Augmentin ES (amoxicillin sodium) powder for suspension 100 ml. 600 mg/42.9 mg/5 ml.

Augmentin ES (amoxicillin sodium) powder for suspension 100 ml. 600 mg/42.9 mg/5 ml.

$35.30

Manufacturer: France

Augmentin ES (amoxicillin) is used for infections caused by penicillin-resistant strains of Streptococcus pneumoniae, such as acute otitis media, community-acquired pneumonia.

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Description

Ingredients

active ingredients : amoxicillin, clavulanic acid;

1 vial contains a powder for the preparation of 100 ml suspension of the following composition:

5 ml suspension contains amoxicillin (in the form of amoxicillin trihydrate) 600 mg of clavulanic acid (in the form of potassium clavulanate) 42.9 mg

excipients : colloidal silicon dioxide, sodium carboxymethylcellulose 12 aspartame (E 951), xanthan gum, silicon dioxide, artificial strawberry flavor.

Dosage form

Powder for oral suspension.

Basic physical and chemical properties : free-flowing white powder with a characteristic strawberry odor.

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 referred to as penicillin-binding proteins, PBPs) during the 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 sensitive to the breakdown of beta-lactamases produced by resistant bacteria, therefore, the spectrum of activity of amoxicillin as a monotherapy does not include microorganisms that produce these enzymes.

Clavulanic acid is a beta-lactam structurally related to penicillins. It disables some of the beta-lactamase enzymes, thereby preventing the inactivation of amoxicillin. Clavulanic acid alone does not provide a clinically useful antibacterial effect.

Fk / PD ratio

The retention time of a drug concentration in excess of the MIC (M > MIC) is considered to be the main determinant of efficacy for amoxicillin.

Mechanisms of resistance

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

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

Indications

Infections in children over 3 months of age weighing less than 40 kg caused or suspected to be caused by penicillin-resistant strains of Streptococcus pneumoniae, such as:

  • acute otitis media,
  • community-acquired pneumonia.

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/clavulanic acid.

Dosage and administration

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

When choosing the dosage of Augmentin for the treatment of a particular infection, the following should be considered:

  • probable causative agents of the disease and their possible sensitivity to antibacterial drugs (see Section “Peculiarities of use”);
  • the severity and location of the infection;
  • age, body weight, and renal function of the patient, as indicated below.

The course of treatment should not exceed 14 days without review (see Section “Peculiarities of use” regarding long-term therapy).

Adults and children weighing ≥ 40 kg

There is no experience with the use of Augmentin, suspension, in adults and children weighing ≥ 40 kg, so there are no recommendations regarding dosing for these patient groups.

Children aged 3 months and older weighing <40 kg

The recommended dose of Augmentin, suspension, is 90 / 6.4 mg / kg / day, in 2 divided doses.

Augmentin ES contains a different amount of clavulanic acid (in the form of a potassium salt) than any other form 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 kidney function. Patients with a creatinine clearance (CrCl) of more than 30 ml/min dose adjustment is not required.

For patients with creatinine clearance less than 30 ml / min, this form of Augmentin is not recommended for use, since there are no recommendations for dose adjustment.

Impaired liver function. Cautious use is recommended with regular monitoring of liver function (see sections “Contraindications” and “Peculiarities of use”).

Mode of application

Augmentin ES is for oral use.

The drug Should be taken with meals to minimize potential gastrointestinal intolerance.

Suspension instructions.

Before use, check the integrity of the seal on the lid. Shake the bottle to loosen the powder. Add the required amount of water (as indicated below), turn over and shake thoroughly. Another way: fill the bottle with water just below the mark on the label, turn over and shake thoroughly, then fill the bottle with water to the mark, turn it over and shake thoroughly again.

Dosage  Volume of water to be added for dissolution (ml) Final volume of dissolved oral suspension (ml)
600 mg/42.9 mg/5 ml  90 100

Shake the bottle thoroughly before each use.

Best before date

2 years. Prepared suspension – 10 days.

Storage conditions

Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Store the prepared suspension in a refrigerator at a temperature of 2 to 8 ° C and use within 10 days. Do not freeze.

Package

A glass bottle with an aluminum screw cap (contains a polymer (polyvinylchloride or polyolefin) film inside), with a first opening control or with a plastic cap with child protection and a plastic measuring spoon marked 2.5 ml and 5 ml, in a cardboard box.

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