Amoxicillin Sandoz 1000 mg 12 pcs. film-coated tablets

Composition per tablet:

Description

Capsule-shaped biconvex tablets from almost white to light yellow in color with a score and a specific odor.

Pharmacotherapeutic group:

antibiotic - semisynthetic penicillin

ATX code:

J01CA04

Special patient groups

Age

The half-life of amoxicillin is approximately the same in children aged 3 months to 2 years, in older children, and in adults. In very young children (including premature newborns), amoxicillin is administered no more than twice a day during the first week of life, taking into account the immaturity of the renal excretion route. Since decreased renal function may occur in the elderly, the dose should be adjusted with caution and renal function periodically monitored in this category of patients.

Floor

After oral administration of amoxicillin to males and females participating in the studies, there was no significant effect of gender on the pharmacokinetics of amoxicillin.

Renal dysfunction

The total plasma clearance of amoxicillin decreases in proportion to the deterioration of renal function.

Liver failure

Caution must be exercised in patients with liver failure, and periodic monitoring of liver function is also necessary.

Amoxicillin FT tablet p/o 1000 mg in container/cell pack No. 6x2

Name

Amoxicillin.

Release forms

pills

INN

Amoxicillin

FTG

Antibiotic; semisynthetic penicillin

Description

Round biconvex tablets, coated from white to almost white, with a slight characteristic odor (for tablets containing 125 mg of amoxicillin); oval biconvex tablets, coated from white to almost white, with a score on both sides, with a slight characteristic odor (for tablets containing 250 mg, 500 mg, 750 mg, 1000 mg of amoxicillin).

Compound

Each coated tablet contains: tablet core: active ingredient: amoxicillin (in the form of amoxicillin trihydrate) - 125 mg, or 250 mg, or 500 mg, or 750 mg, or 1000 mg; excipients: povidone, sodium starch glycolate (type A), magnesium stearate, microcrystalline cellulose; tablet shell: hypromellose, talc, titanium dioxide, macrogol 400.

Pharmacotherapeutic group

Antibacterial agents for systemic use. Beta-lactam antibacterial agents, penicillins. Broad-spectrum penicillins. ATC code: J01CA04.

Pharmacological properties

Amoxicillin is a broad-spectrum semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes involved in peptidoglycan biosynthesis in bacteria. Peptidoglycan is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to a weakening of the cell wall, which usually results in cell lysis and death. Thus, amoxicillin has a bactericidal effect. Amoxicillin can be destroyed by beta-lactamases, enzymes produced by antibiotic-resistant bacteria. Therefore, the spectrum of action of amoxicillin (when used as monotherapy) does not include microorganisms that are capable of producing these enzymes. The main mechanisms ensuring bacterial resistance to amoxicillin are: inactivation by bacterial beta-lactamases; a change in the structure of penicillin-binding proteins, which reduces the affinity of the antibiotic to the target. Bacterial impermeability or efflux mechanisms may mediate or contribute to the development of bacterial resistance, especially in Gram-negative bacteria. Minimum inhibitory concentration (MIC) values ​​for amoxicillin, according to the European Committee on Antimicrobial Susceptibility Testing (EUCAST). Microorganism MIC values ​​(mg/l) Sensitive Resistant >Enterobacteriaceae 81 8 Staphylococcus spp. Note2 Note2 Enterococcus spp. 4 8 Streptococcus groups A, B, C and G Note4 Note4 Streptococcus pneumoniae Note5 Note5 Group of viridans streptococci 0.5 2 Haemophilus influenzae 26 26 Moraxella catarrhalis Note7 Note7 Neisseria meningitidis 0.125 1 Gram-positive anaerobes, with the exception of Clostridium difficile8 4 8 Gram-negative anaerobes8 0 .5 2 Helicobacter pylori 0.1259 0.1259 Pasteurella multocida 1 1 Breakpoints regardless of species 10 2 8 1 Wild type Enterobacteriaceae is characterized as sensitive to aminopenicillins. Some countries prefer to characterize wild-type E. coli and P. mirabilis isolates as intermediate susceptibility organisms. If necessary, a MIC value for sensitive microorganisms S ≤ 0.5 mg/l is used. 2Most staphylococci produce penicillinase, which makes them resistant to amoxicillin. Methicillin-resistant isolates, with rare exceptions, are resistant to all beta-lactam drugs. 3 Susceptibility to amoxicillin can be determined from data for ampicillin. 4 Susceptibility of group A, B, C and G streptococci to penicillins is determined from susceptibility data to benzylpenicillins. 5Breakpoints apply only to “non-meningitis” isolates. For isolates that are intermediately susceptible to ampicillin, oral amoxicillin should be avoided. Sensitivity is determined by the MIC for ampicillin.6 Values ​​are based on data obtained after intravenous administration. Isolates that produce beta-lactamases should be considered resistant.7 Beta-lactamase producers should be considered resistant.8 Susceptibility to amoxicillin can be determined from data for benzylpenicillin.9 Values ​​are based on epidemiological breakpoints that separate wild isolates from isolates with reduced susceptibility.10 Borderline values, regardless of type, are based on data obtained when administering at least 0.5 g 3 or 4 times a day (1.5-2 g per day). The prevalence of resistance may vary geographically and over time for certain species. It is advisable to rely on local resistance information, especially when treating severe infections. If necessary, seek qualified advice if the local prevalence of resistance is such that the effectiveness of the drug in treating specific types of infections is questionable. In vitro sensitivity of microorganisms to amoxicillin Usually sensitive microorganisms are gram-positive aerobes: Enterococcus faecalis, beta-hemolytic streptococci (groups A, B, C and G), Listeria monocytogenes. 2. Microorganisms whose acquired resistance may be a problem in the treatment of infection: gram-negative aerobes: Escherichia coli, Haemophilus influenzae, Helicobacter pylori, Proteus mirabilis, Salmonella typhi, Salmonella paratyphi, Pasteurella multocida; gram-positive aerobes: coagulase-negative staphylococci, Staphylococcus aureus1, Streptococcus pneumoniae, group of viridans streptococci; gram-positive anaerobes: Clostridium spp.; gram-negative anaerobes: Fusobacterium spp.; other microorganisms: Borrelia burgdorferi. 3. Microorganisms with natural resistance2: gram-positive aerobes: Enterococcus faecium2; gram-negative aerobes: Acinetobacter spp., Enterobacter spp., Klebsiella spp., Pseudomonas spp.; gram-negative anaerobes: Bacteroides spp. (many strains of Bacteroides fragilis are resistant); other microorganisms: Chlamydia spp., Mycoplasma spp., Legionella spp. 1Almost all Staphylococcus aureus are resistant to amoxicillin due to the production of penicillinase. In addition, all methicillin-resistant strains are resistant to amoxicillin. 2Natural intermediate sensitivity in the absence of acquired resistance mechanisms. Concomitant food intake does not affect the absorption of amoxicillin. Hemodialysis can be used to remove amoxicillin from the circulation. Animal studies did not reveal significant retention of drug derivatives in body tissues. Amoxicillin, like most penicillins, can be found in breast milk (see section “Use during pregnancy and lactation”). Amoxicillin penetrates the placental barrier (see section “Use during pregnancy and lactation”). The main route of elimination of amoxicillin is through the kidneys. For every child in the first week of life (including premature newborns), the interval between administrations should be at least 12 hours (2 times a day) due to the immaturity of the renal excretion pathway. Since decreased renal function may occur in the elderly, the dose should be adjusted with caution and periodic monitoring of renal function in this category of patients.

