Treatment of bacterial infections in adults and children caused by microorganisms sensitive to Augmentin 1000:
- acute bacterial sinusitis;
- acute otitis media;
- confirmed exacerbation of chronic bronchitis;
- nosocomial pneumonia;
- cystitis;
- pyelonephritis;
- skin and soft tissue infections, including cellulitis, due to animal bites, severe dentoalveolar abscesses with widespread cellulitis;
- bone and joint infections, including osteomyelitis.
Application
The preparation should be used in accordance with the official recommendations for antibiotic therapy and data on local sensitivity to the antibiotic. sensitivity to amoxicillin/clavulanic acid varies in different regions and may change over time. local susceptibility data should be consulted, if available, and microbiological determination and susceptibility testing should be performed if necessary.
The range of suggested doses depends on the expected pathogens and their sensitivity to antibacterial preparations, the severity of the disease and the location of the infection, the age, body weight and kidney function of the patient.
For adults and children with body weight ≥40 kg, the daily dose is 1750 mg of amoxicillin / 250 mg of clavulanic acid (2 tablets), the daily dose is divided into 2 doses.
For children with a body weight of 40 kg, the maximum daily dose is 1000-2800 mg of amoxicillin / 143-400 mg of clavulanic acid (see below for details).
If high doses of amoxicillin are required for treatment, other forms of the preparation should be used to avoid excessively high doses of clavulanic acid.
The duration of treatment is determined by the patient's clinical response to treatment. Some infections (for example, osteomyelitis) require long-term treatment.
Children with a body weight of 40 kg. The dose is from 25 mg / 3.6 mg/kg/day to 45 mg / 6.4 mg/kg/day, divided into 2 doses.
Elderly patients. No dose adjustment is required for elderly patients. If necessary, the dose is adjusted depending on kidney function.
Dosage in case of impaired liver function. Use with caution, it is necessary to regularly monitor liver function. There are insufficient data for dosage recommendations.
Dosage in case of impaired kidney function. The preparation Augmentin 1000 is prescribed only for the treatment of patients with a creatinine clearance of 30 ml/min. Augmentin 1000 is not used in renal failure with a creatinine clearance of 30 ml/min.
The tablet should be swallowed whole, without chewing. If necessary, the tablet can be broken in half and swallowed without chewing.
For optimal absorption and to reduce the severity of possible side effects from the digestive tract, the preparation should be taken at the beginning of a meal.
The duration of treatment is determined individually. Treatment should not be continued for more than 14 days without assessment of the patient's condition.
Treatment can be started with parenteral administration, and then switch to oral administration.
Contraindication
Hypersensitivity to the components of the preparation, any antibacterial agents of the penicillin group.
History of severe hypersensitivity reactions (including anaphylaxis) associated with the use of other β-lactam agents (including cephalosporins, carbapenems or monobactams).
History of jaundice or liver dysfunction associated with the use of amoxicillin / clavulanic acid.
Side effects
Classified by frequency of occurrence: very often (≥1/10); often (≥1/100 and 1/10); infrequently (≥1/1000 and 1/100); rarely (≥1/10,000 and 1/1,000); very rare (1/10,000); unknown (frequency cannot be estimated).
Infections and infestations: often - candidiasis of the skin and mucous membranes; unknown - excessive increase in the number of insensitive microorganisms.
Hematopoietic and lymphatic systems: rarely - reversible leukopenia (including neutropenia) and thrombocytopenia; very rarely - reversible agranulocytosis and hemolytic anemia; increase in bleeding time and prothrombin index.
From the side of the immune system: very rarely - angioedema, anaphylaxis, serum syndrome, allergic vasculitis.
From the side of the nervous system: infrequently - dizziness, headache; very rarely - reversible hyperactivity, aseptic meningitis and convulsions. Convulsions may occur in patients with impaired renal function or in patients receiving high doses of the preparation. Unknown - aseptic meningitis.
From the gastrointestinal tract. Adults Very often - diarrhea; often - nausea, vomiting.
