INN: Amoxicillin, Clavulanic acid

Manufacturer: SmithKline Beecham Limited

Anatomical-therapeutic-chemical classification: Amoxicillin in combination with beta-lactamase inhibitors

Registration number in the Republic of Kazakhstan: No. RK-LS-5 No. 004471

Registration period: 29.12.2016 - 29.12.2021

Instructions

Trade name

Augmentin ®

International nonproprietary name

Dosage form

Powder for the preparation of suspension for oral administration 200 mg/28.5 mg/5 ml, 70 ml

Compound

5 ml of suspension contains

active substances: amoxicillin (as amoxicillin trihydrate) 200 mg;

clavulanic acid (in the form of potassium clavulanate) 28.50 mg,

excipients: xanthan gum, aspartame, succinic acid, anhydrous colloidal silicon dioxide, hypromellose, dry orange flavor 610271 E, dry orange flavor 9/027108, dry raspberry flavor NN07943, dry “Light molasses” flavor 52927/AP, anhydrous silicon dioxide.

Description

White or almost white powder with a characteristic odor. The prepared suspension is white or almost white; When standing, a white or almost white precipitate slowly forms.

Pharmacotherapeutic group

Antibacterial drugs for systemic use. Penicillins in combination with beta-lactamase inhibitors. Clavulanic acid + amoxicillin.

ATX code J01CR02

Pharmacological properties

F armakokinetics

Suction

Amoxicillin and clavulanate are highly soluble in aqueous solutions with a physiological pH value and are quickly and completely absorbed from the gastrointestinal tract after oral administration. Absorption of amoxicillin and clavulanic acid is optimal when taken at the beginning of a meal. After taking the drug orally, its bioavailability is 70%. The profiles of both components of the drug are similar and reach peak plasma concentrations (Tmax) in approximately 1 hour. The concentration of amoxicillin and clavulanic acid in the blood serum is the same both in the case of combined use of amoxicillin and clavulanic acid, and in the case of each component separately.

Distribution

Therapeutic concentrations of amoxicillin and clavulanic acid are achieved in various organs and tissues, interstitial fluid (lungs, abdominal organs, gall bladder, adipose, bone and muscle tissues, pleural, synovial and peritoneal fluids, skin, bile, purulent discharge, sputum). Amoxicillin and clavulanic acid practically do not penetrate into the cerebrospinal fluid.

The binding of amoxicillin and clavulanic acid to plasma proteins is moderate: 25% for clavulanic acid and 18% for amoxicillin. Amoxicillin, like most penicillins, is excreted in breast milk. Trace amounts of clavulanic acid are also found in breast milk. With the exception of the risk of sensitization, amoxicillin and clavulanic acid do not have a negative effect on the health of breastfed infants. Amoxicillin and clavulanic acid penetrate the placental barrier.

Elimination

Amoxicillin is eliminated primarily by the kidneys, while clavulanic acid is eliminated through both renal and extrarenal mechanisms. After a single oral dose of one tablet of 250 mg/125 mg or 500 mg/125 mg, approximately 60-70% of amoxicillin and 40-65% of clavulanic acid are excreted unchanged in the urine during the first 6 hours.

Metabolism

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

Pharmacodynamics

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

Amoxicillin is a semisynthetic broad-spectrum antibiotic that is active against many gram-positive and gram-negative microorganisms. Amoxicillin is destroyed by beta-lactamases and has no effect on microorganisms that produce this enzyme. The mechanism of action of amoxicillin is to inhibit the biosynthesis of peptidoglycans in the bacterial cell wall, which usually leads to cell lysis and death.

Clavulanic acid is a beta-lactamate, similar in chemical structure to penicillins, which has the ability to inactivate beta-lactamase enzymes of microorganisms that are resistant to penicillins and cephalosporins, thereby preventing the inactivation of amoxicillin. Beta-lactamases are produced by many gram-positive and gram-negative bacteria. The action of beta-lactamases can lead to the destruction of some antibacterial drugs even before they begin to act on pathogens. Clavulanic acid blocks the action of enzymes, restoring the sensitivity of bacteria to amoxicillin. In particular, it is highly active against plasmid beta-lactamases, which are often associated with drug resistance, but is less effective against chromosomal type 1 beta-lactamases.

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

Mechanism of resistance development

There are 2 mechanisms for the development of resistance to Augmentin®

Inactivation by bacterial beta-lactamases that are insensitive to the effects of clavulanic acid, including classes B, C, D

Deformation of the penicillin-binding protein, which leads to a decrease in the affinity of the antibiotic for the microorganism

Impermeability of the bacterial wall, as well as pump mechanisms, can cause or contribute to the development of resistance, especially in Gram-negative microorganisms.

Augmentin® has a bactericidal effect on the following microorganisms:

Gram-positive aerobes: Enterococcus faecalis, Gardnerella vaginalis, Staphylococcus aureus (methicillin sensitive) coagulase-negative staphylococci (methicillin sensitive), Streptococcus agalactiae, Streptococcus pneumoniae1 , Streptococcus pyogenes and other beta-hemolytic streptococci, group Streptococcus viridans, Bacillius anthracis, Listeria monocytogenes, Nocardia asteroides

Gram-negative aerobes: Actinobacillus actinomycetemcomitans, Capnocytophaga spp., Eikenella corrodens, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae, Pasteurella multocida

anaerobic microorganisms: Bacteroides fragilis,Fusobacterium nucleatum,Prevotella spp.

