Augmentin 625mg (500mg + 125mg) Tablet No. 14 (2X7)

International name – amoxicillin, clavulanic acid
ATC classification code – JO1CR02

Clinico-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 syrup preparation 200 mg. + 28.5 mg: fl. 70 ml
Powder for syrup preparation 400 mg. + 57 mg: fl. 70 ml

Tablets: 14 pcs. in a pack
1 tab.
Amoxicillin. . . . . . . . . . . .500 mg
Clavulanic acid
(as potassium salt) . . . 125 mg
Tablets: 14 pcs. in a pack
1 tab.
Amoxicillin. . . . . . . . . . . . 875 mg
Clavulanic acid
(as potassium salt) . . . .125 mg
Powder for syrup preparation: 70 ml bottle
5 ml
Amoxicillin. . . . . . . . . . . . 200 mg
Clavulanic acid
(as potassium salt) . . . 28.5 mg
Powder for syrup preparation: 70 ml in a vial
5 ml
Amoxicillin. . . . . . . . . . . . 400 mg
Clavulanic acid
(as potassium salt) . . . 57 mg
Powder for injection: 10 fl. in a pack
1 fl.
Amoxicillin. . . . . . . . . . . . 1000 mg
Clavulanic acid
(as potassium salt) . . . . 200 mg
Clinical-pharmacological group
Inhibitor-protected antibiotic of the penicillin group.
Pharmacological properties
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) that cause ambulatory and hospital infections. The clavulanic acid contained in the drug expands the spectrum of antibacterial activity of amoxicillin, including microorganisms that are resistant to other beta-lactam antibiotics.
Augmentin is a bactericidal antibiotic that is 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 of Augmentin, the mean Cmax of amoxicillin in 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 mean 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 following oral administration of 625 mg of Augmentin is 1.3 hours and 0.8 hours, respectively.
Indications
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;
– genitourinary tract infections – cystitis, urethritis, pyelonephritis, salpingitis, salpingoophoritis, tubo-ovarian abscess, endometritis, bacterial vaginitis, septic abortion, postpartum sepsis, pelvioperitonitis, gonorrhea;
– osteomyelitis;
– sepsis;
– intra-abdominal abscess;
– peritonitis;
– postoperative infections.
Intravenous Augmentin is also used to prevent postoperative infectious complications following major surgical procedures – gastrointestinal, pelvic, head and neck, cardiovascular, renal, biliary tract, and joint reconstruction.
The dosage and administration regimen are determined individually depending on the severity of the infectious process, the location of the infection and the sensitivity of the pathogen. Adults and children over 12 years of age are prescribed 625 mg of Augmentin 1 tablet 2 times a day for mild to moderate infections. In severe infections, one tablet of 1 g of Augmentin is prescribed 2 times a day. It is also possible to administer 1.2 g of Augmentin intravenously every 8 hours. In 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.
Children under 12 years of age are prescribed the drug in syrup form.
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 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 of Augmentin syrup 228 mg/5 ml 2 times a day or 5.0 ml of Augmentin syrup, 457 mg/5 ml, 2 times a day.
Children over 2 years old _ 45/6.4 mg/kg/day for severe infections: – 2-6 years (13-21 kg) 10.0 ml of Augmentin syrup, 228 mg/5 ml, 2 times a day or 5.0 ml of Augmentin syrup, 457 mg/5 ml, 2 times a day;
– 7-12 years 10.0 ml of Augmentin syrup, 457 mg/5 ml, 2 times a day. Dosage for children from 2 months to 2 years
Dosing for children under 2 years of age is based on body weight:

Augmentin Syrup

45

6.4 mg/kg/day twice daily

The recommended single dose of intravenous Augmentin in children aged 3 months to 12 years is 30 mg/kg of body weight every 8 hours; in more severe infections, it is administered every 6 hours.
Premature infants up to 3 months of age are administered 30 mg/kg every 12 hours; and in normal newborns of the perinatal period – every 8 hours. Extension of the course of treatment beyond 14 days without a doctor’s recommendation is not recommended.
Prevention of postoperative complications in surgery: If the operation lasts less than 1 hour, 1.2 g of Augmentin is administered intravenously during induction of anesthesia. For longer surgical interventions, 1.2 g is administered 4 times a day for 24 hours. If the risk of infection is particularly high, the above dosage regimen may be continued for several additional days.
Patients with moderate and severe renal insufficiency require Augmentin dosage adjustment:
Adults
Mild insufficiency (creatinine clearance
30 ml/min) – no dosage adjustment is required. Moderate insufficiency (creatinine clearance 10-30 ml/min) – 1.2 g I.V. then 600 mg I.V. every 12 hours.
Severe renal failure (creatinine clearance <10 ml/min) – 1.2 g IV then 600 mg IV every 24 hours. Dialysis reduces the concentration of Augmentin in the blood serum and therefore an additional dose of Augmentin – 600 mg IV – is required during the dialysis process and after the end of dialysis.
Children
A similar dose adjustment (reduction) is also permissible in children.
Side effects
Gastrointestinal tract: rarely – dyspepsia, nausea, vomiting, diarrhea; isolated cases of liver dysfunction, hepatitis and cholestatic jaundice have been described. Isolated cases of pseudomembranous colitis have also been described.
Allergic reactions: rarely – urticaria, angioedema; very rarely – erythema multiforme, anaphylactic shock, angioedema, Stevens-Johnson syndrome, exfoliative dermatitis.
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.
Contraindications: Hypersensitivity to penicillins, cephalosporins, other beta-lactam antibiotics, or any of the excipients.
Pregnancy and lactation
There is limited information on the use of Augmentin in pregnant women. As with all medicines, it is preferable to avoid taking the drug during pregnancy, especially in the first trimester.
The use of Augmentin during lactation is recommended, provided that the risk of hypersensitivity caused by the excretion of small amounts of the drug in milk has been excluded. The embryotoxic and teratogenic effects of the drug have not been established.
Special instructions
Intravenous Augmentin should be used with caution in patients with impaired liver function.
In case of development of urticaria and erythematous rash, discontinuation of the drug is recommended.
To reduce potential gastrointestinal side effects, it is recommended to take the drug before meals.
Overdose
Treatment: Symptomatic therapy is recommended. Augmentin is removed from the body by hemodialysis.
Interactions with other drugs
Intravenous Augmentin is less stable in infusion solutions containing glucose, dextrans, and bicarbonates. Mixing intravenous Augmentin with blood products and other protein-containing fluids, such as protein hydrolysates or intravenous lipid emulsions, is not recommended. When prescribing Augmentin with aminoglycosides, antibiotics should not be mixed in the same syringe to avoid reducing the effectiveness of the aminoglycosides.
Storage conditions and deadlines
The drug should be stored in a dry place at a temperature not exceeding 25°C.

Country of manufacture: Great Britain