Amoxiclav 400mg+57mg/5ml 17.5g 70ml powder for oral suspension

Amoxiclav 400mg+57mg/5ml 17.5g 70ml powder for oral suspension

pharmachologic effect

Antibiotic - semi-synthetic penicillin + beta-lactamase inhibitor.

Composition and release form Amoxiclav 400 mg + 57 mg/5 ml 17.5 g 70 ml powder for the preparation of suspension for oral administration

Powder for the preparation of a suspension for oral administration - 5 ml of suspension:

• active ingredients: amoxicillin (in the form of trihydrate) - 400 mg; clavulanic acid (in the form of potassium salt) - 57 mg;
• excipients: citric acid (anhydrous) - 2.694 mg; sodium citrate (anhydrous) - 8.335 mg; MCC and carmellose sodium - 28.1 mg; xanthan gum - 10 mg; colloidal silicon dioxide - 16.667 mg; silicon dioxide - 0.217 g; wild cherry flavor - 4 mg; lemon flavoring - 4 mg; sodium saccharinate - 5.5 mg; mannitol - up to 1250 mg.

Powder for the preparation of suspension for oral administration, 400 mg + 57 mg/5 ml. Primary packaging - 8.75 g (35 ml of ready-made suspension), 12.50 g (50 ml of ready-made suspension), 17.50 g (70 ml of ready-made suspension) or 35.0 g (140 ml of ready-made suspension) powder in a bottle dark glass with a screw cap made of HDPE with a control ring and a gasket inside the cap. Or 17.5 g (70 ml of ready-made suspension) in a dark glass bottle with a ring mark (70 ml) with a HDPE screw cap with a control ring and a gasket inside the cap.

Secondary packaging - 1 fl. together with a graduated dosage pipette in a cardboard box.

Description of the dosage form

Powder for oral suspension: white to yellowish-white powder. The finished suspension is an almost white to yellow homogeneous suspension.

Directions for use and doses

Inside

The daily dose of suspensions is 125+31.25 mg/5 ml and 250+62.5 mg/5 ml (to facilitate correct dosing, a dosage pipette is inserted into each package of suspensions 125+31.25 mg/5 ml and 250+62.5 mg/5 ml, graduated at 5 ml, with a scale of division of 0.1 ml or a dosing spoon with a capacity of 5 ml, with ring marks in the cavity at 2.5 and 5 ml).

Newborns and children up to 3 months - 30 mg/kg/day (for amoxicillin), divided into 2 doses (every 12 hours).

Dosing of the drug Amoxiclav® with a dosing pipette - calculation of single doses for the treatment of infections in newborns and children up to 3 months (Table 3).

Table 3

Children over 3 months - from 20 mg/kg for mild and moderate infections to 40 mg/kg for severe infections and lower respiratory tract infections, otitis media, sinusitis (amoxicillin) per day, divided into 3 doses (every 8 h).

Dosing of the drug Amoxiclav® with a dosing pipette - calculation of single doses for the treatment of mild and moderate infections in children over 3 months (at the rate of 20 mg/kg/day (for amoxicillin) (Table 4).

Table 4

Dosing of the drug Amoxiclav® with a dosing pipette - calculation of single doses for the treatment of severe infections in children over 3 months (at the rate of 40 mg/kg/day (for amoxicillin) (Table 5).

Table 5

Dosing of the drug Amoxiclav® with a dosing spoon (in the absence of a dosing pipette) - recommended doses of suspensions depending on the child’s body weight and the severity of the infection (Table 6).

Table 6

Daily dose of suspension 400 mg+57 mg/5 ml

The dose is calculated per kg of body weight depending on the severity of the infection. From 25 mg/kg - for mild and moderate infections to 45 mg/kg - for severe infections and lower respiratory tract infections, otitis media, sinusitis (in terms of amoxicillin) per day, divided into 2 doses.

To facilitate correct dosing, a dosage pipette is inserted into each package of the 400 mg + 57 mg/5 ml suspension, graduated simultaneously into 1, 2, 3, 4, 5 ml and into 4 equal parts.

Suspension 400 mg+57 mg/5 ml is used in children over 3 months.