Microorganisms with possible acquired resistance

Gram-positive aerobes: Enterococcus faecium*

Gram-negative aerobes: Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris

Microorganisms with natural resistance:

gram-negative aerobes: Acinetobacter species, Citrobacter freundii, Enterobacter species, Legionella pneumophila, Morganella morganii, Providenciaspecies, Pseudomonasspecies, Serratiaspecies, Stenotrophomonas maltophilia;

others: Chlamydia trachomatis,Chlamydophila pneumoniae, Chlamydophila psittaci, Coxiella burnetti, Mycoplasma pneumoniae.

* Natural sensitivity in the absence of acquired resistance

1 Excluding strains Streptococcus pneumoniae resistant to penicillins

Indications for use

Acute bacterial sinusitis

Tonsillitis

Acute otitis media

Lower respiratory tract infections (exacerbation of chronic

bronchitis, lobar pneumonia, bronchopneumonia, community-acquired

pneumonia)

Cystitis, urethritis

Pyelonephritis

Gynecological infections, gonorrhea

Infections of the skin and soft tissues (in particular cellulitis, bites

animals, acute abscesses and maxillofacial phlegmon

Bone and joint infections (particularly osteomyelitis)

Directions for use and doses

Sensitivity to Augmentin® may vary by geographic location and time. Before prescribing the drug, whenever possible, the susceptibility of strains should be assessed according to local data and sensitivity should be determined by collecting and testing samples from an individual patient, especially in the case of severe infections.

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

Augmentin® is recommended to be taken at the beginning of a meal. The duration of therapy depends on the patient's response to treatment. Some pathologies (in particular, osteomyelitis) may require a longer course. Treatment should not be continued for more than 14 days without re-evaluating the patient's condition. If necessary, it is possible to carry out stepwise therapy (initially, intravenous administration of the drug, followed by switching to oral administration).

Children from 2 months to 12 years or weighing less than 40 kg

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

From 25 mg/3.6 mg/kg/day to 45 mg/6.4 mg/kg/day, divided into 2 doses, for mild to moderate infections (recurrent tonsillitis, skin and soft tissue infections)

From 45 mg/6.4 mg/kg/day to 70 mg/10 mg/kg/day, divided into 2 doses, for the treatment of more serious infections (otitis media, sinusitis, lower respiratory tract infections).

Table for choosing a single dose of Augmentin® depending on body weight.

*For children weighing >8 kg, use Augmentin® 400 mg/57 mg to avoid a single dose of more than 5 ml of the drug.

There are no clinical data on the use of this dosage of Augmentin® above 45 mg/6.4 mg/kg/day in children under 2 years of age.

There are no clinical data on the use of Augmentin®

200 mg/28.5 mg/5 ml in children under 2 months, and therefore there are no dosing recommendations for this cohort of patients.

For children weighing less than 40 kg, the maximum daily dose is 2400 mg amoxicillin/600 mg clavulanic acid. If it is necessary to prescribe a higher daily dose of amoxicillin, a different dosage of Augmentin® should be prescribed to avoid taking high doses of clavulanic acid unnecessarily.

Patients with impaired renal function

Dose adjustments are based on the maximum recommended dose of amoxicillin and creatinine clearance.

Patients with liver dysfunction

Treatment is carried out with caution; regularly monitor liver function.

Method of application of the suspension

The suspension is diluted immediately before the first use.

Check the integrity of the cap before use. Shake the bottle of powder.

The powder should be dissolved in 64 ml of boiled water, cooled to room temperature, gradually shaking and adding water to the mark on the bottle. The finished volume of the suspension is 70 ml. The bottle should be inverted and shaken thoroughly until completely dissolved. The bottle should be shaken before each use. To dose the drug, you should use a measuring cap, which should be rinsed well with water after each use. For more accurate dosing of small volumes of suspension, especially in children under 3 months, it is necessary to use a standard disposable medical syringe.

When treating children under 2 years of age, the finished Augmentin® suspension can be diluted by half with water.

Side effects

Very common ≥ 1 in 10, common ≥ 1 in 100 and< 1 из 10, иногда ≥ 1 из 1000 и < 1 из 100, редко ≥ 1 из 10000 и < 1 из 1,000, очень редко < 1 из 10000

Often

Candidiasis of the skin and mucous membranes

Nausea, vomiting, diarrhea

Nausea is more common when using high doses of the drug. To reduce the degree of manifestation, it is recommended to take the suspension at the beginning of a meal.

Uncommon

Dizziness, headache

Dyspepsia

Moderate increase in the level of liver enzymes ALT/AST

Skin rash, itching, urticaria

Rarely

Reversible leukopenia (including neutropenia), thrombocytopenia

Erythema multiforme

Unknown

Reversible agranulocytosis and hemolytic anemia, increased bleeding time and prothrombin time index

Angioedema, anaphylaxis; serum sickness-like syndrome, allergic vasculitis

Reversible hyperactivity and seizures

Antibiotic-associated colitis (including pseudomembranous and hemorrhagic)

Black hairy tongue (chronic hyperplasia filiform

papillae of the tongue)

Change in color of the surface layer of tooth enamel

Hepatitis, cholestatic jaundice

Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis

If these symptoms develop, the drug should be discontinued.

Interstitial nephritis, crystalluria

Contraindications

Hypersensitivity to penicillins or any of the components

drug

Known hypersensitivity to other beta-lactams

antibiotics (cephalosporins, carbapenems, monobactams)

Jaundice or impaired liver function developed due to

taking a combination of amoxicillin/clavulanic acid

Phenylketonuria (due to the presence of aspartame in the drug)

Glucose-galactose malabsorption (due to the presence

maltodextrin (glucose) in the composition of the drug)

Drug interactions

It is not recommended to use Augmentin® simultaneously with probenecid. Probenicide reduces the tubular secretion of amoxicillin, and therefore the simultaneous use of Augmentin® and probenecid may lead to an increase in the level of amoxicillin in the blood.