Indications for use

AMOXICILLIN can be used in children and adults to treat the following infections: acute bacterial sinusitis; acute otitis media; acute streptococcal tonsillitis and pharyngitis; exacerbation of chronic bronchitis; community-acquired pneumonia; acute cystitis; asymptomatic bacteriuria in pregnant women; acute pyelonephritis; typhoid and paratyphoid fever; periodontal abscess with spreading cellulite; infections of prosthetic joints; eradication of Helicobacter pylori; Lyme disease. AMOXICILLIN can also be used to prevent endocarditis. When deciding whether to prescribe AMOXICILLIN, one should rely on the general principles of antibacterial therapy and the information provided in official guidelines on the proper use of antibacterial drugs.

Directions for use and doses

Directions for use AMOXICILLIN is intended for oral administration. Eating does not affect the absorption of amoxicillin. Therefore, the tablet can be taken regardless of meals. Treatment can be started with the use of amoxicillin for parenteral (intravenous) administration (in the doses recommended for this route of administration) and continued with the use of the drug AMOXICILLIN in the form of tablets for oral administration. Doses When prescribing a specific dose of amoxicillin for the treatment of a specific infection, the following should be taken into account: the type of suspected pathogen and the antibacterial sensitivity/resistance profile characteristic of this pathogen (see section “Special instructions and precautions”); severity and localization of the infectious process; age, body weight, renal function status of the patient. The duration of treatment should be determined based on the type of infection and the patient’s individual reactions to taking the drug. In general, the duration of the course should be as short as possible. Some infections require long-term therapy with amoxicillin (see section "Special Instructions and Precautions" regarding long-term treatment). When deciding whether to prescribe AMOXICILLIN, one should rely on the general principles of antibacterial therapy and the information provided in official guidelines on the proper use of antibacterial drugs. Adults and children weighing >40 kg Indications for use* Dose* Acute bacterial sinusitis 250-500 mg every 8 hours or 750-1000 mg every 12 hours. For severe infections - 750-1000 mg every 8 hours. For acute cystitis may The following treatment regimen should be used: 3 g of amoxicillin 2 times a day, course of treatment - 1 day. Asymptomaticbacteriuria in pregnant women Acute pyelonephritis Periodental abscess with spreading cellulitis Acute cystitis Acute otitis media 500 mg every 8 hours, 750-1000 mg every 12 hours. For severe infections - 750-1000 mg every 8 hours for 10 days. Acute streptococcal tonsillitis and pharyngitis Exacerbation of chronic bronchitis Community-acquired pneumonia 500-1000 mg every 8 hours Typhoid fever and paratyphoid fever 500-2000 mg every 8 hours Infections of prosthetic joints 500-1000 mg every 8 hours Prevention of endocarditis A single dose of 2 g should be prescribed for 30-60 minutes before the procedure. Eradication of Helicobacter pylori 750-1000 mg 2 times a day in combination with a proton pump inhibitor (for example, omeprazole, lansoprazole) and another antibacterial drug (for example, clarithromycin, metronidazole); course of treatment - 7 days. Lyme disease (see section "Special instructions and precautions") Early stage: 500-1000 mg every 8 hours; the daily dose can be increased to 4 g (maximum daily dose), it should be divided into several doses; course of treatment - 14 days (10-21 days). Late stage (systemic disorders): 500-2000 mg every 8 hours; the daily dose can be increased to 6 g (maximum daily dose), it should be divided into several doses; course of treatment - 10-30 days *Official treatment recommendations for each indication should be taken into account. Overweight children