Table 7

Recommended dose of suspension depending on the child’s body weight and severity of infection

Exact daily doses are calculated based on the child's body weight, not his age.

The maximum daily dose of amoxicillin is 6 g for adults and 45 mg/kg for children.

The maximum daily dose of clavulanic acid (in the form of potassium salt) is 600 mg for adults and 10 mg/kg for children.

In patients with impaired renal function, the dose should be adjusted based on the maximum recommended dose of amoxicillin.

Patients with creatinine Cl >30 ml/min do not require any dose adjustment.

Adults and children weighing more than 40 kg (the indicated dosage regimen is used for moderate and severe infections)

For patients with creatinine Cl 10-30 ml/min - 500/125 mg 2 times a day.

With Cl creatinine

For patients on hemodialysis, the recommended dose is 500/125 mg every 24 hours, plus 500/125 mg during dialysis and another dose at the end of dialysis (since serum concentrations of amoxicillin and clavulanic acid are reduced).

Children weighing less than 40 kg

With creatinine Cl 10–30 ml/min, the recommended dose is 15/3.75 mg/kg 2 times a day (maximum 500/125 mg 2 times a day).

With Cl creatinine

For hemodialysis, the recommended dose is 15/3.75 mg/kg once a day. Before hemodialysis - 15/3.75 mg/kg. To restore appropriate concentrations of the drug in the blood, it is necessary to take another dose of 15/3.75 mg/kg after hemodialysis.

The course of treatment is 5–14 days. The duration of treatment is determined by the attending physician. Treatment should not continue for more than 14 days without repeated medical examination.

Pharmacodynamics

Mechanism of action

Amoxicillin is a semisynthetic broad-spectrum antibiotic that is active against many gram-positive and gram-negative microorganisms. At the same time, amoxicillin is susceptible to destruction by beta-lactamases, and therefore the spectrum of activity of amoxicillin does not extend to microorganisms that produce this enzyme.

Clavulanic acid is a beta-lactamase inhibitor, structurally related to penicillins, and has the ability to inactivate a wide range of beta-lactamases found in microorganisms resistant to penicillins and cephalosporins. Clavulanic acid is sufficiently effective against plasmid beta-lactamases, which most often cause bacterial resistance, and is not effective against type I chromosomal beta-lactamases, which are not inhibited by clavulanic acid.

The presence of clavulanic acid in the drug protects amoxicillin from destruction by enzymes - beta-lactamases, which expands the antibacterial spectrum of amoxicillin.

Below is the activity of the combination of amoxicillin and clavulanic acid in vitro.

Grampore-positive aerobes: Bacillus Anthracis, Enterococcus Faecalis, Listeria MonocyTogenes, NoCardia Asteroides, Streptococcus Pyogenes1,2, Streptococcus Agalactiae1,2, other beta-heemolytic statococci1, 2, Staphylococcus aureus (sensitive to methicillin) 1, Staphylococcus saprophyticus (sensitive to methicillin), coagulase-negative staphylococci (sensitive to methicillin).

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

Other: Borrelia burgdorferi, Leptospira icterohaemorrhagiae, Treponema pallidum.

Gram-positive anaerobes: species of the genus Clostridium, Peptococcus niger, Peptostrepiococcus magnus, Peptostreptococcus micros, species of the genus Pepto streptococcus.

Gram-negative anaerobes: Bcicteroides fragilis, species of the genus Bacteroides, species of the genus Capnocytophaga, Eikenella corrodens, Fusobacterium nucleatum, species of the genus Fusobacterium, species of the genus Porphyromonas, species of the genus Prevotella.

Bacteria for which acquired resistance to the combination of amoxicillin and clavulanic acid is likely

Gram-negative aerobes: Escherichia coli1, Klebsiella oxytoca, Klebsiella pneumoniae, species of the genus Klebsiella, Proteus mirabilis, Proteus vulgaris, species of the genus Proteus, species of the genus Salmonella, species of the genus Shigella. Streptococcus pneumoniae1,2, streptococci of the Viridans group.

Gram-positive aerobes: species of the genus Corynebacterium, Enterococcus faecium.

