Augmentin 228 suspension for children. Special antibiotic for children - Augmentin suspension

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

Dosage form: por. d/p syrup 228.5 mg/5 ml vial. 70 ml
Quantity per package: 1
Manufacturer: SB Pharmaceuticals (UK)

Price: 100 UAH

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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 patient’s age, body weight and kidney function.

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)

Masa tila ditini, kg	Dose 25 mg/kg/double	Dose 45 mg/kg/double

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 powder to the lower level, indicated by a 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.

Rarely: 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 infections 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 “Dosage and Administration”).

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 the membranes of red blood cells, 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 reaction speed 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 the 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™

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.

Body weight (kg)	25 mg/3.6 mg/kg/day	45 mg/6.4 mg/kg/day*
	1.6 ml 2 times a day	2.8 ml 2 times a day
	1.9 ml 2 times a day	3.4 ml 2 times a day
	2.2 ml 2 times a day	3.9 ml 2 times a day
	2.5 ml 2 times a day	4.5 ml 2 times a day
	2.8 ml 2 times a day
	3.1 ml 2 times a day
	3.4 ml 2 times a day
	3.8 ml 2 times a day
	4.1 ml 2 times a day
	4.4 ml 2 times a day
	4.7 ml 2 times a day

*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 have been identified (acenocoumarol and warfarin) 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 the 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, which were more often detected in patients with previous 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 of intravenous administration.

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

039274601477977139_ru.doc	114 kb
588274291477978306_kz.doc	146.5 kb

Pharmacodynamics. amoxicillin is a semisynthetic 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 breaks down under its influence, therefore 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 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 degradation 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.

The microorganisms listed below are categorized according to their in vitro sensitivity to amoxicillin/clavulanic acid:

Sensitive microorganisms:

gram-positive aerobes: Bacillus anthracis, Enterococcus faecalis, Listeria monocytogenes, Nocardia asteroides, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus viridians, other β-hemolytic dbls Streptococcus, Staphylococcus aureus (methicillin-sensitive strains), Staphylococcus sapro phyticus (methicillin-sensitive strains), coagulase-negative staphylococci (methicillin-sensitive strains).

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

Others: Borrelia burgdorferi, Leptospira 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., Porphyromonas spp., Prevotella spp.

Strains with possible acquired resistance:

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

Gram-positive aerobes: Corynebacterium species, Enterococcus faecium.

Insensitive microorganisms:

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

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 quickly absorbed when administered orally.

Distribution. After administration, therapeutic concentrations of amoxicillin and clavulanic acid are determined in tissues and interstitial fluid. Therapeutic concentrations of both substances are detected in the gall bladder, abdominal tissue, skin, adipose and muscle tissue, as well as in synovial and peritoneal fluids, bile and pus. Amoxicillin is not sufficiently distributed into the CSF. 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 concentration in blood plasma. Animal studies have not shown accumulation of any of these components in any organ.

Amoxicillin, like other penicillins, passes into breast milk. Trace amounts of clavulanic acid are also found in breast milk. It was found that amoxicillin and clavulanic acid penetrate the placental barrier.

Excretion. The main route of elimination of amoxicillin is renal excretion, while clavulanic acid is eliminated through both the kidneys and extrarenal mechanisms.

Augmentin powder for the preparation of injection solution. Pharmacokinetic studies of Augmentin for intravenous use were carried out using a group of healthy volunteers who used the drug at a dose of 500/100 (600) mg; 1000/200 mg (1.2 g) and 2000/200 mg (2.2 g) i.v. Average pharmacokinetic parameters for the constituent components of Augmentin are 600 mg and 1.2 g.

Amoxicillin

Clavulanic acid

The pharmacokinetic parameters of Augmentin ES when used to treat children at a dose of 45 mg/kg body weight 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 mcg/h/ml for amoxicillin and 5.29 mcg/h/ml for clavulanic acid, T ½ - 1.27 h for amoxicillin and 1, 03 h - for clavulanic acid, C max of amoxicillin - 17.0 and 2.05 mg/l - for clavulanic acid.

