Amoxiclav (amoxicillin) Quicktab tablets 500 mg/125 mg. №20

Amoxiclav (amoxicillin) Quicktab tablets 500 mg/125 mg. №20

$26.40

Manufacturer: Slovenia

Treatment of bacterial infections caused by microorganisms sensitive to Amoxiclav (amoxicillin), such as:

  • acute bacterial sinusitis (confirmed);
  • acute otitis media;
  • confirmed exacerbation of chronic bronchitis;
  • nosocomial pneumonia;
  • cystitis;
  • pyelonephritis;
  • skin and soft tissue infections, including cellulitis, animal bites, severe dentoalveolar abscesses with widespread cellulitis;
  • infections of bones and joints, including osteomyelitis
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Description

Amoxiclav (amoxicillin) Quicktab tablets 500mg/125mg No. 20 – Instructions for use

Ingredients

active substances : amoxicillin, clavulanic acid;

1 tablet contains 500 mg of amoxicillin in the form of amoxicillin trihydrate and 125 mg of clavulanic acid in the form of a potassium salt;

excipients: aspartame (E 951), silicon dioxide colloidal anhydrous, iron oxide yellow (E 172), “tropical mixture” flavoring, sweet orange flavoring, talc, hydrogenated castor oil, microcrystalline silicate cellulose.

Medicinal form

Dispersible tablets.

Main physico-chemical properties: yellow-brown speckled octagonal tablets with an aromatic smell.

Pharmacotherapeutic group

Antibacterial agents for systemic use. Beta-lactam antibiotics, penicillins. Combinations of penicillins with beta-lactamase inhibitors. ATX code J01C R02.

Pharmacodynamics

Mechanism of action

Amoxicillin is a semi-synthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often called penicillin-binding proteins, PZB) in the process of biosynthetic metabolism of bacterial peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, resulting in cell lysis and death.

Amoxicillin is susceptible to cleavage by beta-lactamases produced by resistant bacteria, therefore, the spectrum of activity of amoxicillin as monotherapy does not include organisms that produce these enzymes.

Clavulanic acid is a beta-lactam structurally related to penicillins. It deactivates some beta-lactamase enzymes, thereby preventing the inactivation of amoxicillin. Clavulanic acid in the form of monotherapy does not show a clinically useful antibacterial effect.

FK/FD ratio

The time exceeding the minimum inhibitory concentration (M>MIC) is considered the main factor that determines the effectiveness of amoxicillin.

Mechanisms of resistance

There are two mechanisms of resistance to amoxicillin/clavulanic acid:

  • inactivation by bacterial beta-lactamases that are not themselves inhibited by clavulanic acid, including class B, C and D;
  • conversion of PZB, which reduces the affinity of the antibacterial drug to the target.

Bacterial impermeability or the reflux pump mechanism can cause or contribute to bacterial resistance, particularly in gram-negative bacteria.

Limit values

MIC breakpoints for amoxicillin/clavulanic acid established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST)

Microorganisms Limit values ​​of sensitivity (μg/ml)
  sensitive Moderately sensitive Resistant
Haemophilus influenzae 1 ≤1 – > 1
Moraxella catarrhalis 1 ≤1 – > 1
Staphylococcus aureus 2 ≤2 – >2
Coagulase-negative staphylococci 2 ≤ 0.25   > 0.25
Enterococcus 1 ≤4 8 > 8
Streptococcus A, B, C, G 5 ≤ 0.25 – > 0.25
Streptococcus pneumoniae 3 ≤ 0.5 1–2 >2
Enterobacteria 1, 4 – – > 8
Gram-negative anaerobic bacteria 1 ≤4 8 > 8
Gram-positive anaerobic bacteria 1 ≤4 8 > 8
Limit values ​​that do not apply to individual species 1 ≤2 4–8 > 8
1 Reported values ​​for amoxicillin concentrations. For sensitivity testing, the concentration of clavulanic acid was set at 2 mg/l.

2 Reported values ​​for oxacillin concentrations.

3 The limit values ​​given in the table are calculated from the limit values ​​for ampicillin.

4 The limit value of resistance R>8 mg/l means that all strains with resistance mechanisms are declared resistant.

5 The limit values ​​given in the table are calculated from the limit values ​​for benzylpenicillin.

The prevalence of resistance may vary geographically and over time for individual species, so local susceptibility information is desirable, especially when treating severe infections. If necessary, an expert opinion is required if the local prevalence of resistance is such that the benefit of the drug, at least in some types of infections, is questionable.

Usually sensitive species
Gram-positive aerobes : Enterococcus faecalis, Gardnerella vaginalis, Staphylococcus aureus

(sensitive to methicillin) £ , Coagulase – negative staphylococci (sensitive to methicillin), Streptococcus agalactiae, Streptococcus pneumoniae 1 , Streptococcus pyogenes and other beta-hemolytic streptococci, Streptococcus viridans group.