Side effect

The most commonly reported adverse reactions were diarrhea, nausea and skin rash. The incidence of adverse reactions is assessed according to the following classification: very often (≥1/10); often (≥1/100 to

Contraindications

The prescription and use of the drug AMOXICILLIN is contraindicated in the following situations: known increased individual sensitivity to amoxicillin and/or to any of the auxiliary components of the drug; known increased individual sensitivity to any penicillin antibiotic; A history of severe immediate hypersensitivity reaction (eg, anaphylaxis) associated with another beta-lactam drug (eg, cephalosporins, carbapenems, or monobactams).

Overdose

Symptoms In case of an overdose of amoxicillin, obvious disturbances in the gastrointestinal tract (nausea, vomiting, diarrhea), and obvious disturbances in water and electrolyte balance may be observed. Crystalluria has been reported with amoxicillin, in some cases leading to renal failure. In patients with impaired renal function or in those patients taking high doses of amoxicillin, seizures may occur (see sections "Special Instructions and Precautions" and "Side Effects"). Treatment If the function of the gastrointestinal tract is impaired, symptomatic treatment is indicated. Particular attention should be paid to normalizing water and electrolyte balance. Amoxicillin can be removed from the vascular bed by hemodialysis.

Interaction with other drugs and other types of interactions

Probenecid Concomitant use of probenecid is not recommended. Probenecid reduces the tubular secretion of amoxicillin in the kidneys. Concomitant use of probenecid may increase amoxicillin concentrations and prolong its plasma half-life. Allopurinol The combined use of amoxicillin and allopurinol may increase the likelihood of allergic skin reactions. Tetracyclines Tetracyclines and other bacteriostatic agents may interfere with the bactericidal effects of amoxicillin. Oral anticoagulants Oral anticoagulants and antibiotics from the penicillin group are widely used in clinical practice, and there are no signs of drug interactions. However, the literature describes cases of an increase in the international normalized ratio (INR) in patients undergoing a course of treatment with amoxicillin while taking acenocoumarol or warfarin. If the combined use of oral anticoagulants and amoxicillin is considered necessary, close monitoring of prothrombin time or INR should be performed when increasing the dose of amoxicillin and after discontinuation of amoxicillin treatment. Moreover, dose adjustment of oral anticoagulants may be required (see sections "Special instructions and precautions" and "Side effects"). Methotrexate Penicillins may decrease the excretion rate of methotrexate, which may increase the likelihood of methotrexate toxicity. Special instructions and precautions Hypersensitivity reactions Before starting treatment with amoxicillin, it is imperative to find out whether the patient has previously had hypersensitivity reactions, the occurrence of which was associated with taking any antibiotic from the group of penicillins, cephalosporins or other beta-lactam (see sections “Contraindications” and "Side effect"). There have been reports of serious hypersensitivity reactions, sometimes fatal, (including anaphylactoid and severe cutaneous adverse reactions) in patients receiving penicillin therapy. These reactions are more common in people with a history of penicillin hypersensitivity and atopy. If an allergic reaction develops, you should stop taking amoxicillin and consult a doctor. Non-susceptible microorganisms Amoxicillin should be used to treat infections only if one of the following conditions is met: the pathogen has been identified and found to be sensitive to amoxicillin; the suspected pathogen is very likely to be sensitive to amoxicillin (see section “Pharmacological properties”). This information is especially important to take into account when deciding whether to prescribe amoxicillin to patients with a urinary tract infection or severe ear, nose, or throat infection. Seizures Seizures may occur in patients: with impaired renal function; taking amoxicillin in high doses; with the presence of predisposing factors (for example, a history of seizures, treated epilepsy or meningeal disorders) (see section "Side effects"). Impaired renal function In patients with impaired renal function, the dose should be adjusted according to the severity of the pathology (see section "Dosage and Administration"). Skin reactions Generalized erythema with fever and pustules that occurs at the beginning of treatment with amoxicillin may be a symptom of acute generalized exanthematous pustulosis (see section "Side effects"). If such a reaction occurs, you should stop taking amoxicillin immediately; further administration of amoxicillin is in any case contraindicated. Amoxicillin