Flaprox (ciprofloxacin) coated tablets 500 mg. №10

Description

Flaprox Storage
active substance: ciprofloxacin;

1 tablet contains 500 mg of ciprofloxacin (in the form of ciprofloxacin hydrochloride monohydrate);

excipients: microcrystalline cellulose, corn starch, crospovidone, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate;

film coating: Opadry white (hypromellose, polyethylene glycol, titanium dioxide (E 171)).

Flaprox Dosage form
Film-coated tablets.

Main physical and chemical properties: white round biconvex tablets, film-coated with a line on one side.

Flaprox Pharmacotherapeutic group
Antibacterial agents for systemic use. Group of fluoroquinolones. ATX code J01M A02.

Pharmacological properties

Pharmacodynamics.

Mechanism of action.

The bactericidal action of ciprofloxacin as a fluoroquinolone antibacterial agent is due to its ability to inhibit type II topoisomerases (DNA gyrase and topoisomerase IV), which are required in many DNA life cycle processes, such as replication, transcription, repair and recombination.

Pharmacokinetic / pharmacodynamic relationships.

Efficacy mainly depends on the ratio between the maximum serum concentration (Cmax) and the minimum inhibitory concentration (MIC) of ciprofloxacin for the bacterial pathogen and the value of the area under the curve (AUC) and MIC.

Mechanism of resistance.

In vitro resistance to ciprofloxacin is usually associated with target site mutations that occur in topoisomerase IV and DNA gyrase by multistage mutations. The degree of cross-resistance between ciprofloxacin and other fluoroquinolones, which is a consequence of the above, varies. Single mutations do not usually lead to clinical resistance, but multiple mutations usually cause clinical resistance to several or all members of the fluoroquinolone class.

Indication
The drug is indicated for the treatment of the following infections (see sections “Features of use” and “Pharmacological properties”).

Prior to initiating therapy, special attention should be paid to all available information on ciprofloxacin resistance.

Official recommendations for the proper use of antibacterial drugs should be taken into account.

Adults.

Lower respiratory tract infections caused by gram-negative bacteria:
exacerbation of chronic obstructive pulmonary disease *;
bronchopulmonary infections in cystic fibrosis or bronchiectasis;
community-acquired pneumonia.
Chronic purulent otitis media.
Exacerbation of chronic sinusitis, especially if it is caused by gram-negative bacteria *.
Urinary tract infections:
uncomplicated acute cystitis *;
acute pyelonephritis;
complicated urinary tract infections;
bacterial prostatitis.
Genital infections:
gonococcal urethritis and cervicitis caused by sensitive strains of Neisseria gonorrhoeae;
orchoepididymitis, in particular caused by susceptible strains of Neisseria gonorrhoeae;
inflammatory diseases of the pelvic organs, in particular caused by sensitive strains of Neisseria gonorrhoeae.
Digestive tract infections (such as traveler’s diarrhea).
Intra-abdominal infections.
Skin and soft tissue infections caused by gram-negative bacteria.
Severe otitis externa.
Bone and joint infections.
Prevention of invasive infections caused by Neisseria meningitidis.
Pulmonary form of anthrax (prevention after contact and radical treatment).