Instructions for use AMOCLAV-1000 (AMOCLAV-1000)
Before starting treatment with Amoklav-1000, it is necessary to collect a detailed history regarding previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam antibiotics (see sections “Contraindications” and “Side Effects”).
Serious, sometimes fatal, hypersensitivity reactions (anaphylactoid reactions) to penicillins have been described. The risk of such reactions is highest in patients with a history of hypersensitivity reactions to penicillins and in individuals with atopy. If an allergic reaction occurs, treatment with amoxicillin/clavulanic acid should be discontinued and alternative therapy should be initiated.
If the infection is confirmed to be due to amoxicillin-susceptible organisms, a switch from amoxicillin/clavulanic acid therapy to amoxicillin therapy should be considered in accordance with official guidelines.
Amoklav-1000 tablets are not suitable for use in cases where there is a high risk that the suspected pathogens have reduced sensitivity or resistance to beta-lactams, which is not mediated by beta-lactamases inhibited by clavulanic acid. These dosage forms should not be used in the treatment of infections caused by penicillin-resistant Streptococcus pneumoniae.
In patients with impaired renal function or when taking high doses of the drug, seizures may occur (see section "Side effects").
The use of amoxicillin/clavulanic acid is not recommended for suspected infectious mononucleosis, since such patients experience a morbilliform rash after taking amoxicillin.
The combined use of allopurinol and amoxicillin increases the risk of allergic skin reactions.
Long-term treatment may lead to excessive proliferation of insensitive microorganisms.
The appearance of pustules on erythematous areas of the skin with fever at the beginning of treatment may be a symptom of acute generalized exanthematous pustulosis. The occurrence of this adverse reaction requires discontinuation of the drug and is a contraindication to further use of amoxicillin. The amoxicillin/clavulanic acid combination should be used with caution in patients with symptoms of liver failure (see sections “Dosage regimen”, “Contraindications”).
Adverse liver events have been observed primarily in men and elderly patients and may be associated with long-term therapy. These adverse events are very rarely observed in children. Signs and symptoms of liver dysfunction usually occur during or immediately after completion of therapy, but in some cases may not appear until several weeks after completion of therapy. As a rule, they are reversible. Adverse effects from the liver can be severe, and in extremely rare cases there have been reports of death. In almost all cases, these were persons with serious comorbidities or persons receiving concomitantly potentially hepatotoxic drugs.
Antibiotic-associated colitis has been reported with virtually all antibacterial agents. This adverse reaction can vary in severity from mild to life-threatening (see section "Side effects"). Therefore, this diagnosis should be considered in patients who develop diarrhea during treatment or after administration of any antibiotics. If antibiotic-associated colitis occurs, the drug should be discontinued immediately. The patient should consult a doctor who will prescribe appropriate treatment. In such a situation, the use of drugs that inhibit peristalsis is contraindicated.
During long-term therapy with Amoclav-1000, it is recommended to periodically monitor renal, liver and hematopoietic function.
In patients receiving a combination of amoxicillin and clavulanic acid, prolongation of prothrombin time has been observed in rare cases. When co-prescribing a combination of amoxicillin and clavulanic acid with anticoagulants, appropriate monitoring should be carried out. To maintain the desired level of anticoagulation, dose adjustment of the anticoagulant may be necessary (see sections “Drug Interactions” and “Side Effects”).
In patients with impaired renal function, the dose of Amoclav-1000 should be adjusted according to the degree of impairment (see section "Dosage regimen").
In patients with reduced diuresis, the development of crystalluria has been reported in very rare cases, mainly with parenteral use of the drug. While taking high doses of amoxicillin, it is recommended to drink enough fluids and maintain adequate diuresis to reduce the chance of amoxicillin crystal formation. In patients with urinary catheters, catheter patency should be checked regularly (see section "Overdose").
