Index of drugs

Treatment of the following bacterial infections in children and adults: acute bacterial sinusitis (properly diagnosed), acute otitis media, exacerbation of chronic bronchitis (properly diagnosed), community acquired pneumonia, cystitis, pyelonephritis, skin and soft tissue infections, especially cellulitis, bites by animals, severe periodontium abscess with widespread cellulitis, and bone and joint infections, in particular osteomyelitis. The official guidelines for the proper use of antibacterial drugs should be taken into account.

1 tabl powl. contains 500 mg or 875 mg of Amoxicillin in the form of a trihydrate and 125 mg of clavulanic acid in the form of a potassium salt.

The preparation is a combination of amoxicillin (semisynthetic penicillin susceptible to many β-lactamases) with clavulanic acid inactivating β-lactamase. Usually susceptible strains: Gram-positive aerobic bacteria:Enterococcus faecalis, Gardnerella vaginalis, Staphylococcus aureus (sensitive to methicillin),Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes and other β-hamolizing streptococci, groupStreptococcus viridans; aerobic Gram-negative bacteria:Capnocytophaga spp., Eikenella corrodens, Haemophilus influenzae, Moraxella catarrhalis, Pasteurella multocida; anaerobic bacteria:Bacteroides fragilis, Fusobacterium nucleatum, Prevotella spp. Strains in which the problem of acquired resistance may occur: aerobic Gram-positive bacteria:Enterococcus faecium; aerobic Gram-negative bacteria:Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris. Microorganisms with inherited resistance: Gram-negative aerobic bacteria:Acinetobacter spp., Citrobacter freundii, Enterobacter spp., Legionella pneumophila, Morganella morganii, Providencia spp., Pseudomonas spp., Serratia spp., Stenotrophomonas maltophilia; other microorganisms:Chlamydophila pneumoniae, Chlamydophila psittaci, Coxiella burnetti, Mycoplasma pneumoniae. Amoxicillin and clavulanic acid are absorbed quickly and well after oral administration. Absorption is optimal when the drug is administered at the beginning of a meal. The bioavailability of amoxicillin and clavulanic acid after oral administration is approximately 70%. The curves for both plasma concentrations are similar and the time to reach maximum plasma concentration is about 1 hour. From the total amount of drug in plasma, about 25% of clavulanic acid and 18% of amoxicillin is bound to proteins. Amoxicillin is partially excreted in the urine as inactive penicillin acid in amounts equivalent to 10-25% of the initial dose of amoxicillin. Clavulanic acid is extensively metabolised and excreted in urine and faeces, and as carbon dioxide excreted in exhaled air. Medium T_0,5 in the phase of elimination of amoxicillin with clavulanic acid is about 1 hour.

Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients. Occurrence of a severe immediate hypersensitivity reaction (ie anaphylaxis) to another β-lactam drug (ie cephalosporin, carbapenem or monobactam) in the past. Occurrence of jaundice or hepatic impairment caused by amoxicillin or clavulanic acid in the past.

Before starting treatment, it is necessary to have an accurate history of previous hypersensitivity reactions to penicillins, cephalosporins or other β-lactam drugs. If an allergic reaction occurs, the treatment should be discontinued and an alternative appropriate treatment should be implemented. If the infection is known to be caused by amoxicillin susceptible organisms, consideration should be given to replacing the amoxicillin / clavulanic acid combination with amoxicillin alone in accordance with official guidelines. This form of the drug is not suitable for use if there is a high risk that the microorganisms that are likely to cause infection have reduced sensitivity or their resistance to β-lactam antibiotics is not induced by β-lactamases sensitive to the inhibitory effects of clavulanic acid. This drug form should not be used to treat infections caused byS. pneumoniae insensitive to penicillin. Patients with impaired renal function or those receiving high doses may experience convulsions.The use of amoxicillin / clavulanic acid should be avoided if infectious mononucleosis is suspected because patients with infectious mononucleosis have been found to have a relationship between the occurrence of odor-like rashes and the use of amoxicillin. Prolonged use can sometimes cause the development of non-susceptible organisms. Generalized erythema with pustules and fever, occurring at the beginning of treatment, may be a symptom of acute generalized pustular exanthema (AGEP) - if such a reaction occurs, it is necessary to discontinue the preparation and any further administration of amoxicillin is contraindicated. The preparation should be used with caution in patients with impaired hepatic function. Liver events have been reported mainly in male and elderly patients and may be associated with prolonged treatment. These events have been reported very rarely in children. In all groups of patients, signs and symptoms usually occur during or shortly after treatment, but in some cases may not be visible for several weeks after treatment. They are usually transient. Liver events can be serious and deaths have been reported in extremely rare cases. They have almost always been present in patients with a serious underlying disorder or at the same time taking other medications with known possible effects on the liver. For patients who have experienced diarrhea during or after antibiotic administration, the possibility of antibiotic-associated colitis should be considered. If antibiotic-associated colitis occurs, the amoxicillin / clavulanic acid should be stopped immediately, the patient's medical examination should be performed and appropriate treatment instituted. In this situation, the use of drugs that inhibit intestinal peristalsis is contraindicated. During long-term treatment, it is recommended to periodically check the functions of internal organs, including the kidneys, liver and hematopoietic system. In patients with impaired renal function the dose should be adjusted to the degree of inefficiency. When administering high doses of Amoxicillin, it is recommended to ensure adequate fluid supply and urinary excretion to minimize the possibility of amoxicillin crystals forming in the urine. In patients with a bladder catheter, the patency of the catheter should be checked regularly.

