Instructions Amoxil-K 1000 film-coated tablets blister No. 14
Composition
active ingredients: 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 silica, magnesium stearate, coating mixture (contains: hydroxypropylmethylcellulose, titanium dioxide (E 171), copovidone, polydextrose, polyethylene glycols (macrogols), medium chain triglycerides).
Dosage form
Film-coated tablets.
Main physicochemical properties: film-coated tablets, white or almost white with a yellowish tinge, oval in shape with a biconvex surface, with a score on one side.
Pharmacotherapeutic group
Antimicrobials for systemic use. Beta-lactam antibiotics, penicillins. Combinations of penicillins with beta-lactamase inhibitors. Amoxicillin and enzyme inhibitor. ATX code J01C R02.
Pharmacological properties
Pharmacodynamics.
Amoxicillin is a semisynthetic antibiotic with a broad spectrum of antibacterial activity against many gram-positive and gram-negative microorganisms. Amoxicillin is sensitive to β-lactamase and undergoes degradation 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 inherent in 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 presence of clavulanic acid in the composition of the drug "Amoxil-K 1000" protects amoxicillin from degradation by β-lactamase enzymes and expands the spectrum of antibacterial action of amoxicillin, including many microorganisms resistant to amoxicillin and other penicillins and cephalosporins.
The microorganisms listed below are classified according to their 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 Streptococcus species, Staphylococcus aureus (methicillin-susceptible strains), Staphylococcus saprophyticus (methicillin-susceptible strains), coagulase-negative staphylococci (methicillin-susceptible 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 may acquire resistance.
Gram-negative aerobes: Escherichia coli, Klebsiella oxytoca, Klebsiella pneumonia, Klebsiella species, Proteus mirabilis, Proteus vulgaris, Proteus species, Salmonella species, Shigella species.
Gram-positive aerobes: Corynebacterium species, Enterococcus faecium.
Insensitive microorganisms.
Gram-negative aerobes: species of Acinetobacter, Citrobacter freundii, species of Enterobacter, Hafnia alvei, Legionella pneumophila, Morganella morganii, species of Providencia, species of Pseudomonas, species of Serratia, Stenotrophomas maltophilia, Yesinia enterolitica.
Others: Chlamydia pneumonia, Chlamydia psittaci, Chlamydia species, Coxiella burnetti, Mycoplasma species.
Pharmacokinetics.
The pharmacokinetic parameters of amoxicillin and clavulanic acid are similar. Peak serum concentrations of both components are reached approximately 1 hour after oral administration. Optimal absorption is achieved if the drug is taken at the beginning of a meal.
Doubling the dose of Amoxil-K 1000 increases the level of the drug in the blood serum approximately twice.
Both components of the drug, both clavulanate and amoxicillin, have a low level of binding to serum proteins, approximately 70% of them remain in the serum in an unbound state.
Indication
Treatment of bacterial infections in adults and children caused by microorganisms sensitive to the drug "Amoxil-K 1000", such as:
- acute bacterial sinusitis;
- acute otitis media;
- confirmed exacerbation of chronic bronchitis;
- community-acquired 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.
Contraindication
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).
History of jaundice or liver dysfunction associated with the use of amoxicillin/clavulanate.
Interaction with other medicinal products and other types of interactions
Concomitant use of probenecid is not recommended. Probenecid reduces renal tubular secretion of amoxicillin. Its simultaneous use with the drug "Amoxil-K 1000" may cause an increase in blood levels of amoxicillin for a long time, but does not affect the levels of clavulanic acid.
Concomitant use of allopurinol during treatment with amoxicillin increases the likelihood of allergic skin reactions. There are no data on the simultaneous use of the combined drug amoxicillin and clavulanic acid with allopurinol.
Like other antibiotics, Amoxil-K 1000 may have an effect on the intestinal flora, reducing the reabsorption of estrogens and the effectiveness of combined oral contraceptives.
There are isolated reports of increased international normalized ratio (INR) in patients treated with acenocoumarol or warfarin and taking amoxicillin. If such use is necessary, prothrombin time or international normalized ratio should be carefully monitored and, if necessary, treatment with Amoxil-K 1000 should be discontinued.
In patients treated with mycophenolate mofetil, the overdosage concentration of the active metabolite of mycophenolic acid may decrease by approximately 50% after initiation of oral amoxicillin/clavulanic acid. This change in overdosage level may not accurately reflect the change in total mycophenolic acid exposure.
Penicillins may reduce the excretion of methotrexate, causing increased toxicity of the latter.
Application features
Before starting therapy with Amoxil-K 1000, it is necessary to accurately determine the presence of a history of hypersensitivity reactions to penicillins, cephalosporins or other allergens.