should be avoided if infectious mononucleosis is suspected. Taking amoxicillin against the background of infectious mononucleosis can lead to the appearance of a measles-like rash. Jarisch-Herxheimer reaction Jarisch-Herxheimer reaction (fever, chills, headache, muscle pain and skin rash) has been reported when amoxicillin is used to treat Lyme disease (see section "Side effects"). Its appearance is a direct consequence of the bactericidal activity of amoxicillin against the bacterium that is the causative agent of Lyme disease (the spirochete Borrelia burgdorferi). Patients should be aware that this reaction is common, usually self-limiting, and is considered a normal consequence of antibiotic therapy for Lyme disease. Excessive growth of non-susceptible microorganisms Long-term use of amoxicillin can sometimes lead to excessive growth of non-susceptible microorganisms. Cases of antibiotic-associated colitis have been reported when taking almost all antibacterial drugs. Its severity can vary from mild to life-threatening (see section "Side effects"). If a patient experiences diarrhea during or after treatment with any antibiotic, this diagnosis should always be assumed. If antibiotic-associated colitis is suspected or the diagnosis is confirmed, amoxicillin should be immediately discontinued and appropriate treatment initiated. In this situation, antiperistaltic drugs are contraindicated. Long-term treatment During long-term treatment with amoxicillin, it is recommended to regularly monitor the function of organ systems, including renal, liver, and hematopoietic function. When taking amoxicillin, there have been cases of increased activity of liver enzymes and changes in the cellular composition of the blood (see section “Side Effects”). Anticoagulants In rare cases, prolongation of prothrombin time has been reported in patients taking amoxicillin. Appropriate monitoring is necessary if the patient is taking amoxicillin along with anticoagulants. It may be necessary to adjust the dose of the oral anticoagulant in order to maintain the level of anticoagulation at the desired level (see sections “Interaction with other drugs and other types of interactions” and “Side effects”). Crystalluria In patients with reduced urine output (reduced diuresis), crystalluria has been observed in very rare cases, mainly when the antibiotic was administered parenterally. When prescribing amoxicillin in high doses, it is recommended to ensure adequate fluid intake and maintain urinary output at a sufficient level in order to reduce the likelihood of crystalluria associated with amoxicillin. In patients with urinary catheters, it is necessary to regularly check the patency of the urinary tract (see sections “Side effects” and “Overdose”). Effect on Laboratory Tests: Increased concentrations of amoxicillin in serum and urine may interfere with the results of certain laboratory tests. Due to high concentrations of amoxicillin in urine, false-positive results are often observed when using chemical diagnostic methods. During treatment with amoxicillin, if it is necessary to determine the concentration of glucose in the urine, it is recommended to use enzymatic glucose oxidase methods. In the presence of amoxicillin, the results of determining estriol concentrations in pregnant women may be distorted.

Use during pregnancy and lactation

Pregnancy Animal studies have not revealed direct or indirect negative effects that are manifestations of reproductive toxicity. Limited data on the use of amoxicillin during human pregnancy do not indicate an increased risk of birth defects. Amoxicillin can be used in pregnant women only in cases where the expected benefits of the drug outweigh the potential risks. Breastfeeding Amoxicillin is excreted in small quantities into breast milk, which creates a possible risk of sensitization. Consequently, breastfed children may experience diarrhea and fungal infections of the mucous membranes; Therefore, breastfeeding should be suspended before starting amoxicillin. Amoxicillin should be used during lactation only after a careful assessment of the benefit/risk ratio by a physician. Fertility There are no data on the effects of amoxicillin on fertility in humans. Reproductive studies in animals have shown no effect on fertility.

Use in children

In children under 6 months of age, it is recommended to use amoxicillin in suspension form. In children weighing ≥40 kg, the amoxicillin dosage regimen is similar to that in adults. Effect on the ability to drive vehicles and operate machinery. Special studies of the effect of amoxicillin on the ability to drive vehicles or other moving mechanisms have not been conducted. However, it should be taken into account that during treatment with amoxicillin, side effects may occur that may affect this ability (for example, allergic reactions, dizziness, convulsions) (see section “Side Effects”).

