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Rapiclav tablet p o 500 mg + 125 mg core x15

Trade name: Rapiclav International name: Amoxicillin + Clavulanic acid

Release forms: film-coated tablets 250 mg+125 mg, 500 mg+125 mg (blisters, strips, dark glass bottles)

Composition: amoxicillin trihydrate 250/500 mg [in terms of amoxicillin], potassium clavulanate 125/125 mg [in terms of clavulanic acid]

Pharmacological group: antibiotic semisynthetic penicillin + beta-lactamase inhibitor

Pharmacological group according to ATK: J01CR02 (Clavulanic acid + amoxicillin)

Pharmacological action: antibacterial, beta-lactamase inhibitor, broad-spectrum penicillin,

Indications: Bacterial infections caused by sensitive pathogens: upper respiratory tract infections (bronchitis, pneumonia, pleural empyema, lung abscess), infections of the ENT organs (sinusitis, tonsillitis, otitis media), biliary tract infections (cholangitis, cholecystitis), intestinal infections ( dysentery, salmonellosis, salmonellosis carriage), infections of the genitourinary system and pelvic organs (pyelonephritis, pyelitis, cystitis, urethritis, prostatitis, cervicitis, salpingitis, salpingo-oophoritis, tubo-ovarian abscess, endometritis, bacterial vaginitis, septic abortion, postpartum sepsis, pelvioperitonitis, chancroid , gonorrhea), skin and soft tissue infections (erysipelas, impetigo, secondarily infected dermatoses, abscess, phlegmon, wound infection), osteomyelitis, endocarditis, meningitis, sepsis, peritonitis, postoperative infections, prevention of infections in surgery.

Dosage regimen: Orally (doses are given in terms of amoxicillin), the dosage regimen is set individually depending on the severity and location of the infection, the sensitivity of the pathogen. Adults and adolescents over 12 years of age are prescribed 250 mg 3 times a day. For severe infections - 500 mg 3 times a day or 1 g 2 times a day.

Children under 12 years of age - in the form of a suspension, syrup or drops for oral administration, 3 times a day. A single dose is set depending on age: for children aged 7-12 years - 250 mg, 2-7 years - 125 mg, 9 months-2 years - 62.5 mg, frequency of administration - 3 times a day. In severe cases, doses may be doubled. Doses for oral administration for children 9 months-2 years - 20-40 mg/kg/day in 3 divided doses, for children 2-12 years old - 20-50 mg/kg/day in 3 divided doses, depending on the severity of the infection.

There is no established oral dosage for children under 9 months of age. When preparing suspension, syrup and drops, water should be used as a solvent.

When administered intravenously, adults and adolescents over 12 years of age are given 1.2 g 3 times a day, if necessary - 4 times a day. The maximum daily dose is 6 g. For children 3 months to 12 years old - 25 mg/kg (30 mg/kg based on the entire drug) 3 times a day, in severe cases - 4 times a day, for children up to 3 months: premature and in the perinatal period - 30 mg/kg 2 times a day, in the postperinatal period - 25 mg/kg 3 times a day.

The duration of treatment is up to 14 days.

To prevent postoperative infections during operations lasting less than 1 hour, a dose of 1.2 g is administered intravenously during induction of anesthesia. For longer operations - 1.2 g every 6 hours during the day. If the risk of infection is high, administration may be continued for several days.

In case of chronic renal failure, the frequency of administration is reduced depending on the CC. When CC is more than 30 ml/min, no dose reduction is required; when CC is 10-30 ml/min, treatment begins with IV administration of 1.2 g, then 600 mg IV or 250-500 mg orally 2 times a day, with CC less than 10 ml/min - 1.2 g, then 600 mg/day IV or 250-500 mg/day orally in one dose. For children, doses should be reduced in the same way.

Hemodialysis reduces serum concentrations, and therefore an additional 500 mg is administered intravenously during and at the end of dialysis.

Contraindications: Hypersensitivity (including to cephalosporins and other beta-lactam antibiotics), infectious mononucleosis (including with the appearance of a measles-like rash).