Bacteria that are naturally resistant to the combination of amoxicillin and clavulanic acid

Gram-negative aerobes: species of the genus Acinetobacter, Citrobacter freundii, species of the genus Enterobacter, Hafhia alvei, Legionella pneumophila, Morganella morganii, species of the genus Providencia, species of the genus Pseudomonas, species of the genus Serratia, Stenotrophomonas maltophilia, Yersinia enterocolitica.

Other: Chlamydia pneumoniae, Chlamydia psittaci, species of the genus Chlamydia, Coxiella burnetii, species of the genus Mycoplasma.

1For these bacteria, the clinical effectiveness of the combination of amoxicillin with clavulanic acid has been demonstrated in clinical studies.

2 strains of these types of bacteria do not produce beta-lactamases. Sensitivity during amoxicillin monotherapy suggests similar sensitivity to the combination of amoxicillin and clavulanic acid.

Pharmacokinetics

Suction

The active ingredients of the drug are quickly and completely absorbed from the gastrointestinal tract (GIT) after oral administration. Absorption of active ingredients is optimal when the drug is used with food.

The following are the pharmacokinetic parameters of amoxicillin and clavulanic acid after administration at a dose of 45 mg/6.4 mg/kg, divided into two doses, by patients under 12 years of age.

Average value of pharmacokinetic parameters

• Cmax - maximum concentration in blood plasma;
• Tmax is the time to reach the maximum concentration in the blood plasma;
• AUC—area under the concentration-time curve;
• T1/2 - half-life.

Metabolism

About 10-25% of the initial dose of amoxicillin is excreted by the kidneys in the form of an inactive metabolite (penicillic acid). Clavulanic acid in the human body undergoes intensive metabolism with the formation of 2,5-dihydro-4-(2-hydroxyethyl)-5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-butan-2-one and is excreted by the kidneys, through the gastrointestinal tract, and also with exhaled air in the form of carbon dioxide.

Distribution

As with intravenous administration of a combination of amoxicillin and clavulanic acid, therapeutic concentrations of amoxicillin and clavulanic acid are found in various tissues and interstitial fluid (gallbladder, abdominal tissue, skin, adipose and muscle tissue, synovial and peritoneal fluids, bile, purulent discharge) .

Amoxicillin and clavulanic acid have a weak degree of binding to plasma proteins. Studies have shown that about 25% of the total amount of clavulanic acid and 18% of amoxicillin in the blood plasma is bound to plasma proteins.

The volume of distribution is approximately 0.3-0.4 L/kg for amoxicillin and approximately 0.2 L/kg for clavulanic acid. Amoxicillin and clavulanic acid do not penetrate the blood-brain barrier when the meninges are not inflamed. Amoxicillin (like most penicillins) is excreted in breast milk.

Trace amounts of clavulanic acid may also be found in breast milk. With the exception of the possibility of sensitization, diarrhea and candidiasis of the oral mucosa, there are no other known negative effects of amoxicillin and clavulanic acid on the health of breastfed infants.

Animal reproductive studies have shown that amoxicillin and clavulanic acid cross the placental barrier. However, no negative effects on the fetus were detected.

Removal

Amoxicillin is eliminated primarily by the kidneys, while clavulanic acid is eliminated through both renal and extrarenal mechanisms. After a single oral dose of 875 mg/125 mg or 500 mg/125 mg, approximately 60-70% of amoxicillin and 40-65% of clavulanic acid are excreted unchanged by the kidneys during the first 6 hours. The average half-life (T1/2) of amoxicillin/clavulanic acid is approximately 1 hour, and the average total clearance is approximately 25 L/h in healthy patients. In various studies, it was found that amoxicillin excretion by the kidneys within 24 hours is approximately 50-85%, clavulanic acid - 27-60%. The largest amount of clavulanic acid is excreted during the first 2 hours after administration.

The pharmacokinetics of amoxicillin/clavulanic acid does not depend on the gender of the patient.

Patients with impaired renal function

The total clearance of amoxicillin/clavulanic acid decreases in proportion to the decrease in renal function. The decrease in clearance is more pronounced for amoxicillin than for clavulanic acid, because Most amoxicillin is excreted by the kidneys. Doses of the drug for renal failure should be selected taking into account the undesirability of amoxicillin accumulation while maintaining normal levels of clavulanic acid.