Release form and packaging

Film-coated tablets, 125 mg each in blister packs No. 10×1, No. 10×2, in jars No. 20; 250 mg each in blister packaging No. 12×1, No. 12 × 2, in jars No. 20 and in blister-free packaging No. 6 × 2, No. 6 × 3, No. 6 × 4, No. 10 × 1, No. 10 × 2 , №10×3; 500 mg each in blister packs No. 12×1, No. 12×2, in jars No. 10, No. 20 and in blister-free packaging No. 6×2, No. 6×3, No. 6×4, No. 10×1, No. 10×2; 750 mg each in blister packaging No. 6×1, No. 6×2, in jars No. 10 and in blister-free packaging No. 6×2, No. 6×3, No. 6×4, No. 10×1, No. 10×2 ; 1000 mg each in blister packaging No. 6×2, in jars No. 10 and in blister-free packaging No. 6×2, No. 6×3, No. 6×4 in packaging No. 1. Together with the package insert, 1 or 2 blister packs, 1, 2, 3 or 4 blister-free packs or jars are placed in a cardboard pack.

Storage conditions

Store in a place protected from light at a temperature not exceeding 25°C. Keep out of the reach of children.

Best before date

2 years. Do not use after the expiration date stated on the packaging.

Vacation conditions

By doctor's prescription.

Buy Amoxicillin FT tablet p/o 1000 mg in container/cell pack No. 6x2 in the pharmacy

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Instructions for use for Amoxicillin FT tablet p/o 1000 mg in container/cell pack No. 6x2

Use during pregnancy and breastfeeding

Results from animal studies do not indicate direct or indirect effects on reproductive toxicity. Limited data on the use of amoxicillin during human pregnancy do not indicate an increased risk of congenital malformations. Amoxicillin can be used during pregnancy only in cases where the expected benefit to the mother outweighs the potential risk to the fetus.

Amoxicillin is excreted into breast milk in small quantities; if necessary, the drug can be used during breastfeeding. A breastfed baby may develop diarrhea, sensitization and fungal infection of the mucous membranes, so it may be necessary to stop breastfeeding. Amoxicillin should be used during breastfeeding only after the attending physician has assessed the benefit/risk ratio.

Amoxicillin EXPRESS

Hypersensitivity reactions

Before starting treatment with amoxicillin, you should pay attention to the presence of hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam antibiotics in the anamnesis (see sections “Contraindications” and “Side effects”).

Severe and sometimes fatal hypersensitivity reactions (including anaphylactic reactions and severe skin reactions) have been reported in patients receiving penicillin therapy. The development of these reactions is more likely in people with a history of hypersensitivity to penicillins and in people with atopy. If an allergic reaction occurs, discontinue treatment with amoxicillin and institute appropriate alternative treatment.

Acute coronary syndrome associated with hypersensitivity (Kounis syndrome)

In rare cases, hypersensitivity reactions (acute coronary syndrome associated with hypersensitivity) have been reported during treatment with amoxicillin. If this reaction occurs, amoxicillin should be discontinued and appropriate treatment should be prescribed.

Insensitive microorganisms

For some types of infections, before prescribing amoxicillin, it is necessary to first establish the pathogen and its sensitivity to the drug, or make sure that the pathogen is likely to be treatable with amoxicillin. This particularly applies to patients with urinary tract infections and severe ear, nose and throat infections.

Convulsions

Convulsions may occur in patients with renal failure, in patients receiving high doses of the drug, as well as in patients with predisposing factors - a history of seizures, treatment for epilepsy or meningitis, etc. (see section “Side Effects”).

Kidney failure

In patients with renal insufficiency, the dose should be adjusted according to the degree of renal insufficiency (see section "Dosage and Administration").

Skin reactions

The occurrence of generalized erythema with fever, accompanied by pustules, at the initial stage of treatment may be a symptom of OHEP (see section “Side effects”). In this case, amoxicillin should be discontinued, and its subsequent use will be contraindicated in any situation.

The use of amoxicillin should be avoided in patients who are suspected of having infectious mononucleosis, since a measles-like rash (exanthema) may occur due to the use of amoxicillin for this disease.

Jarosz-Herxheimer reaction

The Jarisch-Herxheimer reaction has been observed following the use of amoxicillin in patients with Lyme disease. This reaction is associated with the bactericidal effect of amoxicillin on the causative agent of Lyme disease, the spirochete Borrelia burgdorferi. Patients should be advised that this reaction is a common side effect of antibiotic treatment for Lyme disease and usually goes away on its own.

Excessive growth of non-susceptible microorganisms

Long-term use of the drug can sometimes lead to excessive growth of microorganisms that are not sensitive to amoxicillin (superinfection).

When using almost all antibacterial drugs, the development of colitis associated with taking antibiotics is possible. Its severity can range from mild to severe (life-threatening). Therefore, it is important to consider the possibility of this diagnosis in patients who develop diarrhea during or after antibiotic use. If diarrhea develops, the patient should immediately stop taking amoxicillin, consult a doctor and begin appropriate treatment. Medicines that inhibit peristalsis are contraindicated in this situation.

