Pharmacological action: Combined preparation of amoxicillin and clavulanic acid, a beta - lactamase inhibitor. Bactericidal, inhibits synthesis of bacterial walls. 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 strains producing beta-lactamases): Bacteroides spp. including Bacteroides fragilis. Clavulanic acid inhibits II, III, IV and V types of beta-lactamases, inactive against beta-lactamase type I, produced by Enterobacter spp. Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid has a high affinity for penicillinase, thereby forms a stable complex with the enzyme, so it prevents the enzymatic degradation of amoxicillin under the influence of beta-lactamases. Indications: Bacterial infections caused by sensitive pathogens: infections of the upper respiratory tract (bronchitis, pneumonia, empyema, lung abscess), infections of ENT-organs (sinusitis, tonsillitis, otitis media), infections of the biliary tract (cholangitis, cholecystitis), intestinal infections (dysentery, salmonellosis, Salmonella carrier), infections of the genitourinary system and the pelvic organs (pyelonephritis, pyelitis, cystitis, urethritis, prostatitis, cervicitis, salpingitis, salpingo-oophoritis, tubo-ovarian abscess, endometritis, bacterial vaginitis, septic abortion, puerperal sepsis, pelvioperitonit, chancroid, gonorrhoea, infections of skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses, abscess, cellulitis, wound infection), osteomyelitis, endocarditis, meningitis, sepsis, peritonitis, postoperative infection, prevention of infections in surgery.
Contraindications: Hypersensitivity (W. to cephalosporins and other beta-lactam antibiotics), infectious mononucleosis (including the appearance of a morbilliform rash).C caution. Pregnancy, lactation, severe liver failure, gastrointestinal diseases (including colitis in history, associated with the use of penicillins), ESRD. Side effects: Digestive system: nausea, vomiting, diarrhea, liver dysfunction, increased activity of "liver" transaminases, in a few cases - cholestatic jaundice, hepatitis, pseudomembranous colitis. Allergic reactions: urticaria, erythematous rash, rarely - erythema multiform, anaphylactic shock, angioedema, rarely, exfoliative dermatitis, malignant exudative erythema (syndrome Stevens-Johnson). Local reactions: in some cases, phlebitis in place on/in the introduction. Other: candidiasis, development of superinfection, reversible increase in prothrombin time.Overdose. Symptoms: impaired gastrointestinal function and water and electrolyte balance. Treatment: symptomatic. Hemodialysis is effective. The way of application and dose: Inside (doses are given in terms of amoxicillin), the mode set individually, depending on the severity and localization of infection susceptibility. Adults and adolescents over 12 years appoint 250 mg 3 times a day. In severe infections - 500 mg 3 times a day or 1 g 2 times a day. Children under 12 years - in the form of suspension, syrup or drops for oral administration, 3 times per day. Single dose is determined depending on age: for children aged 7-12 years - 250 mg, 2-7 years - 125 mg, 9 months-2 years: 62.5 mg, the multiplicity of the destination to 3 times a day. In severe cases the dose can be doubled. Dose in oral administration for children 9 months to 2 years - 20-40 mg/kg/day in 3 divided doses, for children 2-12 years of age - 20-50 mg/kg/day in 3 divided doses depending on severity of the infection. For children under the age of 9 months dose for oral intake is not installed. When preparing the suspension, syrup and drops as the solvent use water. When in/with the introduction of adults and adolescents over 12 years is administered 1.2 g 3 times a day, if necessary to 4 times a day. The maximum daily dose of 6 g. For children 3 months-12 years - 25 mg/kg (30 mg/kg based on the total preparation) 3 times a day; in severe cases - 4 times daily; for children under 3 months: prematurity and perinatal period of 30 mg/kg 2 times a day, in postperinatal period - 25 mg/kg 3 times a day. Duration of treatment - 14 days.
For the prevention of postoperative infections in operations lasting less than 1 h, during induction of anesthesia is administered at a dose of 1.2 g/in. For longer operations - 1.2 g every 6 h during the day. At high risk of infection, the administration may be continued for several days. When CKD reduce the frequency of administration according to the QC. When CC than 30 ml/min dose reduction is not required; when QC 10-30 ml/min, the treatment is started with the/in the 1.2 g, followed by 600 mg IV or 250-500 mg orally 2 times a day; when KK less 10 ml/min - 1.2 g, followed by 600 mg/day or 250-500 mg/day orally in one dose. For children the dose should be reduced in the same way. Hemodialysis decreases the concentration in the serum, therefore, during and at the end of dialysis is additionally administered at 500 mg/in.Special instructions: In exchange treatment is necessary to carry out monitoring functions of the blood, liver and kidneys. To reduce the risk of adverse effects
from the digestive tract to take the drug with food. The development of superinfection due to the growth insensitive to the hair, which requires a corresponding change in antibiotic therapy. In appointing patients with sepsis may develop reactions of bacteriolysis (reaction Arisa-'s). In patients with hypersensitivity to penicillins, possible cross-allergic reactions to cephalosporin antibiotics. Because pills is the combination of amoxicillin and clavulanic acid 250 and 500 mg contain the same amount of clavulanic acid (125 mg), 2 tablets of 250 mg is not equivalent to 1 tablet of 500 mg. Interaction: Antacids, glucosamine, laxatives drugs, aminoglycosides slow down and reduce absorption; ascorbic acid increases the absorption. Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) have a synergistic effect; bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonism. Increases the efficiency of indirect anticoagulants (inhibiting intestinal microflora, reduces the synthesis of vitamin K and prothrombin index). While receiving anticoagulants should monitor the blood clotting factors. Reduces the effectiveness of oral contraceptives, drugs, in the process of metabolism which produce PABA, ethinyl estradiol is the risk of bleeding breakthrough. Diuretics, allopurinol, phenylbutazone, NSAIDs, etc. drugs that block tubular secretion, increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration). Allopurinol increases the risk of skin rash.