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Rapiclav 500mg+125mg 15 pcs. film-coated tablets

pharmachologic effect

The antibacterial drug is a combination of amoxicillin, a semi-synthetic penicillin with a wide spectrum of antibacterial activity, and clavulanic acid, an irreversible inhibitor of β-lactamases (types II, III, IV, V; inactive against type I).
Clavulanic acid forms a stable inactivated complex with these enzymes and prevents the loss of antibacterial activity of amoxicillin caused by the production of β-lactamases by both the main pathogens and co-pathogens, and opportunistic microorganisms. This combination provides high bactericidal activity of Rapiclav. Active in relation to amoxicillin sensitive and producing β-lactamas of strains of gram-positive aerobes: Streptococcus pneumoniae, Streptococcus pyogenes, streptococcus viridans, streptococcus bovis, staphylococcus au REUS (except for methicillin-resistant strains), Staphylococcus epidermidis (except for methysillin-resisted strains), 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., Shig ella spp., Vibriocholerae, Yersenia enterocolitica; anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Actinimyces israelli.

Composition and release form Rapiclav 500 mg + 125 mg 15 pcs. film-coated tablets

Tablet - 1 tablet:

Active substance: amoxicillin (in the form of trihydrate) 500 mg, clavulanic acid (in the form of potassium salt) 125 mg;
Excipients: colloidal silicon dioxide, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, dibutyl phthalate, purified talc, titanium dioxide, isopropanol, methylene chloride.

3 tablets per blister pack (5) - 15 pcs. 5 blister packs, along with instructions for use, are placed in a cardboard pack.

Description of the dosage form

White to almost white film-coated tablets, oval.

Directions for use and doses

For adults and children over 12 years of age (or with a body weight of more than 40 kg), the average dose for the treatment of mild to moderate infections is 0.5 tablets. 250 mg/125 mg 3 times/day.

For severe infections, 1 tablet is prescribed. 500 mg/125 mg 3 times/day.

The maximum daily dose of clavulanic acid (in the form of potassium salt) is 600 mg for adults and 10 mg/kg body weight for children.

The maximum daily dose of amoxicillin is 6 g for adults and 45 mg/kg body weight for children.

The course of treatment is 5-14 days and is determined individually depending on the clinical situation. The drug should not be taken for more than 14 days without repeated medical examination.

For odontogenic infections, the drug is prescribed 1 tablet. 500 mg/125 mg every 12 hours for 5 days.

In case of renal failure and CC 10-30 ml/min, the drug is prescribed 1 tablet. 500 mg/125 mg every 12 hours, with CC less than 10 ml/min - 1 tablet. 500 mg/125 mg every 24 hours.

For anuria, the interval between taking the drug should be increased to 48 hours or more.

Pharmacokinetics

The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar.

Suction.

Both components are well absorbed from the gastrointestinal tract after taking the drug orally; food intake does not affect the degree of absorption. Cmax of active substances in plasma is determined approximately 1 hour after oral administration.

Distribution.

Both components are characterized by good Vd and are distributed in body fluids and tissues (including the lungs, middle ear, pleural and peritoneal fluids, uterus, ovaries). Amoxicillin also penetrates into the synovial fluid, liver, prostate gland, tonsils, muscle tissue, gall bladder, paranasal sinus secretions, saliva and bronchial secretions.

Amoxicillin and clavulanic acid do not penetrate the BBB when the meninges are not inflamed, but penetrate the placental barrier and are excreted in breast milk in trace concentrations.

Plasma protein binding of amoxicillin and clavulanic acid is low.

Metabolism.

Amoxicillin is partially metabolized, clavulanic acid appears to be extensively metabolized.

Excretion.

Amoxicillin is excreted by the kidneys almost unchanged by tubular secretion and glomerular filtration. Clavulanic acid is excreted by glomerular filtration, partly in the form of metabolites. Small amounts may be excreted through the intestines and lungs. T1/2 of amoxicillin and clavulanic acid is 1-1.5 hours.

Pharmacokinetics in special clinical situations.

In patients with severe renal failure, T1/2 increases to 7.5 hours for amoxicillin and to 4.5 hours for clavulanic acid.

Both substances are removed during hemodialysis, but only slightly during peritoneal dialysis.

Indications for use Rapiclav 500mg+125mg 15 pcs. film-coated tablets

Treatment of infectious and inflammatory diseases caused by pathogens sensitive to the drug combination:

Infections of the ENT organs (acute and chronic sinusitis, acute and chronic otitis media, tonsillitis, pharyngitis);
respiratory infections (acute and chronic bronchitis and pneumonia, pleural empyema);
urinary tract infections (including cystitis, urethritis, pyelonephritis);
gynecological infections (including salpingitis, salpingoophoritis, endometritis, septic abortion, pelvioperitonitis);
infections of bones and joints (including chronic osteomyelitis);
infections of the skin and soft tissues (including cellulitis, wound infection);
biliary tract infections (cholecystitis, cholangitis);
sexually transmitted diseases (gonorrhea, chancroid);
odontogenic infections.

Contraindications

Infectious mononucleosis (including with measles-like rash);
hypersensitivity to the components of the drug, to cephalosporins and other beta-lactam antibiotics.

Effect on the body

The drug has a wide spectrum of antibacterial action.

Application Rapiclav 500mg+125mg 15 pcs. film-coated tablets during pregnancy and breastfeeding

The drug should be prescribed with caution during pregnancy and lactation (breastfeeding).

special instructions

During a course of treatment, it is necessary to monitor indicators of the state of the hematopoietic system, liver and kidney function.

In order to reduce the risk of side effects from the gastrointestinal tract, the drug should be taken with meals.

Superinfection may develop due to the growth of microflora insensitive to the drug, which requires a corresponding change in antibacterial therapy.

When prescribing the drug to patients with sepsis, a bacteriolysis reaction (Jarisch-Heixheimer reaction) may develop.

In patients who are hypersensitive to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible.

Taking Rapiclav leads to the appearance of amoxicillin in the urine. High concentrations of amoxicillin give a false-positive reaction to urine glucose when using Benedict's reagent or Felling's solution. It is recommended to carry out enzymatic reactions with glucose oxidase.

Overdose

Symptoms: dysfunction of the gastrointestinal tract and water-electrolyte balance.

Treatment: if necessary, carry out symptomatic therapy. Hemodialysis is effective.

Side effects Rapiclav 500mg+125mg 15 pcs. film-coated tablets

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 - erythema multiforme, anaphylactic shock, Quincke's edema, Stevens-Johnson syndrome; extremely rarely - exfoliative dermatitis.

Local reactions: in some cases - phlebitis at the site of intravenous administration.

Other: candidiasis, development of superinfection, reversible increase in prothrombin time.

Drug interactions

When taken simultaneously with Rapiclav, antacids, glucosamine, laxatives, aminoglycosides slow down and reduce the absorption of active substances; ascorbic acid increases their absorption.

When used together, bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) have a synergistic effect with Rapiclav; bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonistic.

With simultaneous use, Rapiclav increases the effectiveness of indirect antigoagulants (by suppressing intestinal microflora, reducing the synthesis of vitamin K and the prothrombin index). The use of such a combination requires monitoring of blood clotting parameters.

With simultaneous use, Rapiclav reduces the effectiveness of oral contraceptives, ethinyl estradiol, and drugs during the metabolism of which paraminobenzoic acid is formed.

With simultaneous use of diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion, they increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).

When used simultaneously with Rapiclav, allopurinol increases the risk of developing a skin rash.

Rapiklav

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

Rapiclav tablet p o 500 mg + 125 mg core x15