1 INDICATIONS AND USAGE
Ciprofloxacin Injection is a fluoroquinolone antibacterial indicated in adults (18 years of age) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated:
Skin and Skin Structure Infections (1.1)
Bone and Joint Infections (1.2)
Complicated Intra-Abdominal Infections (1.3)
Nosocomial Pneumonia (1.4)
Empirical Therapy for Febrile Neutropenic Patients (1.5)
Inhalational Anthrax Post-Exposure in Adult and Pediatric Patients (1.6)
Plague in Adult and Pediatric Patients (1.7)
Chronic Bacterial Prostatitis (1.8)
Lower Respiratory Tract Infections (1.9)
Acute Exacerbation of Chronic Bronchitis
Urinary Tract Infections (1.10)
Urinary Tract Infections (UTI)
Complicated UTI and Pyelonephritis in Pediatric Patients
Acute Sinusitis (1.11)
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin Injection and other antibacterial drugs, Ciprofloxacin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.12)
1.1 Skin and Skin Structure Infections
Ciprofloxacin Injection (in 5% Dextrose Injection) is indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes.
1.2 Bone and Joint Infections
Ciprofloxacin Injection is indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.
1.3 Complicated Intra-Abdominal Infections
Ciprofloxacin Injection is indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.
1.4 Nosocomial Pneumonia
Ciprofloxacin Injection is indicated in adult patients for treatment of nosocomial pneumonia caused by Haemophilus influenzae or Klebsiella pneumoniae.
1.5 Empirical Therapy for Febrile Neutropenic Patients
Ciprofloxacin Injection is indicated in adult patients for the treatment of febrile neutropenia in combination with piperacillin sodium [see Clinical Studies (14.1)].
1.6 Inhalational Anthrax (Post-Exposure)
Ciprofloxacin Injection is indicated in adults and pediatric patients from birth to 17 years of age for treatment of inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.
Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.1 Supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001 [see Clinical Studies (14.3)].
1.7 Plague
Ciprofloxacin Injection is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. Efficacy studies of ciprofloxacin could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only [see Clinical Studies (14.4)].
1.8 Chronic Bacterial Prostatitis
Ciprofloxacin Injection is indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis.
1.9 Lower Respiratory Tract Infections
Ciprofloxacin Injection is indicated in adult patients for treatment of lower respiratory tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter
cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or Streptococcus pneumoniae. Ciprofloxacin Injection is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumonia.
Ciprofloxacin Injection is indicated for the treatment of acute exacerbations of chronic bronchitis (AECB) caused by Moraxella catarrhalis.
Because fluoroquinolones, including Ciprofloxacin Injection, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 to 5.16)] and for some patients AECB is self-limiting, reserve Ciprofloxacin Injection for treatment of AECB in patients who have no alternative treatment options.
1.10 Urinary Tract Infections
Urinary Tract Infection in Adults
Ciprofloxacin Injection is indicated in adult patients for treatment of urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter
cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis.
Complicated Urinary Tract Infections and Pyelonephritis in Pediatric Patients Ciprofloxacin Injection is indicated in pediatric patients one to 17 years of age for treatment of complicated urinary tract infections (cUTI) and pyelonephritis due to Escherichia coli [see Use in Specific Populations (8.4)].
Although effective in clinical trials, Ciprofloxacin Injection is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls, including reactions related to joints and/or surrounding tissues. Ciprofloxacin Injection, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals [see Warnings and Precautions (5.13), Adverse Reactions (6.1), Use in Specific Populations (8.4), and Nonclinical Toxicology (13.2)].
1.11 Acute Sinusitis
Ciprofloxacin Injection is indicated in adult patients for treatment of acute sinusitis caused by Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis.
Because fluoroquinolones, including Ciprofloxacin Injection, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 to 5.16)] and for some patients acute sinusitis is self-limiting, reserve Ciprofloxacin for treatment of acute sinusitis in patients who have no alternative treatment options.
1.12 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin Injection and other antibacterial drugs, Ciprofloxacin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. 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 Injection may be initiated before results of these tests are known; once results become available appropriate therapy should be continued.
As with other drugs, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ciprofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.