Ciprofloxacin (Page 2 of 13)

1.11 Urinary Tract Infections

Urinary Tract Infections in Adults

Ciprofloxacin 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.

Acute Uncomplicated Cystitis

Ciprofloxacin is indicated in adult female patients for treatment of acute uncomplicated cystitis caused by Escherichia coli or Staphylococcus saprophyticus.

Because fluoroquinolones, including Ciprofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions ( 5.1– 5.15)] and for some patients acute uncomplicated cystitis is self-limiting, reserve Ciprofloxacin for treatment of acute uncomplicated cystitis in patients who have no alternative treatment options.

Complicated Urinary Tract Infection and Pyelonephritis in Pediatric Patients

Ciprofloxacin is indicated in pediatric patients aged 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 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, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals [see Warnings and Precautions ( 5.12), Adverse Reactions ( 6.1), Use in Specific Populations ( 8.4) and Nonclinical Toxicology ( 13.2)].

1.12 Acute Sinusitis

​ Ciprofloxacin is indicated in adult patients for treatment of acute sinusitis caused by or Ciprofloxacin is indicated in adult patients for treatment of acute sinusitis caused by Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis.

​ Because fluoroquinolones, including Ciprofloxacin, have been associated with serious adverse reactions and for some patients acute sinusitis is self-limiting, reserve Ciprofloxacin for treatment of acute sinusitis in patients who have no alternative treatment options. Because fluoroquinolones, including Ciprofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions ( 5.1– 5.15)] and for some patients acute sinusitis is self-limiting, reserve Ciprofloxacin for treatment of acute sinusitis in patients who have no alternative treatment options.

1.13 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin and other antibacterial drugs, Ciprofloxacin 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 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.

2 DOSAGE AND ADMINISTRATION

Ciprofloxacin Tablets should be administered orally as described in the appropriate Dosage Guidelines tables.

2.1 Dosage in Adults

​ The determination of dosage and duration for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function. The determination of dosage and duration for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function.

Table 1: Adult Dosage Guidelines

​ 1. Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure). 1. Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
​ 2. Used in conjunction with metronidazole. 2. Used in conjunction with metronidazole.
​ 3. Begin drug administration as soon as possible after suspected or confirmed exposure. 3. Begin drug administration as soon as possible after suspected or confirmed exposure.
Infection	Dose	Frequency	Usual Durations 1
Skin and Skin Structure	500–750 mg	every 12 hours	7 to 14 days
Bone and Joint	500–750 mg	every 12 hours	4 to 8 weeks
Complicated Intra–Abdominal 2	500 mg	every 12 hours	7 to 14 days
Infectious Diarrhea	500 mg	every 12 hours	5 to 7 days
Typhoid Fever	500 mg	every 12 hours	10 days
Uncomplicated Urethral and Cervical Gonococcal Infections	250 mg	single dose	single dose
Inhalational anthrax (post-exposure) 3	500 mg	every 12 hours	60 days
Plague 3	500–750 mg	every 12 hours	14 days
Chronic Bacterial Prostatitis	500 mg	every 12 hours	28 days
Lower Respiratory Tract Infections	500–750 mg	every 12 hours	7 to 14 days
Urinary Tract Infections	250–500 mg	every 12 hours	7 to 14 days
Acute Uncomplicated Cystitis	250 mg	every 12 hours	3 days
Acute Sinusitis	500 mg	every 12 hours	10 days

Conversion of IV to Oral Dosing in Adults

Patients whose therapy is started with Ciprofloxacin IV may be switched to Ciprofloxacin Tablets or Oral Suspension when clinically indicated at the discretion of the physician ( Table 2) [see Clinical Pharmacology ( 12.3)].

Table 2: Equivalent AUC Dosing Regimens

Ciprofloxacin Oral Dosage	Equivalent Ciprofloxacin IV Dosage
250 mg Tablet every 12 hours	200 mg intravenous every 12 hours
500 mg Tablet every 12 hours	400 mg intravenous every 12 hours
750 mg Tablet every 12 hours	400 mg intravenous every 8 hours