Children. Often - diarrhea, nausea, vomiting.
Nausea is more often associated with high doses of the preparation. The above-mentioned symptoms from the gastrointestinal tract can be reduced when taking the preparation at the beginning of a meal. Infrequently - indigestion. Very rarely - antibiotic-associated colitis (including pseudomembranous and hemorrhagic colitis, see Features of use), black hairy tongue.
On the part of the hepatobiliary system: infrequently - a moderate increase in the level of AST and / or ALT - is noted in patients who are treated with antibiotics of the β-lactam group. Very rarely - hepatitis and cholestatic jaundice. These phenomena occur when other penicillins and cephalosporins are used.
Hepatitis occurs mainly in men and elderly patients, and their development may be associated with long-term treatment.
Such phenomena occurred very rarely in children.
Symptoms of the disease occur during or immediately after treatment, but in some cases may develop several weeks after the end of treatment. These phenomena are usually reversible. Very rarely, fatal cases are possible, which always occur in patients with a severe underlying disease or patients who simultaneously receive preparations that have a negative effect on the liver.
From the side of the skin and its derivatives: infrequently - rash on the skin, itching, urticaria; rarely - polymorphic erythema; very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous exfoliative dermatitis, acute generalized exanthematous pustulosis.
If any allergic dermatitis appears, the treatment should be stopped.
From the kidneys and urinary system: very rarely - interstitial nephritis, crystalluria (see Conditions and shelf life).
Special instructions
Before starting therapy with the preparation Augmentin 1000, it is necessary to accurately determine the presence of hypersensitivity reactions to penicillins, cephalosporins or other allergens in the anamnesis.
Serious and sometimes even fatal cases of hypersensitivity (anaphylactic reactions) occur in patients during penicillin therapy. These reactions are more likely in individuals with similar reactions to penicillin in the past (see Adverse Reactions). In case of allergic reactions, Augmentin 1000 therapy should be stopped and alternative therapy should be started.
If it is proven that the infection is caused by microorganisms sensitive to amoxicillin, it is necessary to consider the possibility of switching from the combination of amoxicillin / clavulanic acid to amoxicillin according to official recommendations.
This dosage form of the preparation Augmentin 1000 should not be used if there is a high probability that the pathogens are resistant to β-lactams, and should not be used to treat pneumonia caused by penicillin strains of S. pneumoniae.
Augmentin 1000 should not be prescribed if infectious mononucleosis is suspected, since cases of scabies rash have been observed with amoxicillin in this category of patients.
Long-term use of the preparation can cause excessive growth of microflora insensitive to Augmentin 1000.
The development of erythema multiforme associated with pustules at the beginning of treatment may be a symptom of acute generalized exanthematous pustulosis (see Side effects). In this case, it is necessary to stop the treatment, and further use of amoxicillin is contraindicated.
Augmentin 1000 The following should be prescribed with caution to patients with signs of liver failure (see USE, Contraindications, side effects). Adverse reactions from the liver occurred mainly in men and elderly patients and were associated with long-term treatment with the combined preparation amoxicillin / clavulanic acid. Such phenomena have been reported very rarely in children. In all groups of patients, symptoms usually occurred during or immediately after treatment, but in some cases they appeared several months after stopping therapy. In general, these phenomena were reversible. Liver side effects can be severe and very rarely fatal. They have always occurred in patients with severe concomitant diseases or with the simultaneous use of preparations that can adversely affect the liver (see Side effects).
With the use of almost all antibacterial preparations, the occurrence of antibiotic-associated colitis, from mild to life-threatening, has been reported (see Side Effects). It is important to keep this in mind when patients develop diarrhea during or after antibiotic use. In case of development of antibiotic-associated colitis, Augmentin 1000 Next therapy should be stopped immediately and appropriate treatment started.
Rarely, patients taking Augmentin 1000 and oral anticoagulants may experience an increase in prothrombin time (an increase in the international normalized ratio - INR). When taking anticoagulants at the same time, appropriate control of laboratory indicators is necessary. There may be a need to adjust the dose of oral anticoagulants to maintain the required level of coagulation.
