteroides fragilis), kinds Fusobacterium;

other microorganisms: Borrelia burgdorferi, kinds Chlamydia, Leptospira icterohaemorrhagiae, Treponema pallidum.

*Some strains of these bacterial species produce β-lactamase, which makes them insensitive to amoxicillin monotherapy.

Pharmacokinetics. Absorption. Both components of Augmentin (amoxicillin and clavulanic acid) are completely soluble in aqueous solutions at physiological pH values. Both components are well and rapidly absorbed when administered orally. Absorption of Augmentin improves when taken at the beginning of a meal.

Distribution. When administered orally, therapeutic concentrations of amoxicillin and clavulanic acid are determined in tissues and interstitial fluid. Therapeutic concentrations of both substances are detected in the gallbladder, abdominal tissues, skin, adipose and muscle tissues, as well as in synovial and peritoneal fluids, bile and pus. Amoxicillin and clavulanic acid are weakly bound to plasma proteins; studies have found that protein binding rates are 25% for clavulanic acid and 18% for amoxicillin of their total plasma concentration. In studies conducted on animals, no cumulation of any of these components in any organ has been established.

Amoxicillin, like other penicillins, passes into breast milk. Trace amounts of clavulanic acid are also detected in breast milk. Animal reproduction studies have shown that both amoxicillin and clavulanic acid can cross the placental barrier. However, no data have been found regarding reproductive dysfunction or harmful effects on the fetus.

breeding. As with other penicillins, the main route of elimination of amoxicillin is renal excretion, while the excretion of clavulanate is via both the kidneys and extrarenal mechanisms. About 60-70% of amoxicillin and 40-65% of clavulanic acid is excreted in the urine unchanged during the first 6 hours after a single dose of tablets.

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

Pharmacokinetic parameters were studied in studies in which Augmentin tablets 625 mg 500/125 mg (compared with the separate intake of both components) were used on an empty stomach in groups of healthy volunteers and the results of which are given below:

The plasma concentration of amoxicillin achieved with Augmentin (BD) is similar to that achieved with oral administration of amoxicillin alone in equivalent doses. Simultaneous administration of probenecid inhibits the excretion of amoxicillin, but does not affect the renal excretion of clavulanic acid.

Augmentin (BD) tablets 1 g (875/125 mg). Pharmacokinetic parameters when taking Augmentin tablets 875/125 mg (1 g) 2 times a day are as follows: AUC - 53.52 μg / h / ml for amoxicillin and 10.16 μg / h / ml for clavulanic acid, T 1/2 - 1.19 h for amoxicillin and 0.96 h for clavulanic acid, C max in blood plasma - 11.64 μg / ml for amoxicillin and 2.18 μg / ml for clavulanic acid.

Pharmacokinetic studies of Augmentin for intravenous use were performed with a group of healthy volunteers who used the drug at a dose of 500/100 (600) mg or 1000/200 mg (1.2 g) intravenously. The data obtained are shown in the tables. Average pharmacokinetic parameters for the constituent components of Augmentin 600 mg and 1.2 g.

Amoxicillin



clavulanic acid



Pharmacokinetic parameters of Augmentin ES when used for the treatment of children at a dose of 45 mg / kg every 12 hours are shown in the table.

Augmentin SR. Pharmacokinetic parameters when using Augmentin SR tablets 2 times a day: AUC is 71.62 μg / h / ml for amoxicillin and 5.29 μg / h / ml for clavulanic acid, T ½ - 1.27 h for amoxicillin and 1, 03 h - for clavulanic acid, Cmax amoxicillin - 17.0 mg/l and 2.05 mg/l - for clavulanic acid.

INDICATIONS: the drug is intended for the short-term treatment of bacterial infections caused by microorganisms sensitive to the drug.

Augmentin tablets 625 mg (500 mg / 125 mg), Augmentin por. d/n susp. 228.5 mg/5 ml: acute bacterial bronchitis, acute otitis media, confirmed exacerbation of chronic bronchitis, community acquired pneumonia, cystitis, pyelonephritis, skin and soft tissue infections, including cellulitis, animal bites, severe dentoalveolar abscesses with widespread cellulitis, bone and joint infections, including osteomyelitis .