Side effects: From the digestive system: nausea, vomiting, diarrhea, impaired liver function, increased activity of “liver” transaminases, in isolated cases - cholestatic jaundice, hepatitis, pseudomembranous colitis. Allergic reactions: urticaria, erythematous rashes, rarely - exudative erythema multiforme, anaphylactic shock, angioedema, extremely rarely - exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome). Local reactions: in some cases - phlebitis at the site of intravenous administration. Other: candidiasis, development of superinfection, reversible increase in prothrombin time. Overdose. Symptoms: dysfunction of the gastrointestinal tract and water-electrolyte balance. Treatment: symptomatic. Hemodialysis is effective.

Pharmacodynamics: A combined drug of amoxicillin and clavulanic acid, a beta-lactamase inhibitor. It has a bactericidal effect and inhibits the synthesis of the bacterial wall. 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 strains producing beta-lactamases): Escherichia coli, Proteus mirabilis, Proteus vulgaris, Klebsiella spp., Salmonella spp., Shigella spp., Bordetella pertussis, Yersinia enterocolitica, Gardnerella vaginalis, Neisseria meningitidis, Neisseria gonorrhoeae, Moraxella catarrhalis, Haemophilus influenzae, Haemophilus ducreyi, Yersinia multocida (formerly Pasteurella), Campylobacter jejuni, anaerobic gram-negative bacteria (including beta-lactamase producing strains): Bacteroides spp., including Bacteroides fragilis. Clavulanic acid inhibits types II, III, IV and V beta-lactamases, and is inactive against type I beta-lactamases produced by Enterobacter spp., Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid has a high affinity for penicillinases, due to which it forms a stable complex with the enzyme, which prevents the enzymatic degradation of amoxicillin under the influence of beta-lactamases.

Pharmacokinetics: After oral administration, both components are rapidly absorbed into the gastrointestinal tract. Concomitant food intake does not affect absorption. TCmax - 45 min. After oral administration in doses of 375 and 625 mg, the Cmax of amoxicillin was 3.7 and 6.5 mg/l, respectively, and clavulanic acid was 2.2 and 2.8 mg/l. After intravenous administration in doses of 1200 and 600 mg, the Cmax of amoxicillin was 105.4 and 32.2 μg/ml, respectively, and clavulanic acid was 28.5 and 10.5 μg/ml. Communication with plasma proteins: amoxicillin - 17-20%, clavulanic acid - 22-30%. Both components are metabolized in the liver: amoxicillin - by 10% of the administered dose, clavulanic acid - by 50%. T1/2 after administration at a dose of 375 and 625 mg is 1 and 1.3 hours for amoxicillin, 1.2 and 0.8 hours for clavulanic acid, respectively. T1/2 after intravenous administration at a dose of 1200 and 600 mg is 0.9 and 1.07 hours for amoxicillin, 0.9 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 administered dose of amoxicillin and clavulanic acid are excreted, respectively, unchanged during the first 6 hours after administration.

Special instructions: During the course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver and kidneys. In order to reduce the risk of side effects from the gastrointestinal tract, the drug should be taken with meals. It is possible that superinfection may develop due to the growth of microflora that is insensitive to it, which requires a corresponding change in antibacterial therapy. When prescribed to patients with sepsis, the development of a bacteriolysis reaction (Jarisch-Herxheimer reaction) is possible. In patients who are hypersensitive to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible. Because the 250 and 500 mg amoxicillin and clavulanic acid combination tablets contain the same amount of clavulanic acid (125 mg), 2 250 mg tablets are not equivalent to 1 500 mg tablet. Carefully. Pregnancy, lactation, severe liver failure, gastrointestinal diseases (including a history of colitis associated with the use of penicillins), chronic renal failure.

Interaction: 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) have an antagonistic effect. Increases the effectiveness of indirect anticoagulants (suppressing intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index). When taking anticoagulants simultaneously, it is necessary to monitor blood clotting indicators. Reduces the effectiveness of oral contraceptives, drugs, during the metabolism of which PABA is formed, ethinyl estradiol - the risk of developing breakthrough bleeding. Diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration). Allopurinol increases the risk of developing skin rashes.

Storage conditions: List B

Drug registration number: P No. 016024/01

Date of registration (re-registration) of the drug: 11.11.2004

Rapiklav