Indications

Treatment of patients with bacterial infections caused by those sensitive to aug

Pharmacological properties

Pharmacodynamics

Amoxicillin is a semisynthetic 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 breaks down under its influence, therefore 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 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 degradation 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 py ogenes, Streptococcus species, 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, Klebsiella spp.*, Legionella spp., Moraxella catarrhalis* (Branhamella catarrhalis), Neisseria gonorrhoeae*, Neisseria meningitidis*, Pasteurella multocida, Proteus mirabilis*, Proteus vulgaris*, Salmonella spp.*, Shigella spp.*, Vibrio cholerae, Yersinia enterocolitica*;
• Gram-negative anaerobes: Bacteroides species (including Bacteroides fragilis), Fusobacterium species;
• Other microorganisms: Borrelia burgdorferi, Chlamydia species, 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 quickly absorbed when administered orally. Augmentin absorption 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 gall bladder, abdominal tissue, skin, adipose and muscle tissue, 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 concentration in blood plasma. Animal studies have not shown the accumulation of any of these components in any organ.

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

Excretion. As with other penicillins, the main route of elimination for amoxicillin is renal excretion, whereas clavulanate is eliminated through both the kidney and extrarenal mechanisms. About 60-70% of amoxicillin and 40-65% of clavulanic acid are excreted unchanged in the urine 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 dose taken. Clavulanic acid is extensively metabolized in humans 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 in exhaled air.

Augmentin (ВD). Pharmacokinetic parameters were studied in studies in which Augmentin (BD) tablets 625 mg 500/125 mg (compared with the separate administration of both components) were administered on an empty stomach in groups of healthy volunteers and the results of which are shown below:

Creatinine clearance ≤30 ml/min: no dose adjustment required.

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

Creatinine clearance ≤10 ml/min: 1000/200 mg, then 500/100 mg every 24 hours.

Hemodialysis.

amoxicillin. The initial dose is 1000/200 mg, then 500/100 mg every 24 hours. Taking into account the need to maintain effective concentrations, another dose should be administered after the end of hemodialysis.

Liver dysfunction

Care should be taken when dosing; continuous monitoring of liver function at regular intervals. The available data are insufficient to make dosage recommendations.

Elderly patients

No dose adjustment is needed. Dosing is used for adults; if necessary, the dose is adjusted depending on renal function.

Dosing for children

Dosing for children weighing ≤40 kg is based on body weight; The minimum interval between injections is 4 hours.

Children under 3 months of age:

Child body weight ≤4 kg - 25/5 mg/kg every 12 hours; child's body weight is 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 6-8 hours, depending on the course of the infection.

Renal dysfunction.

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

Creatinine clearance ≤30 ml/min - no dose adjustment required.

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

Creatinine clearance ≤10 ml/min - 25/5 mg/kg once a day.

Hemodialysis.

Dose adjustment is based on the maximum recommended doses of amoxicillin - 25/5 mg/kg 1 time per day. 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).

Preparation of the solution.

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

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

During dissolution, a temporary pink color may or may not appear, which disappears. Augmentin solutions are usually colorless or have a pale straw color.

IV injection.

The stability of Augmentin solution is concentration dependent, so Augmentin solution should be used immediately after dissolution and administered slowly over 3-4 minutes. Augmentin can be injected directly into a vein or through a catheter as a 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 600 mg solution to 50 ml of infusion fluid or 1.2 g solution to 100 ml of infusion fluid (it is better to use a mini-container or burette). Carry out the infusion over 30-40 minutes in a 4-hour period after dissolution. The solutions are brought to the full volume, which is introduced, immediately after dissolving the powder. The remaining antibiotic solutions cannot be used.

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 the drug is dissolved and stored at room temperature, the infusion should be carried out for the time indicated below

The stability of Augmentin solutions depends on the concentration. If the solution is prepared at a higher concentration, the period of stability of the solution increases proportionally.

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

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

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

Any unused solution should be destroyed.

Augmentin is not designed for multi-dose use.

Children aged 3 months and older

The recommended dose is 90/6.4 mg/kg/day in 2 divided doses at 12-hour intervals for 10 days (see table below). There is no experience of use for the treatment of children weighing 40 kg and adults. There is also no experience of clinical use for the treatment of children under 3 months of age.

