Amoxil DT (amoxicillin) dispersible tablets 500 mg. №20

$12.90

Manufacturer: Ukraine

Amoxil DT (amoxicillin) is a broad-spectrum antibiotic from the group of semi-synthetic penicillins. Has a bactericidal effect.

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Description

Ingredients

active substance: amoxicillin;

1 tablet contains amoxicillin trihydrate in terms of amoxicillin – 500 mg;

excipients: microcrystalline cellulose; dispersible cellulose; crospovidone; vanillin; mandarin flavoring; flavoring lemon; saccharin; magnesium stearate.

Medicinal form

Dispersible tablets.

The main physical and chemical properties: tablets from white to light yellow in color, oval in shape, with a biconvex surface, with a line on one side of the tablet. Slight roughness and marbling of the surface is allowed.

Pharmacotherapeutic group

Antimicrobial agents for systemic use. Beta-lactam antibiotics. Broad-spectrum penicillins. Amoxicillin. ATX code J01C A04.

Pharmacodynamics

Amoxil DT (amoxicillin) is a broad-spectrum antibiotic from the group of semi-synthetic penicillins. Has a bactericidal effect.

The following table illustrates data on the in vitro sensitivity of some clinically relevant microorganisms to amoxicillin.

Activity

in vitro

Minimum inhibitory concentration (MIC)
0.01-0.1 μg/ml 0.1-1 μg/ml 1-10 μg/ml
Gram-positive microorganisms Streptococci
(B) Streptococci 
S. pneumonie,
C.welchii 
C. tetani
S. aureus (negative for b-lactamase)
B. anthracis 
L. subtilis 
L. monocytogenes
S. faecalis
Gram-negative microorganisms N. gonorrhoeae
N. meningitidis
H. influenzae 
B. pertussis
E. coli
P. mirabilis 
S. typhi 
S. sonnei 
V. cholerae.

Amoxicillin is inactive against microorganisms that produce b-lactamase, such as Pseudomonas and Enterobacter strains . The level of resistance of microorganisms sensitive to amoxicillin can be variable in different territories.

Pharmacokinetics

Absorption. After oral administration of the drug, amoxicillin is absorbed quickly and almost completely (85-90%), the drug is acid-resistant. Eating almost does not affect the absorption of the drug. The maximum concentration of the active substance in blood plasma is reached after 1-2 hours. After taking 375 mg of amoxicillin orally, the maximum concentration of the active substance in blood plasma is 6 μg/l. When doubling (or reducing by 2 times) the dose of the drug, the maximum concentration in blood plasma also varies (increases or decreases) by 2 times.

Distribution. Approximately 20% of amoxicillin binds to blood plasma proteins. Amoxicillin penetrates into mucous membranes, bone tissue and intraocular fluid, sputum in therapeutically effective concentrations. The concentration of amoxicillin in bile exceeds its concentration in blood by 2-4 times. In amniotic fluid and umbilical vessels, the concentration of amoxicillin is 25-30% of its level in the blood plasma of a pregnant woman. Amoxicillin does not diffuse well into the cerebrospinal fluid, but with inflammation of the meninges (for example, meningitis), the concentration in the cerebrospinal fluid is approximately 20% of the concentration in the blood plasma.

Metabolism. Amoxicillin is partially metabolized, most of its metabolites are inactive against microorganisms.

Breeding. Amoxicillin is eliminated mainly by the kidneys, approximately 80% – by tubular excretion, 20% – by glomerular extraction. Approximately 90% of amoxicillin is eliminated after 8 hours, 60-70% is excreted unchanged by the kidneys. In the absence of impaired kidney function, the half-life of amoxicillin is 1-1.5 hours. In premature, newborn children and infants under 6 months of age, the half-life of amoxicillin is 3-4 hours.

When kidney function is impaired (creatinine clearance is equal to or less than 15 ml/min), the half-life of amoxicillin increases and reaches 8.5 hours with anuria.

The half-life of amoxicillin does not change with impaired liver function.

Indications

Infections caused by microorganisms sensitive to the drug:

  • respiratory organs;
  • organs of the genitourinary system;
  • organs of the digestive tract;
  • skin and soft tissues.

