Instructions for use AUGMENTIN®
Before starting treatment with amoxicillin/clavulanic acid, it is necessary to obtain a detailed history regarding previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam antibiotics (see sections “Contraindications” and “Side effects”).
Serious, sometimes fatal, hypersensitivity reactions (anaphylactoid reactions) to penicillins have been described. The risk of such reactions is highest in patients with a history of hypersensitivity reactions to penicillins and in individuals with atopy. If an allergic reaction occurs, treatment with amoxicillin/clavulanic acid should be discontinued and alternative therapy should be initiated.
If the infection is confirmed to be due to amoxicillin-susceptible organisms, a switch from amoxicillin/clavulanic acid therapy to amoxicillin therapy should be considered in accordance with official guidelines.
Augmentin® powder for oral suspension is not suitable for use in cases where there is a high risk that the suspected pathogens have beta-lactam resistance that is not mediated by clavulanic acid-inhibited beta-lactamases. This dosage form should not be used in the treatment of infections caused by penicillin-resistant Streptococcus pneumoniae.
In patients with impaired renal function or when taking the drug in high doses, seizures may occur (see section "Side effects").
The use of amoxicillin/clavulanic acid is not recommended for suspected infectious mononucleosis, since such patients experience a morbilliform rash after taking amoxicillin.
The combined use of allopurinol and amoxicillin increases the risk of allergic skin reactions.
Long-term treatment may lead to excessive proliferation of insensitive microorganisms.
The appearance of pustules on erythematous areas of the skin with fever at the beginning of treatment may be a symptom of acute generalized exanthematous pustulosis. The occurrence of this adverse reaction requires discontinuation of the drug and is a contraindication to further use of amoxicillin.
The combination of amoxicillin/clavulanic acid should be used with caution in patients with signs of liver failure (see sections “Dosage regimen”, “Contraindications”, “Special instructions”).
Adverse liver events have been observed primarily in men and elderly patients and may be associated with long-term therapy. These adverse events are very rarely observed in children. Signs and symptoms of liver dysfunction usually occur during or immediately after completion of therapy, but in some cases may not appear until several weeks after completion of therapy. As a rule, they are reversible. Adverse effects from the liver can be severe, and in extremely rare cases there have been reports of death. In almost all cases, these were patients with serious comorbidities or patients receiving concomitantly potentially hepatotoxic drugs.
Antibiotic-associated colitis has been reported with virtually all antibacterial agents. This adverse reaction can vary in severity from mild to life-threatening (see section "Side effects"). Therefore, this diagnosis should be considered in patients who develop diarrhea during treatment or after administration of any antibiotics. If antibiotic-associated colitis occurs, the drug should be discontinued immediately. The patient should consult a doctor who will prescribe appropriate treatment. In such a situation, the use of drugs that inhibit peristalsis is contraindicated.
During long-term therapy with Augmentin®, it is recommended to periodically evaluate renal, liver and hematopoietic function.
In patients receiving a combination of amoxicillin and clavulanic acid, prolongation of prothrombin time has been observed in rare cases. When co-prescribing a combination of amoxicillin and clavulanic acid with anticoagulants, appropriate monitoring should be carried out. To maintain the desired level of anticoagulation, dose adjustment of the anticoagulant may be necessary (see section “Drug Interactions” and “Side Effects”).
In patients with impaired renal function, the dose of Augmentin® should be adjusted according to the degree of impairment (see section "Dosage regimen").
In patients with reduced diuresis, the development of crystalluria has been reported in very rare cases, mainly with parenteral use of the drug. While taking high doses of amoxicillin, it is recommended to drink enough fluids and maintain adequate diuresis to reduce the chance of amoxicillin crystal formation. In patients with urinary catheters, catheter patency should be checked regularly (see section "Overdose").
During treatment with amoxicillin, if tests for the presence of glucose in urine are necessary, enzymatic methods for determining glucose oxidase should be used due to the possibility of obtaining a false positive result when using non-enzymatic methods.
The presence of clavulanic acid in the drug may cause nonspecific binding of IgG and albumin to red blood cell membranes, which may lead to a false-positive Coombs test result.
Patients taking the amoxicillin/clavulanic acid combination may have a false-positive test result for Aspergillus infection using the Platelia Aspergillus EIA tests. There have been reports of cross-reactions between the Platelia Aspergillus EIA test and non-Aspergillus polysaccharides and polyfuranoses. Therefore, positive test results in patients taking the combination of amoxicillin/clavulanic acid should be interpreted with caution and confirmed by other diagnostic methods.
