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

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

Dosage form: since. d / p syrup 228.5 mg / 5 ml vial. 70 ml
Amount in a package: 1
Manufacturer: SB Pharmaceuticals (UK)

Price: 100 UAH

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Instruction Augmentin™ por. d / p syrup 228.5 mg / 5 ml vial. 70 ml #1:

international name

Amoxicillin and enzyme inhibitor

Antimicrobials for systemic use

J01 Antibacterial agents for systemic use

J01C Beta-lactam antibiotics, penicillins

J01CR Combinations of penicillins, including those with beta-lactamase inhibitors

J01CR02 Amoxicillin and enzyme inhibitor

Pharmacotherapeutic group

Antibacterial agents for systemic use.

active ingredients: amoxicillin, clavulanic acid;

5 ml suspension contains 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.

testimony

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

acute bacterial sinusitis;

acute otitis media;

confirmed exacerbation of chronic bronchitis;

community-acquired pneumonia

pyelonephritis;

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

bone and joint infections, 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).

A history of jaundice or liver dysfunction associated with the use of amoxicillin/clavulanate.

Dosage and administration

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

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 the 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 of amoxicillin / 250 mg of clavulanic acid, divided into 2 doses, and 2625 mg of amoxicillin / 375 mg of clavulanic acid, divided into 3 doses.

For children with body weight<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 (according to amoxicillin)

Masa tila child, kg	Dose 25 mg/kg/dobu	Dose 45 mg/kg/dobu

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

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

Impaired kidney function.

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 suspension 228.5 mg / 5 ml is not recommended.

Impaired liver function. Use with caution, regularly monitor liver function. The available data are insufficient to formulate dosing recommendations.

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

Treatment should not be continued for more than 14 days without medical advice.

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

Suspension instructions.

1. Check the vial cap by first opening it.

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

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

4. Close the cap and shake the vial until a suspension forms.

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

6. Suspension should be allowed to stand for 5 minutes until complete dispersion of the powder.

7. Shake the suspension thoroughly before each use.

To accurately measure the dose, a measuring cap should be used, 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 occurrence of side effects is applied:

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 invasions.

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.

The immune system.

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

Nervous system.

Uncommon: dizziness, headache.

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

Gastrointestinal tract.

adults

Very common diarrhea.

Often: nausea, vomiting.

Often diarrhea, nausea, vomiting.

Nausea is more commonly associated with high doses of the drug. The above symptoms from the gastrointestinal tract can be reduced if the drug is used at the beginning of a meal.

Uncommon: indigestion.

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

hepatobiliary reactions.

Infrequently: a moderate increase in the level of AST and / or ALT was observed in patients who are treated with antibiotics of the beta-lactam group, 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 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 happens in patients with a severe underlying disease or in patients receiving concomitant drugs that adversely affect the liver.

Skin and subcutaneous tissue.

Uncommon: skin rash, itching, urticaria.

Rarely polymorphic erythema.

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

In the event of any allergic dermatitis, 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 a disorder of the 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 by hemodialysis.

Use during pregnancy and lactation

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

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

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

Applied to children aged 2 months.

application features

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

Serious and sometimes even 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 due to microorganisms sensitive to amoxicillin, it is necessary to weigh the possibility of switching from the combination of amoxicillin / clavulanic acid to amoxicillin according to official recommendations.

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

Prolonged use of the drug can 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.

Occasionally, patients taking Augmentin and oral anticoagulants may experience overtime prolongation of PT (an increase in the level of international normalized ratio (INR). Appropriate monitoring is necessary when taking anticoagulants. Dose adjustment of oral anticoagulants may be required to maintain the required level of anticoagulation.

Augmentin should be used with caution in patients with hepatic impairment. 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 the end of treatment.

For patients with impaired renal function, a suspension of Augmentin 228.5 mg / 5 ml is not recommended (see section "Method of application and doses").

In patients with reduced urinary 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 drunk liquid and the excreted urine (see section "Overdose").

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

The presence of clavulanic acid in the preparation can cause non-specific binding of IgG and albumin on erythrocyte membranes, therefore, as a result, a false positive result is possible when conducting a Coombs test.

There have been reports of false positive Aspergillus test results in patients treated with 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.

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

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

There was no negative effect on the ability to drive a car and other mechanisms, but the likelihood of such a side effect as dizziness should be taken into account.

Interaction with other medicinal products and other forms of interaction

Co-administration 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 can reduce the excretion of methotrexate, which can lead to an increase in the toxicity of the latter.