Concomitant use of allopurinol and Augmentin® may increase the risk of allergic reactions. There are currently no data on the simultaneous use of allopurinol and Augmentin®.

Augmentin® affects the intestinal flora and leads to a decrease in reabsorption and a decrease in the effectiveness of combined oral contraceptives.

Cases of increased prothrombin time (acenocoumarol and warfarin) have been identified with simultaneous use of Augmentin ® and anticoagulants, it is necessary to carry out appropriate monitoring with dose adjustment of Augmentin ® if necessary.

Penicillins may reduce the elimination of methotrexate, which has a potential risk of increased toxicity.

In patients taking mycophenolate mofetil, when used in combination with Augmentin ® the concentration of the active metabolite of mycophenolic acid when prescribing the initial dose is reduced by approximately 50%. Changes in the concentration level of the initial dose may not correspond to changes in the concentration of total exposure to mycophenolic acid.

Special instructions

Adults and children over 12 years of age or weighing more than 40 kg are recommended to use Augmentin® tablets.

Before starting treatment with Augmentin ® A detailed history should be obtained regarding previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam antibiotics.

Serious and sometimes fatal hypersensitivity reactions (anaphylactic shock) to penicillins have been described, and are more common in patients with a history of hypersensitivity to penicillins. If an allergic reaction occurs, treatment with Augmentin should be discontinued. ® and start alternative therapy. If serious hypersensitivity reactions develop, the patient should be given adrenaline immediately. Oxygen therapy, intravenous steroids, and airway management including intubation may be required.

If a disease caused by amoxicillin-sensitive strains is confirmed, the amoxicillin/clavulanic acid combination should be discontinued and amoxicillin should be prescribed separately.

It is not recommended to use Augmentin ® with a high risk of possible resistance to the beta-lactam component of the drug. Augmentin ® should not be used to treat pathologies caused by Streptococcus pneumoniae resistant to penicillins.

Augmentin ® should not be prescribed if infectious mononucleosis is suspected, since in patients with this disease amoxicillin can cause a skin rash, which makes diagnosing the disease difficult.

The combined use of allopurinol and amoxicillin increases the likelihood of developing allergic skin reactions.

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

To prevent discoloration of tooth enamel, you should brush your teeth after each use of the suspension.

Cases of pseudomembranous colitis developing due to the use of antibiotics have been identified, the severity of which varied from mild to severe. Thus, it is necessary to keep in mind the possibility of this pathology occurring in patients with diarrhea while taking antibiotics or after completing a course of therapy. In case of development of prolonged or significant diarrhea, in the presence of cramps in the abdominal area, treatment with Augmentin ® should be stopped immediately and patients referred for further evaluation.

Overall, Augmentin ® It is well tolerated and has the low toxicity characteristic of all penicillins. With long-term treatment with Augmentin ® It is recommended to periodically evaluate the functions of the kidneys, liver, and hematopoietic organs.

In patients receiving Augmentin ® , an increase in prothrombin time is occasionally observed, therefore, with the simultaneous use of Augmentin ® and anticoagulants should be appropriately monitored.

Augmentin should be used with caution ® in patients with impaired liver function. Signs and symptoms of liver damage usually occur during or immediately after starting treatment, but in some cases may not appear until several weeks after stopping therapy. As a rule, they are reversible. Liver problems can be very serious and death has been reported in extremely rare cases. They have almost always been reported in patients with a serious underlying medical condition or in those who were concomitantly taking drugs known to have potential effects on the liver.

Cases of antibiotic-associated colitis have been reported while taking Augmentin. ® , the degree of which ranged from minor to life-threatening. Therefore, the possibility of colitis should be considered in patients with diarrhea that develops during or after taking antibiotics. If the diagnosis of colitis is confirmed, Augmentin ® must be canceled immediately; the patient should consult a doctor for the necessary therapy.

In patients with renal failure, the dose of the drug should be adjusted according to the severity of the disease.

In rare cases, crystalluria may occur in patients with reduced diuresis. During administration of high doses of amoxicillin, it is recommended to take sufficient fluids and maintain adequate diuresis to reduce the likelihood of amoxicillin crystal formation. In patients with a catheter, ongoing assessment of their condition is necessary.

During treatment with amoxicillin, enzymatic glucose oxidation methods must be used to determine glucose in urine, as non-enzymatic methods may lead to false-positive results.

Presence of clavulanic acid in Augmentin ® may cause nonspecific binding of IgG and albumin to the erythrocyte membrane, which leads to a false-positive Coombs test.

Augmentin®, powder for oral suspension 200 mg/28.5 mg/5 ml, contains 2.5 mg/ml aspartame, a source of phenylalanine. It is not recommended to use the drug in patients with phenylketonuria.

The drug contains maltodextrin (glucose). It is not recommended to use the drug in patients with glucose-galactose malabsorption.

Pregnancy and lactation

The oral suspension is intended for use in pediatrics.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

No data available; however, due to the possibility of adverse reactions (allergy, dizziness, convulsions), caution must be exercised.

Overdose

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

When prescribing the drug to patients with reduced renal function or when using high doses, seizures may develop.

Deposition of amoxicillin on bladder catheters is possible, especially after high doses administered intravenously.

Treatment: carrying out symptomatic therapy, correction of water and electrolyte balance. Augmentin ® removed from the blood by hemodialysis.

Release form and packaging

Powder for the preparation of suspension for oral administration 200 mg/28.5 mg/5 ml, 70 ml.