Long-term treatment

During long-term therapy, it is necessary to periodically monitor the function of the hematopoietic organs, kidneys and liver. Increased activity of liver enzymes and changes in the number of blood cells were reported.

Anticoagulants

Rare cases of increased prothrombin time have been reported in patients receiving amoxicillin. When prescribing the drug simultaneously with anticoagulants, appropriate monitoring should be carried out, and the dose of oral anticoagulants may need to be adjusted to maintain the required level of blood clotting (see sections “Interaction with other drugs” and “Side effects”).

Crystalluria

In patients with reduced diuresis, crystalluria was very rarely observed, mainly during parenteral therapy. When using high doses of amoxicillin, it is recommended to maintain adequate fluid intake and diuresis to reduce the likelihood of developing crystalluria associated with amoxicillin use. In patients with a catheterized bladder, catheter patency should be checked regularly.

Impact on diagnostic tests

Increased levels of amoxicillin in serum and urine may interfere with some laboratory tests. Due to high concentrations of amoxicillin in urine, chemical methods often give false-positive results.

When determining glucose in urine during treatment with amoxicillin, it is recommended to use enzymatic glucose oxidase tests.

The use of amoxicillin may affect the results of the quantitative determination of estradiol in urine in pregnant women.

Directions for use and doses

Amoxicillin Dispertab® is taken orally regardless of food intake.

The tablet can be swallowed whole with a glass of water, or immediately before use, diluted in water (at least 50 ml) and mixed thoroughly. The resulting mixture, which has a light fruity taste, should be taken immediately after preparation.

Doses

When choosing the dose of Amoxicillin Dispertab® for the treatment of certain infections, the following factors should be considered:

suspected pathogens and their likely sensitivity to antibacterial drugs;

severity and location of infection;

the patient's age, weight, and renal function as described below.

The duration of treatment depends on the type of infection and the patient's clinical response and should be as short as possible. Some infections require longer treatment.

Adults and children ≥ 40 kg

Children weighing ≥ 40 kg

Children weighing more than 40 kg should take the dose recommended for adults.

Children weighing < 40 kg:

Dosage regimen for certain categories of patients

Elderly patients

No dose adjustment is required.

Patients with kidney failure

Patients receiving hemodialysis

Amoxicillin can be removed from the blood during hemodialysis.

Patients receiving peritoneal dialysis

The maximum dose of amoxicillin is 500 mg/day.

Patients with liver dysfunction

Caution should be exercised and liver function should be monitored regularly.

Side effect:

The most common side effects are diarrhea, nausea and skin rash.

The frequency of side effects is determined as follows: very often (≥ 1/10), often (≥ 1/100, < 1/10), infrequently (≥ 1/1000, < 1/100), rarely (≥ 1/10000, < 1/1000), very rare (< 1/10000), unknown (cannot be estimated from available data).

Amoxicillin Sandoz tablets 1000 mg No. 12

A country

Austria
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.

Active substance

Amoxicillin

Compound

1 tablet contains: amoxicillin 1 g.
Excipients: magnesium stearate, polyvidone, sodium starch glycolate, microcrystalline cellulose. Film shell composition: titanium dioxide, talc, hypromellose. White to slightly yellowish film-coated tablets, oval, biconvex, scored on both sides.

pharmachologic effect

Amoxicillin is an aminobenzyl penicillin that has a bactericidal effect by inhibiting bacterial cell wall synthesis. MIC thresholds vary among susceptible organisms. Enterobacteriaceae are considered sensitive when inhibited by amoxicillin at a concentration of ≤ 8 μg/ml amoxicillin and resistant when inhibited by amoxicillin at a concentration ≥ 32 μg/ml. According to NCCLS guidelines and using NCCLS-specified methods, M. catarrhalis (β-lactamase negative) and H. influenzae (β-lactamase negative) are considered susceptible at concentrations ≤ 1 μg/ml and resistant at ≥ 4 μg/ml; Str. pneumoniae are considered susceptible at MIC ≤ 2 μg/ml and resistant at ≥ 8 μg/ml. The prevalence of resistant strains varies geographically, so it is advisable to rely on local resistance information, especially when treating severe infections. At such a level of prevalence of resistant strains, at which the advisability of using the drug becomes questionable, at least in the treatment of some infections, it is better to seek help from a specialist.

Indications for use

- upper respiratory tract infections, including ear, nose and throat infections: acute otitis media, acute sinusitis and bacterial pharyngitis. - lower respiratory tract infections: exacerbation of chronic bronchitis, community-acquired pneumonia. - infections of the lower urinary tract: cystitis. — gastrointestinal tract infections: bacterial enteritis. Combination therapy may be required for infections caused by anaerobic microorganisms. - endocarditis: prevention of endocarditis in patients at risk of developing endocarditis - for example, during dental procedures.