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

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

According to the literature, there are separate reports of an increase in the level of INR 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 termination of treatment with Augmentin.

Pharmacological properties

Pharmacodynamics.

Amoxicillin is a semi-synthetic 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, restores the sensitivity of pathogens to the bactericidal action of amoxicillin. Clavulanate has little 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 susceptibility 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), coagulase-negative staphylococcus-negative 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 spp., Porphyromonas spp., Prevotella spp.

Strains with possible acquired resistance

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

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

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 pneumonia, 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 rapidly and well absorbed when taken orally. The absorption of Augmentin improves when it is used at the beginning of a meal.

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

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

Distribution. With internal administration, therapeutic concentrations of amoxicillin and clavulanic acid are observed in tissues and interstitial fluid. Therapeutic concentrations of both substances in the gallbladder, abdominal tissues, skin, adipose and muscle tissues, as well as in synovial and peritoneal fluids, bile and pus. Amoxicillin and clavulanic acid are weakly bound to proteins; studies have found that protein binding rates are 25% for clavulanic acid and 18% for amoxicillin of their total plasma concentrations. In animal studies, no accumulation of these components in any organ was detected.

Amoxicillin, like other penicillins, can appear in breast milk. Trace amounts of clavulanic acid can also be found in breast milk. Animal reproduction studies have shown that both amoxicillin and clavulanic acid can cross the placental barrier. However, there was 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 the excretion of clavulanate is carried out both by the kidneys and by extrarenal mechanisms. Approximately 60-70% of amoxicillin and 40-65% of clavulanic acid are excreted in the urine unchanged during the first 6:00.

pharmaceutical characteristics.

Basic physical and chemical properties

white or whitish powder with a characteristic odor.

best before date

storage conditions

Store original packages closed below 25°C in a dry place.

Store the prepared suspension in a 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 vials with a measuring cap in a carton.

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

Instruction

Tradename

Augmentin ®

International non-proprietary name

Dosage form

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

Compound

5 ml suspension contains

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

clavulanic acid (as potassium clavulanate) 28.50 mg,

Excipients: xanthan gum, aspartame, succinic acid, colloidal anhydrous silicon dioxide, hypromellose, dry orange flavor 610271 E, dry orange flavor 9/027108, dry raspberry flavor NN07943, dry molasses flavor 52927/AR, anhydrous silicon dioxide.

Description

Powder of white or almost white color with a characteristic smell. The prepared suspension is white or almost white; on 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 armacokinetics

Suction

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

Distribution

Therapeutic concentrations of amoxicillin and clavulanic acid are achieved in various organs and tissues, interstitial fluid (lungs, abdominal organs, gallbladder, 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.

Plasma protein binding of amoxicillin and clavulanic acid is moderate: 25% for clavulanic acid and 18% for amoxicillin. Amoxicillin, like most penicillins, is excreted in breast milk. Trace amounts of clavulanic acid have also been found in breast milk. Except for the risk of sensitization, amoxicillin and clavulanic acid do not adversely affect the health of breastfed infants. Amoxicillin and clavulanic acid cross the placental barrier.

Elimination

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

Metabolism

Amoxicillin is partially excreted in the urine as inactive penicillic 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 excreted in 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 semi-synthetic broad-spectrum antibiotic that is active against many Gram-positive and Gram-negative microorganisms. Amoxicillin is destroyed by the action of beta-lactamases and does not act 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 has high activity against plasmid beta-lactamases, which are often associated with drug resistance, but is less effective against type 1 chromosomal beta-lactamases.

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

Mechanism of development of resistance

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 pumping mechanisms can cause or contribute to the development of resistance, especially in Gram-negative organisms.

Augmentin® has a bactericidal effect on the following microorganisms:

Gram-positive aerobes: Enterococcus faecalis, Gardnerella vaginalis, Staphylococcus aureus (sensitive to methicillin), coagulase-negative staphylococci (sensitive to methicillin), 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 susceptibility 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 phlegmon of the maxillofacial

Bone and joint infections (particularly osteomyelitis)

Dosage and administration

Sensitivity to Augmentin® may vary by geographic location and time. Before prescribing the drug, it is necessary, if possible, to assess the sensitivity of strains in accordance with local data and determine the sensitivity by taking and analyzing samples from the individual patient, especially in 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 the treatment. Some pathologies (particularly osteomyelitis) may require a longer course. Treatment should not be continued for more than 14 days without reassessment of the patient's condition. If necessary, it is possible to carry out stepwise therapy (initially, intravenous administration of the drug, followed by the transition to oral administration).

