Properties
What is it?
AUGMENTIN International name - amoxicillin, clavulanic acid Clinical-pharmacological group - Beta-lactam antibiotics (penicillins and cephalosporins); combined preparations of amoxicillin and clavulanic acid Composition and dosage form Powder for preparation of suspension 200 mg + 28.5 mg: fl. 70 ml Powder for preparation of suspension 400 mg + 57 mg: fl. 70 ml Powder for preparation of suspension: in a 70 ml bottle 5 ml amoxicillin . . . . . . . . . . . 200 mg clavulanic acid (as potassium salt) . . . 28.5 mg Powder for preparation of suspension: in a 70 ml bottle 5 ml amoxicillin . . . . . . . . . . . 400 mg clavulanic acid (as potassium salt) . . . 57 mg Powder for injection: in a package of 10 vials Clinical-pharmacological group Penicillin group inhibitor-protected antibiotic. See blog: AUGMENTIN — What You Need to Know About the Drug for Treating Bacterial Infections Pharmacological properties AUGMENTIN is an inhibitor-protected, broad-spectrum antibiotic of the penicillin group, active against the main Gram-positive and Gram-negative microorganisms causing ambulatory and hospital infections (including beta-lactamase producing strains). Clavulanic acid, included in the preparation, expands the spectrum of antibacterial action of amoxicillin to include microorganisms resistant to other beta-lactam antibiotics. AUGMENTIN is a bactericidal antibiotic active against a wide range of microorganisms. Aerobic Gram-positive microorganisms: Staphylococcus aureus (including beta-lactamase producing strains), Bacillus anthracis*, Corynebacterium species, Enterococcus faecalis*, Enterococcus faecium*, Listeria monocytogenes, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Streptococcus agalactiae, Streptococcus species, Coagulase negative staphylococci* (including Staphylococcus epidermidis); Anaerobic Gram-positive microorganisms: Clostridium species, Peptococcus species, Peptostreptococcus; Aerobic Gram-negative microorganisms: Bordetella pertussis, Brucella species, Escherichia coli*, Gardnerella vaginalis, Haemophilus influenzae*, Helicobacter pylori, Klebsiella species*, Legionella species, Moraxella catarrhalis* (Branhamella catarrhalis), Neisseria gonorrhoeae*, Neisseria meningitidis*, Pasteurella multocida, Proteus mirabilis*, Proteus vulgaris*, Salmonella species*, Shigella species*, Vibrio cholerae, Yersinia enterocolitica*; Anaerobic Gram-negative microorganisms: Bacteroides species* (including Bacteroides fragilis), Fusobacterium species*. Pharmacokinetics Absorption: After oral administration of 625 mg AUGMENTIN, the average Cmax of amoxicillin in blood plasma is 6.5 mg/ml, and for clavulanic acid - 2.8 mg/ml. After intravenous injection of 1.2 g and 600 mg AUGMENTIN, the average Cmax of amoxicillin in plasma is 105.4 mcg/ml and 32.2 mcg/ml, respectively, and for clavulanic acid - 28.5 mcg/ml and 10.5 mcg/ml, respectively. Excretion: The average T1/2 of amoxicillin and clavulanic acid after oral administration of 625 mg AUGMENTIN is 1.3 h and 0.8 h, respectively. Indications Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation: - Acute and chronic bronchitis, lobar pneumonia, bronchopneumonia, pleural empyema, lung abscess; - Skin and soft tissue infections - abscess, cellulitis, wound infection; - Genitourinary system infections - cystitis, urethritis, pyelonephritis, salpingitis, salpingoophoritis, tubo-ovarian abscess, endometritis, bacterial vaginitis, septic abortion, postpartum sepsis, pelvic peritonitis, gonorrhea; - Osteomyelitis; - Sepsis; - Intra-abdominal abscess; - Peritonitis; - Postoperative infections. Intravenous AUGMENTIN is also used for the prevention of postoperative infectious complications in major surgical procedures - gastrointestinal, pelvic, head and neck, cardiovascular, renal, biliary tract, and joint reconstruction. Dosage and administration Determined individually based on the severity of the infectious process, localization of infection, and sensitivity to the pathogen. Adults and children over 12 years of age with mild to moderate infections are prescribed 1 tablet of 625 mg AUGMENTIN twice daily. For severe infections, 1 tablet of 1 g AUGMENTIN is prescribed twice daily. Intravenous injection of 1.2 g AUGMENTIN every 8 hours is also possible. For more severe infections - 1.2 g every 6 hours. The maximum single dose for intravenous injection is 1.2 g, and the maximum daily dose is 7.2 g. For children under 12 years of age, the preparation is prescribed in the form of a suspension. Recommended daily dose: - 25/3.6 mg/kg/day for mild to moderate infections (upper respiratory tract infections, e.g., recurrent tonsillitis, lower respiratory tract infections, and skin and soft tissue infections); - 45/6.4 mg/kg/day