The powder for preparing the suspension is placed in type III transparent glass bottles with a screw-on aluminum cap with an internal varnish coating with tamper-evident protection and a polymer lining made of PVC or polyolefin, equipped with a dispenser cap.

1 bottle, along with instructions for medical use in the state and Russian languages, is placed in a cardboard pack.

Storage conditions

Store in a dry place at a temperature not exceeding 25 °C. Store the prepared suspension in the refrigerator at a temperature from 2 0C to 8 0C and use within 7 days. Do not freeze!

Keep out of the reach of children!

Shelf life

Do not take after expiration date.

Conditions for dispensing from pharmacies

By prescription

Manufacturer

(Clarendon Road, Worthing, West Sussex, BN 14 8QH, United Kingdom).

Registration Certificate Holder

SmithKline Beecham Limited, UK

(980 Great West Road, Brentford, Middlesex, TW89GS, United Kingdom).

Address of the organization that accepts claims from consumers regarding the quality of products (products) on the territory of the Republic of Kazakhstan

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

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

Fax number: +7 727 258 28 90

Email address: [email protected]

Attached files

Augmentin: instructions for use and reviews

Latin name: Augmentin

ATX code: J01CR02

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

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

Updating the description and photo: 19.08.2019

Augmentin™ por. d/p syrup 228.5 mg/5 ml vial. 70 ml No. 1

Price: 100 UAH

increase

Delivery throughout Ukraine!

Instructions Augmentin™ por. d/p syrup 228.5 mg/5 ml vial. 70 ml No. 1:

International name

Amoxicillin and enzyme inhibitor

Antimicrobial agents for systemic use

J01 Antibacterial agents for systemic use

J01CBeta-lactam antibiotics, penicillins

J01CR Combinations of penicillins, including beta-lactamase inhibitors

J01CR02 Amoxicillin and enzyme inhibitor

Pharmacotherapeutic group

Antibacterial agents for systemic use.

active ingredients: amoxicillin, clavulanic acid;

5 ml of suspension contain amoxicillin (in the form of amoxicillin trihydrate) 200 mg and clavulanic acid (in the form of potassium clavulanate) 28.5 mg

Excipients: xanthan gum, aspartame (E 951), succinic acid, colloidal silicon dioxide, hydroxypropyl methylcellulose, dry orange flavors (1 and 2), dry raspberry flavor, dry "Light molasses" flavor, silicon dioxide. Dosage form. Powder for oral suspension.

Pharmacological group

Antibacterial agents for systemic use. ATC code J01C R02.

readings

Treatment of bacterial infections in adults and children caused by microorganisms sensitive to Augmentin:

acute bacterial sinusitis;

acute otitis media;

exacerbation of chronic bronchitis has been confirmed;

community-acquired pneumonia

pyelonephritis;

infections of the skin and soft tissues, incl. cellulitis, animal bites, severe dentoalveolar abscesses with widespread cellulitis;

infections of bones and joints, incl. osteomyelitis.

When prescribing antibacterial drugs, one should be guided by the rules for their proper use.

Contraindications

Hypersensitivity to the components of the drug, to any antibacterial agents of the penicillin group.

A history of severe hypersensitivity reactions (including anaphylaxis) associated with the use of other beta-lactam agents (including cephalosporins, carbapenems or monobactams).

History of jaundice or liver dysfunction associated with amoxicillin/clavulanate use.

Directions for use and doses

The drug should be used in accordance with official recommendations for antibiotic therapy and local antibiotic sensitivity data, if available. Sensitivity to amoxicillin/clavulanate varies between regions and may change over time. If necessary, the sensitivity of the microorganism to the antibiotic should be determined.

Doses are prescribed by the doctor depending on the expected microorganisms and their sensitivity to antibacterial drugs, the severity of the disease and the location of the infection, the age, body weight and kidney function of the patient.

The duration of treatment is determined by the patient's clinical response to treatment. Some infections (such as osteomyelitis) require long-term treatment.

Adults and children weighing ≥ 40 kg

standard dose (for all indications): 875 mg / 125 mg (from 20 to 22.5 ml of prepared solution) 2 times a day;

high doses (especially for infections such as otitis media, sinusitis, infections of the lower

respiratory tract and urinary tract infections): 875 mg / 125 mg (22.5 ml of prepared solution) 3 times a day.

For adults and children weighing ≥ 40 kg, the drug is prescribed in a daily dose of 1750 mg amoxicillin / 250 mg clavulanic acid, divided into 2 doses, and 2625 mg amoxicillin / 375 mg clavulanic acid, divided into 3 doses.

For overweight children<40 кг препарат назначают в дозе 1000-2800 мг амоксициллина / 143-400 мг клавулановой кислоты, при применении как указано ниже.

Approximate calculation of Augmentin suspension (ml) per day (for amoxicillin)

For the treatment of some infections, such as otitis media and sinusitis, lower respiratory tract infections, children over 2 years of age can use daily doses of up to 70/10 mg/kg body weight, divided into 2 doses.

If large doses of amoxicillin need to be prescribed for treatment, other forms of Augmentin should be used to avoid prescribing unnecessary high doses of clavulanic acid.

Renal dysfunction.

For children with a glomerular filtration rate (GFR) greater than 30 ml/min, the dose does not need to be changed. For the treatment of children with GFR less than 30 ml/min, Augmentin 228.5 mg/5 ml suspension is not recommended.

Liver dysfunction. Use with caution and regularly monitor liver function. The available data are insufficient to make dosage recommendations.

For optimal absorption and to reduce possible gastrointestinal side effects, the drug should be taken at the beginning of a meal.