Augmentin (BD) tablets 1 g (875 mg / 125 mg): infections of ENT organs, including recurrent tonsillitis, sinusitis, otitis media; respiratory tract infections, including exacerbation of chronic bronchitis, lobar pneumonia and bronchopneumonia; infections of the urinary system, including cystitis, urethritis, pyelonephritis; infections of the skin and soft tissues, including burns, abscesses, inflammation of the subcutaneous tissue, wound infections; bone and joint infections, including osteomyelitis; dental infections, including dentoalveolar abscesses; other infections, including septic abortion, puerperal sepsis, intra-abdominal sepsis.

Augmentin por. d/p in. solution 600 mg, 1200 mg: infections of ENT organs, including recurrent tonsillitis, sinusitis, otitis media; respiratory tract infections, including exacerbation of chronic bronchitis, lobar pneumonia and bronchopneumonia; infections of the urinary system, including cystitis, urethritis, pyelonephritis, infections of the female genital organs and gonorrhea; skin and soft tissue infections; bone and joint infections, including osteomyelitis; other infections, including intra-abdominal sepsis; prevention of infectious complications during surgical interventions in most cases of operations on the gastrointestinal tract, pelvic organs, head and neck, heart, kidneys, joint replacement and biliary tract surgery.

Augmentin ES: infections of the upper respiratory tract (including ENT organs), including recurrent or persistent otitis media (patients of childhood, as a rule, who received antibiotic therapy for otitis media for at least 3 months or under the age of 2 years or attending preschool institutions); tonsillopharyngitis or sinusitis; infections of the lower respiratory tract, including lobar and bronchopneumonia; skin and soft tissue infections.

Augmentin SR: respiratory tract infections, such as community-acquired pneumonia, exacerbations of chronic bronchitis, and acute bacterial sinusitis.

APPLICATION: the drug should be used in accordance with official recommendations for antibiotic therapy and local antibiotic sensitivity data. The dosage range depends on the expected pathogens and their sensitivity, the severity of the disease and the location of the infection, the age, body weight and renal function of the patient. For optimal absorption and in order to reduce possible undesirable effects on the gastrointestinal tract, the drug should be used at the beginning of a meal. Treatment should not be continued for more than 14 days without assessing the patient's condition. Therapy can be started parenterally, then continued orally.

Augmentin tablets 625 mg (500/125 mg)

Adults and children weighing >40 kg: 1 tablet of Augmentin 500 mg/125 mg 3 times a day.

Children from 6 years old weighing 25-40 kg: dose from 20 mg / 5 mg / kg of body weight per day to 60 mg / 15 mg / kg / day, divided into 3 doses.

Dosing for impaired renal function

used with caution, regular monitoring of liver function is necessary.

Dosage for elderly patients: dose adjustment is not necessary, if necessary, the dose is adjusted depending on renal function.

Augmentin tablets 1 g (875 mg / 125 mg)

Adults and children over the age of 12: in severe infections - 1 tablet of Augmentin 875 mg / 125 mg 2 times a day.

Dosage for impaired renal function: Augmentin tablets 1 g (875 mg / 125 mg) are used only in patients with creatinine clearance> 30 ml / min. In renal failure with creatinine clearance<30 мл/ мин Аугментин 875 мг/125 мг не применяют.

Dosage in violation of liver function: should be used with caution, it is necessary to conduct regular monitoring of liver function. There are insufficient data on dosing recommendations.

Dosage for the elderly: dose adjustment in elderly patients is not necessary; if necessary, the dose is adjusted depending on the state of kidney function.

Augmentin suspension 228.5 mg/5 ml

An approximate calculation of the suspension of Augmentin 228.5 mg / 5 ml / day for amoxicillin (in ml) is shown in the table.

Impaired kidney function. For children with a glomerular filtration rate (GFR) >30 ml/min, the dose does not need to be changed. For the treatment of children with GFR<30 мл/мин суспензию Аугментина 228,5 мг/5 мл применять не рекомендуется.

Impaired liver function. Use with caution, monitoring liver function at regular intervals. The available data are insufficient to formulate dosing recommendations.

Instructions for preparing the suspension: check the vial cap with respect to its previous opening, turn over and shake the vial to loosen the powder in it, pour boiled water into the vial with powder to the lower level indicated by the red line with an arrow, close the cap and shake the vial until a suspension is formed, add the rest of the water to the upper level and shake again, the suspension should be allowed to stand for 5 minutes until the powder is completely dispersed. Shake the suspension thoroughly before each dose. After preparing the suspension, it should be stored in a refrigerator at a temperature of 2-8 ° C for 7 days.