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

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

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)

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

Single dose selection table for 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.

There are no clinical data on the use of this dosage of Augmentin over 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 younger than 2 months, and therefore there are no recommendations for dosing in 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 value.

Patients with impaired liver function

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

How to use the suspension

The suspension is diluted immediately before the first use.

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

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 vial. The finished volume of the suspension is 70 ml. The bottle should be turned over and shaken thoroughly until completely dissolved. The bottle should be shaken before each use. For dosing the drug, use a measuring cap-cap, which must be rinsed well with water after each use. For more accurate dosing of small volumes of suspension, especially in children under 3 months old, it is necessary to use a standard disposable medical syringe.

In the treatment of children under the age of 2 years, the finished suspension of Augmentin® can be half diluted 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 with high doses of the drug. To reduce the degree of manifestation, it is recommended to take the suspension at the beginning of a meal.

Infrequently

Dizziness, headache

Dyspepsia

Moderate elevation 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 overactivity and seizures

Antibiotic-associated colitis (including pseudomembranous and hemorrhagic)

Black hairy tongue (chronic hyperplasia filiform

papillae of the tongue)

Discoloration of the surface layer of tooth enamel

Hepatitis, cholestatic jaundice

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

With the development of these symptoms, the drug should be discontinued.

Interstitial nephritis, crystalluria

Contraindications

Hypersensitivity to penicillins or any component

drug

Known hypersensitivity to other beta-lactam

antibiotics (cephalosporins, carbapenems, monobactams)

Jaundice or impaired liver function that developed against the background

taking amoxicillin/clavulanic acid combination

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

Glucose-galactose malabsorption (due to the presence of

maltodextrin (glucose) as part of the preparation)

Drug Interactions

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

The simultaneous use of allopurinol and Augmentin® may increase the risk of allergic reactions. Data on the simultaneous use of allopurinol and Augmentin® are currently not available.

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

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

Penicillins can reduce the excretion of methotrexate, which is a potential risk of increasing its toxicity.

In patients taking mycophenolate mofetil, when used together with Augmentin ® the concentration of the active metabolite of mycophenolic acid in the appointment of the initial dose is reduced by approximately 50%. Changes in initial dose concentrations may not be consistent with changes in total mycophenolic acid exposure.

special instructions

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

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

Serious and sometimes fatal hypersensitivity reactions (anaphylactic shock) to penicillins have been described, more often in patients with previous hypersensitivity to penicillins. In the event of an allergic reaction, treatment with Augmentin should be discontinued. ® and start alternative therapy. With the development of serious hypersensitivity reactions, adrenaline should be administered to the patient immediately. Oxygen therapy, intravenous steroids, and airway management, including intubation, may be required.

If a disease caused by amoxicillin-sensitive strains is confirmed, the combination of amoxicillin / clavulanic acid should be abandoned 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 it difficult to diagnose the disease.

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

Long-term treatment with Augmentin ® may be accompanied by overgrowth of non-susceptible microorganisms.

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

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

In general, Augmentin ® It is well tolerated and has low toxicity characteristic of all penicillins. With prolonged treatment with Augmentin ® it is recommended to periodically evaluate the functions of the kidneys, liver, hematopoietic organs.

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

Augmentin should be used with caution ® in patients with impaired liver function. Signs and symptoms of liver damage usually occur during or immediately after the start of treatment, but in some cases may not appear for several weeks after stopping therapy. As a rule, they are reversible. Hepatic impairment 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 disease or in those who were concomitantly taking drugs known to potentially affect the liver.

Cases of the development of antibiotic-associated colitis while taking Augmentin have been reported. ® , the degree of which was from insignificant to life-threatening. In this regard, it is necessary to consider the possibility of developing colitis in patients with diarrhea that developed during or after taking antibiotics. When confirming the diagnosis of colitis, Augmentin ® must be canceled immediately; the patient should consult a doctor for the necessary therapy.

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

Rarely, crystalluria may occur in patients with reduced diuresis. During the administration of high doses of amoxicillin, it is recommended to take a sufficient amount of fluid and maintain adequate diuresis to reduce the likelihood of amoxicillin crystal formation. Patients with a catheter need constant evaluation of their condition.

During treatment with amoxicillin, enzymatic glucose oxidation methods should be used to determine the content of glucose in the urine, since non-enzymatic methods can lead to false positive results.

The presence of clavulanic acid in Augmentin ® may be the cause of non-specific binding of IgG and albumin to the erythrocyte membrane, which leads to a false positive Coombs reaction.