Treatment should not be continued for more than 14 days without consulting a doctor.

You can start treatment with parenteral administration of the drug, and continue with the oral form of the drug.

Instructions for preparing the suspension.

1. Check the cap of the bottle after opening it.

2. Turn over and shake the bottle to loosen the powder in it.

3. Pour boiled water into the bottle with the powder to the lower level, indicated by the red line with an arrow.

4. Close the lid and shake the bottle until a suspension is formed.

5. Then add the rest of the water to the top level indicated by the black line with an arrow and shake again.

6. The suspension should be allowed to stand for 5 minutes until the powder is completely dispersed.

7. Shake the suspension thoroughly before each dose.

To accurately measure the dose, use a measuring cap, which should be rinsed with water after each use.

adverse reactions

Side effects were classified according to their frequency of occurrence.

The following classification of the frequency of side effects is used:

very often ³ 1/10;

often ³ 1/100 and<1/10;

infrequently ³ 1/1000 and<1/100;

rarely ³ 1/10000 and<1/1000;

very rarely<1/10000.

Infections and infestations.

Often candidiasis of the skin and mucous membranes.

Circulatory and lymphatic systems.

Rare: reversible leukopenia (including neutropenia) and thrombocytopenia.

Very rarely, reversible agranulocytosis and hemolytic anemia increase bleeding time and prothrombin index.

Immune system.

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

Nervous system.

Uncommon: dizziness, headache.

Very rare: reversible hyperactivity and seizures. Seizures may occur in patients with impaired kidney function or in those receiving high doses of the drug.

Gastrointestinal tract.

adults

Very common diarrhea.

Common: nausea, vomiting.

Often diarrhea, nausea, vomiting.

Nausea is more often associated with high doses of the drug. The above-mentioned gastrointestinal symptoms can be reduced if the drug is used at the beginning of meals.

Uncommon: indigestion.

Very rarely, antibiotic-associated colitis (including pseudomembranous and hemorrhagic colitis), black “hairy” tongue. Very rarely, children experience superficial discoloration of teeth. Proper oral care can prevent this phenomenon. Discoloration can be corrected by brushing your teeth.

Hepatobiliary reactions.

Uncommon: Moderate increases in AST and/or ALT levels have been reported in patients treated with beta-lactam antibiotics, although the clinical significance of this has not been established.

Very rarely, hepatitis and cholestatic jaundice. These phenomena occur with the use of other penicillins and cephalosporins.

Hepatitis occurred mainly in men and elderly patients; their occurrence may be associated with long-term treatment.

In children, such phenomena occurred very rarely.

Symptoms of the disease occur during or immediately after treatment, but in some cases they may occur several weeks after the end of treatment. These phenomena are usually reversible. Liver dysfunction can be severe and very rarely fatal. This almost always occurs in patients with severe underlying disease or in patients receiving concomitant medications that negatively affect the liver.

Skin and subcutaneous tissues.

Uncommon: skin rash, itching, urticaria.

Rarely polymorphic erythema.

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

If any allergic dermatitis occurs, treatment should be discontinued.

Kidney and urinary system.

Very rarely, interstitial nephritis, crystalluria (see section “Overdose”).

Overdose

An overdose may be accompanied by symptoms from the gastrointestinal tract and disturbances in water and electrolyte balance. These phenomena are treated symptomatically, paying attention to the correction of water and electrolyte balance. Cases of crystalluria have been reported, sometimes leading to renal failure (see section "Peculiarities of use"). Augmentin is removed from the blood using hemodialysis.

Use during pregnancy and lactation

Pregnancy. Reproductive studies in animals (mice and rats) of oral and parenteral forms of Augmentin did not reveal any teratogenic effects. One study in women with premature rupture of membranes reported that prophylactic use of Augmentin may be associated with an increased risk of necrotizing enterocolitis in newborns. As with other medications, use of the drug should be avoided during pregnancy, especially in the first trimester, unless such use is necessary in the opinion of a physician.

Breastfeeding period. Both active components of the drug are excreted into breast milk (there is no information regarding the effect of clavulanic acid on a breastfed infant). Accordingly, a breastfed infant may develop diarrhea and fungal infection of the mucous membranes, so breastfeeding should be stopped.

Augmentin can be used during breastfeeding only when, in the opinion of the doctor, the benefits of use will outweigh the risks.

Used for children aged 2 months and older.

application features

Before starting Augmentin therapy, it is necessary to accurately determine whether there is a history of hypersensitivity reactions to penicillins, cephalosporins or other allergens.

Serious and sometimes fatal cases of hypersensitivity (anaphylactoid reactions) have been observed in patients during penicillin therapy. Such reactions are more likely to occur in patients with a history of hypersensitivity to penicillins (see Section “Contraindications”).

If it is proven that the infection is caused by microorganisms sensitive to amoxicillin, it is necessary to weigh the possibility of switching from the amoxicillin/clavulanic acid combination to amoxicillin according to official recommendations.

Augmentin should not be prescribed if infectious mononucleosis is suspected, since cases of morbilliform rash have been reported with the use of amoxicillin for this pathology.

Long-term use of the drug may cause excessive growth of microflora insensitive to Augmentin.

The development of erythema multiforme associated with pustules at the beginning of treatment may be a symptom of acute generalized exanthematous pustulosis. In this case, it is necessary to stop treatment and further administration of amoxicillin is contraindicated.

Rarely, patients taking Augmentin and oral anticoagulants may experience an overtime prolongation of PT (increased international normalized ratio (INR) levels). When taking anticoagulants concomitantly, appropriate monitoring is necessary. Dosage adjustment of oral anticoagulants may be required to maintain the required level of anticoagulation.

