Amoxiclav (amoxicillin) powder oral suspension 400 mg/57 mg. 5 ml. 17.5 70 ml.

Amoxiclav (amoxicillin) powder oral suspension 400 mg/57 mg. 5 ml. 17.5 70 ml.

$29.20

Manufacturer: Slovenia

Category:

Description

Ingredients

active substances: amoxicillin, clavulanic acid;

5 ml of oral suspension contain 400 mg of amoxicillin (in the form of amoxicillin trihydrate) and 57 mg of clavulanic acid (in the form of potassium clavulanate);

auxiliary substances: anhydrous citric acid, anhydrous sodium citrate, microcrystalline cellulose and carmellose sodium, xanthan gum, colloidal anhydrous silicon dioxide, silicon dioxide, wild cherry flavoring, lemon flavoring, sodium saccharin, mannitol (E 421).

Medicinal form

Powder for oral suspension.

Basic physical and chemical properties : white to yellowish- white crystalline powder .

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 have 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 midtocida.

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 (see Dosage and Administration

and “Application features”).

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

Indications

Treatment in adults and children of bacterial infections caused by microorganisms sensitive to Amoxiclav ®  2S, 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;
  • bone and joint infections, including osteomyelitis.

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

Contraindications

  • Hypersensitivity to any components of the drug, to any antibacterial agents of the penicillin group.
  • 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/clavulanic acid.

Dosage and Administration

The dosage is expressed in terms of amoxicillin/clavulanic acid content, except when the dosage is expressed in terms of a separate component.

When prescribing the dosage of Amoxiclav (amoxicillin) powder for oral suspension for the treatment of a separate infection, the following should be taken into account:

  • probable causative agents of the disease and their probable sensitivity to antibacterial drugs;
  • degree of severity and site of infection;
  • age, body weight, and renal function of the patient as indicated below.

If necessary, the possibility of using alternative forms of release of Amoxiclav (amoxicillin) powder for oral suspension  (that is, those containing higher doses of amoxicillin and/or other ratios of amoxicillin and clavulanic acid) should be considered.

The drug is intended for use by children with a body weight < 40 kg.

For children with a body weight < 40 kg, Amoxiclav (amoxicillin) powder for oral suspension provides a maximum daily dose of 1000–2800 mg of amoxicillin/ 143–400 mg of clavulanic acid, subject to the following dosage recommendations. If an increased daily dose of amoxicillin is required to prevent the introduction of too high daily doses of clavulanic acid, it is recommended to choose another dosage form of the drug Amoxiclav.

The duration of treatment should be determined individually for each patient. Some infections (for example, osteomyelitis) require longer treatment. Treatment should not last more than 14 days without revision.

Children with body weight < 40 kg

Recommended doses:

  • from 25 mg/3.6 mg/kg/day to 45 mg/6.4 mg/kg/day, divided into two doses;
  • for the treatment of some infections (such as otitis media, sinusitis and infections of the lower respiratory tract), children from 2 years of age can use a dose of up to 70 mg/10 mg/kg/day divided into two doses.

There are no clinical data on dosage forms of Amoxiclav 7:1 for doses higher than 45 mg/6.4 mg/kg/day for patients under 2 years of age.

There are no clinical data on dosage forms of Amoxiclav 7:1 for patients under 2 months of age. Thus, there are no dosage recommendations for this group of patients. Elderly patients

Dose correction is not required.

Impaired kidney function

No dose adjustment is required for patients with creatinine clearance (CR) > 30 mg/min.

Patients with CK < 30 mg/min are not recommended to use dosage forms of the drug Amoxiclav ® with a 7:1 ratio of amoxicillin to clavulanic acid, as there are no recommendations for dose correction.

Violation of liver function

Careful use and regular monitoring of liver function are recommended.

Application method

Amoxiclav (amoxicillin) powder for oral suspension is intended for oral use.

The drug should be given before meals to minimize possible gastrointestinal intolerance and to optimize the absorption of amoxicillin/clavulanic acid.

Therapy can be started parenterally, using the appropriate dosage form, and continued with Amoxiclav (amoxicillin) powder for oral suspension.

Instructions for preparing the suspension.

35 ml suspension Amoxiclav

Shake the powder bottle well. Add 29.5 ml of water in two portions (first 2/3, and then up to the mark), shaking the bottle well each time. It is good to shake the suspension bottle before each use.

70 ml suspension Amoxiclav ®  2S

Shake the powder bottle well. Add 59 ml of water in two portions (first 2/3, and then up to the mark), shaking the bottle well each time. It is good to shake the suspension bottle before each use.

Shake the bottle, add water as directed, invert the bottle and shake again. The vial should be shaken before each dose.

Children

Used for children aged 2 months and older. Children with a body weight of more than 40 kg are prescribed the drug in a different dosage form.

Expiration date

3 years.

Expiry date after dissolution / dilution.

7 days if stored in the original packaging at a temperature of 2-8 ºС.

Storage conditions

Store at a temperature not higher than 25 ºС. Store in original packaging. Keep out of the reach of children.

Packaging

Bottle with screw cap of 8.75 g (35 ml) or 17.5 g (70 ml) and a dispensing pipette consisting of a piston and a barrel, in a cardboard box.

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