Patients with liver dysfunction

In patients with impaired liver function, the drug is used with caution. It is necessary to constantly monitor liver function.

Both components are removed by hemodialysis and minor amounts by peritoneal dialysis.

Indications for use Amoxiclav 400mg+57mg/5ml 17.5g 70ml powder for the preparation of suspension for oral administration

Infections caused by sensitive strains of microorganisms:

• upper respiratory tract and ENT organs (including acute and chronic sinusitis, acute and chronic otitis media, retropharyngeal abscess, tonsillitis, pharyngitis);
• lower respiratory tract (including acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia);
• urinary tract (eg cystitis, urethritis, pyelonephritis);
• in gynecology;
• skin and soft tissues, including human and animal bites;
• bone and connective tissue;
• biliary tract (cholecystitis, cholangitis);
• odontogenic.

Contraindications

• hypersensitivity to the components of the drug;
• history of hypersensitivity to penicillins, cephalosporins and other beta-lactam antibiotics;
• history of cholestatic jaundice and/or other liver dysfunction caused by taking amoxicillin/clavulanic acid;
• infectious mononucleosis and lymphocytic leukemia;

With caution: history of pseudomembranous colitis, gastrointestinal diseases, liver failure, severe renal impairment, pregnancy, lactation, simultaneous use with anticoagulants.

Application Amoxiclav 400mg+57mg/5ml 17.5g 70ml powder for the preparation of suspension for oral administration during pregnancy and breastfeeding

During pregnancy and lactation, Amoxiclav® is used only if the expected benefit to the mother outweighs the potential risk to the fetus and child.

Amoxicillin and clavulanic acid pass into breast milk in small quantities.

special instructions

During a course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver, and kidneys.

In patients with severe renal impairment, adequate dose adjustment or increased intervals between doses is required.

It is possible that superinfection may develop due to the growth of microflora that is insensitive to it, which requires a corresponding change in antibacterial therapy.

In patients who are hypersensitive to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible.

In women with premature rupture of membranes, it was found that prophylactic therapy with amoxicillin + clavulanic acid may be associated with an increased risk of developing necrotizing colitis in the newborn.

Crystalluria very rarely occurs in patients with reduced diuresis. During the use of large doses of amoxicillin, it is recommended to take sufficient fluids and maintain adequate diuresis to reduce the likelihood of amoxicillin crystal formation.

Lab tests. High concentrations of amoxicillin give a false-positive reaction to urine glucose when using Benedict's reagent or Fehling's solution. It is recommended to use enzymatic reactions with glucosidase.

Impact on the ability to drive a car or perform work that requires increased speed of physical and mental reactions. Due to the possibility of developing side effects from the central nervous system, such as dizziness, headache, convulsions, during treatment, care should be taken when driving and other activities that require concentration and speed of psychomotor reactions.

Overdose

There are no reports of death or life-threatening side effects due to drug overdose.

Symptoms: in most cases - gastrointestinal disorders (abdominal pain, diarrhea, vomiting), anxiety, insomnia, dizziness are also possible, and in isolated cases - seizures.

Treatment: in case of overdose, the patient should be under medical supervision, treatment should be symptomatic.

In case of recent use (less than 4 hours) of the drug, it is necessary to perform gastric lavage and prescribe activated charcoal to reduce absorption. Amoxicillin/potassium clavulanate is removed by hemodialysis.

Side effects Amoxiclav 400mg+57mg/5ml 17.5g 70ml powder for suspension for oral administration

From the digestive system: loss of appetite, nausea, vomiting, diarrhea, abdominal pain, gastritis, stomatitis, glossitis, black “hairy” tongue, darkening of tooth enamel, hemorrhagic colitis (can also develop after therapy), enterocolitis, pseudomembranous colitis, disorder liver function, increased activity of ALT, AST, alkaline phosphatase and/or bilirubin levels in the blood plasma, liver failure (more often in the elderly, men, with long-term therapy), cholestatic jaundice, hepatitis.