Augmentin should be prescribed with caution to patients with impaired liver function. Changes in liver function tests have been reported in some patients treated with Augmentin.

There are isolated reports of cholestatic jaundice, which can be severe but is usually reversible. Symptoms may not appear until 6 weeks after finishing treatment.

For patients with impaired renal function, Augmentin 228.5 mg / 5 ml suspension is not recommended (see Section "Method of administration and dosage").

In patients with reduced urine excretion, crystalluria can very rarely be observed, mainly with parenteral administration of the drug. Therefore, to reduce the risk of occurrence during treatment with high doses, it is recommended to ensure an adequate balance between the liquid drunk and urine excreted (see Section "Overdose").

When treating with amoxicillin, enzymatic reactions with glucose oxidase should be used to determine the level of glucose in urine, since other methods may give false-positive results.

The presence of clavulanic acid in the drug can cause nonspecific binding of IgG and albumin on red blood cell membranes, therefore, as a result, a false positive result is possible when performing the Coombs test.

There have been reports of false-positive test results for the presence of Aspergillus in patients receiving amoxicillin/clavulanic acid (using the Bio-Rad Laboratories Platelis Aspergillus EIA test). Therefore, such positive results in patients receiving amoxicillin/clavulanic acid should be interpreted with caution and confirmed by other diagnostic methods.

Augmentin suspension 228.5 mg / 5 ml contains aspartame 12.5 mg / 5 ml - a source of phenylalanine, so the drug should be prescribed with caution to patients with phenylketonuria.

The ability to influence the reaction rate when driving vehicles or other mechanisms

No negative effects on the ability to drive a car or use other machinery were observed, but the possibility of such a side effect as dizziness should be taken into account.

Interaction with other drugs and other types of interactions

Concomitant use of probenecid is not recommended. Probenecid reduces renal tubular secretion of amoxicillin. Its simultaneous use with Augmentin can lead to an increase in the level of the drug in the blood for a long time, but does not affect the level of clavulanic acid.

Penicillins may reduce the elimination of methotrexate, which can lead to increased toxicity of the latter.

Concomitant use of allopurinol during treatment with amoxicillin may increase the likelihood of allergic reactions. There is no data on the simultaneous use of Augmentin and allopurinol.

Like other antibiotics, Augmentin can affect intestinal flora, which leads to a decrease in estrogen reabsorption and a decrease in the effectiveness of combined oral contraceptives.

According to the literature, there are isolated reports of an increase in INR levels in patients treated with acenocoumarol or warfarin and taking amoxicillin. If such use is necessary, the prothrombin time or INR level should be carefully monitored with the addition or discontinuation of Augmentin treatment.

Pharmacological properties

Pharmacodynamics.

Amoxicillin is a semisynthetic antibiotic with a wide spectrum of antibacterial activity against many gram-positive and gram-negative microorganisms. Antibiotic resistance is caused by the release of bacterial enzymes that destroy the antibiotic before it can act on the bacterium. Clavulanic acid in Augmentin blocks β-lactamase enzymes and restores the sensitivity of pathogens to the bactericidal action of amoxicillin. Clavulanate has insignificant antibacterial activity, but its combination with amoxicillin in Augmentin is an antibacterial drug with a wide range of applications in outpatient and hospital practice.

The microorganisms listed below are categorized according to their sensitivity to amoxicillin/clavulanate in vitro.

sensitive microorganisms

Gram-positive aerobes Bacillus anthracis, Enterococcus faecalis, Listeria monocytogenes, Nocardia asteroids, Streptococcus pyogenes, Streptococcus agalactiae, other β-hemolytic Streptococcus species, Staphylococcus aureus (methicillin-sensitive strains), Staphylococcus saprophyticus (methicillin-sensitive strains), ny staphylococci (methicillin-sensitive strains).

Gram-negative aerobes Bordetella pertussis, Haemophilus influenza, Haemophilus parainfluenzae, Helicobacter pylori, Moraxella catarrhalis, Neisseria gonorrhoeae, Pasteurella multocida, Vibrio cholera.

Others: Borrelia burgdorferi, Leptospirosa ictterohaemorrhagiae, Treponema pallidum.

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

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

Strains with possible acquired resistance

Gram-negative aerobes Escherichia coli, Klebsiella oxytoca, Klesiella pneumonia, Klebsiella spp., Proteus mirabilis, Proteus vulgaris, Proteus spp., Salmonella spp., Shigella spp.

Gram-positive aerobes species Corynebacterium, Enterococcus faecium, Streptococcus pneumonia, Streptococcus viridans group.

microorganisms are insensitive

Gram-negative aerobes Acinetobacter spp., Citrobacter freundii, Enterobacter spp., Hafnia alvei, Legionella pneumophila, Morganella morganii, Providencia spp., Pseudomonas spp., Serratia spp., Stenotrophomas maltophilia, Yesinia enterolitica.

Others: Chlamydia pneumonia, Chlamydia psittaci, Chlamydia species, Coxiella burnetti, Mycoplasma species.

Pharmacokinetics.

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

The concentration of the drug in the blood serum that is achieved when taking Augmentin is similar to that achieved by oral administration of equivalent doses of amoxicillin itself.

Concomitant use of probenecid inhibits the excretion of amoxicillin, but does not affect the renal excretion of clavulanic acid.

Distribution. When administered internally, therapeutic concentrations of amoxicillin and clavulanic acid are observed in tissues and interstitial fluid. Therapeutic concentrations of both substances are found in the gallbladder, abdominal tissue, skin, adipose and muscle tissue, as well as in synovial and peritoneal fluids, bile and pus. Amoxicillin and clavulanic acid are weakly protein bound; Studies have found that protein binding rates are 25% for clavulanic acid and 18% for amoxicillin of their total plasma concentrations. Animal studies have not revealed the accumulation of these components in any organ.

