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Rofloxin 500mg Tablets

Indications :-

Adults :

Uncomplicated and complicated infections caused by ciprofloxacin sensitive pathogens:

  • Infections of the lower respiratory tract.
  • In the treatment of outpatients with pneumonia due to Pneumococcus, ciprofloxacin should not be used as a drug of first choice. Ciprofloxacin can be regarded as a suitable treatment for pneumonias caused by Klebsiella, Enterobacter, Proteus, E. coli, Pseudomonas, Haemophilus, Branhamella, Legionella, and Staphylococcus.
  • Infections of the kidneys and/or the efferent urinary tract.
  • Infections of the genital organs, including adnexitis, gonorrhoea, prostatitis.
  • Infections of the abdominal cavity (e.g. infections of the gastrointestinal tract or of the biliary tract, peritonitis).
  • Infections of the skin and soft tissue.
  • Infections of the bones and joints.
  • Sepsis.
  • Inhalational anthrax (post-exposure): To reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. Ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication.


According to in-vitro investigations, the following pathogens can be regarded as sensitive:


E. coli, Shigella, Salmonella, Citrobacter, Klebsiella, Enterobacter, Serratia, Hafnia, Edwardsiella, Proteus (indole-positive and indole-negative), Providencia, Morganella, Yersinia; Vibrio, Aeromonas, Plesiomonas, Pasteurella, Haemophilus, Campylobacter, Pseudomonas, Legionella, Neisseria, Moraxella, Acinetobacter, Brucella; Staphylococcus, Listeria, Corynebacterium, Chlamydia.


The following show varying degrees of sensitivity:


Gardnerella, Flavobacterium, Alcaligenes, Streptococcus agalactiae, Enterococcus faecalis, Streptococcus pyogenes, Streptococcus pneumoniae, Viridans group Streptococci, Mycoplasma hominis, Mycobacterium tuberculosis, and Mycobacterium fortuitum.


The following are usually resistant:

 

  • Enterococcus faecium, Ureaplasma urealyticum, Nocardia asteroides.
  • With a few exceptions anaerobes are moderately sensitive e.g. Peptococcus, Peptostreptococcus to resistant e.g. Bacteroides.
  • Ciprofloxacin has been shown to be active against Bacillus anthracis both in vitro and by use of serum levels as a surrogate marker.
  • Ciprofloxacin is ineffective against Treponema pallidum.

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Children :

Cystic fibrosis
For the treatment of acute pulmonary exacerbation of cystic fibrosis associated with P. aeruginosa infection in paediatric patients aged 5-17 years.


Inhalational anthrax (post-exposure)
For the indication of inhalational anthrax (post-exposure


Complicated urinary tract infections and pyelonephritis
For complicated urinary tract infections or pyelonephritis due to E.coli in paediatric patients aged 1-17 years. 


The risk-benefit assessment indicates that administration of ciprofloxacin to paediatric patients is appropriate. Treatment should only be initiated after careful benefit/risk evaluation, due to possible adverse events related to joints/surrounding tissues. The use of ciprofloxacin for other indications is not recommended in children.