During treatment with amoxicillin, if tests for the presence of glucose in urine are necessary, enzymatic methods for determining glucose oxidase should be used due to the possibility of obtaining a false positive result when using non-enzymatic methods. The presence of clavulanic acid in the drug may cause nonspecific binding of IgG and albumin to red blood cell membranes, which may lead to a false-positive Coombs test result.
Patients taking the amoxicillin/clavulanic acid combination may experience a false-positive test result for Aspergillus infection when using the Platelia Aspergillus EIA tests. Cross-reactions between the Platelia Aspergillus EIA test and non-Aspergillus polysaccharides and polyfuranoses have been reported. Therefore, positive test results in patients taking the combination of amoxicillin/clavulanic acid should be interpreted with caution and confirmed by other diagnostic methods.
Impact on the ability to drive vehicles and machinery
No special studies have been conducted, but adverse reactions may occur (allergic reactions, dizziness, convulsions), which may affect the ability to drive vehicles and other mechanisms.
Clamosar®
Clamosar is a combination of amoxicillin, a semi-synthetic penicillin with a broad spectrum of antibacterial activity, and clavulanic acid, an irreversible beta-lactamase inhibitor. Amoxicillin is a semi-synthetic penicillin belonging to the group of beta-lactam antibiotics, which has a wide spectrum of antibacterial activity against many gram-positive and gram-negative microorganisms. Amoxicillin is destroyed by beta-lactamases and is not effective against microorganisms that produce these enzymes.
Clavulanic acid has the ability to inactivate beta-lactamases, protects amoxicillin from the destructive effects of beta-lactamases and expands the spectrum of antimicrobial activity of the drug.
The drug is active against aerobic gram-positive bacteria (including strains producing beta-lactamases): Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus anthracis, Streptococcus pneumoniae, Streptococcus viridans, Enterococcus faecalis, Corynebacterium spp., Listeria monocytogenes; anaerobic gram-positive bacteria: Clostridium spp., Peptococcus spp., Peptostreptococcus spp., aerobic gram-negative bacteria (including beta-lactamase producing strains): Escherichia coli, Proteus mirabilis, Proteus vulgaris, Klebsiella spp., Salmonella spp., Shigella spp., Bordetella pertussis, Yersinia enterocolitica, Gardnerella vaginalis, Neisseria meningitidis, Neisseria gonorrhoeae, Moraxella catarrahalis, Haemophilus influenzae, Haemophilus ducreyi, Yersinia multocida (formerly Pasteurella), Campylobacteres jejuni; anaerobic gram-negative bacteria (including strains producing beta-lactamases): Bacteroires spp., including Basteroides fragilis. Clavulanic acid inhibits types II, III, IV and V beta-lactamases, is inactive against type I beta-lactamases produced by Enterobacter spp., Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp.
Pharmacokinetics
After intravenous administration (IV) in doses of 1200 mg and 600 mg, the maximum concentration (Cmax) of amoxicillin is 105.4 μg/ml and 32.2 μg/ml, respectively, clavulanic acid is 28.5 μg/ml and 10.5 μg/ml, respectively. Therapeutic concentrations of amoxicillin and clavulanic acid are created in the abdominal, adipose and muscle tissues of the interstitial fluid, in the skin, lungs and pleural fluid, in the gallbladder, as well as in the synovial and peritoneal fluids, bile and pus. Association with plasma proteins: amoxicillin-17- 20%, clavulanic acid - 22-30%. Both components of the liver are metabolized: moxicillin - by 10% of the administered dose, clavulanic acid - by 50%. The half-life (T½) after intravenous administration at a dose of 1200 mg and 600 mg is 0.9 hours and 1.07 hours for amoxicillin, 0.9 hours and 1.12 hours for clavulanic acid, respectively. Excreted mainly by the kidneys (glomerular filtration and tubular secretion): 50-78% and 25-40% of the dose of amoxicillin and clavulanic acid, respectively, are excreted unchanged during the first 6 hours after administration.
The drug passes into breast milk and through the placental barrier