Augmentin powder for injection solution

Augmentin is administered intravenously (stream slowly, over 3-4 minutes) or drip (infusion time - 30-40 minutes). This form of Augmentin is not used for intramuscular injections.

Dosage for adults: standard dose - 1000/200 mg every 8 hours, severe infections - 1000/200 mg every 4-6 hours.

Prevention of complications in surgical interventions

Operation duration<1 ч — 1000/200 мг препарата вводится до анестезии.

Duration of surgery > 1 hour as above and up to 4 doses of 1000/200 mg administered as directed over 24 hours.

The purpose of the use of Augmentin in surgical interventions is to reduce the risk of postoperative infectious complications. In the event of clinical signs of infection during surgery, it is necessary to conduct a full course of intravenous or oral administration of Augmentin after surgery.

Impaired kidney function.

Creatinine clearance> 30 ml / min: dose adjustment is not required.

Creatinine clearance 10-30 ml / min: 1000/200 mg, then 500/100 mg 2 times a day.

Creatinine clearance<10 мл/мин: 1000/200 мг, затем — 500/100 мг каждые 24 ч.

Hemodialysis. Dose adjustments are based on the maximum recommended doses of amoxicillin. The initial dose is 1000/200 mg, then 500/100 mg every 24 hours. Taking into account the need to maintain an effective concentration, another dose should be administered after the end of hemodialysis.

Impaired liver function. Care must be taken when dosing; continuous monitoring of liver function at regular intervals. The available data are insufficient to formulate dosing recommendations.

Elderly patients. Dose adjustment is not required. Dosage for adults is used, if necessary, the dose is adjusted depending on kidney function.

Dosing for children

Dosing for children with body weight<40 кг зависит от массы тела; минимальный интервал между введениями — 4 ч.

Children under 3 months of age: child's body weight<4 кг — 25/5 мг/кг каждые 12 ч; масса тела ребенка >4 kg - up to 25/5 mg / kg every 8 hours, depending on the course of the infection.

Children aged 3 months to 12 years: 25/5 mg/kg every 6 to 8 hours, depending on the course of the infection.

Impaired kidney function. Dose adjustments are based on the maximum recommended doses of amoxicillin.

Creatinine clearance> 30 ml / min - dose adjustment is not required.

Creatinine clearance 10-30 ml / min - 25/5 mg / kg 2 times a day.

Creatinine clearance<10 мл/мин — 25/5 мг/кг 1 раз в сутки.

Hemodialysis. Dose adjustments are based on the maximum recommended dose of amoxicillin, 25/5 mg/kg once daily. Taking into account the need to restore the effective concentration of the drug, another dose should be administered after the end of hemodialysis (25/5 mg / kg / day).

Solution preparation

600 mg vial: Dissolve contents in 10 ml water for injection (final volume 10.5 ml).

1.2 g vial: Dissolve contents in 20 ml water for injection (final volume 20.9 ml).

IV injection. The stability of the solution of Augmentin has a concentration dependence, so the solution of Augmentin should be applied immediately after dissolution and administered slowly over 3-4 minutes. Augmentin can be administered directly into a vein or through a catheter drip.

IV infusion. Augmentin can be administered intravenously as an infusion, dissolved in water for injection or in 0.9% sodium chloride solution for injection. Add a solution of 600 mg to 50 ml of infusion fluid or 1.2 g of solution to 100 ml of infusion fluid (it is better to use a mini-container or burette). Conduct infusion over 30-40 minutes in a 4-hour period after dissolution. Solutions are adjusted to the full volume, which is injected immediately after the dissolution of the powder. The remaining solutions of the antibiotic can not be used.

The stability of the prepared solution. To dissolve Augmentin for intravenous infusion, various intravenous solutions can be used. A satisfactory concentration of the antibiotic is maintained at 5 ° C, at room temperature (25 ° C) in the recommended volumes of the infusion solutions indicated below. When dissolving the drug and storing it at room temperature, the infusion should be performed during the time indicated below.

When stored at 5°C, the 1000/200 mg and 500/100 mg solutions can be added to a pre-chilled infusion solution (in a sterile plastic container) and the resulting product can be stored at this temperature for up to 8 hours.

