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Antiinfectives for Systemic Use

Flaprox (Tablets)
(Ciprofloxacin)



CONTENT:
Film coated tablets. Tablet contains ciprofloxacin (as hydrochloride) 250 mg, 500 mg or 750 mg.
 
PHARMACOLOGICAL PROPERTIES:
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.
 
THERAPEUTIC INDICATIONS:
- Infectious diseases caused by sensitive to the preparation microorganisms including:
- 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);
- 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).
 
CONTRAINDICATIONS:
- hypersensitivity to ciprofloxacin orotherfluoroquinolones preparations;
- children and adolescence under 18 years.
 
SIDE EFFECTS:
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 quantity reduction.
From cardio-vascular system: tachycardia, heart rhythm disorder, arterial hypotension. Allergy.
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 creatinine clearance.
 
PACKAGING:
10 tablets in blister.
1 blister with enclosed leaflet in carton box.
 
 
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