$9.50
Manufacturer: Ukraine
Treatment of bacterial infections caused by microorganisms sensitive to Amoxil-K, such as:
- severe throat, nose and ear infections (mastoiditis, peritonsillar infections, epiglottitis and sinusitis with accompanying severe systemic signs and symptoms);
- exacerbation of chronic bronchitis (after confirming the diagnosis);
- nosocomial pneumonia;
- cystitis;
- pyelonephritis;
- skin and soft tissue infections, including bacterial cellulitis, animal bites, severe dentoalveolar abscesses with widespread cellulitis;
- infections of bones and joints, including osteomyelitis;
- intra-abdominal infections;
- genital infections in women.
Prevention of bacterial infections during major surgical interventions in the following areas:
- gastrointestinal tract;
- pelvic organs;
- head and neck;
- bile ducts
Description
Ingredients
active substances: amoxicillin, clavulanic acid;
1 vial contains a sterile mixture (5:1) of amoxicillin sodium salt and clavulanate potassium salt in terms of amoxicillin 1.0 g and clavulanic acid 0.2 g.
Medicinal form
Powder for solution for injection.
Main physicochemical properties: white or almost white powder, hygroscopic.
Pharmacotherapeutic group
Antibacterial agents for systemic use. Combinations of penicillins, including with beta-lactamase inhibitors.
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 beta-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 beta-lactam structure similar to that of penicillins. In addition, it is able to inactivate beta-lactamase enzymes, which are part of microorganisms resistant to penicillins and cephalosporins. Clavulanic acid is active against clinically important plasmid beta-lactamases, which are often responsible for cross-resistance to antibiotics. The presence of clavulanic acid in Amoxyl-K protects amoxicillin from degradation under the action of beta-lactamase enzymes and extends the spectrum of antibacterial action of amoxicillin, including microorganisms that are generally resistant to amoxicillin and other penicillins and cephalosporins.
Thus, Amoxil-K exhibits the properties of a broad-spectrum antibiotic and beta-lactamase inhibitor. The drug has a bactericidal effect on a wide range of microorganisms, including:
gram-positive aerobes: Bacillus anthracis *, Corynebacterium species, Enterococcus faecalis*, Enterococcus faecium*, Listeria monocytogenes, Nocardia asteroides, Staphylococcus aureus*, coagulase-negative staphylococci (including Staphylococcus epidermidis), Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans species ;
Gram-positive anaerobes: Clostridium species , Peptococcus species, Peptostreptococcus species ;
gram-negative aerobes: Bordetella pertussis, Brucella species, Escherichia coli*, Gardnerella vaginalis, Haemophilus influenzae*, Helicobacter pylori, Klebsiella species * , Legionella species, Moraxella catarrhalis* (Branhamella catarrhalis), Neisseria gonorrhoeae*, Neisseria meningitidis*, Pasteurella multocida, Proteus mirabilis*, Proteus vulgaris*, Salmonella species*, Shidella species *, Vibrio cholerae, Yersinia enterocolitic a*;
Gram-negative anaerobes: Bacteroides species (including Bacteroides fragilis), Fusobacterium species ;
other microorganisms: Borrelia burgdorferi, species of Chlamydia, Leptospira icterohaemorrhagiae, Treponema pallidum.
Note* Some representatives of these types of bacteria produce beta-lactamase, which makes them insensitive to monotherapy with amoxicillin.
Indications
Treatment of bacterial infections caused by microorganisms sensitive to Amoxil-K, such as:
- severe throat, nose and ear infections (mastoiditis, peritonsillar infections, epiglottitis and sinusitis with accompanying severe systemic signs and symptoms);
- exacerbation of chronic bronchitis (after confirming the diagnosis);
- nosocomial pneumonia;
- cystitis;
- pyelonephritis;
- skin and soft tissue infections, including bacterial cellulitis, animal bites, severe dentoalveolar abscesses with widespread cellulitis;
- infections of bones and joints, including osteomyelitis;
- intra-abdominal infections;
- genital infections in women.
Prevention of bacterial infections during major surgical interventions in the following areas:
- gastrointestinal tract;
- pelvic organs;
- head and neck;
- bile ducts
Contraindications
Increased sensitivity to active substances, penicillin and other components of the drug.
A history of severe immediate-type allergic reaction (eg, anaphylaxis) to another beta-lactam antibiotic (cephalosporin, carbapenem, or monobactam).
History of jaundice/hepatic dysfunction caused by amoxicillin/clavulanic acid.
Dosage and Administration
Doses are given as amoxicillin/clavulanic acid content unless a dose of an individual component is specified.
When choosing a dose of Amoxil-K for the treatment of a certain infection, it is necessary to consider:
- expected pathogens and their expected sensitivity to antibacterial substances ;
- severity and localization of infection;
- the patient’s age, body weight, and renal function status, as described below.
