$35.60
Manufacturer: Slovenia
Treatment of bacterial infections in adults and children caused by microorganisms sensitive to the combination of amoxicillin/clavulanic acid, 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;
- infections of bones and joints, including osteomyelitis
Description
Ingredients
active substances : amoxicillin, clavulanic acid;
1 tablet contains 875 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. ATX code J01C R02.
Pharmacodynamics
Amoxiclav (amoxicillin) Quicktab is a combination of amoxicillin, a penicillin antibiotic with a broad spectrum of antibacterial activity, and clavulanic acid, an irreversible beta-lactamase inhibitor, which forms an inactive complex with enzymes and protects amoxicillin from destruction. Clavulanate potassium has weak antibacterial activity and does not affect the mechanism of action of amoxicillin.
Because clavulanic acid inhibits beta-lactamases that normally inactivate amoxicillin, their combination is effective against many beta-lactamase-producing microorganisms resistant to amoxicillin.
The combination is active both in vitro and in the case of clinical infections against non-producing and penicillinase-producing gram-positive and gram-negative microorganisms :
- Gram-positive aerobes: penicillin-sensitive strains of Streptococcus pneumoniae , Streptococcus pyogenes , methicillin-sensitive strains of Staphylococcus aureus , Listeria spp ., Enterococcus faecalis , Enterococcus faecium , Corynebacterium spp .;
- gram-positive anaerobes: Peptococcus spp ., Peptostreptococcus spp ., Clostridium perfringens , Actinomyces israelli ;
- Gram-negative aerobes: Haemophillus influenzae , Moraxella catarrhalis , Escherichia coli , Klebsiella spp ., Proteus mirabilis , Proteus vulgaris , Neisseria gonorrhoeae , Neisseria meningitid and s , Pasteurella multocida , Salmonella spp ., Shigella spp . , Vibrio cholerae , Helicobacter pylori , Bordetella pertussis ;
- Gram-negative anaerobes: Bacteroides spp ., Fusobacterium spp ., Prevotella spp .
Pseudomonas aeruginosa , methicillin-resistant strains of Staphylococcus aureus , Legionella spp ., Chlamydia spp ., Mycoplasma spp. are resistant to the drug .
Pharmacokinetics
The main pharmacokinetic properties of amoxicillin and clavulanic acid are similar. Both components are well absorbed after oral administration; food does not affect the degree of absorption. Maximum concentrations in blood serum are reached approximately 1-2 hours after taking the drug. Both components are characterized by a high volume of distribution in body fluids and tissues (lungs, middle ear exudate, maxillary sinus secretion, nasal sinus secretion, pleural and peritoneal fluid, prostate gland, tonsils, sputum, bronchial secretion, liver, gall bladder, uterus, ovaries, synovial fluid). Amoxicillin and clavulanic acid do not penetrate the blood-brain barrier in non-inflamed meninges.
Both components penetrate the placental barrier and are present in small amounts in breast milk.
Amoxicillin and clavulanic acid are characterized by low binding to blood plasma proteins.
Both components are excreted by the kidneys; amoxicillin is metabolized by 10-20%, and clavulanic acid by almost 50%. A small amount can be excreted through the intestines and lungs. The half-life of amoxicillin and clavulanic acid is 1-1.5 hours, increasing to 7.5 hours and 4.5 hours, respectively, in patients with severe renal impairment. Both substances are well removed by hemodialysis, but to a lesser extent by peritoneal dialysis.
Indications
Treatment of bacterial infections in adults and children caused by microorganisms sensitive to the combination of amoxicillin/clavulanic acid, 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;
- 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
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. If necessary, local susceptibility data should be consulted and, if necessary, microbiological determination and susceptibility testing should be performed.
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.
Adults and children with body weight ≥ 40 kg. 1 tablet of 875 mg/125 mg 2 times a day (the daily dose is 1750 mg of amoxicillin/250 mg of clavulanic acid).
Children with a body weight of 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. The maximum daily dose is 1000-2800 mg of amoxicillin/143-400 mg of clavulanic acid.
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.
The duration of treatment 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.
Elderly patients. Dose correction is not required. If necessary, adjust the dose depending on kidney function.
Violation of liver function. Apply carefully; liver function should be monitored at regular intervals. There are insufficient data for dosage recommendations.
Impaired kidney function.
Amoxiclav (amoxicillin) Quicktab 875 mg/125 mg is prescribed only for the treatment of patients with a creatinine clearance of more than 30 ml/min. Do not use Amoxiclav (amoxicillin) Quicktab 875 mg/125 mg in case of renal insufficiency with creatinine clearance less than 30 ml/min.
For optimal absorption and reduction of possible side effects from the digestive tract, the drug 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.
Treatment can be started with parenteral administration, and then continue with oral administration.
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