Augmentin® in powder form for oral suspension contains 2.5 mg of aspartame (E951) per ml of suspension, which is a source of phenylalanine, and therefore the drug should be used with caution in patients with phenylketonuria.
This medicine contains maltodextrin (glucose). The drug should not be prescribed to patients with impaired absorption of glucose-galactose.
Impact on the ability to drive vehicles and machinery
No special studies have been conducted. However, adverse reactions may occur (allergic reactions, dizziness, convulsions), which may affect the ability to drive vehicles and other mechanisms.
AUGMENTIN por. d/prig. susp. 200+28.5 mg/5 ml vial. 70 ml
Directions for use and doses
The dosage regimen is set individually depending on the age, body weight, kidney function of the patient, as well as the severity of the infection.
For optimal absorption and to reduce possible side effects from the digestive system, Augmentin is recommended to be taken at the beginning of a meal.
The minimum course of antibacterial therapy is 5 days.
Treatment should not continue for more than 14 days without reviewing the clinical situation.
If necessary, it is possible to carry out stepwise therapy (at the beginning of therapy, parenteral administration of the drug followed by switching to oral administration).
Adults and children over 12 years of age or weighing 40 kg or more
1 tablet 250 mg/125 mg 3 times a day (for mild to moderate infections), or 1 tablet 500 mg/125 mg 3 times a day, or 1 tablet 875 mg/125 mg 2 times a day, or 11 ml of suspension 400 mg/57 mg/5 ml 2 times a day (equivalent to 1 tablet of 875 mg/125 mg).
2 tablets of 250 mg/125 mg are not equivalent to 1 tablet of 500 mg/125 mg.
Children from 3 months to 12 years weighing less than 40 kg
The drug is prescribed in the form of a suspension for oral administration.
The dose is calculated depending on age and body weight, indicated in mg/kg body weight/day (calculation based on amoxicillin) or in ml of suspension.
The frequency of administration of the suspension is 125 mg/31.25 mg in 5 ml - 3 times a day every 8 hours.
The frequency of administration of the suspension is 200 mg/28.5 mg in 5 ml or 400 mg/57 mg in 5 ml - 2 times a day every 12 hours.
The recommended dosage regimen and frequency of administration are presented below:
Frequency of administration: 3 times/day, suspension 4:1 (125 mg/31.25 mg in 5 ml):
- Low doses - 20 mg/kg/day.
- High doses - 40 mg/kg/day.
Frequency of administration: 2 times/day, suspension 7:1 (200 mg/28.5 mg in 5 ml or 400 mg/57 mg in 5 ml):
- Low doses - 25 mg/kg/day.
- High doses - 45 mg/kg/day.
Low doses of Augmentin are used to treat skin and soft tissue infections, as well as recurrent tonsillitis.
High doses of Augmentin are used to treat diseases such as otitis media, sinusitis, lower respiratory tract and urinary tract infections, bone and joint infections.
There is insufficient clinical data to recommend the use of Augmentin at a dose of more than 40 mg/kg/day in 3 divided doses (4:1 suspension) in children under 2 years of age.
Children from birth to 3 months
Due to the immaturity of the excretory function of the kidneys, the recommended dose of Augmentin (calculated according to amoxicillin) is 30 mg/kg/day in 2 doses in the form of a 4:1 suspension.
The use of a 7:1 suspension (200 mg/28.5 mg in 5 ml or 400 mg/57 mg in 5 ml) is not recommended in this population.
Children born prematurely
There are no recommendations regarding dosage regimen.
Elderly patients
No dose adjustment is required. In elderly patients with impaired renal function, the dose should be adjusted as indicated below for adults with impaired renal function.
Patients with impaired renal function
Dose adjustments are based on the maximum recommended dose of amoxicillin and are carried out taking into account QC values.
Adults
Tablets 250 mg+125 mg or 500 mg+125 mg:
- CC > 30 ml/min - no dosage adjustment required.
- CC 10-30 ml/min - 1 tablet. 250 mg+125 mg 2 times a day or 1 tablet. 500 mg+125 mg (for mild to moderate infection) 2 times a day.
- QC
Suspension 4:1 (125 mg/31.25 mg in 5 ml):
- CC > 30 ml/min - no dosage adjustment required.
- CC 10-30 ml/min - 15 mg/3.75 mg/kg 2 times/day, maximum dose - 500 mg/125 mg 2 times/day.
- QC
Tablets 875 mg + 125 mg and suspension 7:1 (200 mg/28.5 mg in 5 ml or 400 mg/57 mg in 5 ml) should only be used in patients with CC > 30 ml/min, and no dose adjustment is required required.