This dosage form of Amoxil-K can be used in a daily dose of up to 3000 mg of amoxicillin and 600 mg of clavulanic acid. If it is necessary to use a higher dose of amoxicillin, another form of Amoxil-K should be prescribed to avoid excessively high daily doses of clavulanic acid.
The duration of treatment is determined by the doctor individually. Some infections (for example, osteomyelitis) require longer treatment. The duration of treatment should not exceed 14 days without evaluating the results of use and the clinical picture.
Dosage for adults and children with body weight ≥ 40 kg
Standard dose: 1000/200 mg every 8 hours.
Prevention of complications during surgical interventions.
For operations lasting less than 1 hour, the recommended dose is from 1000/200 mg to 2000/200 mg under anesthesia (a dose of 2000/200 mg can be achieved with the use of another intravenous form of amoxicillin/clavulanic acid).
For operations lasting more than 1 hour, the recommended dose is from 1000/200 mg to 2000/200 mg when administered under anesthesia, a dose of 1000/200 mg can be administered 3 times within 24 hours.
If there are clinical signs of infection in the postoperative period, a course of treatment with intravenous or oral administration of the drug should be prescribed.
Dosage for children with body weight < 40 kg
Children aged 3 months and older: 25/5 mg/kg of body weight every 8 hours.
Children under 3 months of age or weighing less than 4 kg: 25/5 mg/kg of body weight every 12 hours.
Elderly patients
Dose correction is not required.
Impaired kidney function
Dosage adjustments are based on the maximum recommended doses of amoxicillin.
Creatinine clearance > 30 ml/min – dose adjustment is not required.
Adults and children with body weight ≥ 40 kg
Creatinine clearance 10-30 ml/min | 1000/200 mg, then 500/100 mg 2 times a day |
Creatinine clearance < 10 ml/min | 1000/200 mg, then 500/100 mg every 24 hours |
Hemodialysis | The first dose is 1000/200 mg, then 500/100 mg every 24 hours + 500/100 mg after dialysis |
Adults and children with body weight < 40 kg
Creatinine clearance 10-30 ml/min | 25/5 mg/kg every 12 hours |
Creatinine clearance < 10 ml/min | 25/5 mg/kg every 24 hours |
Hemodialysis | 25/5 mg/kg every 24 hours + 12.5/2.5 mg after dialysis |
Violation of liver function
Care should be taken when dosing, and liver function should be continuously monitored at regular intervals.
Amoxil-K is administered by intravenous injections (jet) or by periodic infusions (drip). Amoxil-K cannot be administered intramuscularly.
Children under the age of 3 months should be prescribed Amoxil-K only as an intravenous infusion.
Treatment with Amoxil-K can be started with intravenous administration and continued with dosage forms for oral use.
Preparation of solution for intravenous injections
1000/200 mg: dissolve the contents of the vial in 20 ml of water for injections (final volume – 20.9 ml).
During dissolution, a temporary pink color may appear, which disappears. Amoxil-K solutions are usually colorless or have a pale straw color.
Amoxil-K should be administered within 20 minutes after dissolution.
Preparation of solution for intravenous infusion
Dissolved as above, the 1000/200 mg solution is then added without delay to 100 ml of infusion liquid (it is better to use a mini-container or burette). The infusion should be carried out for 30-40 minutes. After dissolution, Amoxil-K is chemically and physically stable for 2-3 hours at a temperature of 25 °C or 8 hours at a temperature of 5 °C. From a microbiological point of view, the prepared solution should be administered immediately.
Intravenous infusions of Amoxil-K can be carried out using various intravenous solutions. A satisfactory concentration of the antibiotic is maintained at 5 ºС and at room temperature (25 ºС) in the recommended volumes of the infusion solutions indicated below. When the drug is dissolved and stored at room temperature, the infusion should be carried out within the time indicated below.
Solution for intravenous (IV) administration | Stability period at 25 °C, hours |
Water for injections | 3 |
0.9% sodium chloride solution | 3 |
Combined sodium chloride solution (Ringer’s solution) | 2 |
Combined sodium lactate solution (Hartmann’s solution) | 2 |
0.3% solution of potassium chloride and 0.9% solution of sodium chloride | 2 |
In the case of storage at a temperature of 5 °C, solutions of 1000/200 mg can be added to a pre-cooled solution for infusions (water for injections or 0.9% sodium chloride solution), the resulting drug can be stored at the specified temperature for up to 8 hours.
After the solution reaches room temperature, it should be used immediately.
The stability of Amoxil-K solutions depends on the concentration. If you prepare a solution of a higher concentration, the period of stability of the solution increases proportionally.
Amoxil-K is less stable in solutions of glucose, dextran, and bicarbonate, so solutions based on this should be used within 3-4 minutes after dissolution.
Any unused solution should be disposed of in accordance with applicable requirements.
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