for severe infections (upper respiratory tract infections, e.g., otitis media and sinusitis, lower respiratory tract infections, e.g., bronchopneumonia, and urinary tract infections). Dosage for children Children over 2 years of age - 25/3.6 mg/kg/day for mild to moderate infections: - 2-6 years (13-21 kg) 5.0 ml of AUGMENTIN suspension, 228 mg/5 ml, twice daily or 2.5 ml of AUGMENTIN suspension, 457 mg/5 ml, twice daily; - 7-12 years (22-40 kg) 10.0 ml of AUGMENTIN suspension 228 mg/5 ml twice daily or 5.0 ml of AUGMENTIN suspension, 457 mg/5 ml, twice daily. Children over 2 years of age - 45/6.4 mg/kg/day for severe infections: - 2-6 years (13-21 kg) 10.0 ml of AUGMENTIN suspension, 228 mg/5 ml, twice daily or 5.0 ml of AUGMENTIN suspension, 457 mg/5 ml, twice daily; - 7-12 years 10.0 ml of AUGMENTIN suspension, 457 mg/5 ml, twice daily. Dosage for children from 2 months to 2 years In children under 2 years of age, dosing is based on body weight: Weight (kg) AUGMENTIN suspension 25/3.6 g/kg twice daily 45/6.4 mg/kg/day twice daily 2 0.3 0.6 3 0.5 0.8 4 0.6 1.1 5 0.8 1.4 6 0.9 1.7 7 1.1 2.0 8 1.3 2.3 9 1.4 2.5 10 1.6 2.8 11 1.7 3.1 12 1.9 3.4 13 2.0 3.7 14 2.2 3.9 15 2.3 4.2 In children from 3 months to 12 years, the recommended single dose of intravenous AUGMENTIN is 30 mg/kg body weight every 8 hours; for more severe infections, it is administered every 6 hours. In premature infants under 3 months of age, it is administered at 30 mg/kg every 12 hours; in full-term newborns in the perinatal period - every 8 hours. Prolonging the course of treatment for more than 14 days without a doctor's recommendation is not advised. Prevention of postoperative complications in surgery: If the surgery lasts less than 1 hour, 1.2 g AUGMENTIN is administered intravenously during induction of anesthesia. For longer surgical interventions, 1.2 g is administered 4 times daily for 24 hours. If the risk of developing infection is particularly high, the above dosage regimen may be continued for several additional days. Patients with moderate to severe renal insufficiency require dose adjustment of AUGMENTIN: Adults Mild insufficiency (creatinine clearance >30 ml/min) - no dose adjustment required. Moderate insufficiency (creatinine clearance 10-30 ml/min) - 1.2 g I.V. followed by 600 mg I.V. every 12 hours. Severe insufficiency (creatinine clearance Children Similar dose adjustment (reduction) is permissible in children. Side effects Gastrointestinal tract: rarely – dyspepsia, nausea, vomiting, diarrhea; isolated cases of liver function impairment, hepatitis, and cholestatic jaundice have been reported. Isolated cases of pseudomembranous colitis have also been reported. Allergic reactions: rarely – urticaria, Quincke's edema; very rarely – erythema multiforme, anaphylactic shock, angioneurotic edema, Stevens-Johnson syndrome, exfoliative dermatitis. CNS: headache. Side effects caused by the biological action of the preparation: rarely – candidiasis and other types of superinfection. Local reactions: in rare cases, phlebitis may develop at the injection site. Contraindications Hypersensitivity to penicillins, cephalosporins, other beta-lactam antibiotics, and other components of the preparation. Pregnancy and lactation There is limited information on the use of AUGMENTIN in pregnant women. As with all other preparations, it is advisable to avoid taking the preparation during pregnancy, especially in the first trimester. The administration of AUGMENTIN during lactation is recommended, provided, of course, that the risk of developing hypersensitivity due to the excretion of even small amounts of the preparation in milk is excluded. Embryotoxic and teratogenic effects of the preparation have not been established. Special instructions Intravenous AUGMENTIN should be used with caution in patients with impaired liver function. In case of urticaria and erythematous rash, it is recommended to discontinue the preparation. To reduce potential gastrointestinal side effects, it is recommended to take the preparation before meals. Overdose Treatment: Symptomatic therapy is recommended. AUGMENTIN is eliminated from the body by hemodialysis. Drug interactions Intravenous AUGMENTIN is less stable in infusion solutions containing glucose, dextrans, and bicarbonates. Mixing intravenous AUGMENTIN with blood-containing products and other protein-containing fluids, such as protein hydrolysates or intravenous lipid emulsions, is not recommended. When AUGMENTIN is administered with aminoglycosides, the antibiotics should not be mixed in the same syringe to avoid reducing the effectiveness of aminoglycosides. Storage conditions and expiry dates The preparation should be stored in a dry place at a temperature not exceeding 25°C.