Amoxicillin, like other penicillins, can be excreted in breast milk. Trace amounts of clavulanic acid can also be found in breast milk. Animal reproductive studies have shown that both amoxicillin and clavulanic acid can cross the placental barrier. However, there is no evidence of impaired fertility or harmful effects on the fetus.

Conclusion. The main route of elimination of amoxicillin, like other penicillins, is renal excretion, while clavulanate is eliminated by both the kidneys and extrarenal mechanisms. Approximately 60-70% of amoxicillin and 40-65% of clavulanic acid are excreted unchanged in the urine during the first 6:00.

Pharmaceutical characteristics.

Basic physical and chemical properties

white or whitish effervescent powder with a characteristic odor.

best before date

storage conditions

Store original packaging closed at temperatures below 25 ° C in a dry place.

Store the prepared suspension in the refrigerator at a temperature of 2 to 8 ° C for 7 days. Keep out of the reach of children.

package

Powder for oral suspension 70 ml (200 mg / 28.5 mg / 5 ml) in bottles with a measuring cap in a cardboard package.

SmithKline Beecham Pharmaceuticals, UK.

Key phrases Augmentin™ buy Augmentin™ detailed information Augmentin™ instructions Augmentin™

Augmentin is a combination drug of the penicillin group of synthetic antibiotics with a broad spectrum of action.

Intended for treatment of adults and children. Augmentin contains the active substances amoxicillin trihydrate and potassium clavulanate (clavulanic acid).

The release form of Augmentin is tablets, syrup, powder for injection, dry substance for the preparation of suspensions. Syrup and suspension are intended for the treatment of children under 12 years of age. This form of the drug is quite easily tolerated even by the smallest patients. However, caution must be exercised when taking it, as there is a risk of allergic reactions.

On this page you will find all the information about Augmentin: complete instructions for use for this drug, average prices in pharmacies, complete and incomplete analogues of the drug, as well as reviews from people who have already used Augmentin in the form of a suspension. Would you like to leave your opinion? Please write in the comments.

Clinical and pharmacological group

A broad-spectrum penicillin antibiotic with a beta-lactamase inhibitor.

Conditions for dispensing from pharmacies

Dispensed with a doctor's prescription.

Prices

How much does Augmentin suspension cost? The average price in pharmacies is:

• Augmentin powder for preparing a suspension 125/31.25 – 118 – 161 rubles;
• Augmentin powder for preparing a suspension 200/28.5 – 126 – 169 rubles;
• Augmentin powder for preparing a suspension 400/57 – 240 – 291 rubles;
• Augmentin EC powder for preparing a suspension 600/42.9 – 387 – 469 rubles;

Release form and composition

The medication consists of:

1. Amoxicillin (it is represented by trihydrate);
2. Clavulanic acid (it comes in the form of potassium salt).

Available in different forms:

1. Powder. It is intended for the production of oral suspension. The following excipients are used: dry flavors (orange, light molasses, raspberry), succinic acid, colloidal silicon dioxide, xanthan gum, hydroxypropyl methylcellulose, aspartame. Contains powder inside the bottles. The bottle is placed in a package made of cardboard.
2. Pills. The following substances were used in their creation: silicon dioxide (colloidal anhydrous), sodium starch glycolate, titanium dioxide, cellulose (microcrystalline), dimethicone 500, magnesium stearate, macrogol, hypromellose (5, 15 cps). Packed in 7, 10 tablets per blister. Inside a pack of such blisters (made of foil) there is a pair.

The powder intended for the production of a suspension is produced in the UK (SmithKline Beecham Pharmaceuticals).

Pharmacological effect

A bacteriolytic effect was noted. The medication is active against aerobic/anaerobic gram-positive and aerobic gram-negative microorganisms. It is very effective against strains that are capable of producing beta-lactamase. Under the influence of clavulanic acid, the resistance of amoxicillin to the influence of a substance such as beta-lactamase increases. At the same time, an expansion of the influence of this substance is observed.

The drug is active against:

• Legionella;
• Yersinia enterocolitica;
• Streptococcus pneumoniae;
• Fusobacterium;
• Bordetella pertussis;
• Peptococcus spp.;
• Bacillus anthracis;
• Peptostreptococcus spp.;
• Enterococcus faecium;
• Streptococcus agalactiae;
• Vibrio cholerae;
• Listeria monocytogenes;
• Borrelia burgdorferi;
• Moraxella catarrhalis;
• Streptococcus;
• Proteus mirabilis;
• Peptococcus spp.;
• Leptospira icterohaemorrhagiae;
• Streptococcus pyogenes;
• Neisseria meningitidis;
• Treponema pallidum;
• Helicobacter pylori;
• Brucella spp.;
• Streptococcus viridans;
• Gardnerella vaginalis;
• Haemophilus influenza.

When prescribing medicine to a child, the doctor must calculate the required amount of suspension for him.

Indications for use

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

• infections of bones and joints: osteomyelitis;
• odontogenic infections: periodontitis, odontogenic maxillary, severe dental abscesses;
• infections of the skin, soft tissues;
• respiratory tract infections: lobar bronchopneumonia, empyema, lung abscess;
• infections of the genitourinary system: abortion sepsis, infections of organs in the pelvic area;
• infections that arise as a complication after surgery: peritonitis.

The medication is also used in therapy and prevention of infectious complications that can occur during operations on the gastrointestinal tract, neck, head, pelvis, kidneys, joints, heart, bile ducts.