When heated to room temperature, the solution should be used immediately.

Augmentin is less stable in solutions of glucose, dextran and bicarbonate. Solutions on the specified basis must be used within 3-4 minutes after dissolution.

Any unused solution should be destroyed.

Augmentin is not designed for a multidose regimen.

Augmentin ES

Augmentin ES contains 42.9 mg of clavulanic acid per 5 ml suspension, while Augmentin 200 mg/5 ml suspension contains 28.5 mg of clavulanic acid per 5 ml, and 400 mg/5 ml suspension contains 57 mg of clavulanic acid per 5 ml. Therefore, Augmentin ES cannot be replaced by any other form of Augmentin suspension.

Impaired liver function. Use with caution, monitoring liver function at regular intervals. Available data are insufficient to formulate dosing recommendations.

Suspension preparation

Add 90 ml of water to the powder vial. Water is added in 2 doses. First, add approximately 100% of the indicated amount of water so that the powder in the vial is freely covered with water, close the cap and shake the vial until a suspension is formed. Then add the rest of the water and shake again. At the first dilution, the suspension should be allowed to stand for 5 minutes until complete dispersion. When diluted, a white suspension with a yellowish or grayish tint is formed. Store the prepared suspension in a refrigerator at a temperature of 2 to 8 "C and use within 10 days.

Augmentin SR

The drug is intended for treatment in adults and adolescents aged >16 years.

The drug tablet has a break line that allows it to be split in half if the patient cannot swallow it whole. Both halves in this case should be taken at the same time. The recommended dose is 2 tablets 2 times a day.

Respiratory tract infections - 2 tablets 2 times a day for 7-10 days, including:

  • community-acquired pneumonia - 2 tablets 2 times a day for 7-10 days;
  • exacerbation of chronic bronchitis - 2 tablets 2 times a day for 7 days;
  • acute bacterial sinusitis - 2 tablets 2 times a day for 10 days.

Elderly patients. Dose adjustment is not required.

Dosage for impaired renal function. Augmentin SR is indicated only for the treatment of patients with creatinine clearance >30 ml/min. which does not require dose adjustment.

Dosage in violation of liver function. Apply with caution; monitoring of hepatic function at regular intervals is necessary. There are insufficient data to recommend dosing.

CONTRAINDICATIONS: hypersensitivity to any of the components of the drug, to any antibacterial drug of the penicillin group, a history of severe hypersensitivity reactions (including anaphylaxis) associated with the use of other beta-lactams (including cephalosporins, carbapenems or monobactams), the presence in a history of jaundice or abnormal liver function associated with the use of amoxicillin / clavulanate.

SIDE EFFECTS: side effects were classified by organs and systems and by frequency of occurrence. According to the frequency of occurrence, they are divided into the following categories: very often (<1/10), часто (>1/100 and< 1/10), нечасто (>1/1000 and<1/100), редко (>1/10 000 and<1/1000), очень редко (< 1/10 000).

Infections and infestations

Often: candidiasis of the skin and mucous membranes.

circulatory and lymphatic systems

Rare: reversible leukopenia (including neutropenia) and thrombocytopenia.

Very rare: reversible agranulocytosis and hemolytic anemia, increased bleeding time and prothrombin index.

The immune system

Very rare: angioedema, anaphylaxis, serum sickness-like syndrome, allergic vasculitis.

Nervous system

Uncommon: dizziness, headache.

Very rarely: reversible hyperactivity and convulsions. Convulsions may occur in patients with impaired renal function or in patients receiving the drug in high doses.

Vascular disorders

Rare: thrombophlebitis at the injection site.

Very often: diarrhea (when using tablet forms).

Often: diarrhea (when using a suspension and injectable forms), nausea, vomiting.

Uncommon: indigestion.

Nausea is more often noted when using the drug in high doses. The severity of the above symptoms from the gastrointestinal tract can be reduced when taking the drug at the beginning of a meal.

Very rare: antibiotic-associated colitis, including pseudomembranous and hemorrhagic colitis (the likelihood of its development is much lower with parenteral administration of the drug), black and "hairy" tongue.

Hepatobiliary reactions

Infrequently: a moderate increase in liver transaminases has been determined in patients taking beta-lactam antibiotics, but the clinical significance of this has not been established.

