$12.30
Manufacturer: Ukraine
Amoxicillin is a semi-synthetic antibiotic with a broad spectrum of antibacterial activity against many gram-positive and gram-negative microorganisms. Amoxicillin is sensitive to β-lactamase and undergoes disintegration under its influence, therefore the spectrum of activity of amoxicillin does not include microorganisms that synthesize this enzyme. Clavulanic acid has a β-lactam structure similar to penicillins, as well as the ability to inactivate β-lactamase enzymes characteristic of microorganisms that are resistant to penicillins and cephalosporins. In particular, it has pronounced activity against clinically important plasmid β-lactamases, which are often responsible for the emergence of cross-resistance to antibiotics.
Description
Ingredients
active substances: amoxicillin and clavulanic acid;
1 tablet contains amoxicillin (in the form of amoxicillin trihydrate) 875 mg, clavulanic acid (in the form of potassium clavulanate) 125 mg;
excipients: microcrystalline cellulose, sodium starch glycolate (type A), colloidal anhydrous silicon dioxide, magnesium stearate, coating mixture (contains: hydroxypropyl methylcellulose, titanium dioxide (E 171), copovidone, polydextrose, polyethylene glycols (macrogols), medium chain triglycerides).
Medicinal form
Film-coated tablets.
The main physical and chemical properties: tablets covered with a film shell, white or almost white with a yellowish tinge, oval-shaped with a biconvex surface, with a line on one side.
Pharmacotherapeutic group
Antimicrobial agents for systemic use. Beta-lactam antibiotics, penicillins. Combinations of penicillins with beta-lactamase inhibitors. Amoxicillin and an enzyme inhibitor. ATX code J01C R02.
Pharmacodynamics
Amoxicillin is a semi-synthetic antibiotic with a broad spectrum of antibacterial activity against many gram-positive and gram-negative microorganisms. Amoxicillin is sensitive to β-lactamase and undergoes disintegration under its influence, therefore the spectrum of activity of amoxicillin does not include microorganisms that synthesize this enzyme. Clavulanic acid has a β-lactam structure similar to penicillins, as well as the ability to inactivate β-lactamase enzymes characteristic of microorganisms that are resistant to penicillins and cephalosporins. In particular, it has pronounced activity against clinically important plasmid β-lactamases, which are often responsible for the emergence of cross-resistance to antibiotics.
The microorganisms listed below are classified according to susceptibility to amoxicillin/clavulanate in vitro.
Sensitive microorganisms.
Gram-positive aerobes: Bacillus anthracis, Enterococcus faecalis, Listeria monocytogenes, Nocardia asteroids, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus viridans, other β-hemolytic species of Streptococcus, Staphylococcus aureus (methicillin-sensitive strains), Staphylococcus saprophyticus (methicillin-sensitive strains), coagulase-negative staphylococci (methicillin-sensitive strains).
Gram-negative aerobes: Bordetella pertussis, Haemophilus influenza, Haemophilus parainfluenzae, Helicobacter pylori, Moraxella catarrhalis, Neisseria gonorrhoeae, Pasteurella multocida, Vibrio cholera.
Others: Borrelia burgdorferi, Leptospirosa icterohaemorrhagiae, Treponema pallidum.
Gram-positive anaerobes: Clostridium species, Peptococcus niger, Peptostreptococcus magnus, Peptostreptococcus micros, Peptostreptococcus species .
Gram-negative anaerobes: Bacteroides species (including Bacteroides fragilis), Capnocytophaga species, Eikenella corrodens, Fusobacterium species, Porphyromonas species, Prevotella species .
Strains that can acquire 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 of Corynebacterium, Enterococcus faecium.
Insensitive microorganisms.
Gram-negative aerobes: Acinetobacter species, Citrobacter freundii, Enterobacter species, Hafnia alvei, Legionella pneumophila, Morganella morganii , Providencia species, Pseudomonas species, Serratia species, Stenotrophomas maltophilia, Yesinia enterolitica.
Others: Chlamydia pneumonia, Chlamydia psittaci, Chlamydia species , Coxiella burnetti, Mycoplasma species .
Pharmacokinetics
Pharmacokinetic parameters of amoxicillin and clavulanic acid are similar. The peak concentration in blood serum of both components is reached approximately 1 hour after oral administration of the drug. The optimal level of absorption is achieved if the drug is taken at the beginning of a meal.
Doubling the dose of the drug “Amoxil-K 1000 (amoxicillin)” increases the level of the drug in blood serum by approximately two times.
Both components of the drug, clavulanate and amoxicillin, have a low level of binding to blood serum proteins, approximately 70% of them remain in the blood serum in an unbound state.
Indications
Treatment of bacterial infections in adults and children caused by microorganisms sensitive to the drug “Amoxil-K 1000 (amoxicillin)”, such as:
- acute bacterial sinusitis;
- 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.
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 β-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 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. Local susceptibility data should be consulted, if available, 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 age, body weight and kidney function of the patient.
For adults and children with a body weight ≥ 40 kg, the daily dose is 1750 mg of amoxicillin/ 250 mg of clavulanic acid (2 tablets), the daily dose is divided into 2 doses.
For children weighing < 40 kg, the maximum daily dose is 1000-2800 mg amoxicillin/ 143-400 mg clavulanic acid (see below for details).
If higher doses of amoxicillin are required for treatment, other forms of the drug should be used to avoid excessively high doses of clavulanic acid.
The duration of treatment is determined by the patient’s clinical response to treatment. Some infections (for example, osteomyelitis) require longer treatment.
Children with body weight < 40 kg
The dose is from 25 mg/3.6 mg/kg of body weight/day to 45 mg/6.4 mg/kg of body weight/day, divided into 2 doses.
Elderly patients
Dose adjustment is not required for elderly patients. If necessary, the dose is adjusted depending on kidney function.
Dosage in case of impaired liver function.
Use with caution, it is necessary to regularly monitor liver function. There are insufficient data for dosage recommendations.
Dosage in case of impaired kidney function
The drug “Amoxil-K 1000 (amoxicillin)” is prescribed only for the treatment of patients with a creatinine clearance of more than 30 ml/min. In renal failure with creatinine clearance less than 30 ml/min, the drug “Amoxil-K 1000 (amoxicillin)” is not used.
The tablet should be swallowed whole, without chewing. If necessary, the tablet can be broken in half and swallowed without chewing.
For optimal absorption and reduction of possible side effects from the digestive tract, the drug should be taken at the beginning of a meal.
The duration of treatment is determined individually. Treatment should not be continued for more than 14 days without assessment of the patient’s condition.
Treatment can be started with parenteral administration, and then switch to oral administration.
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