In most cases, whenever possible, parenteral therapy should be preferred.
Patients on hemodialysis
Dose adjustments are based on the maximum recommended dose of amoxicillin: 2 tablets. 250 mg/125 mg in one dose every 24 hours, or 1 tablet. 500 mg/125 mg in one dose every 24 hours, or suspension at a dose of 15 mg/3.75 mg/kg 1 time/day.
Tablets: during a hemodialysis session, an additional 1 dose (one tablet) and another 1 dose (one tablet) at the end of the dialysis session (to compensate for the decrease in serum concentrations of amoxicillin and clavulanic acid).
Suspension: Before a hemodialysis session, one additional dose of 15 mg/3.75 mg/kg should be administered. To restore the concentrations of the active components of the drug Augmentin in the blood, a second additional dose of 15 mg/3.75 mg/kg should be administered after a hemodialysis session.
Patients with liver dysfunction
Treatment is carried out with caution, and liver function is regularly monitored. There is insufficient data to adjust the dosage regimen in this category of patients.
Rules for preparing the suspension
The suspension is prepared immediately before the first use.
Suspension (125 mg / 31.25 mg in 5 ml): add approximately 60 ml of boiled water, cooled to room temperature, to the bottle with the powder, then close the bottle with a lid and shake until the powder is completely diluted, let the bottle stand for 5 minutes to ensuring complete dilution. Then add water up to the mark on the bottle and shake the bottle again. In total, about 92 ml of water is required to prepare the suspension. The bottle should be shaken well before each use. For accurate dosing of the drug, you should use a measuring cap, which must be rinsed well with water after each use. After dilution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen.
For children under 2 years of age, a measured single dose of Augmentin suspension can be diluted by half with water.
Suspension (200 mg/28.5 mg in 5 ml or 400 mg/57 mg in 5 ml): add approximately 40 ml of boiled water, cooled to room temperature, to the bottle with the powder, then close the bottle with a lid and shake until the powder is completely diluted , allow the vial to stand for 5 minutes to ensure complete dilution. Then add water up to the mark on the bottle and shake the bottle again. In total, about 64 ml of water is required to prepare the suspension. The bottle should be shaken well before each use. For precise dosing of the drug, use a measuring cap or dosing syringe, which must be rinsed well with water after each use. After dilution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen.
For children under 2 years of age, a measured single dose of Augmentin suspension can be diluted with water in a 1:1 ratio.
Buy Augmentin powder for oral suspension 200mg+28.5mg/5ml 7.7g 70ml in pharmacies
Augmentin Buy Augmentin in pharmacies DOSAGE FORMS powder for the preparation of oral suspension 200mg+28 5mg/5ml powder for the preparation of suspension for oral administration 200mg+28 5mg/5ml
MANUFACTURERS Smithkline Beacham (Great Britain) Smithkline Beacham PLC (Great Britain)
GROUP Combined antimicrobial agents
COMPOSITION Active substance: amoxicillin + clavulanic acid.
INTERNATIONAL NON-PROPENTED NAME Amoxicillin + Clavulanic acid
SYNONYMS Amoxiclav, Amoxiclav Quiktab, Arlet, Augmentin EU, Augmentin SR, Clamosar, Medoclav, Panclave, Ranclave, Rapiclav, Sinulox, Sinulox RTU, Flemoclav Solutab, Ecoclave
PHARMACOLOGICAL ACTION Broad spectrum antibacterial. Blocks the synthesis of peptidoglycan of the membrane of microbial cells (amoxicillin), inhibits beta-lactamases (clavulanic acid). Clavulanic acid forms a stable inactivated complex with these enzymes and protects amoxicillin from the loss of antibacterial activity caused by the production of beta-lactamases by the main pathogens and opportunistic microorganisms. Active against gram-positive aerobes: Streptococcus pneumoniae, S.pyogenes, S.viridans, S.bovis, Staphylococcus aureus (except methicillin-resistant strains), S.epidermidis (except methicillin-resistant strains), Listeria spp., Enterococcus spp. Gram-negative aerobes: Bordetella pertussis , Brucella spp., Campylobacter jejuni, E.coli, Gardnerella vaginalis, H.influenzae, H.ducreyi, Klebsiella spp., Moraxella catarrhalis, N.gonorrhoeae, N.meningitidis, Pasteurella multocida, Proteus spp., Salmonella spp., Shigella spp., Vibrio cholerae, Yersinia enterocolitica. Anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Actinomyces israelii. Rapidly absorbed after oral administration (food intake does not affect absorption). The maximum concentration is reached 1 hour after administration. The maximum plasma concentration after a bolus injection of 1.2 g is 105.4 mg/l (for amoxicillin) and 28.5 mg/l (for clavulanic acid). It has a large volume of distribution - high concentrations are found in body fluids and tissues (lungs, pleural, peritoneal, synovial fluid, tonsils, bronchial secretions, prostate gland, peritoneal abscess, muscle tissue, adipose tissue, paranasal sinus secretions, middle ear, etc. .). Peak concentrations in body fluids are observed 1 hour after peak plasma concentrations are reached. Does not pass through the BBB when the meninges are not inflamed, passes through the placental barrier and penetrates into breast milk in trace concentrations. Weakly binds to plasma proteins. Amoxicillin is partially metabolized, clavulanic acid undergoes intensive metabolism. Amoxicillin is excreted by the kidneys almost unchanged by tubular secretion and glomerular filtration; clavulanic acid - by glomerular filtration, partly in the form of metabolites. Small amounts are excreted by the intestines and lungs. The half-life is 1-1.5 hours, with severe renal failure it increases to 7.5 (for amoxicillin) and 4.5 hours (for clavulanic acid). It is removed during hemodialysis, and slightly - during peritoneal dialysis.