Very rare: hepatitis and cholestatic jaundice. The same phenomena were noted with the use of other penicillins or cephalosporins.

Hepatitis occurred mainly in men and elderly patients, its development may be associated with prolonged treatment with the drug. In children, such manifestations occurred very rarely.

Signs and symptoms occur during or immediately after treatment, but in some cases may appear several weeks after stopping treatment. These phenomena are usually reversible. It is extremely rare (less than 1 message per -4 million prescriptions) to report fatal outcomes in patients with a severe underlying disease or while taking drugs that have a negative effect on the liver.

Skin and subcutaneous tissue

Uncommon: skin rash, itching and urticaria.

Rare: erythema multiforme.

Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis and acute generalized exanthematous pustulosis.

In the event of any allergic dermatitis, treatment should be discontinued.

Kidneys and urinary system

Very rare: interstitial nephritis, crystalluria (see OVERDOSE).

SPECIAL INSTRUCTIONS: Before starting therapy with Augmentin, it is necessary to exclude the presence of a history of hypersensitivity reactions to penicillins and cephalosporins or other allergens.

Severe, sometimes fatal hypersensitivity reactions (anaphylactoid reactions) have developed in patients during penicillin therapy. Such reactions are more likely in patients with a history of hypersensitivity to penicillins (see CONTRAINDICATIONS). In the event of allergic reactions, treatment with Augmentin should be discontinued and alternative therapy prescribed. Severe anaphylactic reactions require emergency treatment with epinephrine, oxygen therapy. in / in the introduction of GCS and ensuring the function of external respiration, including intubation.

Augmentin should not be prescribed if infectious mononucleosis is suspected, since cases of a measles-like rash have been noted with the use of amoxicillin in individuals with this pathology.

Prolonged use of the drug can cause excessive growth of microflora insensitive to Augmentin.

Usually, Augmentin is well tolerated, exhibits low toxicity inherent in penicillin antibiotics. With prolonged use, the functions of organs and systems, including the functions of the kidneys, liver and hematopoiesis, should be periodically monitored.

Occasionally, in patients taking Augmentin, an increase in prothrombin time is noted. When taking anticoagulants at the same time, appropriate monitoring is necessary.

Augmentin should be used with caution in individuals with hepatic impairment.

In patients with impaired renal function, it is necessary to adjust the dose according to the severity of renal failure.

If parenteral administration of the drug in high doses is necessary, the concentration of sodium in the solutions administered to patients on a sodium-controlled diet should be taken into account.

In patients with reduced diuresis, crystalluria very rarely occurs, mainly with parenteral use of the drug. Therefore, to reduce the risk of its occurrence during treatment with the drug in high doses, it is recommended to ensure an adequate balance between drunk and excreted fluid (see OVERDOSE).

Augmentin ES contains aspartame (each 5 ml suspension contains 7 mg of phenylalanine), so this form of the drug should be used with caution in the treatment of patients with phenylketonuria.

During pregnancy and breastfeeding. Pregnancy (category B). Reproductive animal studies of oral and parenteral forms of Augmentin did not reveal a teratogenic effect. In one study in women with premature rupture of the membranes, it was reported that the prophylactic use of Augmentin during pregnancy may be associated with an increased risk of necrotizing enterocolitis in newborns. As with the use of other drugs, the use of the drug during pregnancy, especially in the first trimester, should be avoided, unless, in the opinion of the doctor, such use is necessary.

Children. Augmentin SR is not used to treat children under the age of 16 years. Augmentin BD (875 mg/125 mg) is not recommended for use in children under 12 years of age.

There was no negative effect on the ability to drive vehicles and work with other mechanisms, however, the possibility of developing such a side effect as dizziness should be taken into account.

INTERACTIONS: concomitant use of probenecid is not recommended because probenecid reduces the tubular secretion of amoxicillin. Its simultaneous use with Augmentin can lead to an increase in the level of amoxicillin in the blood plasma for a long time; does not affect the level of clavulanic acid.

The simultaneous use of allopurinol during treatment with amoxicillin increases the likelihood of skin allergic reactions. There are no data on the combined use of Augmentin and allopurinol.

