1 INDICATIONS AND USAGE
Ciprofloxacin Tablets, USP are indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below.
Ciprofloxacin Tablets, USP are a fluoroquinolone antibacterial indicated in adults (18 years of age) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated.
Urinary tract infections (
1.1) and Acute uncomplicated cystitis (
1.2)
Chronic bacterial prostatitis (
1.3)
Lower respiratory tract infections (
1.4)
Acute sinusitis (
1.5)
Skin and skin structure infections (
1.6)
Bone and joint infections (
1.7)
Complicated intra-abdominal infections (
1.8)
Infectious diarrhea (
1.9)
Typhoid fever (enteric fever) (
1.10)
Uncomplicated cervical and urethral gonorrhea (
1.11)
Complicated urinary tract infections and pyelonephritis in pediatricpatients (
1.12)
Inhalational anthrax post exposure in adult and pediatric patients (
1.13)
Plague in adult and pediatric patients (
1.14)
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 bacteria. (
1.16)
1.1 Urinary Tract Infections
Ciprofloxacin Tablets, USP are 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.
1.2 Acute Uncomplicated Cystitis
Ciprofloxacin Tablets, USP are indicated in adult female patients for treatment of acute uncomplicated cystitis caused by
Escherichia coli or
Staphylococcus saprophyticus.
1.3 Chronic Bacterial Prostatitis
Ciprofloxacin Tablets, USP are indicated in adult patients for treatment of chronic bacterial prostatitis caused by
Escherichia coli or
Proteus mirabilis.
1.4 Lower Respiratory Tract Infections
Ciprofloxacin Tablets, USP are 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. Also, Ciprofloxacin Tablets, USP are indicated for the treatment of acute exacerbations of chronic bronchitis caused by
Moraxella catarrhalis [see Indications and Usage (
1.15
)].
1.5 Acute Sinusitis
Ciprofloxacin Tablets, USP are indicated in adult patients for treatment of acute sinusitis caused by
Haemophilus influenzae, Streptococcus pneumoniae, or
Moraxella catarrhalis.
1.6 Skin and Skin Structure Infections
Ciprofloxacin Tablets, USP are 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, methicillinsusceptible
Staphylococcus aureus, methicillin-susceptible
Staphylococcus epidermidis, or
Streptococcus pyogenes.
1.7 Bone and Joint Infections
Ciprofloxacin Tablets, USP are indicated in adult patients for treatment of bone and joint infections caused by
Enterobacter cloacae, Serratia marcescens, or
Pseudomonas aeruginosa.
1.8 Complicated Intra-Abdominal Infections
Ciprofloxacin Tablets, USP are 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..
1.9 Infectious Diarrhea
Ciprofloxacin Tablets, USP are indicated in adult patients for treatment of infectious diarrhea caused by
Escheri
chia
coli (enterotoxigenic isolates),
Campylobacter jejuni,
Shigella boydii
,
Shigella dysenteriae,
Shigella flexneri or
Shigella sonnei
when antibacterial therapy is indicated.
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.
1.10 Typhoid Fever (Enteric Fever)
Ciprofloxacin Tablets, USP are indicated in adult patients for treatment of typhoid fever (enteric fever
) caused by
Salmonella
typhi. The efficacy of ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated.
1.11 Uncomplicated Cervical and Urethral Gonorrhea
Ciprofloxacin Tablets, USP are indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to
Neisseria gonorrhoeae [see Warnings and Precautions (
5.16
)].
1.12 Complicated Urinary Tract Infections and Pyelonephritis
Ciprofloxacin Tablets, USP are 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 Indications and Usage (
1.15
) and Use in Specific Populations (
8.4
)].
1.13 Inhalational Anthrax (post-exposure)
Ciprofloxacin Tablets, USPare indicated in adults and pediatric patients from birth to 17 years of age for 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 Clinical Studies (
14.2
).]
1.14 Plague
Ciprofloxacin Tablets, USPare 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 (
14.3
)].
1.15 Limitation of Use
Use in Pediatric Patients
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
. Ciprofloxacin Tablets, USP, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals
[see Warnings and Precautions (
5.11
), Adverse Reactions (
6.1
), Use in Specific Populations (
8.4
) Nonclinical Toxicology (
13.2
)].
Lower Respiratory Tract Infections
Ciprofloxacin Tablets, USPare not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to
Streptococcus pneumoniae [see Indications and Usage (
1.4
)].
1.16 Usage
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.
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 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.