Mode of application

Inside. Treatment of infections: As a rule, therapy is recommended to be continued for 2-3 days after symptoms disappear. In the case of infections caused by β-hemolytic streptococcus, complete eradication of the pathogen requires therapy for at least 10 days. Parenteral therapy is indicated when oral therapy is not possible and in the treatment of severe infections. Adult dosage (including elderly patients): Usual dosage: Usual dosage ranges from 750 mg to 3 g of amoxicillin per day in divided doses. In some cases, it is recommended to limit the dose to 1500 mg per day in several doses. Short course of therapy: Uncomplicated urinary tract infections: double administration of the drug, 3 g for each administration, with an interval between doses of 10 - 12 hours. Children's dosages (up to 12 years) The daily dose for children is 25 - 50 mg / kg / day in several doses (maximum 60 mg/kg/day) depending on the indication and severity of the disease. Children weighing over 40 kg should receive the adult dosage. Dosing in Renal Impairment: In patients with severe renal impairment, the dose should be reduced. If renal clearance is less than 30 ml/min, it is recommended to increase the interval between doses or reduce subsequent doses. In case of renal failure, short courses of therapy 3 g are contraindicated. Adults (including elderly patients): Creatinine clearance ml/min | Dose | Interval between injections > 30 | No dose change required | 10-30 | 500 mg | 12 hours For hemodialysis: 500 mg should be administered after the end of the procedure. Impaired renal function in children weighing less than 40 kg: Creatinine clearance ml/min | Dose | Interval between injections >30 | No dose change required | 10-30 | 15 mg/kg | 12h10 | 15 mg/kg | 24 hours Prevention of endocarditis To prevent endocarditis in patients not under general anesthesia, 3 g of amoxicillin should be administered 1 hour before surgery and, if necessary, another 3 g after 6 hours. For children, amoxicillin is recommended at a dose of 50 mg/kg. For more detailed information and descriptions of the categories of patients at risk for endocarditis, local official guidelines should be consulted.

Side effects

Side effects are classified as follows: Often: 10%, or less often, but more often than 1% Uncommon: 1%, or less often, but more often than 0.1% Rare. 0.1% or less, but more often 0.01% Very rare, including isolated cases: 0.01% or less. Infections and infection Uncommon Prolonged and repeated use of the drug can lead to the development of superinfection and colonization of resistant microorganisms or fungi, for example, oral and vaginal candidiasis. Blood and lymphatic system disorders Rare: Eosinophilia and hemolytic anemia. Very rare Isolated cases of leukopenia, granulocytopenia, thrombocytopenia, pancytopenia, anemia, myelosuppression, agranulocytosis, prolongation of bleeding time and prothrombin time have been reported. All changes were reversible upon cessation of therapy. Immune system disorders Rare: Laryngeal edema, serum sickness, allergic vasculitis, anaphylaxis and anaphylactic shock in rare cases. Neurological disorders Rare CNS reactions are rare and include hyperkinesis, dizziness and convulsions. Seizures may occur in patients with renal failure or in patients receiving high doses of the drug. Gastrointestinal disorders Common: Discomfort, nausea, loss of appetite, vomiting, flatulence, loose stools, diarrhea, enanthemas (especially on the oral mucosa), dry mouth, impaired taste perception. As a rule, these effects are mild in severity and often disappear as therapy continues or very quickly after its cessation. The incidence of these complications can be reduced by taking amoxicillin with food. When severe persistent diarrhea develops, the possibility of a very rare complication, pseudomembranous colitis, must be considered. The use of medications that suppress peristalsis is contraindicated. Very rare The appearance of a black color of the tongue. Disorders of the liver and biliary system: Uncommon Transient moderate increase in the level of liver enzymes. Rare cases of hepatitis and cholestatic jaundice. Skin and subcutaneous tissue disorders: Often Skin reactions in the form of exanthema, itching, urticaria; A typical morbilliform exanthema appears on days 5–11 from the start of therapy. The immediate development of urticaria indicates an allergic reaction to amoxicillin and requires discontinuation of therapy. Rare (see also section 4.4) Angioedema (Quincke's edema), exudative erythema multiforme, acute generalized pustular rashes, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous and exfoliative dermatitis. Renal disorders Rare In rare cases, acute interstitial nephritis. General disorders Rare In rare cases, drug fever may develop.

Contraindications

- hypersensitivity to penicillin;
- it is also necessary to consider the possibility of cross-allergy with other beta-lactam antibiotics, such as cephalosporins, carbopenems. With caution: - Ospamox should be used with caution in patients with allergic diathesis and asthma. - in patients with renal failure, the elimination of amoxicillin may be slowed down, which, depending on the degree of failure, may require a reduction in the daily dose of the drug. - should be used with caution in children, premature infants and newborns: it is necessary to monitor renal, liver and hematological functions. - Ospamox should be used with caution in patients with viral infections, acute lymphoblastic leukemia and infectious mononucleosis (due to an increased risk of erythematous skin rash). Use during pregnancy and breastfeeding Use of the drug during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. If it is necessary to use the drug during lactation, the issue of stopping breastfeeding should be decided.