Augmentin ES does not contain the same amount of clavulanic acid (as the potassium salt) as other forms of Augmentin suspension. Augmentin ES contains 42.9 mg clavulanic acid per 5 ml suspension, while Augmentin 200 mg/5 ml suspension contains 28.5 mg clavulanic acid per 5 ml, and 400 mg/5 ml suspension contains 57 mg clavulanic acid per 5 ml. Therefore, Augmentin ES cannot be replaced by any other form of Augmentin suspension.

Liver dysfunction.

Use cautiously and monitor liver function at regular intervals. The available data are insufficient to make dosage recommendations.

In order to minimize the risk of undesirable effects of Augmentin ES on the gastrointestinal tract, the drug is taken at the beginning of a meal, while the absorption of Augmentin ES is optimal.

Treatment can be started with parenteral administration of the drug, and continued with an oral form of the drug.

Preparation of the suspension

Add 90 ml of water to the bottle with powder. Water is added in 2 additions. First, add approximately 2/3 of the specified amount of water so that the powder in the bottle is freely covered with water, close the lid and shake the bottle until a suspension is formed. Then add the rest of the water and shake again. When diluting the first time, the suspension should be allowed to stand for 5 minutes until completely dispersed. When diluted, a white suspension with a yellowish or grayish tint is formed. Store the prepared suspension in the refrigerator at a temperature of 2 to 8 °C and use for 10 days.

Contraindications

Hypersensitivity to beta-lactams, i.e. penicillins and cephalosporins, a history of jaundice/liver dysfunction after using Augmentin.

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), often (≥1/100 and ≤1/10), infrequently (≥1/1000 and ≤1/100), rarely (≥1/10 000 and ≤1/1000), very rare (≤1/10,000).

Infections and infestations

Common: candidiasis of the skin and mucous membranes.

Circulatory and lymphatic systems

Rarely: reversible leukopenia (including neutropenia) and thrombocytopenia.

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

Immune system

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

Nervous system

Uncommon: dizziness, headache.

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

Vascular disorders

Rarely : thrombophlebitis at the injection site.

Very often : diarrhea (when using tablet forms).

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

Uncommon: indigestion.

Nausea is more often noted when using the drug in high doses. The above gastrointestinal symptoms can be reduced by 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

Uncommon: Moderate increases in liver transaminase levels have been detected 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; their occurrence 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. Extremely rare (less than 1 report in approximately 4 million prescriptions) deaths occur, which always occur in patients with a severe underlying disease or while taking drugs that have a negative effect on the liver.

Skin and subcutaneous tissues

Uncommon: skin rash, itching and urticaria.

Rarely: erythema multiforme.

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

If any allergic dermatitis occurs, treatment should be discontinued.

Kidneys and urinary system

Very rare: interstitial nephritis, crystalluria (see).

Special instructions

Before starting Augmentin therapy, it is necessary to exclude a history of hypersensitivity reactions to penicillins and cephalosporins or other allergens.

Severe, sometimes fatal hypersensitivity reactions (anaphylactoid reactions) have occurred in patients during penicillin therapy. Such reactions are more likely in patients with a history of hypersensitivity to penicillins (see). If allergic reactions occur, treatment with Augmentin should be discontinued and alternative therapy should be prescribed. Severe anaphylactic reactions require emergency treatment with adrenaline, oxygen therapy, intravenous administration of corticosteroids and provision of pulmonary function, including intubation.

Augmentin should not be prescribed if infectious mononucleosis is suspected, since cases of measles-like 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.

Augmentin is usually well tolerated and exhibits low toxicity typical of 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, patients taking Augmentin experience an increase in prothrombin time. When taking anticoagulants concomitantly, appropriate monitoring is necessary.

Augmentin should be used with caution in patients with impaired liver function.

In patients with impaired renal function, the dose must be adjusted according to the severity of renal failure.

If parenteral administration of high doses of the drug is necessary, the sodium concentration in 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 the fluid drunk and excreted (see).

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

The period of pregnancy and lactation. Pregnancy (category B).

Reproductive studies in animals (using doses 10 times higher than human doses) of oral and parenteral forms of Augmentin did not reveal teratogenic effects. One study in women with premature rupture of membranes reported that prophylactic use of Augmentin during pregnancy may be associated with an increased risk of necrotizing enterocolitis in the newborn. Prescribing the drug during pregnancy, especially in the first trimester, should be avoided, unless the benefit of the drug outweighs the potential risk.

