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Antiinfectives for Systemic Use

Rofloxan (Tablets)
(Ofloxacin)



CONTENT:
Film coated tablet. Tablet contains ofloxacin 200 mg.
 
PHARMACOLOGICAL PROPERTIES:
PHARMACODYNAMICS. Rofloxan - antimicrobial preparation of wide bactericidal spectrum of action from fluoroquinolones group. It inhibits DNA-hyraze, affects DNA synthesis, growth and bacteria division. Ofloxacin acts mainly on gram-negative and some gram-positive microorganisms. It is active to the microorganisms resistant to the most of antibiotics and sulfonamide preparations. Anaerobic microorganisms are resistant to the preparation (including most kind of bacteriodes, Clostridia). PHARMACOKINETICS. It is well absorbed from gastrointestinal tract (absorption - 95%). Bioavailability - more than 96%. Plasma protein binding - 25%. Maximum concentration after oral intake appears in 1 - 2 h. About 5% are metabolized in the liver. The half-life period is 4.5 - 7 h (independently of dose). It is removed from the organisms by kidneys in unchanged form in 75 - 90%, with feces - about 4%.
 
THERAPEUTIC INDICATIONS:
- respiratory infection (bronchitis, pneumonia);
- sinusitis, pharyngitis, otitis media, laryngitis, tracheitis;
- skin and soft tissue infection, bon and joints infections;
- infection-inflammatory abdominal cavity diseases (biliary and GIT infections);
- kidneys infections (pyelonephritis) and urinary tracts infections (cystitis, urethritis);
- infections of pelvic organs (endometritis, salpingitis, oophoritis, cervititis, parametritis, prostatitis) and genitals organ infection (colpitis, orchitis, epididymitis);
- gonorrhea, clamidiosis;
- meningitis;
- infection prophylaxis in patients with immunological status impairment.
 
CONTRAINDICATIONS:
- Hypersensitivity to the preparation;
- glucose-6-phosphate dehydrogenase deficiency;
- epilepsy, readiness for convulsions threshold reduction;
- under 18 years (before bones growth completion);
- pregnancy and lactation period.
 
SIDE EFFECTS:
From GIT: anorexia, nausea, vomiting, diarrhea, flatulence, abdominal pain, rise in hepatic transaminase activity, hyperbilirubinemia, cholestatic jaundice, pseudomembranous enterocolitis.
From CSN and peripheral nervous system: headache, dizziness, discoordination of movements, tremor, spasms, intensive dreams, psychotic reactions, anxiety, psychomotor agitation, phobia, depression, mental confusion, visual disturbances hallucinations, colordisturbances, diplopia, derangements of taste, smell and balance.
From musculoskeletal system: tendinitis, mlalgia, artralgia, tendoslnovlt, tendon tear. From cardio-vascular system: tachycardia, BP lowering, collapse. From blood system: leukopenia, agranulocytosis, anaemia, thrombocytopenia, pancytopenia, hemolytic and aplastic anemia.
From urinary system: acute interstitial nephritis, kidney disfunction, hypercreatininemia, hyperuricemia.
Dermatologic reactions: punctual hemorrhage, bullous hemorragic dermatitis, papulous rash,vasculitis. Allergic reactions.
Others: dysbacteriosis, superinfection, hypoglycemia (at diabetes mellitus patients), vaginitis.
 
DOSAGEAND ADMINISTRATION:
Rofloxan is administered orally without chewing before or during meal, washing down with water.
The doses are selected individually against localization and severity of infectious, and
also microorganism sensitivity, general state of patient and function of liver and kidney.
For adults: 200 - 400 mg 2 times a day. Treatment course: 7-10 days. The dose up to 400
mg a day can be administered in one application, preferably in the morning. Daily dose:
200-800 mg. For gonorrhoea: 400 mg single dose.
In patients with disorder of kidney functions dose should be corrected.
The duration of treatment course is determined by sensitivity of causative agent and
clinical picture. The treatment should be continued still minimum 3 days after
disappearance of disease symptoms and temperature normalization.
 
PACKAGING:
5 tablets in blister.
2 blisters in carton box with enclosed leaflet.
 
 
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