Augmentin®, powder for oral suspension 200 mg / 28.5 mg / 5 ml, contains 2.5 mg / ml of 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

Suspension for oral administration is intended for use in pediatrics.

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

No data; however, due to the possibility of developing adverse reactions (allergies, dizziness, convulsions), care must be taken.

Overdose

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

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

Precipitation of amoxicillin on vesical catheters is possible, especially after administration of high doses by 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 suspension for oral administration 200 mg / 28.5 mg / 5 ml, 70 ml.

The powder for the preparation of the suspension is placed in type III transparent glass vials with an aluminum screw cap with an internal lacquer coating with protection against the first opening and a PVC or polyolefin polymeric liner, equipped with a dispenser cap.

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

Storage conditions

Store in a dry place at a temperature not exceeding 25°C. The prepared suspension should be stored in a refrigerator at a temperature from 20C to 80C and used within 7 days. Do not freeze!

Keep out of the reach of children!

Shelf life

Do not take after the expiration date.

Terms of dispensing from pharmacies

On 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 accepting claims from consumers on the quality of products (goods) on the territory of the Republic of Kazakhstan

Representation 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

E-mail address: [email protected]

Attached files

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

Pharmacodynamics. Amoxicillin is a semi-synthetic 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, so the spectrum of activity of amoxicillin does not include microorganisms that synthesize this enzyme. clavulanic acid has a beta-lactam structure similar to that of penicillins, and also has the ability to inactivate beta-lactamase enzymes produced by microorganisms resistant to penicillins and cephalosporins. in particular, it has a pronounced activity against clinically important plasmid beta-lactamases, which are often responsible for the occurrence of cross-resistance to antibiotics. the presence of clavulanic acid in augmentin protects amoxicillin from degradation by beta-lactamase enzymes and expands the spectrum of antibacterial action of amoxicillin, including many microorganisms resistant to amoxicillin and other penicillins and cephalosporins.

The organisms below are categorized according to amoxicillin/clavulanic acid in vitro susceptibility:

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-susceptible strains), Staphylococcus saprophylin-susceptible strains (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 rapidly 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 gallbladder, abdominal tissues, skin, adipose and muscle tissues, as well as in synovial and peritoneal fluids, bile and pus. Amoxicillin is not distributed sufficiently in 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 plasma concentration. In the course of animal studies, no accumulation of any of these components in any organ has been established.

Amoxicillin, like other penicillins, passes into breast milk. Trace amounts of clavulanic acid are also detected in breast milk. Amoxicillin and clavulanic acid have been found to cross the placental barrier.

Withdrawal. The main route of elimination of amoxicillin is renal excretion, while the excretion of clavulanic acid is carried out both through the kidneys and by extrarenal mechanisms.

Augmentin powder for the preparation of injection solution. Pharmacokinetic studies of Augmentin for intravenous use were performed with a group of healthy volunteers who used the drug at a dose of 500/100 (600) mg; 1000/200 mg (1.2 g) and 2000/200 mg (2.2 g) IV. The average pharmacokinetic parameters for the constituent components of Augmentin are 600 mg and 1.2 g.

Amoxicillin

clavulanic acid

Pharmacokinetic parameters of Augmentin ES when used for the treatment of children at a dose of 45 mg / kg of 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 μg / h / ml for amoxicillin and 5.29 μg / h / ml for clavulanic acid, T ½ - 1.27 h for amoxicillin and 1, 03 h - for clavulanic acid, C max amoxicillin - 17.0 and 2.05 mg/l - for clavulanic acid.

Indications

Treatment of patients with bacterial infections caused by auger-sensitive

Pharmacological properties

Pharmacodynamics

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

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

• Gram-positive aerobes: Bacillus anthracis*, Corynebacterium spp., Enterococcus faecalis*, Enterococcus faecium*, Listeria monocytogenes, Nocardia asteroides, Staphylococcus aureus*, coagulase-negative staphylococci (including Staphylococcus epidermidis), Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus spp. 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 spp. (including Bacteroides fragilis), Fusobacterium spp.;
• Other microorganisms: Borrelia burgdorferi, Chlamydia species, Leptospira icterohaemorrhagiae, Treponema pallidum.

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

Pharmacokinetics

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

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

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

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

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

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

Creatinine clearance ≤30 ml / min: dose adjustment is not needed.

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 an effective concentration, another dose should be administered after the end of hemodialysis.