Contraindications

All dosage forms of Augmentin Contraindicated for use if a person has the following conditions or diseases:

• Allergic reaction or hypersensitivity to amoxicillin, clavulanic acid or antibiotics from the penicillin or cephalosporin group;
• Development of jaundice and liver dysfunction in the past during the use of drugs containing amoxicillin and clavulanic acid.

Some dosage forms of Augmentin In addition to those indicated, they have the following additional contraindications:

1. Suspension 125/31.25:

• Phenylketonuria.

2. Suspensions 200/28.5 and 400/57:

• Phenylketonuria;
• Creatinine clearance less than 30 ml/min;
• Age less than 3 months.

3. Tablets of all dosages (250/125, 500/125 and 875/125):

• Age under 12 years or body weight less than 40 kg;
• Creatinine clearance less than 30 ml/min (only for tablets 875/125).

Instructions for use

Children under 12 years of age or weighing less than 40 kg should take Augmentin only in suspension form. In this case, babies under 3 months can only be given a suspension with a dosage of 125/31.25 mg. In children over 3 months of age, it is allowed to use suspensions with any dosage of active ingredients. It is precisely because the Augmentin suspension is intended for children that it is often called simply “children’s Augmentin”, without indicating the dosage form (suspension). Suspension dosages are calculated individually based on the child’s age and body weight.

The instructions for use indicate that the required amount of the finished suspension (solution) is measured using a measuring cup or syringe. To take the medicine to children, you can mix the suspension with water in a one to one ratio, but only after the required dosage has been determined.

1. In order to reduce discomfort and side effects from the gastrointestinal tract, it is recommended to take tablets and suspension at the beginning of meals. However, if for some reason this is not possible, then the tablets can be taken at any time in relation to food, since food does not have a significant effect on the effects of the drug.
2. Taking tablets and suspensions, as well as intravenous administration of Augmentin solution should be done at regular intervals. For example, if you need to take the drug twice a day, then you should maintain the same 12-hour interval between doses. If you need to take Augmentin 3 times a day, then you should do this every 8 hours, trying to strictly observe this interval, etc.

Suspension 200 mg.

• Up to one year, weight from 2 to 5 kg. – 1.5 – 2.5 ml 2 times a day;
• From 1 to 5 years, weight from 6 to 9 kg – 5 ml 2 times a day.

Suspension 400 mg.

• Children from one year to 5 years, weight from 10 to 18 kg – 5 ml 2 times a day;
• From 6 to 9 years old, weighing from 19 to 28 kg -7.5 ml 2 times a day;
• Children 10 to 12 years old, weight 29 to 39 kg – 10 ml twice a day.

Suspension 125 mg.

• Up to one year, weight from 2 to 5 kg – 1.5 – 2.5 ml 3 times a day;
• Children from one year to 5 years, weight from 6 to 9 kg – 5 ml three times a day;
• From one year to 5 years, weight from 10 to 18 kg – 10 ml 3 times a day;
• From 6 to 9 years, weight from 19 to 28 kg – 15 ml 3 times a day;
• From 10 to 12 years, weight from 29 to 39 kg - 20 ml 3 times a day.

The dosage of the drug is calculated depending on the type of infection, stage of progression, weight and age of the patient. It must be remembered that only a doctor can prescribe the required dosage to the patient. When calculating the dosage, it is recommended to take into account only the content of amoxicillin sodium.

Rules for preparing the suspension

The suspension must be prepared immediately before taking the drug. Cooking rules:

1. Add 60 ml of boiled water at room temperature to the container with the powder, close the lid and shake until the powder is completely dissolved. Next, you need to let the container stand for 5 minutes, this ensures complete dissolution of the drug.
2. Add water to the mark on the medicine container and shake the bottle again.
3. For a dose of 125 mg/31.25 mg, 92 ml of water will be required; for a dose of 200 mg/28.5 mg and 400 mg/57 mg, 64 ml of water will be required.

The container with the medicine must be shaken thoroughly before each use. In order to ensure accurate dosing of the medicine, it is recommended to use the measuring cap, which is included in the kit. The measuring cap must be thoroughly cleaned after each use.

The shelf life of the finished suspension is no more than 1 week in the refrigerator. The suspension must not be frozen.

For patients under 2 years of age, the finished single dose of the drug can be diluted with boiled water 1:1.

Side effects

The antibiotic is considered safe for children. The drug has been tested for many years, due to this the mechanism of its action is quite well studied. Naturally, side effects may occur, but the likelihood of their occurrence is quite low.

• The following negative reactions may occur from the digestive system: vomiting, nausea, diarrhea. Diarrhea is a common side symptom when taking an antibiotic. When using the suspension, the color of the enamel on the child’s teeth may change; this does not pose a great danger.
• In certain cases, various allergic reactions may occur. Among them: anaphylactic shock, dermatitis, vasculitis, Stevens-Johnson disease. In certain cases, an allergic rash, erythema, and urticaria develops. The child may experience severe headache and dizziness.

A complete list of side effects of Augmentin for children can be found in the instructions for the drug. The instructions for use also contain a complete list of recommendations and dosages on how to carry out a course of antibiotic treatment.

To protect the child’s body from these undesirable effects, it is necessary to strictly adhere to the dosage of the drug prescribed by a qualified specialist.

Overdose

An overdose is manifested by dehydration, disruption of the digestive tract, and disturbances in the concentration of electrolytes in the blood.

In this case, symptomatic therapy is indicated to support the condition of the baby’s internal organs. To avoid it, you need to follow the instructions strictly and do not exceed the dose of the drug.

Drug interactions

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