Use in children Use with caution in children, premature infants and newborns: renal, liver and hematological parameters must be monitored.

special instructions

Before starting amoxicillin therapy, it is important to ensure that there is no history of hypersensitivity reactions to penicillins and cephalosporins, which can cause a cross-allergic reaction (10 - 15%). There are reports of severe, sometimes fatal, hypersensitivity reactions (anaphylactoid) during penicillin therapy. These reactions are more common in people with a history of hypersensitivity to beta-lactams. In the presence of severe disorders of the gastrointestinal tract with diarrhea and vomiting, Ospamox should not be used, since these conditions may reduce its absorption. For such patients, parenteral amoxicillin is recommended. When severe persistent diarrhea develops, the possibility of pseudomembranous colitis (usually caused by Clostridium difficile) must be considered. Long-term use of amoxicillin in some cases can lead to the growth of bacteria and fungi that are insensitive to it. Therefore, patients should be closely monitored for the development of superinfection. Anaphylactic shock and other severe manifestations of allergic reactions after oral administration of amoxicillin are rare. If such a reaction occurs, a set of emergency measures is necessary: ​​intravenous administration of epinephrine, then antihistamines, volume replacement and administration of glucorticoids. Patients require careful observation and other therapeutic procedures if necessary (artificial respiration, oxygen). The presence of amoxicillin in high concentrations in the urine can cause precipitation of the drug in the urinary catheter, so catheters should be checked periodically. When using amoxicillin in high doses in order to minimize the risk of amoxicillin crystalluria, it is important to monitor the adequacy of fluid intake and excretion. Forced diuresis leads to a decrease in the concentration of amoxicillin in the blood as a result of accelerated elimination. Diarrhea may impair absorption and reduce the effectiveness of medications. When determining the presence of glucose in urine during amoxicillin therapy, it is recommended to use enzymatic glucose oxidant methods. When using chemical methods, high concentrations of amoxicillin in the urine can cause frequent false positive test results. Amoxicillin may reduce urinary estriol concentrations in pregnant women. At high concentrations, amoxicillin can reduce glycemic levels. Amoxicillin may interfere with protein assay results when using a colorimetric assay.

Overdose

Symptoms Amoxicillin usually does not cause acute toxic effects, even with accidental ingestion of high doses. An overdose can be manifested by symptoms of gastrointestinal disorders and disturbances in water and electrolyte balance. In patients with severe renal impairment, overdose of large doses of amoxicillin may be accompanied by signs of nephrotoxicity and crystalluria. Therapy There is no specific antidote for amoxicillin. Therapy includes the administration of activated charcoal (there are usually no indications for gastric lavage) or symptomatic measures. Particular attention should be paid to water and electrolyte balance. Hemodialysis may be used.

Drug interactions

Concomitant use is not recommended: Allopurinol Concomitant use with allopurinol may lead to the development of allergic skin reactions. Digoxin The absorption of digoxin may increase during therapy with Ospamox. Anticoagulants Concomitant use of amoxicillin and anticoagulants such as coumarin may increase the likelihood of bleeding due to prolongation of prothrombin time. When prescribing anticoagulants along with Ospamox, monitoring of homeostatic parameters is required. Probenecid Probenecid inhibits the excretion of amoxicillin through the kidneys, and leads to an increase in the concentration of amoxicillin in bile and blood. Other antibiotics There is a possibility of antagonism of the action of amoxicillin with the simultaneous administration of bacteriostatic drugs: macrolides, tetracyclines, sulfonamides and chloramphenicol. Methotrexate Concomitant use of methotrexate and amoxicillin may increase the degree of methotrexate toxicity, possibly as a result of competitive inhibition of tubular renal secretion of methotrexate by amoxicillin. Amoxicillin should be used with caution with the following drugs: Oral hormonal contraceptives The use of amoxicillin can lead to a transient decrease in the concentration of estrogen and progesterone in the blood, and reduce the effectiveness of contraceptives. In this regard, it is recommended to additionally use other non-hormonal methods of contraception during treatment with amoxicillin.

Dispensing conditions in pharmacies

On prescription

Release form

Dispersible tablets 125 mg, 250 mg, 500 mg, 1000 mg.

5 tablets (dosage 125 mg, 250 mg, 500 mg and 1000 mg) or 7 tablets (dosage 125 mg) or 10 tablets (dosage 125 mg, 250 mg) in a blister pack made of polyvinyl chloride / polyvinylidene chloride film and aluminum foil printed varnished.

4 blister packs of 5 tablets (dosage 125 mg, 250 mg, 500 mg and 1000 mg) or 2 blister packs of 5 tablets (dosage 125 mg) or 2 or 4 blister packs of 7 tablets (dosage 125 mg) or 2 blister packs of 10 tablets (dosage 125 mg, 250 mg) are placed in a cardboard pack.