For patients with impaired renal function, it is necessary to adjust the dose according to the degree of renal insufficiency (see Method of use).
Crystalluria can very rarely be observed in patients with reduced urinary excretion, mainly with parenteral administration of the preparation. Therefore, to reduce the risk of crystalluria during treatment with high doses of amoxicillin, maintain fluid balance in the body (see Conditions and shelf life).
During treatment with amoxicillin, enzymatic reactions with glucose oxidase should be used to determine the level of glucose in the urine, since other methods can give false positive results.
The presence of clavulanic acid in the preparation can cause nonspecific binding of IgG and albumin on the membranes of erythrocytes, as a result of which a false positive result is possible when conducting the Coombs test.
There have been reports of false-positive Aspergillus test results in patients receiving amoxicillin/clavulanic acid (using the Bio-Rad Laboratories Platelis Aspergillus EIA test). Therefore, such positive results in patients receiving amoxicillin / clavulanic acid should be interpreted with caution and confirmed by other diagnostic methods.
Use during pregnancy and breastfeeding. In reproductive studies on animals (at doses 10 times higher than human doses), oral and parenteral forms of the combination of amoxicillin and clavulanic acid did not reveal any teratogenic effects. One study in women with premature rupture of membranes reported that prophylactic use of amoxicillin and clavulanic acid increased the risk of necrotizing enterocolitis in newborns. It is necessary to avoid the use of the preparation during pregnancy, especially in the I trimester, except in cases where the benefit of using the preparation exceeds the potential risk.
Both active components of the preparation are excreted in breast milk (there is no information on the effect of clavulanic acid on breastfed children). Accordingly, diarrhea and fungal infection of the mucous membranes are possible in infants, so breastfeeding should be stopped.
The preparation Augmentin 1000 during breastfeeding can be used only when, in the opinion of the doctor, the benefit of use will outweigh the risk.
Children. The preparation in this dosage and dosage form is not recommended for the treatment of children under 12 years of age.
The ability to influence the speed of reaction when driving a motor vehicle or working with other mechanisms. Studies on the ability of the preparation to influence the speed of reaction when driving a motor vehicle or other mechanisms were not conducted. However, side effects (such as allergic reactions, dizziness, convulsions) may occur, which may affect the ability to drive or operate machinery.
Interactions
Simultaneous use of probenecid is not recommended. probenecid reduces the renal tubular secretion of amoxicillin. its simultaneous use with the preparation Augmentin 1000 can lead to an increase in the level of the preparation in the blood for a long time, but does not affect the level of clavulanic acid.
Simultaneous use of allopurinol during treatment with amoxicillin increases the likelihood of allergic reactions. There are no data on the simultaneous use of the combined preparation amoxicillin and clavulanic acid with allopurinol.
Like other antibiotics, Augmentin 1000 can affect the intestinal flora, reducing the reabsorption of estrogens and the effectiveness of combined oral contraceptives.
There is evidence of increased INR in patients treated with acenocoumarol or warfarin and amoxicillin. If such use is necessary, prothrombin time or INR should be carefully monitored and, if necessary, Augmentin 1000 treatment should be discontinued.
In patients treated with mycophenolate mofetil, after starting oral amoxicillin with clavulanic acid, the predose concentration of the active metabolite of mycophenolic acid may decrease by approximately 50%. This change in predose level may not exactly correspond to the change in total mycophenolic acid exposure.
Penicillins can reduce the excretion of methotrexate, which can lead to an increase in the toxicity of the latter.
Overdose
It can be accompanied by symptoms from the gastrointestinal tract and a violation of the water-electrolyte balance. these phenomena should be treated symptomatically, paying attention to correcting the water-electrolyte balance. cases of crystalluria, sometimes leading to renal failure, have been reported (see special instructions). the preparation Augmentin thousand can be removed from the bloodstream by hemodialysis.
Storage conditions
In the original packaging at a temperature not higher than 25 °C.