ROCIPRO Caplet

For the treatment of infections caused by susceptible microorganisms in conditions:

- Urinary tract infections including prostatitis.

- Urethral and cervical gonorrhea.

- Gastrointestinal tract infections, including typhoid and paratyphoid fever.

- Respiratory tract infections, except pneumoniae caused by streptococcus.

- Skin and soft tissues infections.

- Bone and joint infections.

DOSAGE AND ADMINISTRATIONS

The recommended doses are:

- Mild to moderate urinary tract infections: 250m 2 times a day.

- Severe urinary tract infections: 500mg 2 times a day.

- Mild to moderate respiratory tract infections, bone and joint infections, skin and soft tissues infections: 750mg 2 times a day.

- Gastrointestinal tract infections: 500mg 2 times a day.

- Acute gonorrhea: 250mg as single dose.

- To achieve adequate concentration in acute osteomyelitis, the dosage should not be less than: 2750mg/daily.

Doge for impaired renal function

See the package insert about the details.

- Patients with hypersensitivity to Ciprofloxacin or any member of the quinolone derivatives.

- Woman in pregnancy and breast-feeding.

- Children and adolescents.

Generally, it is rare event of adverse reaction while taking ROCIPRO, but sometime may occurred such as:

- Adverse reactions on gastrointestinal tract (nausea, diarrhea, gastrointestinal disorders, dyspepsia, abdominal pain and meteorismus).

- Adverse reactions on central nervous system (dizziness, headache, tiredness, sometimes visual disturbances).

- Skin reactions.

- Temporary increase in liver enzyme level, especially in patients with impaired liver function.

- Gastrointestinal tract: in the event of severe or persistent diarrhea during or after treatment, a doctor should be informed since this symptom may hide a serious intestinal disease (e.g. pseudomembranous colitis) requiring immediate treatment. If this event occurs, ROCIPRO should be discontinues and appropriate therapy initiated (e.g. vancomycin, orally 4250mg a day). Meanwhile drugs that inhibit peristaltic activity are contraindicated.

- Adverse reactions on renal: renal failure, interstitial nephritis, urinary retention, urethral bleeding, vaginitis and acidosis.

- Adverse reactions on hematologic: eosinophilia, leukocytopenia and leucocytosis anemia.

- Others: mild photosensitivity, tinnitus, fatigue, myalgia, tendovaginitis, hearing loss (especially to high frequency), palpitations and tachycardia.

- The absorption of ROCIPRO is affected by antacid e.g. aluminum or magnesium hydroxide. Consequently, do not be administered concomitantly. ROCIPRO should be taken either 1-2 hours before or after taking antacids.

- If ROCIPRO (over 1500mg daily) is administered concurrently with theophylline, it may cause an increase in the theophylline serum concentrations. If concurrent use of the drugs is unavoidable, the theophylline serum concentrations should be monitored and the theophylline dose should be appropriately reduced.

- It should be taken carefully the possibility of interaction if Ciprofloxacin is administered simultaneously with probenecid, clindamycin and metronidazole.

- Concurrent administration with anticoagulant may prolong bleeding time.

Contraindicated.

- In patients who have suffered from cerebral disorders, ROCIPRO should only be used if the patients have gained appropriate treatment of anticonvulsant.

- Ciprofloxacin should be given carefully to patients with impairment of renal function.

- Do not administer over the recommended dosage.

- Even when the drug is taken exactly as prescribed, it may affect the ability to drive or to operate machinery. This reaction is potentiated particularly in combination with alcohol.

- Such other antimicroorganisms, long-term administrations of ciprofloxacin can induce overgrowth of non-susceptible microorganisms.

- It is necessary to monitor liver and renal function, and hematopoietic periodically if Ciprofloxacin is administered in long-term.

- Ciprofloxacin should be swallowed with adequate water to prevent crystalluria.

- Ciprofloxacin should be given carefully to patients with past history of gastrointestinal disorder especially colitis.

- Safety and effectiveness in teenage below 18 years old have not established yet.

- Excessive sunlight should be avoided. Therapy should be discontinued if photosensitivity occurs.

In vitro studied have shown that antibacterial mechanism of Ciprofloxacin based on the inhibition of bacterial gyrase. Beside, due to its specific mechanism of action, Ciprofloxacin have not shown parallel resistant to others antibiotic excluded quinolin carboxylate derivatives. Thus, Ciprofloxacin is very effective to bacteria that resistant to others antibiotics such as : aminoglycoside, penicillins, cephalosporins and tetracyclins.

Ciprofloxacin is a broad-spectrum antibacterial which effective against gram positive and negative bacteria as listed follow:

- Gram positive bacteria: Enterococcus faecalis, Staphylococcus spp., Streptococcus pyogenes.

- Gram negative bacteria: Campylobacter jejuni, Citrobacter diversus, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Morganella morganii, Neisseria gonorrhoeae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Pseudomonas aeruginosa, Salmonella typhi, Serratia marcescens, Shigella flexneri, Shigella sonnei.

CLINICAL PHARMACOLOGY

Absolute bioavailability of Ciprofloxacin is approximate to 70-80%. The maximum serum concentrations are attained 60-90 minutes after oral administration. The concentrations level of Ciprofloxacin at infected side e.g. body fluid and tissue higher than at serum. ROCIPRO is adequately administered twice daily in the morning and evening.