Contraindications

Hypersensitivity to amoxicillin or other beta-lactam antibiotics (penicillins and cephalosporins), as well as to auxiliary substances of the drug.

Dosage and Administration

For mild or moderate infections, the following doses are recommended:

Adults (including elderly patients): orally 500-750 mg 2 times a day or 500 mg 3 times a day.

Children with body weight <40 kg

The daily dose for children is 40-90 mg/kg/day, divided into 2-3 doses (do not exceed a dose of 3 g/day), depending on the indications, the severity of the disease and the sensitivity of microorganisms (see the sections “Features of use”, “Pharmacological properties”).

Data on pharmacokinetics and pharmacodynamics show that the application three times a day has better effectiveness than when taking it twice a day (recommended if the doses are the upper limit of the recommended doses).

Children with a body weight of more than 40 kg should be used in doses recommended for adults.

Special recommendations.

Tonsillitis: 50 mg/kg/day, divided into 2 doses.

Acute otitis media: in an area of ​​high prevalence of pneumococci with reduced sensitivity to penicillins, the dosage regimen should be in accordance with national/local recommendations.

Early stage Lyme disease (isolated erythema migrans): 50 mg/kg/day, divided into 3 doses, for 14-21 days.

Prevention of endocarditis: 50 mg of amoxicillin/kg of body weight, when taking a single dose 1 hour before a planned surgical procedure.

Gonorrhea (acute, uncomplicated): taking a single dose of 3 g.

In the treatment of infections with difficult-to-reach foci, for example, acute bacterial otitis media, it is preferable to take the drug three times.

In the treatment of chronic diseases, in case of relapses, severe infections, it is recommended to take the drug 3 times a day in doses of 750-1000 mg 3 times a day; children – up to 60 mg/kg/day (divided into 3 doses).

Duration of use. 

In the case of mild and moderate infections, Amoxil DT (amoxicillin) should be taken for 5-7 days. However, in the case of infections caused by streptococcus, the duration of treatment should be at least 10 days.

In the treatment of chronic diseases, local infectious lesions, severe infections, the dose of Amoxil DT (amoxicillin) should be determined by the clinical picture of the disease.

Taking the drug should be continued for 48 hours after the symptoms of the disease disappear.

Patients with impaired kidney function.

It is necessary to reduce the dose of the drug in patients with severe renal insufficiency.

In patients with creatinine clearance below 30 ml/min, it is recommended to increase the interval between taking the drug and reduce the daily dose of the drug (see the section “Particulars of use”).

Renal failure in adult patients (including elderly patients)

Creatinine clearance, ml/min Dose The interval between receptions
>30 There is no need to adjust the dose
10-30 500 mg 12 o’clock
<10 500 mg 24 hours

Hemodialysis: at the end of the hemodialysis procedure, it is necessary to take 500 mg of amoxicillin.

Kidney failure in children weighing less than 40 kg

Creatinine clearance, ml/min Dose The interval between receptions
>30 Usual dose There is no need to change
10-30 Usual dose 12 hours (corresponding to 2/3 of the dose)
<10 Usual dose 24 hours (corresponding to 1/3 of the dose)

Patients with impaired liver function.

Impaired liver function does not affect the half-life of Amoxil DT (amoxicillin)

Application method. The drug should be prescribed regardless of meals (before meals, during meals, after meals). Amoxil DT (amoxicillin) can be swallowed with 1 glass of water; it can also be diluted in water (in 20 ml – ½ cup), with the formation of a sweetish suspension that has a pleasant lemon-tangerine taste.

Children.

For children with a body weight <40 kg, the daily dose is 40-90 mg/kg/day, divided into 2-3 doses (do not exceed 3 g/day), depending on the indications, the severity of the disease and the sensitivity of microorganisms.

Pharmacokinetic/pharmacodynamic data show that better efficacy is observed when taking 3 times a day, so twice a day is recommended only if the dose of the upper recommended limit is used.

Children with a body weight of more than 40 kg should be used in doses recommended for adults.