Like other antibiotics, Augmentin can affect the intestinal flora, which leads to a decrease in estrogen reabsorption and a decrease in the effectiveness of combined oral contraceptives. The presence of clavulanic acid in Augmentin can cause non-specific binding of IgG and albumin on erythrocyte membranes, as a result of which the Coombs reaction may be false positive.

Incompatibility. Augmentin injection should not be mixed with blood products, other liquids containing protein, in particular protein hydrolysates, with fat emulsions for IV use.

If Augmentin is used simultaneously with aminoglycosides, antibiotics should not be mixed in the same syringe or other container due to inactivation of the aminoglycoside.

OVERDOSE: may be accompanied by symptoms from the digestive tract and disturbances in water and electrolyte balance. The treatment is symptomatic, correction of water and electrolyte disorders is carried out. Crystalluria may occur, which in some cases leads to renal failure. There are reports of precipitation of amoxicillin in the urinary catheter when using intravenous Augmentin in high doses, so its patency should be checked regularly. Augmentin can be removed from the bloodstream during hemodialysis.

STORAGE CONDITIONS: original packages are stored closed in a dry place inaccessible to children at a temperature below 25 °C. The prepared suspension is stored in a refrigerator (2-8 ° C) and used within 7 days (Augmentin ES - up to 10 days). Augmentin for intravenous administration should be administered immediately after dissolution.

Sometimes childhood infections require the appointment of antibacterial drugs. Injectable and tablet forms are not the best option for young children, so the French pharmacological company Glaxo Wellcome Production has released a special antibiotic for children Augmentin suspension.

The advantage of this tool is that you can easily calculate the required dosage by body weight, and any child will drink the fruit-flavored powder dissolved in water without any problems.

Compound

Augmentin suspension for children refers to antibiotics used against a large number of bacteria. In pharmacies you can find three types of Augmentin:

  • Augmentin suspension 0.125;

The composition of the antibiotic contains the following components:

  • Amoxicillin at a dosage of 0.125, 0.2 or 0.4, depending on the type of drug;
  • clavulanic acid;
  • Flavors: orange, raspberry and light molasses;
  • Excipients.

Amoxicillin is a penicillin drug with a powerful antibacterial effect. The downside of amoxicillin is that it is not effective against microorganisms that can synthesize the b-lactamase enzyme, which destroys it. This omission is compensated by clavulanic acid, which has a structure similar to penicillin antibiotics. Clavulanic acid protects amoxicillin from splitting. The combination of two active ingredients provides broad antibacterial activity.

The drug, when mixed with water, forms a suspension that is convenient for taking by small children.

Absorption of the drug occurs in the gastrointestinal tract. It is best to take the drug before meals for the most complete absorption of the antibiotic.

The substance is distributed with blood throughout the body, which ensures the effectiveness of the antibiotic in infections of the respiratory system, gastrointestinal tract, excretory system, and skin diseases.

In children, in response to the administration of the drug, sensitization may develop, which is manifested by an allergy. In this case, it is recommended to replace the combination of ammoxicillin and clavulanic acid with another antibiotic.

The drug is excreted through the kidneys along with urine and to a lesser extent with feces.

Release form

All three types of Augmentin containing powder are produced in the same kit:

  • glass bottle;
  • The drug in the form of a powder of the required concentration - 0.125, 0.2 or 0.4 to obtain a suspension;
  • Measuring spoon, with which it is more convenient to measure the suspension for use.

Augmentin suspension with a dosage of 0.125 is considered a drug exclusively for children. Other types of funds can be taken by adults suffering from a violation of the passage of food through the esophagus.

Indications

The use of Augmentin should always be carried out as prescribed by a doctor. Although the drug itself does not have a pronounced side effect and is well tolerated by young patients, its use not according to indications and without observing the regimen can lead to the development of resistance in the flora that caused the infection.

Augmentin in this case will no longer have the proper medicinal effect and the antibiotic will have to be changed to a stronger and more toxic one.

The antibacterial drug effectively fights infection caused by most gram-positive and gram-negative microorganisms.

The instructions for use indicate the following indications for taking Augmentin suspension:

  1. Infectious diseases of the oral cavity and teeth (jaw abscess, periodontitis);
  1. Infectious otolaryngological diseases and upper respiratory tract (otitis media, sinusitis, tonsillitis, laryngitis);
  1. Infectious diseases of the lower respiratory tract (bronchitis, pneumonia, pleural empyema and lung abscess);
  1. Infectious diseases of the urinary system (pyelonephritis, cystitis, urethritis);
  1. Infectious diseases of soft tissues (furuncle, carbuncle, abscess).

