CIPROFLOXACIN DEMOGEN (Demogen Australia Pty Ltd trading as DEMOGEN Pharmaceuticals)
CIPROFLOXACIN DEMOGEN Injection for Intravenous Infusion is indicated for use in the following:
- Hospitalised adult patients in whom oral ciprofloxacin is indicated but cannot be administered or where the oral form is inappropriate.
- For the treatment of serious or life threatening infections due to sensitive organisms involving the following organ systems:
- Lower respiratory tract infections (gram‐negative organisms)
- Skin and skin structure
- Septicaemia
- Bone and joint
- Urinary tract
- 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.
Note: Because gram‐positive organisms are generally less sensitive to ciprofloxacin, it may not be the drug of choice in cases with gram‐positive infections due to Streptococcus pneumoniae.
If anaerobic organisms are suspected of contributing to the infection, use of other suitable drugs should be considered.
Strains of Neisseria gonorrhoea resistant to ciprofloxacin have been reported in Australia. Therefore, ciprofloxacin injection is used for the treatment of infections of the genital tract only after the exclusion of resistant Neisseria gonorrhoeae.
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with ciprofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.
Ciprofloxacin is suitable to treat mixed infections caused by susceptible strains of both gram‐negative and gram‐positive aerobic bacteria. If anaerobic organisms are suspected as accompanying aetiologic agents, additional therapy should be considered.
Ciprofloxacin should not be used as first-line therapy for uncomplicated infections.