Flemoclav (amoxicillin and clavulanic acid) Soliutab tablets 500 mg/125 mg. №20

Description

Flemoclav 500 mg/125 mg Storage
active substances: amoxicillin, clavulanic acid;

1 tablet 125 / 31,25 contains 125 mg of amoxicillin (as amoxicillin trihydrate),

31.25 mg of clavulanic acid (as potassium clavulanate);

1 tablet 250 / 62.5 mg contains 250 mg of amoxicillin (as amoxicillin trihydrate), 62.5 mg of clavulanic acid (as potassium clavulanate);

1 tablet of 500/125 mg contains 500 mg of amoxicillin (as amoxicillin trihydrate),

125 mg of clavulanic acid (as potassium clavulanate);

excipients: microcrystalline cellulose, crospovidone, vanillin, apricot flavor, saccharin, magnesium stearate.

Flemoclav 500 mg/125 mg Dosage form
Dispersible tablets.

Main physical and chemical properties: tablets 125 / 31.25 mg – oblong, white or almost white, without streaks, marked “421” and;

tablets 250 / 62.5 mg – oblong, white or almost white, without streaks, marked “422” and;

tablets 500/125 mg – oblong, white or almost white, without streaks, marked “424” and.

When storing tablets from white to yellow; possible formation of brown speckled spots.

Pharmacotherapeutic group
Antibacterial agents for systemic use. Combinations of penicillins with beta-lactamase inhibitors. ATX code J01C R02.

Flemoclav 500 mg/125 mg Pharmacological properties

Pharmacodynamics.

Amoxicillin is a semi-synthetic antibiotic with a broad spectrum of antibacterial activity against many gram-positive and gram-negative microorganisms. Amoxicillin is sensitive to β-lactamase and decomposes under its influence, so the spectrum of activity of amoxicillin does not include microorganisms that synthesize this enzyme. Clavulanic acid has a β-lactam structure similar to penicillins, and can also inactivate β-lactamase enzymes inherent in microorganisms that are resistant to penicillins and cephalosporins. In particular, it has a pronounced activity against clinically important plasmid β-lactamases, which are often responsible for the development of cross-resistance to antibiotics. The presence of clavulanic acid in the drug protects amoxicillin from degradation by β-lactamase enzymes and expands the spectrum of antibacterial action of amoxicillin, including many microorganisms resistant to amoxicillin and other penicillins and cephalosporins.

The microorganisms listed below are classified according to their sensitivity to amoxicillin / clavulanate in vitro.

Sensitive microorganisms

Gram-positive aerobes: Bacillus anthracis, Enterococcus faecalis, Listeria monocytogenes, Nocardia asteroids, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus viridans, other β-hemolytic species of Streptococcus, Staphylococcus aureus (metytsylinchutlyvi strains), Staphylococcus saprophyticus (metytsylinchutlyvi strains) koahulazonehatyvni staphylococci (methicillin-sensitive strains).

Indication
Treatment of bacterial infections caused by sensitive microorganisms, such as:

confirmed acute bacterial sinusitis;
acute otitis media;
confirmed exacerbation of chronic bronchitis;
community-acquired pneumonia;
cystitis;
pyelonephritis;
skin and soft tissue infections, including cellulite, animal bites, severe dentoalveolar abscesses with widespread cellulite;
bone and joint infections, including osteomyelitis.
Contraindication
Hypersensitivity to any components of the drug, to any antibacterial agents of the penicillin group.

Presence of a history of severe hypersensitivity reactions (including anaphylaxis) associated with the use of other beta-lactam antibiotics (including cephalosporins, carbapenems or monobactams).

History of jaundice or hepatic dysfunction associated with amoxicillin / clavulanate (see Adverse Reactions).