Flemoxin Solutab, 500 mg 20 pcs

Pharmacological action Pharmacological action – antibacterial, bactericidal.
Pharmacodynamics

Active against such Gram-positive and Gram-negative microorganisms as Streptococcus pyogenes, Streptococcus pneumonia, Clostridium tetani, C.welchii, Neisseria gonorrhoeae, Neisseria meningitidis, Staphylococcus aureus (not producing beta-lactamase), Bacillus anthracis, Listeria monocytogenes, Helicobacter pylori. Less active against Enterococcus faecalis, Escherichia coli, Proteus mirabilis, Salmonella typhi, Shigella sonnei, Vibrio cholerae. It is not active against beta-lactamase-producing microorganisms, Pseudomonas spp., indole-positive Proteus spp., Serratia spp., Enterobacter spp.

Pharmacokinetics

Absorption

After oral administration is quickly and almost completely absorbed (about 93%), acid resistant. After an oral dose of 500 mg, the Cmax of the active substance in plasma is 5 µg/ml and is noted in blood plasma after 2 hours. If the drug dose is increased or decreased by a factor of 2, the Cmax in plasma also changes by a factor of 2. Food intake has almost no effect on absorption of the drug.

Distribution

The binding to plasma proteins is about 20%. Amoxicillin penetrates well into the mucous membranes, bone tissue, intraocular fluid and sputum at therapeutically effective concentrations. The concentration of amoxicillin in bile exceeds its concentration in blood plasma by 2-4 times. In amniotic fluid and umbilical vessels amoxicillin concentration is 25-30% of its level in the blood plasma of a pregnant woman.

It penetrates poorly through the BBB, but in inflammation of the cerebral membranes, the concentration in the cerebrospinal fluid is about 20% of the plasma concentration.

Metabolism

Partially metabolized, most of its metabolites are inactive against microorganisms.

Elimination

Eliminated mainly by the kidneys, about 80% by tubular excretion, 20% by glomerular filtration. In the absence of renal dysfunction, T1/2 is 1-1.5 h. In premature infants, newborns and children younger than 6 months it is 3-4 hours.

Pharmacokinetics in special clinical cases.

The T1/2 of amoxicillin does not change with impaired liver function.

In impaired renal function (creatinine Cl ≤15 ml/min), the T1/2 of amoxicillin may increase and reach 8.5 h in anuria.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

Respiratory tract infections;

Genitourinary tract infections;

Gastrointestinal tract infections;

Active ingredient

Composition

1 tablet contains:

The active ingredient:

amoxicillin (in trihydrate form) 500 mg.

Excipients:

dispersible cellulose,

microcrystalline cellulose,

crospovidone,

vanillin,

flavorings (mandarin, lemon),

saccharin,

magnesium stearate.

How to take, the dosage

The drug is taken orally. The drug is prescribed regardless of meals. The tablet may be swallowed whole or in parts or chewed with a glass of water, or it may be diluted in water to form syrup (20 ml) or suspension (100 ml) with pleasant fruity taste. Dosing regimen is set individually, taking into account the severity of the disease, the susceptibility of the pathogen to the drug, the age of the patient. In case of mild to moderate inflammatory diseases, the drug should be used according to the following regimen: For adults and children over 10 years old, 500-750 mg 2 times a day or 375-500 mg 3 times a day; for children aged 3 to 10 years old, 375 mg 2 times a day or 250 mg 3 times a day; for children aged 1 to 3 years old, 250 mg 2 times a day or 125 mg 3 times a day.

The daily dose of the drug for children (including children under 1 year of age) is 30-60 mg/kg/day divided into 2-3 doses.

In hard-to-reach areas of infection (e.g., acute otitis media), three doses are recommended.

In chronic diseases, recurrent infections, infections of severe course, adults are prescribed 0.75-1 g 3 times/day; children – 60 mg/kg/day, divided into 3 doses.

In acute uncomplicated gonorrhea 3 g of the drug in 1 dose in combination with 1 g of probenecid is prescribed.

In patients with impaired renal function at CK≤10 ml/min, the drug dose is reduced by 15-50%.

In case of infections of mild to moderate course the drug is taken for 5-7 days. However, in case of infections caused by Streptococcus pyogenes, the duration of treatment should be at least 10 days.

In the treatment of chronic diseases and infections with a severe course the duration of drug administration should be determined by the clinical picture of the disease.
The drug should be continued for 48 hours after the cessation of symptoms.

Interaction

Special Instructions

History of erythroderma is not a contraindication for prescribing Flemoxin Solutab®.

Cross-resistance with penicillin-type drugs and cephalosporins is possible.

As with other penicillin-type drugs, superinfection is possible.

The occurrence of severe diarrhea characteristic of pseudomembranous colitis is an indication for discontinuation of the drug.

The drug should be used with caution in patients with infectious mononucleosis and lympholeukemia because of high probability of exanthema of non-allergic genesis.

Contraindications

Hypersensitivity to the drug and other beta-lactam antibiotics.

With caution:

Polyvalent hypersensitivity to xenobiotics;

Infectious mononucleosis;

Lympholeukemia;

A history of gastrointestinal disease (especially colitis associated with antibiotic use);

Renal failure;

Pregnancy;

Lactation period.

Side effects

Gastrointestinal organs: rare – change of taste, nausea, vomiting, diarrhea; in some cases – moderate increase in liver transaminase activity; very rare – pseudomembranous and hemorrhagic colitis.

Urinary system disorders: very rarely – development of interstitial nephritis.

Hematopoietic system disorders: agranulocytosis, neutropenia, thrombocytopenia, hemolytic anemia are also possible, but they are observed extremely rarely.

Nervous system adverse effects when using amoxicillin in the dosage form of dispersible tablets have not been reported.

Allergic reactions: skin reactions, mainly in the form of specific maculopapular rash; rarely – erythema multiforme (Stevens-Johnson syndrome); in rare cases – anaphylactic shock, angioedema.

Overdose

Symptoms: nausea, vomiting, diarrhea, violation of water-electrolyte balance.

Treatment: gastric lavage, prescription of activated charcoal, saline laxatives, correction of water-electrolyte balance.

Pregnancy use

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