Avoid taking this medicine during pregnancy, except when the use is necessary. Limited data on the use of amoxicillin / clavulanic acid in pregnant women do not indicate an increased risk of congenital malformations. In a single study in women with premature rupture of the bladder, it has been shown that prophylactic treatment may increase the risk of necrotic enterocolitis in the newborn. Both substances are excreted into breast milk (the influence of clavulanic acid on a breastfed infant is unknown); there is a risk of diarrhea and fungal infections of the mucous membranes of the infant, and breastfeeding may need to be stopped. While breastfeeding, use only after assessing the risk / benefit ratio.

Very often: diarrhea. Common: skin and mucosal candidiasis, nausea, vomiting. Uncommon: pain and dizziness, indigestion, increased AST and / or ALT, skin rash, pruritus, urticaria. Rare: transient leukopenia (including neutropenia), thrombocytopenia, erythema multiforme. Not known: excessive growth of non-susceptible bacteria, aseptic meningitis, transient agranulocytosis, haemolytic anemia, prolonged bleeding time and prothrombin time, Kounis syndrome, angioneurotic edema, anaphylactic reaction, serum sickness syndrome, allergic vasculitis, transient hyperactivity, convulsions (mainly in patients with impaired renal function or receiving high doses), antibiotic-associated colitis (including pseudomembranous colitis and hemorrhagic inflammation of the large intestine), black hairy tongue, hepatitis (liver dysfunction can be severe, in extreme cases rare cases, deaths were noted), congestive jaundice, cholangitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized pustular exanthema (AGEP), pancreatitis, crystalluria.Treatment should be discontinued if any cutaneous hypersensitivity reaction occurs.

Orally.Table. powl. 625 mg. Adults and children about the month of ≥40 kg: 1 tabl. 3 times a day.Children about the month of <40 kgfrom 20 mg + 5 mg / kg / day to 60 mg / 15 mg / kg / day given in 3 divided doses. Clinical data on use in children <2 years, doses higher than (40 mg + 10 mg) / kg are not available. daily preparations containing amoxicillin and clavulanic acid in a 4: 1 ratio. Do not prolong treatment for more than 14 days without re-checking the patient's health.Special groups of patients. It is not necessary to adjust the dose in elderly patients. No dosage adjustment is required in patients with creatinine clearance> 30 ml / min. In impaired renal function in adults and children of ≥40 kg depending on the creatinine clearance: 10-30 ml / min - 1 tablet 2 times a day; <10 ml / min - 1 tablet once a day; hemodialysis - 1 tabl. every 24 h, additionally 1 tabl. during dialysis and 1 tabl. at the end of dialysis. In kidney disorders in children with b. <40 kg depending on the creatinine clearance: 10-30 ml / min - 1 dose (15 mg + 3.75 mg) / kg. administered twice a day (up to 500 mg + 125 mg 2 times a day); <10 ml / min - 1 dose (15 mg + 3.75 mg) / kg administered once a day (up to 500 mg + 125 mg); hemodialysis - 1 dose (15 mg + 3.75 mg) / kg administered once a day, before the hemodialysis an additional dose (15 mg + 3.75 mg) / kg should be given to restore the proper concentration of the drug in the bloodstream, after hemodialysis the Next dose should be given (15 mg + 3.75 mg) / kg mc. Caution should be exercised when dosing, regularly monitoring liver function. Table. powl. 1000 mg. Adults and children about the month of ≥40 kg: standard dose: (in all indications) 1 tabl. 2 times a day; higher dose (especially in infections such as otitis media, sinusitis, lower respiratory tract infections and urinary tract infections): 1 tabl. 3 times a day.Children about the month of <40 kg: (25 mg + 3.6 mg) / kg / day to (45 mg + 6.4 mg) / kg / day given in 2 divided doses; doses up to (70 mg + 10 mg) / kg / day administered in 2 divided doses can be considered in infections such as otitis media, sinusitis and lower respiratory tract infections. Clinical data are not available for use in children below 2 years of doses higher than (45 mg + 6.4 mg) / kg. daily preparations containing amoxicillin and clavulanic acid in a ratio of 7: 1. Due to the lack of clinical data on the use of doses of preparations containing amoxicillin and clavulanic acid in the ratio of 7: 1 in children under 2 months, it is not possible to provide recommendations in this population. Do not prolong treatment for more than 14 days without re-checking the patient's health.Special groups of patients. It is not necessary to adjust the dose in elderly patients. No dosage adjustment is required in patients with creatinine clearance> 30 ml / min. In patients with a creatinine clearance <30 ml / min, it is not recommended to use the pharmaceutical forms of the preparation containing amoxicillin and clavulanic acid in the ratio of 7: 1, due to the lack of recommendations on the possibility of adjusting the dose. In patients with impaired hepatic function, caution should be exercised when dosing, regularly monitoring liver function.Way of giving. Take the medicine at the beginning of the meal.