Before starting treatment, bacteriological seeding of biological material obtained from the patient (sputum, mucus, urine) on the media is carried out, and an assessment of the sensitivity of bacteria to antibiotics is also carried out. This is necessary to determine the causative agent of the disease and identify a drug that will be effective. The analysis is usually ready a few days after the collection of the material, and treatment begins on the first day of going to the hospital. Therefore, if it turns out that the flora is not sensitive to the antibiotic that is being treated, then the drug is replaced with a more effective one.

Contraindications

In some cases, the use of the drug is unacceptable. In order to avoid unwanted complications, these features should be clarified before using the drug.

Contraindications for admission are as follows:

  • Hypersensitivity to amoxicillin and clavulanic acid, it is also necessary to take into account cross-sensitization when taking penicillin antibiotics of a number;
  • The development of side effects with the previous intake of Augmentin;
  • Decompensated pathology of the kidneys and liver;
  • Phenylketonuria as a contraindication only for Augmentin for the preparation of a suspension.

Augmentin suspension with a dosage of 0.2 and 0.4 should not be used in children under three months old. Augmentin suspension 0.125 should not be used in children over 12 years of age.

Method of application and dosage

The attending physician should deal with the appointment of dosages and the period of taking the remedy. This is especially important for young children, in whom the dose per dose is calculated based on body weight.

The minimum course of treatment should be at least five days. For more than ten days, treatment should not be continued without medical supervision, especially if the symptoms of the disease persist.

In this case, it is obvious that the antibiotic is not effective and should be replaced with another one.

It is necessary to take the drug before meals, as this improves its absorption in the stomach.

There are three groups of pediatric patients who will receive Augmentin differently:

  1. Patients younger than 3 months receive Augmentin 0.125 only based on their body weight. The dosage is calculated based on the information that 30 mg of amoxicillin is taken per 1 kg of weight. For example, a child weighs 5 kg, so 30 mg x 5 ml = 150 mg. To calculate how many ml of suspension to take, we make up a proportion. On the package we read that 125 mg equals 5 ml of suspension, and 150 mg equals X ml. We find ICS according to the formula - 150 x 5/125 = 6 ml. This means that we should divide 6 ml into two doses. Therefore, a child weighing 5 kg needs 3 ml of the suspension twice a day.
  2. Children from 3 months to 12 years old (weighing less than 40 kg) do not take the standard dosage, it is recommended to calculate it per 1 kg of the child's weight, as shown in the previous paragraph.
  3. Children over 12 years of age usually take 11 ml of suspension twice a day with a dosage of 400 mg / 5 ml.

It is necessary to proceed from the information that Augmentin 0.125 suspensions are calculated per 1 kg of 20-40 mg, and Augmentin 0.2 or 0.4 25-45 mg per 1 kg of weight. The dosage interval is due to the fact that infections can be of varying severity and severity.

Augmentin 0.125 is administered three times a day after 8 hours (for example, at 6:00, 14:00 and 22:00). Augmentin 200 mg and 400 mg are taken twice daily 12 hours apart. The time interval between doses must be strictly observed.

Instructions for the preparation of Augmentin suspension for children are very easy to use, the main thing is to follow all the rules so as not to reduce the content of the active substance.

Basic Rules:

  1. The entire volume of the suspension is prepared before the start of the first dose.
  2. It is forbidden to dilute the powder in parts, as this changes the content of amoxicillin in 5 ml of suspension.
  3. 60 ml of warm clean water is added to a glass bottle with powder, the mixture is well shaken to a homogeneous consistency without sediment.
  4. Pour clean warm water into a glass bottle up to the mark. In the case of a dosage of 125 mg, this is about 90 ml, and for Augmentin 200 mg and 400 mg, about 65 ml.
  5. The proportions should be very strictly observed so that the water does not turn out to be more than the mark, since this will change the concentration of the active substance in the suspension.
  6. You can not use the solution after a week of storage in the refrigerator, if the course of treatment is less, then you need to pour out the unused medicine.

When taking, you need to pour the required amount of the solution into a measuring cap and give it to the child.

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