Impaired liver function

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

Elderly patients

Dose adjustment is not needed. Apply dosing for adults, if necessary - the dose is adjusted depending on the function of the kidneys.

Dosing for children

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

Children under 3 months of age:

Child weight ≤4 kg - 25/5 mg / kg every 12 hours; body weight of a child 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.

Impaired kidney function.

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

Creatinine clearance ≤30 ml / min - dose adjustment is not needed.

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

Creatinine clearance ≤10 ml / min - 25/5 mg / kg 1 time per day.

Hemodialysis.

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

Preparation of solution.

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

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

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

IV injection.

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

IV infusion.

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

The stability of the prepared solution.

To dissolve Augmentin for intravenous infusion, various intravenous solutions can be used. A satisfactory concentration of the antibiotic is maintained at 5 °C at room temperature (25 °C) in the recommended volumes of the following infusion solutions. When dissolving the drug and storing it 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 stability period of the solution increases proportionally.

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

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

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

Any unused solution should be destroyed.

Augmentin is not designed for a multidose regimen.

Children aged 3 months and older

The recommended dose is 90/6.4 mg/kg/day in 2 divided doses 12 hours apart 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 the age of 3 months.

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

Impaired liver function.

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

In order to minimize the risk of an undesirable effect 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.

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

Suspension preparation

Add 90 ml of water to the powder vial. Water is added in 2 doses. First, approximately 2/3 of the indicated amount of water is added so that the powder in the vial is freely covered with water, close the cap and shake the vial until a suspension is formed. Then add the rest of the water and shake again. At the first dilution, the suspension should be allowed to stand for 5 minutes until complete dispersion. When diluted, a white suspension with a yellowish or grayish tint is formed. Store the prepared suspension in the refrigerator at a temperature of 2 to 8 ° C and use within 10 days.

Contraindications

Hypersensitivity to beta-lactams, i.e. to penicillins and cephalosporins, a history of jaundice / abnormal liver function after the use of 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

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, increased bleeding time and prothrombin index.

The immune system

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

Nervous system

Uncommon: dizziness, headache.

Very 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.

Often : diarrhea (when using tablet forms).

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

Uncommon: indigestion.

Nausea is more often noted when using the drug in high doses. The above symptoms from the gastrointestinal tract 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

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

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

Hepatitis occurred mainly in men and elderly patients, 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) fatal outcomes occur, which always occur in patients with 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.

Rare: erythema multiforme.

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

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

Kidneys and urinary system

Very rare: interstitial nephritis, crystalluria (see).

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 developed in patients during penicillin therapy. Such reactions are more likely in patients with a history of hypersensitivity to penicillins (see). In the event of allergic reactions, treatment with Augmentin should be discontinued and alternative therapy prescribed. Severe anaphylactic reactions require emergency therapy with the use of adrenaline, oxygen therapy, intravenous corticosteroids and provision of respiratory function, including intubation.

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

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

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

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

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

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

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

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

During pregnancy and breastfeeding. Pregnancy (category B).

Reproductive animal studies (when using doses 10 times higher than human doses) oral and parenteral forms of Augmentin teratogenic effects have not been identified. In one study in women with premature rupture of the membranes, it was reported that the prophylactic use of Augmentin during pregnancy may be associated with an increased risk of necrotizing enterocolitis in newborns. Prescribing the drug during pregnancy, especially in the first trimester, should be avoided, except in cases where the benefit of using the drug outweighs the potential risk.

breastfeeding period.

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

Children.

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

Interactions

Co-administration 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 non-specific binding of IgG and albumin on erythrocyte membranes, as a result of which the Coombs reaction may be false positive.

Incompatibility

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

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

Overdose

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

Storage conditions

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

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

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

Compound

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

• Augmentin suspension 0.125;

The composition of the antibiotic contains the following components:

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

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

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

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

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

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

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

Release form

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

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

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

Indications

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

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

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

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

1. Infectious diseases of the oral cavity and teeth (jaw abscess, periodontitis);

1. Infectious otolaryngological diseases and upper respiratory tract (otitis media, sinusitis, tonsillitis, laryngitis);

1. Infectious diseases of the lower respiratory tract (bronchitis, pneumonia, pleural empyema and lung abscess);

1. Infectious diseases of the urinary system (pyelonephritis, cystitis, urethritis);

1. Infectious diseases of soft tissues (furuncle, carbuncle, abscess).

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

Contraindications

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

Contraindications for admission are as follows:

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

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

Method of application and dosage

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

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

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

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

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

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

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

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

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

Basic Rules:

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

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