Rapiklav tablets 500 + 125mg, No. 15

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

• ENT infections (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, salpingo-oophoritis, endometritis, septic abortion, pelvioperitonitis);

• infections of bones and joints (including chronic osteomyelitis);

• infections of the skin and soft tissues (including phlegmon, wound infection);

• biliary tract infections (cholecystitis, cholangitis);

• sexually transmitted diseases (gonorrhea, chancroid);

• odontogenic infections.

The tablets should be taken orally with meals, without chewing, with a little water.

For adults and children over 12 years old (or weighing more than 40 kg), the average dose for the treatment of infections of mild to moderate severity is 1 tab. 250 mg / 125 mg 3 times / day.

For severe infections, 2 tablets are prescribed. 250 mg / 125 mg 3 times / day or 1 tab. 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 of body weight for children. The maximum daily dose of amoxicillin is 6 g for adults and 45 mg / kg of body weight for children. The course of treatment is 5-14 days and is set individually depending on the clinical situation. The drug should not be taken for more than 14 days without a second medical examination.

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

With renal failure and QC 10-30 ml / min, the drug is prescribed 1 tab. 500 mg / 125 mg every 12 hours, with CC less than 10 ml / min - 1 tab. 500 mg / 125 mg every 24 hours. In case of anuria, the interval between taking the drug should be increased to 48 hours or more.

Coated tablets from white to almost white, oval.

1 tab.

amoxicillin (in the form of trihydrate)

clavulanic acid (in the form of potassium salt)

Excipients: colloidal silicon dioxide, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, dibutyl phthalate, purified talc, titanium dioxide, isopropanol, methylene chloride.

• infectious mononucleosis (including with a measles-like rash);

• hypersensitivity to the components of the drug, to cephalosporins and other beta-lactam antibiotics.

• The drug is prescribed with caution to patients with severe hepatic impairment, gastrointestinal diseases (including with a history of colitis associated with the use of penicillins), with chronic renal failure.

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 ?-lactamases (II, III, IV, V type; in relation to type I, it is inactive). Clavulanic acid forms a stable inactivated complex with these enzymes and prevents the loss of the antibacterial activity of amoxicillin caused by the production of ?-lactamases by both the main pathogens and co-pathogens and opportunistic microorganisms. This combination provides Rapiklav's high bactericidal activity. The drug has a wide spectrum of antibacterial action. Active against amoxicillin-sensitive and ?-lactamase-producing strains of gram-positive aerobes: Streptococcus pneumoniae, Streptococcus pyogenes,Streptococcus viridans, Streptococcus bovis, Staphylococcus aureus (except for methicillin-resistant strains), Staphylococcus epidermidis (except for methicillin-resistant 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. spp., Vibriocholerae, Yersenia enterocolitica; anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Actinimyces israelli.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. spp., Vibriocholerae, Yersenia enterocolitica; anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Actinimyces israelli.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. spp., Vibriocholerae, Yersenia enterocolitica; anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Actinimyces israelli.Shigella spp., Vibriocholerae, Yersenia enterocolitica; anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Actinimyces israelli.Shigella spp., Vibriocholerae, Yersenia enterocolitica; anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Actinimyces israelli.

Pharmacokinetics

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

Suction

Both components are well absorbed from the gastrointestinal tract after oral administration, food intake does not affect the degree of absorption. Cmax of active substances in plasma are 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, palatine tonsils, muscle tissue, gallbladder, sinuses, saliva and bronchial secretions. Amoxicillin and clavulanic acid do not penetrate the BBB with non-inflamed meninges, 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 metabolized in part, clavulanic acid undergoes, apparently, intensive metabolism.

Withdrawal

Amoxicillin is excreted by the kidneys practically unchanged by tubular secretion and glomerular filtration. Clavulanic acid is excreted by glomerular filtration, partly in the form of metabolites. Small amounts can 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 up to 4.5 hours for clavulanic acid. Both substances are removed during hemodialysis, with peritoneal dialysis - insignificantly.

Side effect

From the digestive system: nausea, vomiting, diarrhea, abnormal liver function, increased activity of hepatic transaminases; in isolated cases - cholestatic jaundice, hepatitis, pseudomembranous colitis. Allergic reactions: urticaria, erythematous rash; rarely - erythema multiforme, anaphylactic shock, Quincke's edema, Stevens-Johnson syndrome; extremely rare - exfoliative dermatitis. Local reactions: in some cases - phlebitis at the intravenous injection site. Others: candidiasis, development of superinfection, reversible increase in prothrombin time.

Application during pregnancy and lactation

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

Application for violations of liver function

The drug is prescribed with caution to patients with severe hepatic impairment.

Application for impaired renal function

The drug is prescribed with caution to patients with chronic renal failure.

Application in children

For children over 12 years old (or weighing more than 40 kg), the average dose for the treatment of infections of mild to moderate severity is 1 tab. 250 mg / 125 mg 3 times / day.

special instructions

During the course of treatment, it is necessary to monitor the 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. The development of superinfection due to the growth of microflora insensitive to the drug is possible, which requires a corresponding change in antibiotic therapy. When prescribing the drug to patients with sepsis, the development of a bacteriolysis reaction (Jarisch-Heixheimer reaction) is possible. In patients with hypersensitivity to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible. Taking Rapiklav 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, symptomatic therapy is performed. Hemodialysis is effective.

Drug interactions

When taken simultaneously with Rapiklav, 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 Rapiklav; bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonistic. With the simultaneous use of Rapiklav increases the effectiveness of indirect antigoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index). The use of such a combination requires monitoring blood clotting parameters. With the simultaneous use of Rapiklav reduces the effectiveness of oral contraceptives, ethinyl estradiol,medicines, in the process of metabolism of which paraminobenzoic acid is formed. With the simultaneous use of diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion, increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration). When used simultaneously with Rapiklav, allopurinol increases the risk of developing skin rashes.