International name – amoxicillin, clavulanic acid
Classification code – JO1CR02
clinical-pharmacological group – beta-lactam antibiotics (penicillins and cephalosporins); Combined preparations of amoxicillin and clavulanic acid
Composition and release form
Tab. 500 mg + 125 mg: 14 pcs.
Tab. 875 mg + 125 mg: 14
Powder for preparation of syrup 200 mg. + 28.5 mg: fl. 70 ml
Powder for preparation of syrup 400 mg. + 57 mg: fl. 70 ml
Tablets: 14 pcs in a package.
Amoxicillin. . . . . . . . . . . .500 mg
(in the form of potassium salt). . . 125 mg
Tablets: 14 pcs in a package.
Amoxicillin. . . . . . . . . . . . 875 mg
(in the form of potassium salt). . . .125 mg
Powder for preparation of syrup: 70 ml in a bottle
Amoxicillin. . . . . . . . . . . . 200 mg
(in the form of potassium salt). . . 28.5 mg
Powder for preparation of syrup: 70 ml in a bottle
Amoxicillin. . . . . . . . . . . . 400 mg
(in the form of potassium salt). . . 57 mg
Powder for injection: 10 fl.
Amoxicillin. . . . . . . . . . . . 1000 mg
(in the form of potassium salt). . . . 200 mg
An inhibitor-protected antibiotic of the penicillin group.
Augmentin is an inhibitor-protected broad-spectrum antibiotic of the penicillin group, which is active against the main gram-positive and gram-negative microorganisms (including beta-lactamase-producing strains) causing ambulatory and hospital infections. Clavulanic acid included in the preparation expands the spectrum of antibacterial action of amoxicillin to include microorganisms that are resistant to other beta-lactam antibiotics.
Augmentin is a bactericidal antibiotic active against a wide range of microorganisms. Aerobic gram-positive microorganisms: Staphylococcus aureaus (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*.
Absorption: After oral administration of 625 mg of Augmentin, the average value of 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 of augmentin, the average Cmax of amoxicillin in plasma is 105.4 μg/ml and 32.2 μg/ml, respectively, and for clavulanic acid – 28.5 μg/ml and 10.5 μg/ml, respectively .
Elimination: The mean T1/2 of amoxicillin and clavulanic acid after oral administration of 625 mg of Augmentin is 1.3 h and 0.8 h, respectively.
Infectious-inflammatory diseases caused by microorganisms sensitive to the drug:
– acute and chronic bronchitis, lobar pneumonia, bronchopneumonia, pleural empyema, lung abscess;
– skin and soft tissue infections – abscess, cellulitis, wound infection;
– infections of the genitourinary system – cystitis, urethritis, pyelonephritis, salpingitis, salpingo-oophoritis, tubo-ovarian abscess, endometritis, bacterial vaginitis, septic abortion, postpartum sepsis, pelvioperitonitis, gonorrhea;
– intra-abdominal abscess;
– Postoperative infections.
Intravenous Augmentin is also used to prevent postoperative infectious complications of major surgical procedures – gastrointestinal, pelvic, head and neck, cardiovascular, renal, biliary tract and joint reconstruction.
Administration rules and dosages
It is determined individually depending on the severity of the infectious process, localization of the infection and sensitivity to the cause. Adults and children over 12 years of age are prescribed 625 mg Augmentin 1 tablet 2 times a day for mild and moderate infections. In case of severe infections, one tablet of 1 g of Augmentin is prescribed 2 times a day. It is also possible to inject 1.2 g of Augmentin intravenously every 8 hours. In case of more severe infections – 1.2 g every 6 hours. During intravenous injection, the maximum single dose is 1.2 g, and the maximum daily dose is 7.2 g.
For children under 12 years of age, the drug is prescribed as a syrup.
Recommended daily dose:
– 25/3.6 mg/kg/day for mild to moderate infections (upper respiratory tract infections, eg recurrent tonsillitis, lower respiratory tract infections and skin and soft tissue infections);
– 45/6.4 mg/kg/day in severe infections (upper respiratory tract infections, eg, otitis media and sinusitis, lower respiratory tract infections – eg, bronchopneumonia, and urinary tract infections).