Breastfeeding period.

Augmentin can be used during breastfeeding. Excluding the risk of hypersensitivity associated with the excretion of trace amounts of Augmentin in breast milk, no harmful effects on a breastfed child have been identified.

Children.

No negative effects on the ability to drive vehicles or operate other machinery have been identified, but the possibility of developing a side effect such 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.

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 nonspecific binding of IgG and albumin on red blood cell membranes, as a result of which the Coombs test may be false positive.

Incompatibility

Augmentin in solution for injection should not be mixed with blood products, other liquids containing protein, in particular, with protein hydrolysates, with fat emulsions for intravenous 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. Treatment is symptomatic, correction of water and electrolyte disturbances is carried out. Crystalluria may occur, which in some cases leads to renal failure. There are reports of amoxicillin precipitation in the urinary catheter when using IV Augmentin in high doses, so its patency should be checked regularly. Augmentin can be removed from the bloodstream by hemodialysis.

Storage conditions

The original packaging is stored closed, out of reach of children, in a dry place at a temperature below 25 °C. The prepared suspension is stored in the refrigerator (2-8 °C) and used for 7 days (Augmentin ES - up to 10 days). Augmentin for intravenous administration should be administered immediately after dissolution.

Sometimes childhood infections require the prescription of antibacterial drugs. Injection 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 product is that you can easily calculate the required dosage based on body weight, and any child can drink the fruit-flavored powder dissolved in water without any problems.

Compound

Augmentin suspension for children is an antibiotic used against a large number of bacteria. In pharmacies you can find three types of Augmentin:

• Augmentin suspension 0.125;

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

The medication, when mixed with water, forms a suspension that is convenient for small children to take.

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 carried through the blood throughout the body, which ensures the effectiveness of the antibiotic against infections of the respiratory system, gastrointestinal tract, excretory system, and skin diseases.

Children may develop sensitization in response to the administration of the drug, which manifests itself as 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 in smaller quantities with feces.

Release form

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

• 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;
• A 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 medication can be taken by adults suffering from impaired 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 has no significant side effects and is well tolerated by young patients, its use off-label and without compliance with the regimen can lead to the development of resistance in the flora that caused the infection.

In this case, Augmentin will no longer have the proper medicinal effect and you will have to change the antibiotic to a stronger and more toxic one.

The antibacterial drug effectively fights infections 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) is carried out on media, and the sensitivity of bacteria to antibiotics is also assessed. 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 material is collected, 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 being treated, then the drug is replaced with a more effective one.

Contraindications

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

Contraindications for use are as follows:

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

Augmentin suspension at dosages of 0.2 and 0.4 should not be used in children under three months of age. Augmentin suspension 0.125 should not be used by children over 12 years of age.

Directions for use and dosage

The dosage and duration of administration of the drug should be prescribed by the attending physician. This is especially important for young children, for whom the dose per dose is calculated based on body weight.

The minimum course of treatment should be at least five days. Treatment should not be continued for more than ten days without medical supervision, especially if 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 take Augmentin differently:

1. Patients younger than 3 months receive Augmentin 0.125 based on their body weight only. 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 much ml of suspension you need to take, we make up a proportion. On the packaging we read that 125 mg equals 5 ml of suspension, and 150 mg equals ICS ml. We find the ICS using the formula - 150 x 5/125 = 6 ml. This means that we must divide 6 ml into two doses. Therefore, a child weighing 5 kg needs 3 ml of suspension twice a day.
2. Children from 3 months to 12 years (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 at a dosage of 400 mg/5 ml.

You need 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 vary in severity and intensity.

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

Instructions for preparing 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 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 shaken well until a homogeneous consistency without sediment.
4. Fill the glass bottle with clean warm water 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, approximately 65 ml.
5. The proportions must be strictly observed so that the water does not exceed the mark, since this will change the concentration of the active substance in the suspension.
6. You cannot use the solution after storing it in the refrigerator for a week; if the course of treatment is shorter, then you need to discard the unused medicine.

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