Gram-negative aerobes : Capnocytophaga spp., Eikenella corrodens, Haemophilus influenzae 2 , Moraxella catarrhalis, Pasteurella multi ocida .

Anaerobes : Bacteroides fragilis, Fusobacterium nucleatum, Prevotella spp.
Species for which the acquisition of resistance may be a problem
Gram-positive aerobes: Enterococcus faecium $ .

Gram-negative aerobes : Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris.
Naturally resistant microorganisms
Gram-negative aerobes : Acinetobacter sp., Citrobacter freundii, Enterobacter sp., Legionella pneumophila, Morganella morganii, Providencia spp., Pseudomonas sp., Serratia sp., Stenotrophomonas maltophilia.

Other microorganisms:

Chlamydophila pneumoniae, Chlamydophila psittaci, Coxiella burnetti, Mycoplasma pneumoniae
$ Natural moderate sensitivity in the absence of an acquired resistance mechanism.

£ All staphylococci resistant to methicillin are resistant to amoxicillin/clavulanic acid.

1 Penicillin-resistant Streptococcus pneumoniae should not be treated with this formulation of amoxicillin/clavulanic acid (.

2 Strains with reduced sensitivity have been registered in some EU countries with a frequency higher than 10%.

Indications

Treatment of bacterial infections caused by microorganisms sensitive to Amoxiclav (amoxicillin), such as:

  • acute bacterial sinusitis (confirmed);
  • acute otitis media;
  • confirmed exacerbation of chronic bronchitis;
  • nosocomial pneumonia;
  • cystitis;
  • pyelonephritis;
  • skin and soft tissue infections, including cellulitis, animal bites, severe dentoalveolar abscesses with widespread cellulitis;
  • infections of bones and joints, including osteomyelitis

Contraindications

Hypersensitivity to amoxicillin, clavulanic acid or other components of the drug; allergic reactions in history to any antibiotic of the penicillin series, infectious mononucleosis and lymphocytic leukemia.

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

Amoxiclav (amoxicillin) Quicktab should be used in accordance with the official recommendations on antibiotic therapy and data on local sensitivity to the antibiotic. Susceptibility to amoxicillin/clavulanate varies between regions and may change over time. If necessary, local susceptibility data should be consulted and microbiological determination and susceptibility testing should be performed if necessary.

The range of suggested doses depends on the expected pathogens and their sensitivity to antibacterial drugs, the severity of the disease and the location of the infection, the patient’s age, body weight and kidney function.

Adults and children with body weight ≥ 40 kg. 1 tablet 3 times a day (the daily dose is 1500 mg of amoxicillin/375 mg of clavulanic acid).

Children aged 6 years and over with a body weight of 25 to 40 kg.

The dose is from 20 mg/5 mg/kg of body weight/day to 60 mg/15 mg/kg of body weight/day, divided into 3 doses. The maximum daily dose is 2400 mg of amoxicillin/600 mg of clavulanic acid (4 tablets).

Since the tablet cannot be split, children weighing less than 25 kg should not be given this dosage form.

Elderly patients. Dose correction is not required. If necessary, adjust the dose depending on kidney function.

Impaired kidney function. The dosage is based on the calculation of the maximum level of amoxicillin. With creatinine clearance > 30 ml/min, no dosage change is required.

Adults and children with body weight ≥ 40 kg.

Creatinine clearance 10-30 ml/min 1 tablet of 500 mg/125 mg 2 times a day
Creatinine clearance < 10 ml/min 1 tablet of 500 mg/125 mg once a day
Hemodialysis 1 tablet of 500 mg/125 mg every 24 hours plus 1 tablet of 500 mg/125 mg during dialysis (taking into account the reduction in serum concentrations of amoxicillin and clavulanic acid)

Children aged 6 years and over with a body weight of 25 to 40 kg. Since the tablet cannot be divided, children aged 6 years and older with a body weight of 25 to 40 kg, creatinine clearance less than 30 ml/min or children on hemodialysis should not be prescribed this dosage form.

Violation of liver function. Apply carefully; liver function should be monitored at regular intervals.

For optimal absorption and reduction of possible side effects from the digestive tract, Amoxiclav (amoxicillin) Quicktab should be taken at the beginning of a meal. Amoxiclav (amoxicillin) Quicktab tablet should be dissolved in ½ glass of water (at least 100 ml), thoroughly mixed before taking or chewed before swallowing.

The duration of treatment with Amoxiclav (amoxicillin) Quicktab is determined individually and should not exceed 14 days without an assessment of the patient’s condition. The duration of treatment is determined by the patient’s clinical response to treatment. Some infections (for example, osteomyelitis) require longer treatment.

If higher doses of amoxicillin are required for treatment, dosage forms with a different amoxicillin/clavulanic acid ratio should be used to avoid prescribing excessively high doses of clavulanic acid.

Treatment can be started with parenteral administration, and then continue with oral administration.

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