Serious and sometimes fatal cases of hypersensitivity (anaphylactic reactions) have been reported in patients receiving penicillin therapy. These reactions are more likely to occur in individuals with a history of similar reactions to penicillin (see Contraindications). If allergic reactions occur, Amoxil-K 1000 should be discontinued and alternative therapy instituted.
If the infection is proven to be caused by microorganisms susceptible to amoxicillin, consideration should be given to switching from amoxicillin/clavulanic acid to amoxicillin in accordance with official recommendations.
This dosage form of the drug "Amoxil-K 1000" should not be used if there is a high probability that pathogens are resistant to β-lactams, and should not be used to treat pneumonia caused by penicillin-resistant strains of S. pneumoniae.
"Amoxil-K 1000" should not be prescribed if infectious mononucleosis is suspected, since cases of crust-like rash have been observed when amoxicillin was used for this pathology.
Prolonged use of the drug can sometimes cause excessive growth of microflora insensitive to the drug "Amoxil-K 1000".
The development of erythema multiforme associated with pustules at the beginning of treatment may be a symptom of acute generalized exanthematous pustulosis (see section "Adverse reactions"). In such cases, treatment should be discontinued and further use of amoxicillin is contraindicated.
"Amoxil-K 1000"
Caution should be exercised in patients with signs of hepatic insufficiency (see sections "Method of administration and dosage", "Contraindications", "Adverse reactions"). Adverse reactions from the liver occurred mainly in men and elderly patients and were associated with long-term treatment with the combined drug amoxicillin / clavulanic acid. Such events have been reported very rarely in children. In all patient groups, symptoms usually occurred during or immediately after treatment, but in some cases they appeared several months after discontinuation of treatment. In general, these events were reversible. Adverse reactions from the liver can be severe and very rarely fatal. They always occurred in patients with severe concomitant diseases or with concomitant use of drugs that can adversely affect the liver (see section "Adverse reactions").
Antibiotic-associated colitis, ranging from mild to life-threatening, has been reported with nearly all antibacterial agents (see section 4.8). This should be borne in mind when patients develop diarrhoea during or after antibiotic treatment. If antibiotic-associated colitis occurs, Amoxil-K 1000 should be discontinued immediately and appropriate treatment should be initiated.
Rarely, patients taking "Amoxil-K 1000" and oral anticoagulants may experience a prolongation of prothrombin time [increased international normalized ratio (INR)]. When anticoagulants are taken simultaneously, appropriate monitoring of laboratory parameters is necessary. Dose adjustment of oral anticoagulants may be required to maintain the required level of coagulation.
In patients with reduced urine output, crystalluria may occur very rarely, mainly with parenteral administration of the drug. Therefore, to reduce the risk of crystalluria, it is recommended to maintain fluid balance in the body during treatment with high doses of amoxicillin (see section "Overdose").
During treatment with amoxicillin, enzymatic reactions with glucose oxidase should be used to determine the level of glucose in the urine, as other methods may give false-positive results.
The presence of clavulanic acid in the drug may cause nonspecific binding of immunoglobulin G and albumin on erythrocyte membranes, resulting in a false-positive result when performing the Coombs test.
False-positive Aspergillus test results have been reported in patients receiving amoxicillin/clavulanic acid (using the Bio-Rad Laboratories Platelis Aspergillus EIA test). Therefore, such positive results in patients receiving amoxicillin/clavulanic acid should be interpreted with caution and confirmed by other diagnostic methods.
Use during pregnancy or breastfeeding
Animal reproduction studies (at doses 10 times the human dose) with oral and parenteral formulations of amoxicillin/clavulanic acid have not revealed any teratogenic effects. One study in women with premature rupture of membranes reported that prophylactic use of amoxicillin/clavulanic acid increased the risk of necrotizing enterocolitis in the newborn. The drug should be avoided during pregnancy, especially in the first trimester, unless the potential benefit outweighs the potential risk.
Both active components of the drug are excreted in breast milk (there is no information on the effects of clavulanic acid on breast-fed infants). Thus, diarrhea and fungal infection of the mucous membranes may occur in infants, so breastfeeding should be discontinued.
The drug "Amoxil-K 1000" during breastfeeding can be used only when, in the opinion of the doctor, the benefit of use will outweigh the risk.
Ability to influence reaction speed when driving vehicles or other mechanisms
No studies have been conducted to study the ability of the drug to affect the reaction speed when driving or using other mechanisms. However, adverse reactions (e.g. allergic reactions, dizziness, convulsions) may occur that may affect the ability to drive or use other mechanisms.
Method of administration and doses
The product should be used in accordance with official antibiotic treatment guidelines and local antibiotic susceptibility data. Susceptibility to amoxicillin/clavulanate varies between regions and may change over time. Local susceptibility data should be consulted, if available, and microbiological identification and susceptibility testing should be performed as appropriate.
