Floxium (levofloxacin) coated tablets 0.5 g. №10

Description

Floxium №10 Storage
active substance: levofloxacin;

1 tablet contains levofloxacin hemihydrate in terms of levofloxacin – 500 mg;

Excipients: crospovidone (polyplasdon XL), microcrystalline cellulose, potato starch, talc, hypromellose (hydroxypropylmethylcellulose), sodium lauryl sulfate, sodium starch glycolate (type A), calcium stearate, mixture for coating50 “Yellow22; ; lactose, monohydrate; titanium dioxide (E 171); polyethylene glycol; iron oxide yellow (E 172)).

Floxium №10 Dosage form
Film-coated tablets.

Main physical and chemical properties: tablets, film-coated creamy yellow, oval with a biconvex surface, with a line on one side of the tablet and embossed “KMP” on the other side. The yellowish nucleus is visible in the cross section.

Floxium №10 Pharmacotherapeutic group
Antibacterial agents of the quinolone group. Fluoroquinolones.

ATX code J01M A12.

Pharmacological properties

Pharmacodynamics.

Levofloxacin is characterized by a broad spectrum of antibacterial action. The bactericidal effect is provided by the inhibition by levofloxacin of the bacterial enzyme DNA gyrase, which belongs to type II topoisomerases. The result of such suppression is the impossibility of the transition of bacterial DNA from a state of relaxation to an over-twisted state, which, in turn, makes it impossible to further divide (multiply) bacterial cells. The spectrum of activity of the drug Floxium® includes gram-positive, gram-negative bacteria together with non-fermenting bacteria.

Usually sensitive species

Gram-positive aerobes: Bacillus anthracis, Staphylococcus aureus methicillin, Staphylococcus saprophyticus Streptococci, group C and G, Streptococcus agalactiae, Streptococcus pneumonia, Streptococcus pyogenes.

Gram-negative aerobes: Eikenella corrodens, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella oxytoca, Moraxella catarrhalis, Pasteurella multocida, Proteus vulgaris, Providencia rettgeri.

Anaerobes: Peptostreptococcus.

Others: Chlamydophila pneumonia, Chlamydophila psittaci, Chlamydia trachomatis, Legionella pneumophila, Mycoplasma pneumonia, Mycoplasma hominis, Ureaplasma urealyticum.

Indication
Floxium® is indicated for the treatment in adults of infections caused by levofloxacin-sensitive microorganisms:

acute bacterial sinusitis;
exacerbation of chronic obstructive pulmonary disease, including bronchitis;
community-acquired pneumonia;
uncomplicated cystitis;
complicated skin and soft tissue infections.
In the treatment of the above infections, the drug is used only when the use of other antibacterial agents, which are usually prescribed for the initial treatment of these infections, is not possible;

complicated urinary tract infections (including acute pyelonephritis);
chronic bacterial prostatitis;
pulmonary form of anthrax: post-exposure prophylaxis and treatment.
Floxium® in this dosage form (tablets) can be used to complete the course of therapy in patients who have shown improvement during the initial treatment with Floxium®, solution for infusion.

Formal recommendations for the proper use of antibacterial agents should be considered.

Contraindication
Hypersensitivity to levofloxacin, to other fluoroquinolones or to any component of the drug.

Epilepsy.

Tendon damage associated with previous use of fluoroquinolones.

Children’s age.

Pregnancy and breastfeeding.