Instructions for use AUGMENTIN® ES
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 Augmentin® EC should be discontinued and alternative therapy 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.
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 with the drug 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 (see section “Side effects”). 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 simultaneously receiving potentially hepatotoxic drugs (see section "Side effects").
Antibiotic-associated colitis has been reported with virtually all antibacterial agents, including amoxicillin. 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® EC, it is recommended to periodically evaluate the function of the kidneys, liver and hematopoietic organs.
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 anticoagulants, dose adjustment may be required (see section “Drug Interactions” and “Side Effects”).
In patients with reduced diuresis, the development of crystalluria has been reported in very rare cases, mainly with parenteral use of the drug. When 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® EC in powder form for oral suspension contains 2.72 mg of aspartame (E951) per ml of suspension, which is a source of phenylalanine, so the drug should be used with caution in patients with phenylketonuria.
Augmentin® EC contains maltodextrin (glucose), so the drug should not be prescribed to patients with glucose-galactose malabsorption.
Impact on the ability to drive vehicles and operate 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 (see section “Side Effects”).
Clinical studies of high-dose amoxicillin/clavulanate
The effectiveness of amoxicillin/clavulanate in children has most often been studied in patients with acute otitis media who underwent tympanocentesis before treatment and after 4–6 days of treatment. This makes it possible to assess both the type of pathogen and the degree of its resistance, as well as the bacteriological effectiveness of treatment. For drugs with a dose of 45/6.4 mg/kg/day in 2 doses, efficacy was shown (86.7% for H. influenzae), superior to that of azithromycin (10 mg/kg on the 1st day, then 5 mg/kg). kg 4 days) – 39.4%. Such doses of amoxicillin/clavulanate, while effective against susceptible and intermediately resistant S. pneumoniae, may be ineffective against about 20% of resistant strains [10, 11].
A study of the bacteriological effectiveness of “enhanced” amoxicillin/clavulanate (90/6.4 mg/kg/day in 2 doses) in a large group of children with acute otitis media showed its high effectiveness against H. influenzae (94%) and S. pneumoniae ( 96%), including in relation to its strains resistant (MIC 2–4 μg/ml) to penicillin (91%). On the 12th–15th day from the onset of the disease, 89% of children recovered [12].
In a similar study, the effectiveness of amoxicillin/clavulanate (90/6.4 mg/kg/day in 2 divided doses for 10 days) was compared with that of a 5-day course of azithromycin (10 mg/kg/day, then 5 mg/kg/day). Clinical effectiveness at the end of therapy (days 12–14 of illness) was 90.5 and 80.9%, respectively (p < 0.01). The clinical effect during therapy and at follow-up (days 21–25) for amoxicillin/clavulanate was 94.9 and 88.0% versus 80.3 and 71.1% for azithromycin. Thus, amoxicillin/clavulanate showed not only a higher percentage of recovery, but also a lower rate of clinical relapse than azithromycin. The eradication rate of the pathogen was 94.2 and 70.3%, respectively. Amoxicillin/clavulanate contributed to the eradication of 96% of all S. pneumoniae (versus 89.7% in the azithromycin group) and among them 92% of completely resistant strains (versus 54.5%). Eradication of H. influenzae was achieved in 89.7 and 80.4%, and of β-lactamose-positive strains in 92.0 and 49.1%, respectively [13].
“Strengthened” forms of amoxicillin/clavulanate are used not only for otitis media; A randomized, double-blind, placebo-controlled study of this drug (90/6.4 mg/kg/day in 2 divided doses) for the treatment of acute bacterial sinusitis in 56 children 1–10 years of age was recently published. Cure was achieved in 50% of children in the experimental group and in 14 in the placebo group; complete treatment failure occurred in 14 and 68% of children, respectively [14].
Note!
Description of the drug Augmentin ES por. d/oral. susp. 600mg/42.9mg/5ml vial. No. 1 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.
Overdose
Symptoms
Symptoms consistent with gastrointestinal upset and fluid and electrolyte imbalance may occur. Crystalluria associated with the use of amoxicillin has been observed, which in some cases led to the development of renal failure.
In patients with impaired renal function and in patients taking high doses of the drug, seizures may occur.
Amoxicillin deposits have been reported in bladder catheters, primarily after administration at high doses. Patency of catheters should be checked regularly.
Treatment
Gastrointestinal disorders can be treated symptomatically with attention to fluid/electrolyte balance. Amoxicillin/clavulanic acid can be removed from the bloodstream using hemodialysis.
Safety
Side effects when taking amoxicillin/clavulanate are usually mild; stool disorders, rashes (hepatic dermatitis), and vomiting are more common. Published studies show a lower incidence of diarrhea with amoxicillin/clavulanate twice daily compared with three times daily [15, 16]. Consistent with this, a lower frequency of twice-daily “boosted” drug administration was noted compared with thrice-daily administration of the drug [17].
Comparison of the frequency of side effects when taking regular and “strengthened” amoxicillin/clavulanate 2 times a day did not reveal any serious differences: diarrhea (stool more than 3 times within 2 days) was observed in 11 and 8.8% of children. The average stool frequency between groups (1.5–1.6 per day), as well as the maximum frequency (2.7–2.8 per day), also did not differ [18].
In a large study (521 children), high-dose amoxicillin/clavulanate caused diarrhea (3 loose stools per day or 2 loose stools for 2 days or more) in 12.5% of children, but was a concern in only 4% of parents. Equally common are rashes (5.4%), and less common are vomiting (2.3%). Treatment was discontinued in 5% of children [12].
Storage conditions
Store at a temperature not exceeding 25°C, out of the reach of children.
Store the prepared suspension in the refrigerator at a temperature from 2°C to 8°C and use within 10 days. Do not freeze.
Shelf life: 2 years (prepared suspension: 10 days).
Product description certified by the manufacturer Glaxo
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Verified
Sevryukov Alexander Viktorovich
Features of application
Pregnant
The use of the drug should be avoided during pregnancy, unless the doctor considers it necessary.
Both active components of the drug are excreted into breast milk (there is no information regarding the effect of clavulanic acid on a breastfed infant). Accordingly, a breastfed baby may develop diarrhea and fungal infection of the mucous membranes, so breastfeeding should be stopped. The possibility of allergic reactions should be taken into account. Amoxicillin/clavulanic acid should only be used during breastfeeding when, in the opinion of the physician, the benefits will outweigh the risks.
Drivers
Studies on the ability of the drug to influence the reaction rate when driving vehicles and working with machinery have not been conducted. However, undesirable effects may occur (such as allergic reactions, dizziness, convulsions), which may affect the ability to drive a car and operate machinery.
