INDICATIONS AND USAGE
Ciprofloxacin tablets, USP are indicated for the treatment of
infections caused by susceptible strains of the designated microorganisms in the
conditions and patient populations listed below. Please see
DOSAGE AND ADMINISTRATION
for specific
recommendations.
Adult Patients:
Urinary Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae,
Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella
morganii, Citrobacter diversus, Citrobacter freundii, Pseudomonas
aeruginosa, methicillin-susceptible Staphylococcus
epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis.
Acute Uncomplicated Cystitis in females caused by
Escherichia coli or Staphylococcus saprophyticus.
Chronic Bacterial Prostatitis caused by Escherichia coli or Proteus
mirabilis.
Lower Respiratory Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae,
Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus
parainfluenzae, or penicillin-susceptible Streptococcus pneumoniae. Also, Moraxella catarrhalis for the treatment of acute
exacerbations of chronic bronchitis.
NOTE: Although effective in clinical trials, ciprofloxacin is not a drug of
first choice in the treatment of presumed or confirmed pneumonia secondary to
Streptococcus pneumoniae.
Acute Sinusitis caused by Haemophilus influenzae, penicillin-susceptible Streptococcus pneumoniae, or Moraxella
catarrhalis.
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.
Bone and Joint Infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.
Complicated Intra-Abdominal Infections (used in
combination with metronidazole) caused by Escherichia coli,
Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or
Bacteroides fragilis.
Infectious Diarrhea caused by Escherichia coli (enterotoxigenic strains), Campylobacter jejuni, Shigella boydii
,
Shigella
dysenteriae, Shigella flexneri or Shigella
sonnei
when antibacterial therapy is
indicated.
Typhoid Fever (Enteric Fever) caused by Salmonella typhi.
NOTE: The efficacy of ciprofloxacin in the eradication of the chronic typhoid
carrier state has not been demonstrated.
Uncomplicated cervical and urethral gonorrhea due to
Neisseria gonorrhoeae.
Pediatric patients (1 to 17 years of age):
Complicated Urinary Tract Infections and
Pyelonephritis due to Escherichia coli.
NOTE: Although effective in clinical trials, ciprofloxacin is not a drug of
first choice in the pediatric population due to an increased incidence of
adverse events compared to controls, including events related to joints and/or
surrounding tissues. (See
WARNINGS,
PRECAUTIONS, Pediatric Use,
ADVERSE
REACTIONS
and
CLINICAL
STUDIES
.) Ciprofloxacin, like other fluoroquinolones, is associated
with arthropathy and histopathological changes in weight-bearing joints of
juvenile animals. (See
ANIMAL
PHARMACOLOGY
.)
Adult and Pediatric Patients:
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.5 Supportive
clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was
obtained during the anthrax bioterror attacks of October 2001. (See also,
INHALATIONAL ANTHRAX
ADDITIONAL
INFORMATION)).
Although treatment of infections due to this organism
in this organ system demonstrated a clinically significant outcome, efficacy was
studied in fewer than 10 patients.
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 tablets, USP may be initiated
before results of these tests are known; once results become available
appropriate therapy should be continued. As with other drugs, some strains 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.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of ciprofloxacin tablets, USP and other antibacterial drugs,
ciprofloxacin tablets, USP 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.