The suggested dose range depends on the expected pathogens and their susceptibility to antibacterial drugs, the severity of the disease and the location of the infection, the age, body weight and renal function of the patient.
For adults and children weighing ≥ 40 kg, the daily dose is 1750 mg amoxicillin/250 mg 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 unnecessarily high doses of clavulanic acid.
The duration of treatment is determined by the patient's clinical response to treatment. Some infections (e.g. osteomyelitis) require longer treatment.
Children weighing < 40 kg
Dose from 25 mg/3.6 mg/kg body weight/day to 45 mg/6.4 mg/kg body weight/day, divided into 2 doses.
Elderly patients
No dose adjustment is required for elderly patients. If necessary, the dose is adjusted depending on renal function.
Dosage in liver dysfunction.
Use with caution, liver function should be monitored regularly. Data are insufficient to make dosage recommendations.
Dosage in renal impairment
The drug "Amoxil-K 1000" is prescribed only for the treatment of patients with creatinine clearance more than 30 ml/min. In renal failure with creatinine clearance less than 30 ml/min, the drug "Amoxil-K 1000" is not used.
The tablet should be swallowed whole without chewing. If necessary, the tablet can be broken in half and swallowed whole 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 longer than
14 days without assessing the patient's condition.
Treatment can be started with parenteral administration and then switched to oral administration.
Children
The drug in this dosage and dosage form is not recommended for the treatment of children under 12 years of age.
Overdose
Overdose may be accompanied by gastrointestinal symptoms and disturbances of water and electrolyte balance. These phenomena should be treated symptomatically, paying attention to the correction of water and electrolyte balance. Cases of crystalluria have been reported, sometimes leading to renal failure (see section "Special instructions"). The drug "Amoxil-K 1000" can be removed from the bloodstream by hemodialysis.
Adverse reactions
Side effects were classified according to their frequency of occurrence:
very common ≥1/10; common ≥1/100 and <1/10; uncommon ≥1/1000 and <1/100; rare ≥1/10000 and <1/1000; very rare <1/10000, not known (frequency cannot be estimated).
Infections and invasions.
Often – candidiasis of the skin and mucous membranes.
Unknown – excessive increase in the number of non-susceptible microorganisms.
Hematopoietic and lymphatic systems.
Rarely - reversible leukopenia (including neutropenia) and thrombocytopenia.
Very rare: reversible agranulocytosis and hemolytic anemia. Increased bleeding time and prothrombin index.
From the immune system.
Very rare: angioedema, anaphylaxis, serum sickness syndrome, allergic vasculitis.
From the nervous system.
Uncommon: dizziness, headache.
Very rare: reversible hyperactivity, aseptic meningitis and convulsions. Convulsions may occur in patients with impaired renal function or in those receiving high doses of the drug, unknown: aseptic meningitis.
From the gastrointestinal tract.
Adults
Very often - diarrhea.
Often - nausea, vomiting.
Children
Often - diarrhea, nausea, vomiting.
Nausea is more commonly associated with high doses of the drug. The above gastrointestinal symptoms may be reduced by taking the drug at the beginning of a meal.
Uncommon: indigestion.
Very rare: antibiotic-associated colitis (including pseudomembranous colitis and hemorrhagic colitis - see section "Special warnings and precautions for use"), black "hairy" tongue.
On the part of the hepatobiliary system.
Uncommon – moderate elevations in aspartate aminotransferase and/or alanine aminotransferase have been observed in patients treated with β-lactam antibiotics.
Very rare: hepatitis and cholestatic jaundice. These phenomena occur with the use of other penicillins and cephalosporins.
Hepatitis occurs mainly in men and elderly patients, and its occurrence may be associated with prolonged treatment.
Such phenomena occurred very rarely in children.
Symptoms of the disease occur during or immediately after treatment, but in some cases may occur several weeks after the end of treatment. These phenomena are usually reversible. Fatal cases are extremely rare, which always occur in patients with severe underlying disease or in patients who are simultaneously treated with drugs that have a negative effect on the liver.
On the part of the skin and its derivatives.
Uncommon: skin rash, itching, urticaria.
Rarely – polymorphic erythema.
Very rare: Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis.
If any allergic dermatitis occurs, treatment should be discontinued.
On the part of the kidneys and urinary system.
Very rare: interstitial nephritis, crystalluria (see section "Overdose").
Expiration date
1.5 years.
Storage conditions
Store in original packaging, at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
7 tablets in a blister, 2 blisters in a pack.
Vacation category
According to the recipe.
Producer
PJSC "Kyivmedpreparat".
Location of the manufacturer and its business address
Ukraine, 01032, Kyiv, Saksaganskoho St., 139.