Allergic reactions: itching, urticaria, erythematous rashes, erythema multiforme exudative, angioedema, anaphylactic shock, allergic vasculitis, exfoliative dermatitis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, a syndrome similar to serum sickness, toxic epidermal necrolysis.

From the hematopoietic system and lymphatic system: reversible leukopenia (including neutropenia), thrombocytopenia, hemolytic anemia, reversible increase in PT (when used together with anticoagulants), reversible increase in bleeding time, eosinophilia, pancytopenia, thrombocytosis, agranulocytosis.

From the central nervous system: dizziness, headache, convulsions (may occur in patients with impaired renal function when taking high doses of the drug).

From the urinary system: interstitial nephritis, crystalluria, hematuria.

Other: candidiasis and other types of superinfection.

From the side of the central nervous system: hyperactivity. Feelings of anxiety, insomnia, behavior changes, agitation.

Drug interactions

Antacids, glucosamine, laxatives, aminoglycosides slow down absorption, ascorbic acid increases absorption.

Diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion (probenecid) increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).

The simultaneous use of Amoxiclav® and methotrexate increases the toxicity of methotrexate.

Prescription together with allopurinol increases the incidence of exanthema. Concomitant use with disulfiram should be avoided.

Reduces the effectiveness of drugs, during the metabolism of which PABA is formed; ethinyl estradiol - risk of breakthrough bleeding.

The literature describes rare cases of increased INR in patients with the combined use of acenocoumarol or warfarin and amoxicillin. If simultaneous use with anticoagulants is necessary, PT or INR should be carefully monitored when prescribing or discontinuing the drug.

The combination with rifampicin is antagonistic (mutual weakening of the antibacterial effect). The drug Amoxiclav® should not be used simultaneously in combination with bacteriostatic antibiotics (macrolides, tetracyclines), sulfonamides due to a possible decrease in the effectiveness of the drug Amoxiclav®.

The drug Amoxiclav® reduces the effectiveness of oral contraceptives.

The drug Amoxiclav® and aminoglycoside antibiotics are chemically incompatible.

Amoxiclav® should not be mixed in a syringe or infusion bottle with other drugs.

Avoid mixing with solutions of dextrose, dextran, sodium bicarbonate, as well as with solutions containing blood, proteins, lipids.

Dosage

To reduce possible side effects from the digestive tract, Amoxiclav 400 mg + 57 mg suspension should be taken with food. Before use, check the integrity of the cap, shake the bottle so that the powder separates from the walls, add drinking water in two portions (first 2/3 of the bottle, then up to the circular mark on the bottle), shaking the bottle. Shake well before each use.

The dosage of Amoxiclav suspension 400 mg + 57 mg/5 ml for children is set individually depending on age, body weight, kidney function, and severity of infection.

The daily dose of Amoxiclav suspension 400 mg + 57 mg/5 ml is calculated per kilogram of body weight, taking into account the severity of the disease. From 25 mg/kg for mild and moderate infections to 45 mg/kg for severe infections and lower respiratory tract infections, otitis media, sinusitis, divided into 2 doses.

Amoxiclav suspension 400 mg+57 mg/5 ml is used in children over 3 months.

Use during pregnancy and breastfeeding

The use of Amoxiclav 400 mg + 57 mg may be associated with an increased risk of developing necrotizing enterocolitis in newborns. The use of Amoxiclav should be avoided during pregnancy, especially in the first trimester, unless the benefits of use outweigh the potential risks.

The active components of Amoxiclav 400 mg + 57 mg pass into breast milk, the baby may experience diarrhea, as well as fungal infection of the mucous membranes. Use during breastfeeding is only possible after a thorough risk assessment.

Possible side effects

In children, the described side effects are extremely rare. Liquid Amoxiclav 400 mg + 57 mg is well tolerated by children, sometimes children experience stomach upset or skin reactions that go away after stopping the antibiotic.

From the digestive system:

• loss of appetite, nausea, vomiting, diarrhea;
• rarely - stomach pain, liver dysfunction, increased activity of liver enzymes (ALT or AST);
• cholestatic jaundice, hepatitis, pseudomembranous colitis.

