Composition
1 tablet contains amoxicillin trihydrate 500 mg, clavulanic acid 125 mg; excipients: polyvinylpyrrolidone (povidone), talc (magnesium hydrosilicate), starch 1500, calcium stearic acid (calcium stearate), aerosil (colloidal silicon dioxide), microcrystalline cellulose. shell composition: hypromellose (hydroxypropylmethylcellulose), propylene glycol, titanium dioxide, polyethylene oxide 4000 (macrogol 4000).
Pharmacological action
Arlet is a combination of amoxicillin (a semisynthetic penicillin with a broad spectrum of antibacterial activity) and clavulanic acid (an irreversible beta-lactamase inhibitor). Clavulanic acid forms a stable inactivated complex with these enzymes and ensures the resistance of amoxicillin to the effects of beta-lactamases produced by microorganisms. Clavulanic acid, similar in structure to beta-lactam antibiotics, has a weak intrinsic antibacterial activity. Arlet has a wide spectrum of antibacterial action. Active against amoxicillin-sensitive strains, including beta-lactamase-producing strains: – gram-positive aerobes: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Streptococcus bovis, Staphylococcus aureus (also the methicillin-resistant strains), Staphylococcus epidermidis (except methicillin-resistant strains), Staphylococcus saprophyticus, Listeria spp., Enteroccocus spp. ;- gram-negative aerobes: Bordetella pertussis, Brucella spp., Campylobacter jejuni, Escherichia coli, Gardnerella vaginalis, Haemophilus influenzae, Haemophilus ducreyi, Klebsiella spp., Moraxella catarrhalis, Neisseria gonorrhoeae, Neisseria meningitidis, Pasteurela multocida, Proteus spp., Salmonella spp. Shigella spp. Vibrio cholerae, Yersinia enterocolitica, Helicobacter pylori, Eikenella corrodens;- gram-positive anaerobes: Peptococcus spp., Peptostreptococcus spp. Clostridium spp. Actinomyces israelii, Fusobacterium spp., Prevotella spp. ;- gram-negative anaerobes: Bacteroides spp.
Indications
Infections caused by sensitive strains of microorganisms: – infections of the upper respiratory tract and ENT organs (acute and chronic sinusitis, acute and chronic otitis media, pharyngeal abscess, tonsillitis, pharyngitis);- lower respiratory tract infections (acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia);- urinary tract infections; – gynecological infections; – skin and soft tissue infections; – bone and connective tissue infections; – biliary tract infections (cholecystitis, cholangitis); – odontogenic infections.
Use during pregnancy and lactation
Arlet can only be prescribed during pregnancy if the intended benefit to the mother outweighs the potential risk to the fetus. Amoxicillin and clavulanic acid pass into breast milk in small amounts, so if you need to use the drug during lactation, you should decide whether to stop breastfeeding.
Contraindications
Hypersensitivity (including to cephalosporins, etc. beta-lactam antibiotics), infectious mononucleosis (including when a crust-like rash appears), children under 3 years of age (for this lek. forms). With caution-pregnancy, lactation, severe liver failure, diseases of the gastrointestinal tract (including colitis in the anamnesis associated with the use of penicillins), chronic renal failure.
Side effects
From the digestive system: loss of appetite, nausea, vomiting, diarrhea; rarely-impaired liver function, increased activity of alanine aminotransferase (ALT) or asparagine aminotransferase (ACT); in rare cases – cholestatic jaundice, hepatitis, pseudomembranous colitis. Allergic reactions: pruritus, urticaria, erythematous rashes; rarely-erythema multiforme, angioedema, anaphylactic shock; in rare cases-exfoliative dermatitis, Stevens-Johnson syndrome. From the hematopoietic system: reversible increase in prothrombin time, leukopenia, reversible agranulocytosis and hemolytic anemia. From the central nervous system: dizziness, headache, reversible hyperactivity and seizures. From the side of the kidneys and urinary tract: interstitial nephritis, crystalluria. Other services: candidiasis and other types of superinfection.
Interaction
Concomitant use with methotrexate increases the toxicity of methotrexate. Co-use with allopurinol increases the incidence of exanthema. Antacids, glucosamine, laxatives, aminoglycosides-slow down and reduce absorption; ascorbic acid increases absorption. Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) have a synergistic effect; bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) – antagonistic. Increases the effectiveness of indirect anticoagulants (suppressing intestinal microflora, reduces the synthesis of vitamin K and prothrombin index). When taking anticoagulants at the same time, it is necessary to monitor blood clotting parameters. Reduces the effectiveness of oral contraceptives, drugs that produce paraaminobenzoic acid and ethinyl estradiol in the process of metabolism – the risk of developing “breakthrough” bleeding. Diuretics, allopurinol, phenylbutazone, nonsteroidal anti-inflammatory drugs, and other drugs that block tubular secretion increase the concentration of amoxicillin (clavulanic acid is mainly excreted by glomerular filtration).
How to take, course of use and dosage
Arlet is taken orally. Adults and children over 12 years of age (or with a body weight >40 kg) with mild or moderate infection-1 table. Arlet 500/125 mg every 12 hours, in case of severe infection and respiratory tract infections — 1 table 500/125 mg every 8 hours.
Overdose
In most cases, symptoms of overdose include disorders of the gastrointestinal tract (abdominal pain, diarrhea, vomiting), anxiety, insomnia, dizziness, and in some cases – convulsive seizures. In case of overdose, the patient should be under the supervision of a doctor, treatment is symptomatic. In the case of a recent intake (less than 4 hours), gastric lavage should be performed and activated charcoal should be prescribed to reduce absorption. Amoxicillin / potassium clavulanate is removed by hemodialysis.
Special instructions
During the course of treatment, it is necessary to monitor the state of function of the hematopoietic organs, liver, and kidneys. In patients with severe renal impairment, adequate dose adjustment or increased dosing intervals are required. In order to reduce the risk of side effects from the gastrointestinal tract, you should take the drug with meals.
Form of production
Film-coated tablets.
Storage conditions
Store in a dry place, protected from light, at a temperature not exceeding 25 °C
Shelf life
2 years
Active ingredient
Amoxicillin, Clavulanic Acid
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
Description
Children as directed by a doctor, Children over 12 years of age, Adults as directed by a doctor
Indications
Bronchitis, Cholecystitis, Pneumonia, Osteomyelitis, Sore Throat, Tonsillitis, Urinary Tract Infections, Periodontitis, Pharyngitis, Otitis Media, Sinusitis, Skin Infections
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