INDICATIONS FOR USE Infectious diseases of the upper (acute and chronic sinusitis, acute and chronic otitis media, retropharyngeal abscess, tonsilopharyngitis) and lower respiratory tract (acute and chronic bronchitis, pneumonia, pleural empyema); urinary tract infections (including cystitis, urethritis, pyelonephritis), gynecological infections (including salpingitis, salpingoophoritis, endometritis, septic abortion, pelvioperitonitis); biliary tract (cholecystitis, cholangitis), bone and connective tissue (including chronic osteomyelitis), skin and soft tissue (phlegmon, wound infection), odontogenic infections (periodontitis); sexually transmitted infections (gonorrhea, chancroid).
CONTRAINDICATIONS Hypersensitivity; history of allergic reactions to antibiotics of the penicillin and cephalosporin group; cholestatic jaundice, hepatitis caused by taking penicillin antibiotics (in history); liver failure; infectious mononucleosis, lymphocytic leukemia. Use during pregnancy and breastfeeding: possible if the expected effect of therapy exceeds the potential risk to the fetus. Breastfeeding should be stopped during treatment.
SIDE EFFECTS In most cases, side effects are weak and transient, most often affecting the gastrointestinal tract: loss of appetite, nausea, vomiting, diarrhea. Possible development of superinfection, stomatitis, vaginitis; in rare cases - pseudomembranous colitis with severe diarrhea. Allergic reactions may occur: itching, skin rashes; in sensitive patients, immediate hypersensitivity reactions may develop (angioedema, bronchospasm, rarely - anaphylactic shock). It is extremely rare that a transient increase in the level of transaminases in the blood plasma can be observed. There are isolated reports of cholestatic jaundice, hepatitis, and liver dysfunction.
INTERACTION When used simultaneously with methotrexate, the toxicity of methotrexate increases, with allopurinol - the incidence of exanthema, and with anticoagulants - the prothrombin time is prolonged. Reduces the effectiveness of oral contraceptives. Concomitant use with disulfiram should be avoided. The effectiveness of Amoxiclav is weakened by combination with bacteriostatic antibiotics (macrolides, tetracyclines), combination with rifampicin is antagonistic. Probenecid reduces the excretion of amoxicillin, increasing its serum concentration. Pharmaceutically incompatible with solutions containing blood, proteins, lipids, glucose, dextran, bicarbonate. Do not mix in a syringe or infusion bottle with other drugs. Incompatible with aminoglycosides.
DOSAGE AND ADMINISTRATION The dose of the drug depends on age, body weight and kidney function.
OVERDOSE Symptoms: in most cases nausea, diarrhea, vomiting, possible agitation, insomnia, dizziness, and in some cases seizures. There are no reports of deaths or life-threatening side effects. Treatment: symptomatic, in case of recent use (less than 4 hours), remove the drug from the gastrointestinal tract (gastric lavage, taking activated charcoal to reduce absorption), hemodialysis is effective.
SPECIAL INSTRUCTIONS Prescribe with caution to patients prone to allergic reactions to cephalosporins and other beta-lactam antibiotics (risk of cross-sensitivity), with severe impairment of liver and kidney function (dosage regimen adjustment is necessary). High concentrations give a false positive reaction for glucose in urine when using Benedict's reagent or Felling's solution (it is recommended to use enzymatic reactions with glucose oxidase).
STORAGE CONDITIONS List B. At room temperature.