Allergic reactions:

• itching, urticaria, erythematous rash;
• rarely - exudative erythema multiforme, angioedema, anaphylactic shock, allergic vasculitis;
• rarely - exfoliative dermatitis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis.

From the hematopoietic system, lymphatic system:

• rarely - reversible leukopenia (including neutropenia), thrombocytopenia;
• very rarely - hemolytic anemia, reversible increase in prothrombin time (when used together with anticoagulants), eosinophilia, pancytopenia.

From the nervous system:

• dizziness, headache;
• very rarely - convulsions (may occur in patients with impaired renal function when taking high doses of Amoxiclav 400 mg + 57 mg), hyperactivity, anxiety, insomnia.

From the urinary system:

• very rarely - interstitial nephritis, crystalluria.

Other:

• rarely - development of superinfection, candidiasis.

Analogs

Analogs of the Amoxiclav 400 mg + 57 mg suspension contain a combination of amoxicillin/clavulanic acid. Preparations with one of the components do not have a wide spectrum of action of the drug. An absolute analogue is Augmentin.

Cheap analogues with the same active ingredient:

1. Amoxicillin;
2. Amosin;

Substitutes with a similar effect, but a different active ingredient:

1. Azithromycin;
2. Flemoxin Solutab;
3. Sumamed;
4. Suprax;

Prices

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Use in children

The use of Amoxiclav 400 mg + 57 mg is possible according to indications in compliance with the dosage regimen.

The bottle with the powder must be shaken vigorously, water must be added in two additions (up to the mark) to achieve complete dissolution of the powder.

The suspension should be shaken well before use.

To prepare the suspension, the powder is diluted with boiled water at room temperature.

The prepared suspension of Amoxiclav 400 mg + 57 mg is stored in the refrigerator.

It is not recommended to heat the drug before use; room temperature is sufficient.

After administration, the dosing pipette is washed with boiled water.

Features of use

Before starting therapy with Amoxiclav 457 mg in suspension, it is necessary to accurately determine the presence of a history of hypersensitivity reactions to penicillins, cephalosporins or other allergens. If allergic reactions occur, treatment should be discontinued.

If the infection is proven to be caused by microorganisms sensitive to amoxicillin, the possibility of switching from the amoxicillin/clavulanic acid combination to amoxicillin should be considered according to official recommendations.

Amoxiclav 400 mg + 57 mg suspension should not be used in cases of high risk that pathogens are resistant to β-lactams, and is not used for the treatment of pneumonia caused by penicillin-resistant strains of S. pneumoniae.

Children with impaired renal function or those receiving high doses may experience seizures.

Amoxiclav 400 mg + 57 mg should not be prescribed if infectious mononucleosis is suspected, since cases of morbilliform rashes have been observed with the use of amoxicillin for this pathology.

Long-term use of the drug can cause excessive growth of insensitive microflora and the development of pseudomembranous colitis of varying severity. In the presence of severe persistent diarrhea after the use of antimicrobial agents, it is important to ensure that it is not associated with this pathology. Drugs that suppress peristalsis are contraindicated. If colitis occurs, treatment should be stopped immediately and consult a doctor.

With long-term use, superinfection with resistant bacteria and fungi (Pseudomonas spp, Candida albicans) may occur, which requires discontinuation of therapy.

During long-term therapy, it is recommended to periodically assess organ functions, including renal, hepatic, and hematopoietic functions.

Declaration of Conformity

Drug interactions

The simultaneous use of probenecid and Amoxiclav 400 mg + 57 mg is not recommended. Probenecid reduces renal tubular secretion of amoxicillin.

The use of allopurinol during treatment with amoxicillin may increase the likelihood of allergic reactions.

An antibiotic can affect intestinal flora.

The drug Amoxiclav 400 mg + 57 mgm should not be used together with bacteriostatic chemotherapeutic agents, antibiotics (chloramphenicol, macrolides, tetracyclines or sulfonamides).

The simultaneous use of Amoxiclav with methotrexate may increase the toxicity of the latter (leukopenia, thrombocytopenia, formation of skin ulcers).

Recommended dose depending on the child's body weight and severity of infection

The exact daily doses of Amoxiclav 400 mg + 57 mg are calculated based on the child’s body weight, not his age.