ალიმენტური ტრაქტი და მეტაბოლიზმი
სისტემური გამოყენების ინფექციის საწინააღმდეგო
სისხლი და სისხლ-წარმომქმნელი ორგანოები
სამომავლოდ დაგეგმილი პროდუქტები
Antiinfectives for Systemic Use
Film coated tablets. Tablet contains ciprofloxacin (as hydrochloride) 250 mg,
500 mg or 750 mg.
PHARMACODYNAMICS. Flaprox- is a broad spectrum antimicrobial preparation from
fluoroquinolone. It inhibits bacterial DNAgyrase, what leads to blocking of
replication of DNAand synthesis of proteins. It acts as bactericidal agent both
in relation to the growing microorganisms and microorganism in resting phase. It
is active in relation to gram- negative and gram-positive bacteria. The
development of parallel resistance to other antibiotics (not belonging to gyrase
inhibitors) doesn't happen at the application of Flaprox. It makes the
preparation highly efficient in relation to bacteria resistant to other
antibiotics. PHARMACOKINETICS. After the intake of the preparation,
ciprofloxacin is quickly absorbed from gastro-intestinal tract. The
bioavailability of the preparation makes 50-85%. The plasma protein binding -
30%. It penetrates through the placental barrier. It eliminates predominantly
via urine. The elimination half-life is about 3-5 hours.
- Infectious diseases caused by sensitive to the preparation microorganisms
- infections of respiratory tract;
- infections of ear, throat and nose;
- infections of kidneys and urinary tract;
- infections of genital organs (gonorrhea, prostatitis, adnexitis, postnatal
- infections of oral cavity and digestive system (including teeth, jaw), gall-bladder
and biliary tracts;
- infections of skin, mucous membranes and soft tissues;
- infections of muscosceletal system;
- sepsis, peritonitis;
- meningitis, caused by gram-negative microflora;
- tuberculosis (in combination therapy at drug resistant tuberculosis);
- prophylaxis and infections treatment at patients with low immunity (against a
background of treatment by immunosuppressive agents).
- hypersensitivity to ciprofloxacin orotherfluoroquinolones preparations;
- children and adolescence under 18 years.
From the digestive system: nausea, vomiting, diarrhea, abdominal pain, appetite
lowering, pseudomembranous colitis.
From central nervous system: dizziness, headache, feeling of tiredness,
somnolence, nightmares, hallucinations, syncope, and impairment of vision. From
urinary system: crystalluria, interstitial glomerulonephritis, disuria, poliuria,
albuminuria, hematuria, transitory increase of creatinine serum in blood.
From heamopoietic system: eosinophilia, leucopenia, neutropenia, trombocites
From cardio-vascular system: tachycardia, heart rhythm disorder, arterial
Others: arthralgia; rare - photosensibilisation.
DOSAGE AND ADMINISTRATION:
Flaprox is taken on an empty stomach, washing down with enough quantity of water.
The dosage regimen is selected individually according to the localization and
infection severity, the state of organism, age, body weight, kidney function of
the patients. At noncomplicated kidney and urinary tracts infections preparation
is prescribed in dose 250 mg 2 times/day, at complicated - 500 mg 2 times/day.
At urinary tracts infections caused by Chlamydia, if necessary, a daily dose of
Flaprox is increased up to 750 mg 2 times/day.
At lower respiratory diseases - 250 mg 2 times/day, in severe cases - 500 mg 2
times/day. At gonorrhea it is prescribed as a single dose of250-500 mg.
At enteritis, colitis, gynecological infections, prostatitis, osteomelitis - 500
mg 2 times/day. For diarrhea treatment - 250 mg 2 times/day.
At very severe life threatening infections (streptococcus pneumonia, recurrent
infections at cystic fibrosis, bones and joints, septicemia, peritonitis) - 750
mg 2 times/day. Time duration of therapy depends on the disease severity.
At chronic kidney dysfunction the preparation is prescribed depending on the
10 tablets in blister.
1 blister with enclosed leaflet in carton box.