Drug Information: Indications, Side Effects, Warnings
Antibiotic, penicillin semisynthetic + beta-lactamase inhibitor
Description of the active substance :
Amoxicillin + Clavulanic acid
The selling Generic AugmentinÂ (Amoxicillin And Clavulanate) is by prescription
lyophilisate for solution for intravenous injection, powder for oral drops [for children] with concentration, powder for solution for intravenous injection, powder for suspension.
Combined formulations of amoxycillin and clavulanic acid, – beta-lactamase inhibitor. Bactericidal effect, inhibits the synthesis of bacterial cell wall. Active against aerobic Gram-positive bacteria (including strains that produce beta-lactamase): 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-lactamase): 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 that produce beta-lactamase): Bacteroides spp., including Bacteroides fragilis. Clavulanic acid inhibits II, III, IV and V types of beta-lactamases, is inactive against beta-lactamase type I, produced by Enterobacter spp., Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid has a high affinity for penicillinases, thereby forming a stable complex with the enzyme, thus preventing the enzymatic degradation under the influence of amoxicillin beta-lactamase.
Bacterial infections caused by susceptible pathogens: upper respiratory tract infection (bronchitis, pneumonia, empyema, lung abscess), infections of upper respiratory tract (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, oophoritis, tubo-ovarian abscess, endometritis, vaginitis bacterial, septic abortion, puerperal sepsis, pelvioperitonit, chancroid, gonorrhea ), infections of the 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.
Hypersensitivity (including cephalosporins and others. Beta-lactam antibiotics), infectious mononucleosis (including when a morbilliform rash) .With caution. Pregnancy, lactation, severe liver failure, gastrointestinal diseases (including a history of colitis associated with the use of penicillins), chronic renal failure.
From the digestive system: nausea, vomiting, diarrhea, abnormal liver function, increased activity of “liver” transaminases, in rare cases – cholestatic jaundice, hepatitis, pseudomembranous colitis. Allergic reactions: rash, erythematous rash, rarely – exudative erythema multiforme, anaphylactic shock, angioedema, rarely – exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome). Local reactions: in some cases – phlebitis at the site / in the introduction. Other: candidiasis, the development of superinfection. Symptoms: impaired function of the gastrointestinal tract and water and electrolyte balance. Treatment: symptomatic. Hemodialysis is ineffective.
Dosage and administration:
Inside (the dose given in terms of amoxicillin) dosing regimen set individually depending on the severity and localization of infection susceptibility. Adults and adolescents over 12 years: 250 mg 3 times a day. In severe infections – 500 mg 3 times daily or 1 g 2 times a day. Children under 12 years – in the form of suspension, syrup or drops for the oral administration, 3 times per day. A single dose is determined depending on the age: for children aged 7-12 years – 250 mg, 2-7 years – 125 mg, 9 months-2 years – 62.5 mg, the multiplicity of purposes – 3 times a day. In severe cases, the dose can be doubled. Dose orally for children 9 months-2 years – 20-40 mg / kg / day in 3 divided doses, for children 2-12 years – 20-50 mg / kg / day in 3 divided doses, depending on the severity of the infection. For children under the age of 9 months oral dose has not been established. When preparing the suspension, syrup and drops as the solvent, use water. When i / in the introduction of adults and adolescents over 12 years of age are administered 1.2 g 3 times a day, if necessary – 4 times a day. The maximum daily dose – For children of 6 months 3 years 12 – 25 mg / kg (30 mg / kg, based on the whole preparation), 3 times a day; in severe cases – 4 times a day; for children up to 3 months: prematurity and perinatal – 30 mg / kg 2 times a day, postperinatalnom period – 25 mg / kg 3 times a day. Duration of treatment – 14 days. To prevent postoperative infection during operations lasting at least 1 h, during induction of anesthesia is administered at a dose of 1.2 g / in. At longer operation – by 1.2 g every six hours during the day. At high risk of infection, administration may be continued for several days. When CRF reduce the frequency of administration depending on the spacecraft. When more than 30 ml of QC / min dose reduction is required; with CC 10-30 ml / min, treatment begins with a / in the introduction of 1.2 g, followed by 600 mg / in or 250-500 mg orally 2 times a day; QC at least 10 ml / min – 1.2 g, and then 600 mg / day in / or 250-500 mg / day orally in a single dose. For children, the dose should be reduced in the same manner. Hemodialysis reduces the concentration of serum in this connection during and after dialysis is additionally introduced 500 mg / in.
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In exchange treatment is necessary to monitor the state functions of blood, liver and kidneys. To reduce the risk of side effects from the gastrointestinal tract should take the drug during meals. Perhaps the development of superinfection due to growth insensitive to it microflora, which requires a corresponding change in antibiotic therapy. In appointing the patients with sepsis may develop bacteriolysis reaction (Jarisch-Herxheimer). In patients with increased sensitivity to penicillin, may be cross-allergic reactions to cephalosporin antibiotics. Since Tablets – amoxicillin and clavulanic acid of 250 500 mg and contain the same amount of clavulanic acid (125 mg), two tablets equivalent to 250 mg 1 tablet 500 mg.
Antacids, glucosamine, laxatives, drugs, aminoglycosides slow down and reduce absorption; Ascorbic acid enhances the absorption. Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) have synergistic effect; bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) – antagonistic. Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index). While receiving anticoagulants must monitor the parameters of blood clotting. Reduces the effectiveness of oral contraceptives, drugs, during the metabolism that produce PABA, ethinyl estradiol – the risk of bleeding “breakthrough.” Diuretics, allopurinol, phenylbutazone, NSAIDs, and others. Drugs that block tubular secretion, increase the concentration of amoxicillin (Clavulanic acid is derived mainly by glomerular filtration). Allopurinol increases the risk of skin rash.
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