Dosage for children Children over 2 years of age _ 25/3.6 mg/kg/day for mild and moderate infections:
– 2-6 years (13-21 kg) 5.0 ml of augmentin syrup, 228 mg/5 ml, 2 times a day or 2.5 ml of augmentin syrup, 457 mg/5 ml, 2 times a day;
– 7-12 years (22-40 kg) 10.0 ml Augmentin syrup 228 mg/5 ml 2 times a day or 5.0 ml Augmentin syrup 457 mg/5 ml 2 times a day.
Children over 2 years _ 45/6.4 mg/kg/day in severe infections: – 2-6 years (13-21 kg) 10.0 ml Augmentin syrup, 228 mg/5 ml, 2 times a day or 5.0 ml Augmentin syrup, 457 mg/5 ml, 2 times a day;
– 7-12 years 10.0 ml Augmentin syrup, 457 mg/5 ml, 2 times a day. Dosage for children from 2 months to 2 years
For children under 2 years of age, the dosage is based on body weight:
|25/3.6 g/kg twice a day||45/6.4 mg/kg/day twice daily|
In children aged 3 months to 12 years, the recommended single dose of intravenous Augmentin is 30 mg/kg of body weight every 8 hours; In case of more severe infections, it is prescribed every 6 hours.
Premature children under 3 months of age are prescribed 30 mg/kg every 12 hours; And in normal newborns of the perinatal period – every 8 hours. It is not recommended to extend the course of treatment for more than 14 days without a doctor’s recommendation.
Prevention of postoperative complications in surgery: if the operation lasts less than 1 hour, 1.2 g of Augmentin is administered intravenously during the induction of anesthesia. During a longer operation, 1.2 g is prescribed 4 times a day for 24 hours. If the risk of infection is particularly high, the above dosing regimen may be continued for several additional days.
Patients with moderate and severe renal failure require Augmentin dosage adjustment:
Mild insufficiency (creatinine clearance >30 ml/min) – do not require dose correction. Moderate failure (creatinine clearance 10-30 ml/min) – 1.2 g I.V. Then 600 mg I.V. Kovel in 12 hours.
Severe insufficiency (creatinine clearance <10 ml/min) – 1.2 g I.V. Then 600 mg I.V. Kovel in 24 hours. Dialysis reduces the concentration of Augmentin in the blood serum and therefore the additional dose of Augmentin – 600 mg I.V. – Appointment is required during dialysis and after dialysis.
A similar dose correction (reduction) is also allowed in children.
Gastrointestinal tract: rarely – dyspepsia, nausea, vomiting, diarrhea; Individual cases of liver dysfunction, hepatitis and cholestatic jaundice have been described. Single cases of pseudomembranous colitis have also been described.
Allergic reactions: rarely – urticaria, Quincke’s edema; Very rarely – erythema multiforme, anaphylactic shock, angioedema, Stevens-Johnson syndrome, exfoliative dermatitis.
On the part of the CNS: headache.
Side effects caused by the biological action of the drug: rarely – candidiasis and other types of superinfection.
Local reactions: in rare cases, phlebitis may develop at the injection site.
Hypersensitivity to penicillins, cephalosporins, other beta-lactam antibiotics and other components of the drug.
Pregnancy and lactation
Little information is available on the use of Augmentin in pregnant women. Like all other drugs, it is advisable to avoid taking the drug during pregnancy, especially in the first trimester.
The appointment of Augmentin during lactation is recommended, if, of course, the risk of developing hypersensitivity caused by the excretion of the smallest amount of the drug in milk has been excluded. The embryotoxic and teratogenic effect of the drug has not been established.
Intravenous augmentin should be used with caution in patients with impaired liver function.
In case of development of urticaria and erythematous rash, it is recommended to stop taking the drug.
To reduce potential gastrointestinal side effects, it is recommended to take the drug before meals.
Treatment: symptomatic therapy is recommended. Augmentin is removed from the body through hemodialysis.
Interaction with other drugs
Intravenous Augmentin is less stable in infusion solutions containing glucose, dextrans and bicarbonates. Mixing of intravenous Augmentin with blood products and other protein-containing fluids such as protein hydrolysates or intravenous lipid emulsions is not recommended. When Augmentin is prescribed with aminoglycosides, antibiotics should not be mixed in one syringe to avoid reducing the effectiveness of aminoglycosides.
Storage conditions and terms
The drug is stored in a dry place at a temperature of no more than 25°C.
Country of manufacture